00284-03 bpfk adment - npra.gov.my · status ms iso 9002 di mana ini membawa maksud semua prosedur...

JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚

DATE: 11-02-03

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KANDUNGANCONTENTS

MukasuratPage

Kata-kata AluanForeword 1

Struktur OrganisasiOrganizational Structure 3

Carta OrganisasiOrganizational Chart 4

Senarai JawatanList of Posts 5

Falsafah OrganisasiOrganizational Philosophy 6

Piagam PelangganClient’s Charter 7

Ringkasan Aktiviti BPFKSummary of NPCB Activities 10

Laporan BahagianDivisional Reports 15

Kursus / SeminarCourses / Seminars 57

L a p o r a n T a h u n a n 2 0 0 1A n n u a l R e p o r t 2 0 0 1

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1L a p o r a n T a h u n a n 2 0 0 1A n n u a l R e p o r t 2 0 0 1

BPFK adalah badan eksekutif yang bertindakselaku sekretariat kepada PBKD. Sudah melebihi20 tahun institusi ini ditubuhkan. Peranannyaadalah untuk memastikan semua keluaran yangberada di pasaran adalah berkualiti, selamatdan berkesan. Jika diteliti tanggungjawab iniamatlah besar untuk dipikul.Walaubagaimanapun, dengan dianggotai oleh60 pegawai farmasi, 68 pembantu farmasi, 18orang pembantu tadbir, BPFK telah berjayamelaksanakan amanah yang diberi. Hal iniadalah berkat kegigihan kakitangan BPFK yangtelah bertungkus lumus melaksanakan tugasmasing-masing. Syabas diucapkan.

Kerjasama antara BPFK dengan pihak industrijuga telah menghasilkan sinergi yang optimum.BPFK sentiasa bersikap terbuka dengansebarang teguran. Permasalahan pihak industrisentiasa diberi perhatian. Komunikasi dua halasering dipraktikkan. Lebih- lebih lagi melalui sesidialog di antara industri dan BPFK. Sesi dialogini diadakan dua kali setahun. Pihak industriakan mengemukakan sebarang masalah yangtimbul dan BPFK akan memberi maklumbalassecara terus. Selain daripada itu jawatankuasateknikal [TWG] juga diwujudkan untukmenyelesaikan sesuatu isu yang khas. Apabilaisu tersebut selesai, jawatankuasa ini akandibubarkan.

Selaras dengan pembangunan negara Malaysiayang maju dan berteknologi tinggi ke arahnegara IT, BPFK turut seiring dengan arusperubahan tersebut. BPFK telah mewujudkan

The National Pharmaceutical Control Bureau(NPCB) is an executive body which acts as thesecretariat to the Drug Control Authority (DCA).This institution has been established for over 20years. Our core function is to ensure that allproducts in the market are of quality, efficaciousand safe. And of course with power comes hugeresponsibility. Nevertheless, with a group ofdedicated workforce comprising of 60pharmacists, 68 assistant pharmacists and 18administrative staff, NPCB has succeeded inaccomplishing the task bestowed upon her. Thisoutstanding success can only be achieved due tothe hard work, perseverance, sheer dedicationand commitment of our beloved staff.Congratulations to all!

The co-operation between NPCB and theindustrial sector has been overwhelming,resulting in an optimal synergy. While vigorouslypursuing our goal, we have never neglected theproblems faced by the industry. A two-waycommunication is always practiced. In order toachieve this, dialogue sessions are always heldbetween the industrial sector and NPCB. Thesesessions are held twice a year. If necessary, atechnical working group (TWG) will be set up tooversee impending issues.

We have seen Malaysia moving into theinformation revolution with big high-techambitions. In conjunction with this, NPCB hasdeveloped an ‘On-Line Registration’ for thepurpose of registering cosmetics. This is to


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KATA–KATA ALUANDARIPADA PENGARAH

MESSAGE FROM THEDIRECTOR

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2 B i r o Pe n g a w a l a n F a r m a s e u t i k a l Ke b a n g s a a nN a t i o n a l P h a r m a c e u t i c a l C o n t r o l B u r e a u

satu sistem ‘On-Line Registration’ untukpendaftaran produk kosmetik. Ini adalahbertujuan untuk memudahkan danmemendekkan proses pendaftaran. Beberapasiri taklimat telah diadakan di seluruh Malaysiabagi memberi pendedahan kepada pihakindustri tentang sistem tersebut di sampingmewar-warkan tentang keperluan pendaftaranproduk kosmetik di Malaysia.

Sekali lagi saya ingin mengucapkan syabaskepada semua kakitangan BPFK yangbertungkus-lumus untuk memastikan AuditCompliance ISO MS 9002 berjaya.

Pada Julai 2001 BPFK telah berjaya memperolehistatus MS ISO 9002 di mana ini membawamaksud semua prosedur yang dijalankan olehBPFK didokumenkan dan mematuhi syarat-syarat ISO.

Setelah mencapai status ISO adalah menjaditanggungjawab warga BPFK untuk mematuhidan mengikuti setiap prosedur yang ada iaitu‘Buat apa yang didokumenkan dandokumenkan apa yang dibuat’.

Selaras dengan saranan kerajaan agar institusikerajaan membantu pihak swasta, maka BPFKtelah mengambil inisiatif menjadi ahli PIC/S.Juruaudit BPFK telah diaudit sebanyak dua kalioleh wakil PIC/S. Dan akhirnya mereka berpuashati dengan prestasi juruaudit BPFK. Padamesyuarat PIC/S dalam bulan November 2001 diGeneva, Malaysia telah diterima sebagai negaraPIC/S yang ke-26 mulai 1 Januari 2002. Dengandiiktiraf sebagai ahli PIC/S sijil GMP dariMalaysia diiktiraf bertaraf antarabangsa. Makahalangan teknikal dari segi regulatori dapatdiatasi.

Adalah diharapkan dengan kerjasama yang jitudi antara kakitangan BPFK serta usaha yanggigih maka prestasi kecemerlangan dapatdikekalkan seterusnya dapat ditingkatkan padamasa-masa mendatang. Ibarat kata, “Bulat airkerana pembetung, bulat kata keranamuafakah”.

(HAJI NORMAL BIN SHARIF)PengarahBiro Pengawalan Farmaseutikal KebangsaanKementerian Kesihatan Malaysia

simplify and shorten the registration process. Aseries of briefing have been done throughoutthe nation to give an exposure to the industryand the public regarding this on-lineregistration system.

Once again, I would like to express my deepestgratitude to all NPCB staff who have workedvery hard towards the success of the MS ISO9002 Compliance Audit.

On July 2001, NPCB succeeded in obtaining theMS ISO 9002 certification from SIRIM. Hence, allprocedures involved will be documented and itis also our duty to ensure all our activitiescomply with MS ISO standards. As the sayinggoes, ‘Do what you document, and documentwhat you do’.

It has always been the government’s policy towork alongside and guide the private sector. Inthe case of NPCB, we have become a member ofthe Pharmaceutical Inspection Co-operationScheme (PIC/S) and we have adopted itsguideline into our existing GMP guidelines.Auditors from NPCB have been audited twice bytwo delegations from the PIC/S and we areproud to say that the results have been morethan satisfactory. Malaysia was officiallyappointed as the 26th member of PIC/S as from1st January 2002 in the November 2001 PIC/Smeeting held in Geneva and through this; ourGMP standards have obtained internationalrecognition. As such, previous trading barriersfrom the regulatory aspect have been overcome.

I hope with the full cooperation of the NPCBstaff, our exellent performance will bemaintained and we shall excel further in timesto come. “Ability is what you’re capable ofdoing, motivation determines what you do,attitude determines how well you do it”.

(HAJI NORMAL BIN SHARIF)DirectorNational Pharmaceutical Control BureauMinistry of Health Malaysia


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STRUKTUR ORGANISASIORGANIZATIONAL STRUCTURE OF

BAHAGIAN PERKHIDMATAN FARMASIPHARMACEUTICAL DIVISION

KEMENTERIAN KESIHATAN MALAYSIAMINISTRY OF HEALTH

KETUA PENGARAH KESIHATAN

DIRECTOR GENERAL OF HEALTH

TIMBALAN KETUA PENGARAH KESIHATAN

(Penyelidikan & Sokongan Teknikal)

DEPUTYDIRECTOR GENERAL OF HEALTH(Research & Technical Support)

PENGARAHPERKHIDMATAN FARMASI

DIRECTOR OF PHARMACEUTICAL SERVICES

PENGARAHBPFK

DIRECTORNPCB

TIMBALANPENGARAH

(Perlesenan &Penguatkuasaan)

DEPUTY DIRECTOR(Licensing &

Enforcement)

TIMBALANPENGARAH(Pengurusan

Farmasi)

DEPUTYDIRECTOR

(PharmaceuticalCare)

KETUA PEGAWAIFARMASI

(Hospital KualaLumpur)

CHIEF PHARMACIST(Kuala Lumpur

Hospital)

13 TIMBALANPENGARAH

KESIHATAN NEGERI(Farmasi)

13-STATE DEPUTYDIRECTORS OF

HEALTH(Pharmacy)

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PengarahDirector

Bhg. Penilaian &Keselamatan Produk

Product Evaluation &Safety Division

Bahagian APB &Pelesenan

GMP & LicensingDivision

Bhg. PembangunanOrganisasi & Teknologi

Maklumat

Org. Development& Info. Technology

Division

Bahagian Surveilans &Farmakovigilans

Surveillance &Pharmacovigilance

Division

BahagianPentadbiran

AdministrativeDivision

BahagianAnalisis Ubat

Drug Analysis Division

Unit Sekretariat

Secretariat Unit

Unit Racun

Poisons Unit

Unit Bukan Racun

Non-PoisonsUnit

Unit Ubat Tradisional

Traditional Medicines Unit

Unit Entiti Kimia Baru

New Chemical Entity Unit

Unit Kosmetik

Cosmetics Unit

MakmalKimia

Farmaseutikal

Pharmaceutical ChemistryLaboratory

MakmalMikrobiologiFarmaseutikal

PharmaceuticalMicrobiologyLaboratory

MakmalFarmakologi/Toksikologi

Pharmacology/Toxicology Laboratory

MakmalTeknologi

Farmaseutikal

PharmaceuticalTechnology Laboratory

Unit PiawaiRujukan

Reference Standards Unit

MakmalUbat

Tradisional

Traditional MedicinesLaboratory

CARTA ORGANISASIORGANIZATIONAL CHART

BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAANNATIONAL PHARMACEUTICAL CONTROL BUREAU

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at

sis

Senarai jawatan pada 31 Disember 2001List of posts as at 31 December 2001

Jawatan (Post)Bil. Nama Jawatan Gred Bil. Diisi KosongNo. Position Grade No. Filled Vacant

1. Pengarah BPFKDirector of NPCB C 1 1 0

2. Pegawai FarmasiPharmacist U1 2 1 1



5. Penolong Pegawai PerangkaanAssistant Statistic Officer N6 1 0 1

6. Pembantu FarmasiPharmacy Assistant U7 8 7 1

7. Pembantu FarmasiPharmacy Assistant U8 65 61 4

8. Pembantu TadbirAdministrative Assistant N7 1 1 0

9. Pembantu Tadbir (Kesetiausahaan)Administrative Assistant (Secretary) N7 1 1 0

10. Pembantu PerpustakaanLibrary Assistant S7 1 1 0

11. Pembantu TadbirAdministrative Assistant N9 11 10 1

12. Pembantu Tadbir (Kesetiausahaan)Administrative Assistant (Secretary) N9 2 2 0

13. Pembantu Tadbir (Setor)Administrative Assistant (Store) N9 1 1 0

14. Operator Mesin Prosesan DataData Processing Operator F9 2 1 1

15. Pembantu Tadbir RendahTypist N11 4 2 2

16. Pembantu Tadbir Rendah(Operator Telefon)Administrative Assistant N11 1 1 0(Telephone Operator)

17. Pembantu Am RendahGeneral Assistant N13 2 0 2

18. Atendan KesihatanHealth Attendant U16 10 7 3

19. Pengawal KeselamatanSecurity Guard KP10 3 1 2

20. Pemandu Kenderaan BermotorDriver R10 3 2 1

JUMLAH (Total) 182 158 24

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FALSAFAH ORGANISASI

WAWASANBiro Pengawalan Farmaseutikal Kebangsaan sebagaipusat kecemerlangan unggul dalam bidangregulatori farmaseutikal demi menjamin kesihatandan kesejahteraan insan sejagat.

MISIBiro Pengawalan Farmaseutikal Kebangsaan akanmemastikan kualiti, keberkesanan dan keselamatankeluaran farmaseutikal melalui perlaksanaanundang-undang oleh tenaga kerja yangberketerampilan dan usahasama strategik ke arahpeningkatan status kesihatan rakyat.

MATLAMATMemastikan bahawa bahan-bahan terapeutik yangdibenarkan di pasaran tempatan adalah selamat,berkesan dan bermutu, serta menentukan bahawakosmetik-kosmetik yang dibenarkan di pasaranadalah selamat dan bermutu.

STRATEGIMemastikan kecekapan dan keberkesanan organisasimelalui permodenan dan automasi sistem-sistempejabat, makmal dan pendaftaran, peninjauan sertapembaikan perkhidmatan secara regular.

Memperkukuhkan aktiviti penguatkuasaan undang-undang berkaitan.

Memastikan suasana kefahaman dua hala dankerjasama berterusan sentiasa wujud antara pihakpengawalan dengan sektor swasta melalui sessidialog dan bimbingan.

Meningkatkan potensi serta kepakaran personel.

Mewujudkan satu kumpulan tenaga kerja yangberdedikasi dan penuh komitmen melalui motivasi,penghargaan serta ganjaran yang berpatutan.

Mempergiatkan aktiviti penyelidikan sertameningkatkan kemudahan-kemudahan bagi tujuantersebut.

Mewujudkan suatu suasana yang menggalakkankakitangan bekerja secara berpasukan dengan sikappenyayang, serta melaksanakan tugas masing-masingsecara profesional.

ORGANIZATIONAL PHILOSOPHY

VISIONThe National Pharmaceutical Control Bureau will be acentre of excellence in pharmaceutical regulatorymatters to ensure the health and well-being ofmankind.

MISSIONThe National Pharmaceutical Control Bureau shallensure the quality, efficacy and safety ofpharmaceutical products through theimplementation of the relevant legislation by acompetent workforce working together in strategicalliances towards improving the health of thepeople.

OBJECTIVETo ensure that therapeutic substances approved forthe local market are safe, effective and of quality andalso to ensure that cosmetic products approved aresafe and of quality.

STRATEGYTo ensure organizational efficiency and effectivenessthrough modernisation and automation of the office,laboratory and registration systems and regularreview and improvement of services.

To strengthen enforcement activities of the relatedlegislation.

To ensure continuous mutual understanding and co-operation between the regulatory body and theprivate sector through dialogues and guidances.

To upgrade personnel potential and expertise.

To attain a dedicated and fully committed work forcethrough motivation, appreciation and appropriaterenumeration.

To strengthen research activities and upgradefacilities for such purposes.

To create a working environment conducive for thepersonnel to work as a team with a caring attitudewhilst discharging their duties in a professionalmanner.


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MOTTOUTAMAKAN KUALITI, EFIKASI DAN KESELAMATAN

EMPHASIZE QUALITY, EFFICACY AND SAFETY

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PIAGAM PELANGGAN

A. KEWAJIPAN BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN TEMA PIAGAM

Ditujukan khas kepada setiap pelanggan yangberurusan dengan BPFK.

1. AM

1.1. KEMUDAHAN UNTUK PELANGGAN

(i) Setiap pelanggan biro boleh mendapat perkhidmatan sewajarnya.

(ii) Setiap pelanggan yang tergolong dalam keadaan yang memerlukan perhatian segera akan diberi layanan dengan segera.

1.2. TARAF PERKHIDMATAN

(i) Setiap pelanggan akan dilayan dengan baik, mesra, bertimbang rasa, hormat dan ikhlas.

(ii) Setiap pelanggan akan diberi perkhidmatan yang terbaik secara profesional.

1.3. MAKLUMAT PERKHIDMATAN

Setiap pelanggan boleh mendapat penjelasan dan nasihat mengenai perkhidmatan yang diberikan kepadanya.

2. AKTIVITI - PENDAFTARAN

2.1. Memastikan bahawa semua keluaran farmaseutikal yang berdaftar adalah selamat, berkesan dan berkualiti serta menentukan bahawa kosmetik-kosmetik yang berdaftar adalah selamat.

2.2. Semua permohonan akan dinilai dengan adil dan saksama berlandaskan kepada peraturan-peraturan yang berkaitan.

2.3. Semua dokumen yang dikemukakan oleh pelanggan akan disimpan dalam keadaan selamat dan terkawal.

CLIENT’S CHARTER

A. THE OBLIGATION OF THE NATIONAL PHARMACEUTICAL CONTROL BUREAU CHARTER THEME :

Exclusive concern for clients who deal withNPCB.

1. GENERAL

1.1. FACILITIES FOR CLIENTS

(i) Every client of the bureau shall receive the appropriate service.

(ii) Every client who requires immediate attention shall be served immediately.

1.2. STANDARD OF SERVICE

(i) Every client shall be treated with courtesy, understanding, respect and sincerity.

(ii) Every client shall be given the best possible professional service.

1.3. INFORMATION SERVICE

Every client shall be given explanation and advice on the services provided.

2. ACTIVITY - REGISTRATION

2.1. To ensure the safety, efficacy and quality of all registered pharmaceutical products and the safety of registered cosmetic products.

2.2. All applications shall be evaluated fairly and with impartiality in accordance with the relevant regulations.

2.3. All documents forwarded by clients shall be kept in a secure and organized manner.


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3. AKTIVITI - MAKMAL

3.1. Semua ujian makmal akan dijalankan dengan adil dan saksama mengikut peraturan-peraturan dan prosedur-prosedur yang berkaitan.

4. AKVITIVI - PENGUATKUASAAN DAN KOMPLIANS

4.1. Setiap tindakan penguatkuasaan ke atas mana-mana pelanggaran undang-undang yang dikuatkuasakanakan dilakukan dengan adil dan saksama tanpa dipengaruhi oleh apa-apa kepentingan dan prasangka.

4.2. Bersedia bekerjasama dengan agensi penguatkuasaan lain dalam perkara yang berkaitan dengan penguatkuasaan ubat-ubatan.

5. SETIAP PERMOHONAN YANG LENGKAP AKAN DIPROSES MENGIKUT JANGKAMASA BERIKUT

(i) Lesen Untuk Percubaan Klinikal - tidak lebih dari 3 bulan.

(ii) Lesen Untuk Pemborong, Pengilang, Pengimport - tidak lebih dari 3 bulan.

(iii) Lesen Baru Untuk Pemborong, Pengilang, Pengimport - tidak lebih dari 6 bulan.

(iv) Pendaftaran.

Peringkat 1 - tidak lebih dari6 minggu.

Peringkat 2 - tidak lebih dari 4 bulan.

Peringkat 3 - Generik - tidak lebih dari 6 bulan.

NCE - tidak lebih dari 12 bulan.

Tambahan Indikasi - tidak lebih dari 6 bulan.

3. ACTIVITY - LABORATORY

3.1. All laboratory tests shall be carried out fairly and impartially in accordance with the relevant regulations and procedures.

4. ACTIVITY - ENFORCEMENT &COMPLIANCE

4.1. Every enforcement action on any offence under the law shall be carried out fairly and impartially without influence from whatsoever vested interest and prejudice.

4.2. Ever ready to co-operate with other enforcement agencies in matters related to drug enforcement.

5. EVERY COMPLETE APPLICATION SHALL BE PROCESSED IN ACCORDANCE TO THE FOLLOWING TIME-FRAME :

(i) Licence For Clinical Trial - Not more than 3 months.

(ii) Licence For Wholesalers, Manufacturers and Importers - Not more than 3 months.

(iii) New Licence For Wholesalers, Manufacturers and Importers - Not more than 6 months.

(iv) Registration

Stage 1 - Not more than 6 weeks.

Stage 2 - Not more than 4 months.

Stage 3 - Generic - Not more than6 months.

NCE - Not more than 12 months.

Additional Indications - Not more than 6 months.


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(v) Laporan Pemeriksaan APB.

Susulan - tidak lebih dari 2 bulan.

Baru/Rutin - tidak lebih dari 3 bulan.

(vi) Perakuan Keluaran.

Alat Perubatan - tidak lebih dari 2 minggu.

Farmaseutikal - tidak lebih dari 1 bulan.

B. KEWAJIPAN PELANGGAN

Bagi membolehkan piagam ini dilaksanakandengan berkesan, pelanggan adalahberkewajipan untuk :

(i) Mematuhi semua undang-undang dan peraturan-peraturan yang berkaitan.

(ii) Menggunakan kemudahan-kemudahan yang disediakan secara bertanggungjawab.

(v) GMP Inspection Report

Follow-up - Not more than 2 months.

New/Routine - Not more than 3 months.

(vi) Product Certificate

Medical Device - Not more than 2 weeks.

Pharmaceuticals - Not more than 1 month.

B. CLIENT’S OBLIGATION

To enable this charter to be implementedeffectively, clients are obliged to fulfill thefollowing:-

(i) Comply with the requirements of the relevant legislation and regulations.

(ii) Use the facilities provided responsibly.


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RINGKASAN AKTIVITI BPFK

Aktiviti-aktiviti Biro Pengawalan Farmaseutikal

Kebangsaan pada amnya termasuk :-

1. Menguatkuasakan skim pendaftaran ubat

dan kosmetik melalui penilaian data

teknikal, ujian makmal, penyelidikan dan

maklumat yang diterima dari badan-badan

antarabangsa.

2. Menjalankan ujian analisa, farmaseutik,

mikrobiologi, farmakologi serta toksikologi

ke atas ubat-ubatan dan kosmetik untuk

menentukan mutu, keberkesanan dan

keselamatan keluaran-keluaran tersebut.

3. Menguatkuasakan skim kawalan mutu ubat-

ubatan di pasaran melalui penyampelan

rambang dan menjalankan ujian-ujian

analisa.

4. Menguatkuasakan skim pelesenan

pengilang, pengimport, pemborong ubat-

ubatan, termasuk skim pelesenan untuk

percubaan klinikal.

5. Mendorong dan membantu pengilang-

pengilang ubat tempatan untuk

meningkatkan mutu pengilangan setaraf

dengan Amalan Perkilangan Baik (Good

Manufacturing Practice) yang disarankan

oleh Pertubuhan Kesihatan Sedunia.

6. Menguruskan program pemonitoran kesan

advers ubat dan menganggotai Program

Pemonitoran Ubat Antarabangsa WHO.

7. Menguruskan skim panggilbalik ubat-ubat

yang didapati atau dibuktikan merbahaya

kepada pengguna.

SUMMARY OF NPCB ACTIVITIES

The activities of NPCB are :-

1. To implement the drug and cosmetic

registration scheme through evaluation of

technical data, laboratory analysis, research

and information received from international

agencies.

2. To carry out analytical, pharmaceutical,

microbiological, pharmacological and

toxicological tests on drugs and cosmetics to

determine quality, efficacy and safety of

such products.

3. To implement the regulatory scheme on

quality of pharmaceutical products in the

market through random sampling and

carrying out analytical tests.

4. To implement the licensing scheme for

pharmaceutical manufacturers, importers

and wholesalers including a licensing

scheme for clinical trials.

5. To encourage and assist local

pharmaceutical manufacturers to upgrade

manufacturing standards to levels

equivalent to the requirements of Good

Manufacturing Practice as recommended by

the World Health Organisation (WHO).

6. To manage the Adverse Drug Reaction

Monitoring Program and participate in the

WHO International Adverse Drug Reaction

Monitoring Program.

7. To manage the product recall scheme for

pharmaceutical products which are found to

be substandard or dangerous to consumers.


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8. Mengendalikan sistem pengumpulan dan

penyebaran maklumat ubat-ubatan selaras

dengan peranannya sebagai Pusat

Maklumat Ubat Kebangsaan.

9. Menjalankan penyelidikan metodologi dan

penyelidikan asas untuk tujuan menilai

mutu, keberkesanan dan keselamatan ubat -

ubatan/kosmetik.

10. Menubuhkan sistem pembentukan piawai

rujukan untuk kegunaan negara ini dan

negara jiran melalui skim kerjasama dalam

bidang farmaseutikal di antara negara-

negara ASEAN.

11. Menjalankan latihan bagi pegawai-pegawai

farmasi, pegawai-pegawai profesional lain

dan juga pegawai-pegawai separuh

profesional yang ditempatkan di Institusi ini

dari masa ke semasa melalui skim latihan

tempatan atau skim kerjasama

antarabangsa.

8. To manage the drug information collecting

and disseminating system in line with its role

as a national drug information centre.

9. To carry out research on methodology and

basic research for the purpose of evaluating

quality, efficacy and safety of

drugs/cosmetics.

10. To establish a reference standard system for

use in this country and also for

neighbouring countries through a scheme of

cooperation in the field of pharmaceuticals

among ASEAN countries.

11. To carry out training for pharmaceutical

officers, other professional and semi-

professional officers who are placed in this

institution from time to time through local

training or international cooperational

schemes.


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LAPORANBAHAGIANDIVISIONAL

REPORTS

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BAHAGIAN PENTADBIRAN

Bahagian Pentadbiran adalah bertanggungjawabdalam menguruskan semua hal berhubungdengan kewangan, pentadbiran am, hasil dantugas-tugas lain yang bukan bidang profesional.

OBJEKTIF

• Memastikan bahawa semua anggota menikmati upahan gaji bulanan dan tuntutan-tuntutan rasmi dibayar dalam tempoh yang ditetapkan

• Segala keperluan asas dan yang penting diuruskan segera

• Urusan Perkhidmatan yang wajib dan perlu dikemaskinikan

• Mengawal peruntukan kewangan supaya sentiasa mencukupi bagi menjamin setiap aktiviti yang dirancang boleh mencapai objektif keseluruhannya

KEWANGAN

Mengurus pembayaran upahan dan gaji untuk151 anggota berjumlah RM 4,646,591.00

KUTIPAN HASIL

Kutipan hasil diterima daripada pelangganuntuk bayaran Pendaftaran Ubat-Ubatan, UjianMakmal, Lesen, Perkhidmatan Nasihat, JualanBuku-buku Garispaduan dan lain-lain. Jumlahkutipan hasil mengikut disiplin adalah seperti dibawah :-

ADMINISTRATIVE DIVISION

The Administrative Division is responsible forthe management of all matters pertaining tofinance, general administration and other non-professional tasks.

OBJECTIVES

• To ensure all emoluments and claims are paid within the stipulated time

• To take immediate action on basic and urgent matters

• To constantly update compulsory records

• To oversee that financial allocations are sufficient and ensure that each planned program and activity meets its objective

FINANCE

Payment to 151 staff members is RM4,646,591.00

REVENUE

Revenue is collected from the public for DrugRegistration, Laboratory Tests, Licences,Advisory Services, Sale of Guideline Books andothers. The breakdown of total revenue is asfollows :-


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KUTIPAN HASIL ( RM) SEHINGGA AKHIR TAHUN 2001REVENUE UNTIL END OF 2001

Tahun Pendaftaran Lesen Makmal Pemeriksaan Bahan Cetak Lain-lainYear Registration Licence Laboratory Inspection Printed Materials Other

1998 793,825 129,350 750,360 8,400 18,296 12,100

1999 959,405 158,350 484,860 14,350 39,605 18,871

2000 1,111,440 152,100 502,620 6,500 28,340 27,193

2001 914,020 203,200 460,880 12,200 26,485 64,072

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TINJAUAN BELANJAWAN / BUDGET REVIEW

Peruntukan dan Perbelanjaan Mengurus BPFK Bagi Tahun 2001 2001 NPCB Operating Allocation and Expenditure

Kod Objek Jenis Peruntukan (RM) Perbelanjaan Baki

Object code Perbelanjaan Allocation (RM) Expenditure Balance

Am

Expenditure Asal Dipinda Perbelanjaan

Original Amended Bersih (RM)

Actual % (RM) %

Expenditure

(RM)

10000 Emolumen 4,134,000 4,847,800 4,646,591 95.85 201,208 4.15

Emolument

20000 Perkhidmatan

dan Bekalan 5,032,700 7,199,700 6,743,260 93.66 456,440 6.34

Services and

Supply

30000 Aset (Harta

Modal) 300,000 300,000 297,265 99.08 2,734 0.911

Asset

(Property)

Jumlah 9,466,700 12,347,500 11,687,116 94.65 660,383 5.35

Total

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17

Bahagian Penilaian danKeselamatan Produk

OBJEKTIF

Untuk memastikan semua keluaran berdaftar dinilaidari segi kualiti, keselamatan dan efikasi.

Untuk memberikan sokongan teknikal danpentadbiran dalam semua bidang yang berhubung dengan pendaftaran keluaran.

PENCAPAIAN

Pemohonan yang diterima

diterima Sejumlah 48,324 permohonan diterima daritahun 1985 sehingga 2001, dimana 14,550 (30.4%)ubat racun, 10,450 (21.7%) ubat bukan racun, 21,445(44.2%) ubat tradisional dan 1,879 (3.8%) kosmetik(Jadual 1). Jumlah permohonan telah meningkatdengan ketara dari 6,448 pada 1986 kepada 20,257pada 1992. Aliran yang sama dapat diperhatikanpada 1992 hingga 1999, dimana jumlah permohonanmeningkat sebanyak 53.2%, kerana permohonanyang banyak untuk ubat tradisional dan kosmetik.Walau bagaimanapun, pada tahun 2001 jumlahpermohonan telah menurun sedikit bagi ubattradisional serta kosmetik dan meningkat sedikit bagiubat racun dan ubat bukan racun.

Produk berdaftar

didaftarkan Sejumlah 27,359 keluaran telahdidaftarkan sehingga 2001, dimana 8,893 (33.6%)ialah ubat racun, 6,996 (26.1%) ubat bukan racun,9,894 (36.9%) ubat tradisional dan 1,776 (6.6%)kosmetik (Jadual 2). Jumlah keluaran yangdidaftarkan menunjukkan peningkatan bagi semuakategori.

Permohonan Ditolak

ditolak Sehingga 2001, sejumlah 16,640permohonan telah ditolak dan ini meliputi kira-kira34.4% dari jumlah permohonan yang diterima.

Product Evaluation andSafety Division

OBJECTIVES

To ensure that all registered products have beenevaluated for quality, safety and efficacy.

To provide technical and administrative support in allmatters pertaining to registration of products.

ACHIEVEMENTS

Application received

Applications A total of 48,324 applications werereceived from 1985 to 2001, of which received 14,550(30.4%) were prescription drugs, 10,450 (21.7%) OTCproducts, 21,445 (44.2%) traditional medicines and1,879 (3.8%) cosmetics (Table 1). The number ofapplications had increased significantly, from 6,448 in1986 to 20,257 in 1992. A similar increasing trend wasobserved from 1992 to 1999, where the number ofapplications had gone up by almost 53.2%, mainlydue to the enormous number of traditional medicinesand cosmetics applications. However, the totalapplication for registration of prescription drugs andOTC products has increased slightly in year 2001.

Products Registered

A total of 27,359 products had been registered by2001, of which 8,893 registered (33.6%) areprescription drugs, 6,996 (26.1%) OTCs, 9,894 (36.9%)traditional medicines and 1,776 (6.6%) cosmetics(Table 2). The number of products registered displayincreasing trends for all categories.

Applications Rejected

Up until 2001, a total of 16,640 applications had beenrejected and this rejected represents approximately34.4% of the total number of applications received.

Jadual 1 : Permohonan untuk pendaftaran, 1985 – 2001Table 1 : Applications received for registration, 1985 – 2001

Ubat racun Ubat bukan Ubat Jumlah / TotalTahun Prescription racun tradisional KosmetikYear drugs OTC Traditional Cosmetics Tahunan Annual

products medicines Kumulatif Cumulative1985 9 - - - 9 91986 6,439 - - - 6,439 6,4481987 824 56 - - 880 7,3281988 702 2,532 - - 3,234 10,5621989 664 2,750 - - 3,414 13,9761990 528 597 - - 1,125 15,1011991 481 305 - 42 828 15,9291992 150 60 3,973 145 4,328 20,2571993 376 111 7,059 51 7,597 27,8541994 400 168 4,080 31 4,679 32,5331995 440 239 288 58 1,025 33,5581996 617 671 415 130 1,833 35,3911997 532 635 668 123 1,958 37,3491998 587 606 938 277 2,408 39,7571999 796 789 1,347 610 3,542 43,2992000 427 444 1,523 262 2,656 45,9552001 578 487 1,154 150 2,369 48,324

JumlahTotal 14,550 10,450 21,445 1,879 48,324 48,324

Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau

L a p o r a n T a h u n a n 2 0 0 1A n n u a l R e p o r t 2 0 0 1

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Permohonan yang dibatalkan atau ditarik-balik

Sehingga 2001, sejumlah 7,069 permohonantelah dibatalkan atau ditarik-balik, dan inimeliputi 2,317 (32.8%) ubat racun, 1,334(18.9%) ubat bukan racun, 3,352 (32.3%) ubattradisional dan 66 (0.9%) kosmetik (Jadual 4).Jumlah keluaran yang dibatalkan atau ditarik-balik adalah 14.6% daripada jumlahpermohonan yang diterima.

Applications cancelled or withdrawn

Up until 2001, a total of 7,069 applications hadbeen cancelled or withdrawn, which consists of2,317 (32.8%) prescription drugs, 1,334 (18.9%)OTCs, 3,352 (32.3%) traditional medicines andcosmetics 66 (0.9%) (Table 4). The total numberof products cancelled or withdrawn representsabout 14.6% of the total number of applicationsreceived.


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Jadual 2 :Kumulatif keluaran yang didaftarkan ( 1991 – 2001 )Table 2 :Cumulative number of products registered ( 1991 – 2001)

Tahun Ubat racun Ubat bukan racun Ubat tradisional Kosmetik JumlahYear Prescription drugs OTC products Traditional medicines Cosmetics Total

1991 5,332 3,331 - - 8,6631992 5,862 3,743 - 14 9,6191993 6,131 3,867 5 109 10,1121994 6,444 3,954 57 149 10,6041995 6,691 4,023 339 183 11,2361996 7,027 4,237 1,852 292 13,4081997 7,525 4,830 4,347 476 17,1781998 8,187 5,415 7,819 664 22,0851999 8,792 5,942 7,966 1,235 23,9352000 8,813 6,072 8,550 1,467 24,9022001 8,993 6,696 9,894 1,776 27,359

JumlahTotal 8,993 6,696 9,894 1,776 27,359


Jadual 3 : Kumulatif permohonan yang ditolak (1986 – 2001)Table 3 : Cumulative applications rejected by the DCA, 1986 – 2001

Tahun Ubat racun Ubat bukan racun Ubat tradisional Kosmetik JumlahYear Prescription drugs OTC products Traditional medicines Cosmetics Total

1986 955 - - - 9551987 2,043 - - - 2,0431988 2,389 329 - - 2,7181989 2,889 1,083 - - 3,9721990 3,206 1,318 - - 4,5241991 3,495 1,585 - - 5,0801992 3,693 2,127 - 14 5,8341993 3,770 2,262 0 92 6,1241994 3,860 2,362 410 98 6,7301995 3,938 2,592 1,253 98 7,8811996 4,020 2,783 2,570 98 9,3731997 4,132 2,963 3,915 98 11,1081998 4,164 3,065 7,190 98 14,5171999 4,186 3,125 8,975 98 16,3842000 4,206 3,165 9,021 98 16,3922001 4,248 3,188 9,104 100 16,640

JumlahTotal 4,248 3,188 9,104 100 16,640


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RAYUAN

Jumlah rayuan yang diterima telah menurunkepada 16 pada tahun 2001 berbanding dengan32 pada 2000 dan 370 pada 1999.

ENTITI KIMIA BARU

Dari 1985 hingga 2001, sejumlah 1,173permohonan diterima untuk keluaran entitikimia baru (Rajah 1). Daripada jumlah ini, 790(67.2%) telah diluluskan, 299 (25.5%) ditolakdan 53 (4.5%) tertangguh.

TAMBAHAN INDIKASI

Tambahan indikasi bagi produk-produk yangtelah berdaftar juga dinilai dan diluluskan olehPBKD. Sebanyak 27 permohonan telah diterimabagi tahun 2000 dan 71 pada tahun 2001.Jumlah permohonan meningkat lebih dua kaliganda pada tahun 2001 berbanding tahun 2000.

LESEN IMPORT PENYELIDIKAN KLINIKAL (LIPK)

Jumlah permohonan LIPK yang diterima telahmeningkat pada tahun 2000 dan 2001berbanding dengan tahun 1998 dan 1999 (Rajah2). Dari tahun 1997 hingga 2001, sejumlah 243permohonan LIPK diterima.

APPEALS

The number of appeals received has decreasedsignificantly to 16 for the year 2001, ascompared to 32 in 2000 and 370 in 1999.

NEW CHEMICAL ENTITIES

From 1985 to 2001, a total of 1,173applications were received for productsclassified as new chemical entities (Figure 1).Out of these, 790 (67.2%) had been approved,299 (25.5%) rejected and 53 (4.5%) deferred.

ADDITIONAL INDICATIONS

New indications for registered products werealso assessed and approved by the DCA. A totalof 27 applications were received in 2000 and 71in the year 2001. The number of application foradditional indication has increased double inyear 2001 compared to year 2000.

CLINICAL TRIALS IMPORT LICENCE (CTIL)

The number of CTIL received has increasedsignificantly in 2000 and 2001 as compared to1998 and 1999 (Figure 2). From 1997 to 2001, atotal of 243 applications of CTIL were received.


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Jadual 4 : Permohonan yang dibatalkan /ditarik-balik ( 1989 – 2001)Table 4 : Applications cancelled/withdrawn, 1989 – 2001

Ubat racun Ubat bukan Ubat Jumlah / TotalTahun Prescription racun tradisional KosmetikYear drugs OTC Traditional Cosmetics Tahunan Annual

products medicines Kumulatif Cumulative

1989 166 0 - - 166 1661990 114 0 - - 114 2801991 103 37 - - 140 4201992 0 15 - - 15 4351993 6 0 0 - 6 4411994 9 28 0 - 37 4781995 39 59 0 - 98 5761996 59 62 0 - 121 6971997 62 76 0 - 138 8351998 0 23 595 - 618 1,4531999 1,367 609 1,613 66 3,655 5,1082000 306 120 499 - 925 6,0332001 86 305 645 - 1,036 7,069

JumlahTotal 2,317 1,334 3,352 66 1,036 7,069


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TEMPATAN VS. IMPORT

Sebanyak 44.2% (12,103) daripada jumlahkeluaran yang didaftarkan adalah dikilangkansecara tempatan, sementara 55.8% (15,256)adalah diimport. Keluaran tempatan dankeluaran import yang didaftarkan dari 1991sehingga 2001, mengikut kategori berlainandiilustrasikan pada Jadual 5.

LOCAL VS. IMPORT

About 44.2% (12,103) of the total number ofproducts registered are locally-manufactured,while 55.8% (15,256) are imported. Locally-manufactured and imported products registeredfor period between 1991 to 2001, according todifferent categories, are cumulatively illustratedin Table 5.


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Rajah 1 : Status pendaftaran keluaran entiti kimia baruFigure 1 : Registration status of new chemical entities

1985 - 2001

Rajah 2 : Lesen Import Penyelidikan KlinikalFigure 2 : Clinical Trial Import Licence

1997 - 2001

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Semenjak 2001, peratusan nisbah antara produktempatan dan produk import untuk ubat racunadalah 31:69 seperti data dalam Jadual 5. Bagiubat bukan racun, peratusan keluarantempatan adalah lebih tinggi seperti manaditunjukkan dalam nisbah 52:48. Peratusanuntuk ubat tradisional adalah 56:44,menunjukkan peratusan keluaran yang dikilangsecara tempatan adalah lebih tinggi manakalaperatusan nisbah kosmetik pula adalah 18:82.

Merujuk kepada jumlah produk tempatan yangdidaftarkan (n = 12,103) seperti pada Jadual 5,2770 (22.9%) adalah ubat racun, 3, 454 (28.5%)ubat bukan racun, 5,560 (45.9%) ubattradisional dan 319 (2.7%) kosmetik. Untukproduk import, berdasarkan kepada jumlahyang didaftarkan (n = 15,256), 6,223 (40.8%)adalah ubat racun, 3,242 (21.3%) ubat bukanracun, 4,334 (28.4%) ubat tradisional dan 1,457(9.1%) kosmetik (Rajah 3).

As of 2001, the percentage ratio betweenlocally-manufactured and imported products forprescription drugs is in the order of 31:69 asshown by data in Table 5. For OTC products thepercentage of locally- manufactured products isslightly higher as indicated by a ratio of 52:48.The percentage ratio for traditional medicines isshown to be 56:44, indicating a higherproportion of locally manufactured productswhereas the percentage ratio for cosmetics is18:82.

Based on the total number of locally-manufactured products registered (n = 12,103)as presented in Table 5,2,770 (22.9%) areprescription drugs, 3,454 (28.5%) OTC products,5,560 (45.9%) traditional medicines and 319(2.7%) cosmetics. For imported products, basedon the total number registered (n = 15,256),6,223 (40.8%) are prescription drugs, 3,242 (21.3%) OTC products, 4,334 (28.4%) traditionalmedicines and 1,457 (9.1%) cosmetics (Figure 3).


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Jadual 5 : Jumlah kumulatif produk tempatan dan produk importTable 5 : Cumulative number of locally-manufactured and imported products registered

( 1991 – 2001 )

Ubat racun Ubat bukan racun Ubat tradisionalPrescription drugs OTC products Traditional Kosmetik Jumlah

Tahun medicines Cosmetics TotalYear Temp Import Temp Import Temp Import Temp Import Temp Import

Local Import Local Import Local Import Local Import Local Import

1991 1,602 3,730 1,750 1,581 - - - - 3,352 5,3111992 1,760 4,102 1,983 1,760 - - 2 12 3,745 5,8741993 1,867 4,264 2,032 1,835 1 4 22 87 3,922 6,1901994 1,951 4,493 2,081 1,873 17 40 22 127 4,071 6,5431995 2,041 4,650 2,083 1,940 145 194 22 161 4,291 6,9451996 2,213 4,814 2,202 2,035 950 942 72 220 5,437 8,0111997 2,347 5,178 2,475 2,355 2,300 2,047 72 404 7,194 9,9841998 2,602 5,585 2,755 2,660 4,246 3,573 106 558 9,709 12,3761999 2,781 6,011 3,052 2,890 4,098 3,868 197 1,038 10,128 13,8072000 2,742 6,071 3,080 2,992 4,400 4,150 215 1,252 10,451 14,4652001 2,770 6,223 3454 3,242 5,560 4,334 319 1,457 12,103 15,256

JumlahTotal 8,993 6,696 9,894 1,776 27,359



Rajah 3 : Produk Berdaftar - Tempatan vs Import 2001Figure 3 : Registered Products - Local vs Import 2001

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KEBENARAN EKSPORT

Pengeluaran sijil perakuan keluaranfarmaseutikal [Certificates of PharmaceuticalProducts (CPP)] dan sijil perakuan penjualanbebas [Certificates of Free Sale (CFS)] untukalatan perubatan dan kosmetik telahbertambah sejak 1987 sehingga 2001. Sejumlah2,131 CPP dan 1,551 CFS telah dikeluarkan padatahun 2001 berbanding 2,478 CPP dan 1,719 CFSpada tahun 2000 (Rajah 4).

SUMBER PRODUK

10 negara pengeluar utama ialah China,Amerika Syarikat, Australia, Indonesia, Thailand,Jerman, India, Switzerland, Perancis dan Itali.Negara-negara ini meliputi lebih kurang 75%(9,433) daripada jumlah keluaran import.Produk yang diimport dari negara-negaraASEAN seperti Indonesia, Thailand, Singapura,dan Filipina meliputi hampir 14.6 % (1,841).

EXPORT AUTHORISATION

Issuance of certificates of pharmaceuticalproducts (CPP) and certificates of free sale (CFS)for medical devices and cosmetics for exportauthorisation had increased steadily since 1987and 2001 respectively. A total of 2,131 CPP and1,551 CFS had been issued in year 2001compared to 2,478 CPP and 1,719 CFS in year2000 (Figure 4).

SOURCES OF PRODUCTS

The top 10 leading foreign sources includeChina, United States of America (USA), Australia,Indonesia, Thailand, Germany, India,Switzerland, France and Italy. Together theyaccount for approximately 75% (9,443) of ourtotal imports. Products imported fromneighbouring ASEAN countries, which includeIndonesia, Thailand, Singapore and Philippinesconstitute nearly 14.6% (1,841).


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Rajah 1 : Pengeluaran Sijil Perakuan Keluaran Farmaseutikaldan Sijil Perakuan Penjualan Bebas 1991-2001

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BAHAGIAN APB DAN PELESENAN

OBJEKTIF

Objektif utama bahagian ini ialah untukmemastikan premis-premis pengilang keluaranfarmaseutikal dan ubat-ubatan tradisionalmematuhi keperluan Amalan Perkilangan Baik(APB). Bahagian ini juga bekerjasama denganUnit Penguatkuasaan Farmasi Negeri (UPFN)dalam memastikan premis pengimport danpemborong mematuhi keperluan AmalanPenstoran Baik (ASB).

AKTIVITI

Bahagian ini menjalankan aktiviti-aktivitiseperti berikut :

• Memeriksa premis pengilang, pengimport dan pemborong keluaran-keluaran berdaftar.

• Memproses permohonan dan mengeluarkan lesen pengilang, pengimport dan pemborong keluaran-keluaran berdaftar.

• Mengeluarkan senarai tambahan keluaran-keluaran berdaftar.

• Menilai pelan susun-atur premis pengilang keluaran berdaftar.

• Memberi khidmat nasihat dan bimbingan kepada industri berkenaan dalam aspek APB, ASB dan pelesenan.

• Menganjur kursus latihan APB untuk industri farmaseutikal dan tradisional serta pelawat-pelawat luar negara.

• Mengadakan perbincangan teknikal dengan industri farmaseutikal untuk meningkatkan tahap APB premis pengilang tempatan.

• Mengumpul maklumat berkaitan industri farmaseutikal dan tradisional.

• Mengeluarkan perakuan APB dan mengesahkan salinan dokumen-dokumen berkaitan lesen.

PENCAPAIAN

Pemeriksaan APB

Sebanyak 126 pemeriksaan APB telah dijalankanpada tahun 2001 berbanding 126 pada tahun2000 dan 120 pada tahun 1999. Pemeriksaantersebut meliputi 61 premis pengilang keluaranracun, 19 keluaran bukan racun, 45 ubattradisional dan 1 kosmetik. Rajah 1menunjukkan statistik pemeriksaan APB bagitahun 1995 hingga 2001.

GMP AND LICENSING DIVISION

OBJECTIVES

The main objective of this division is to ensurethat pharmaceutical and traditional medicinemanufacturing premises adhere to therequirement of Good Manufacturing Practice(GMP). This division also co-operates with theState Pharmacy Enforcement Units to ensurethat the premises of importers and wholesaleradhere to Good Storage Practice (GSP).

ACTIVITIES

This division carries out the following activities:

• Inspection of premises for manufacturers, importers and wholesalers of registered products.

• Processing of licence application for manufacturers, importers and wholesalers of registered products.

• Issuance of additional lists of registered products.

• Evaluation of lay-out plans for manufacturing premises for registered products.

• Advisory service to relevant industries on technical aspects regarding GMP, GSP and licensing.

• Provide training courses for pharmaceutical and traditional medicines industries and also overseas visitors.

• Technical discussion with pharmaceutical industries to upgrade the GMP standard of local manufacturing premises.

• Collection of information related to pharmaceutical and traditional industries.

• Issuance of GMP certificates and endorsement of licence related documents.

ACHIEVEMENTS

GMP Inspection

A total of 126 inspections were conducted in2001 as compared with 126 in 2000 and 120 in1999. These inspections included 61 premises forscheduled poison manufacturers, 19 non-scheduled poison manufacturers, 45 traditionalmedicines and 1 cosmetic. Figure 1 shows thenumber of GMP inspections carried out since1995 until 2001.


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Penilaian Pelan Premis Pengilang

Sejumlah 35 pelan susun-atur premis pengilangbaru dan sediada telah dinilai, termasuk 7premis pengilang keluaran racun, 9 keluaranbukan racun, 13 ubat tradisional, 3 kosmetikdan 3 lain-lain.

Status Perkembangan Premis Berlesen

Status perkembangan premis-premis pengilang,pengimport dan pemborong berlesen bagitahun 1987 hingga 2001 adalah seperti yangdipaparkan dalam Rajah 2. Pada tahun 2001,jumlah pengilang berlesen ialah 227,pengimport 315 dan pemborong 722,menjadikan jumlah besar adalah 1,264.

Senarai serta maklumat lengkap mengenaipremis-premis berlesen boleh dilayari menerusilaman web BPFK (www.bpfk.gov.my).

Evaluation of Manufacturing Premises Lay-out Plans

A total of 35 lay-out plans for new and existingmanufacturing premises were evaluated, whichincluded 7 premises of scheduled poisonsmanufacturers, 9 non-scheduled poison, 13traditional medicines, 3 cosmetics and 3 others.

Growth Status of Licensed Premises.

Growth status of licensed premises formanufacturers, importers and wholesalers forthe year 1987 until 2001 are shown in Figure 2.In 2001, there were 227 licensed manufacturers,315 licensed importers and 722 licensedwholesalers contribute to 1264 in total.

List and detail information on licensed premisescan be browsed via NPCB homepage atwww.bpfk.gov.my. Information is updatedmonthly.


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Rajah 1 : Pemeriksaan APB Premis PengilangFigure 1 : GMP Inspection of Manufacturing Premise

1995 - 2001

Rajah 2 : Bilangan Premis BerlesenFigure 2 : Number Of Licensed Premises

1987 - 2001

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Taburan Geografi Premis Berlesen

Taburan geografi premis-premis berlesen bagitahun 2001 adalah seperti yang digambarkandalam Rajah 3. Negeri Selangor mempunyaipremis berlesen yang paling banyak, diikuti olehWilayah Persekutuan (Kuala Lumpur) dan PulauPinang di tempat ketiga.

Kategori Pengilang Berlesen

Kategori premis pengilang berlesen bagi tahun2001 adalah seperti yang dipaparkan dalamRajah 4. Negeri selangor mempunyai bilanganpremis pengilang yang tertinggi diikuti olehJohor dan Pulau Pinang.

Geographical Distribution of Licensed Premises.

Geographical distribution of licensed premisesfor the year 2001 is illustrated in Figure 3.Selangor scored the highest number of licensedpremises, followed by Wilayah Persekutuan(Kuala Lumpur) and Pulau Pinang at the thirdplace.

Categories of Licensed Manufacturing Premises

Categories of licensed manufacturing premisesfor the year 2001 are illustrated in Figure 4.Selangor scored the highest number of licensedmanufacturing premises, followed by Johor andPulau Pinang.


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Rajah 3 : Taburan Geografi Premis BerlesenFigure 3 : Geographical Distribution Of Licensed Premisis

2001

Rajah 4 : Kategori Premis Pengilang BerlesenFigure 4 : Categories Of Licensed Manufacturing Premises

2001

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Kadar Pertumbuhan Premis Berlesen

Kadar pertumbuhan premis berlesen adalahseperti yang digambarkan dalam Rajah 5. Bagitahun 2001, pengimport menunjukkan kadarpertumbuhan yang paling tinggi berbandingpengilang dan pemborong. Padakeseluruhannya, kadar pertumbuhan yangdicatatkan ialah 3.9% berbanding 7.5% padatahun 2000.

Khidmat Nasihat

Bagi tahun 2001, sebanyak 125 khidmat nasihattelah diberikan berbanding 210 pada tahun2000, 196 pada tahun 1999, 185 pada tahun1998 dan 140 pada tahun 1997. Daripada jumlahyang dicapai, 13 daripadanya adalah berkaitanAPB keluaran racun, 15 keluaran bukan racun,73 ubat tradisional, 17 kosmetik dan 7 lain-lain.Statistik bagi tahun 1997 hingga 2001 adalahseperti yang ditunjukkan dalam Rajah 6.

Growth Rate of Licensed Premises

Growth rate of licensed premises are illustratedin Figure 5. In 2001, importer shows the highestgrowth rate as compared to manufacturer andwholesaler. As a whole, recorded growth ratewas 3.9% compared to 7.5% in year 2000.

Advisory Service

In 2001, a total of 125 advisory services weregiven compared to 210 in 2000, 196 in 1999, 185in 1998 and 140 in 1997. From these numbers ofachievements, 13 of them were related to GMPscheduled poison, 15 non-scheduled poison, 73traditional medicine, 17 cosmetic and 7 others.Statistics for the year 1997 until 2001 isillustrated in Figure 6.


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Rajah 5 : Kadar Pertumbuhan Premis BerlesenFigure 5 : Growth Rate of Licensed Premises

1988 - 2001

Rajah 6 : Khidmat NasihatFigure 6 : Advisory Service

1997 - 2001

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PEMPROSESAN LESEN

Lesen Pengilang

Sebanyak 247 lesen pengilang telah diprosespada tahun 2001 berbanding 289 pada tahun2000, 237 pada tahun 1999, 148 pada tahun1998 dan 100 pada tahun 1997. Daripada jumlahini, 26 adalah permohonan baru manakala 221lagi adalah pembaharuan.

lesen Pengimport

Bagi lesen pengimport, sebanyak 330permohonan telah diterima dan diproses.Daripada jumlah ini, 41 daripadanya adalahpermohonan baru dan 289 adalahpembaharuan. Bilangan permohonan didapatitelah menurun berbanding 424 pada tahun2000, 305 pada tahun 1999, 255 pada tahun1998 dan 171 pada tahun 1997. Bilanganpermohonan yang diterima telah menurunsebanyak 22.2% daripada tahun sebelumnya.

Lesen Pemborong

Bilangan permohonan lesen pemborong yangdiproses adalah sebanyak 774, di mana 73daripadanya adalah permohonan baru dan 701adalah pembaharuan. Bilangan permohonanyang diproses telah meningkat 6.3%berbanding tahun 2000.

Senarai Tambahan Keluaran Berdaftar

Jumlah permohonan yang diproses pada tahun2001 adalah sebanyak 255 dan ini meliputisebanyak 937 produk. Pada tahun 2000, jumlahpermohonan adalah sebanyak 299 danmelibatkan 1,228 produk berbanding 314permohonan yang melibatkan 1,928 produkpada tahun 1999 dan 343 permohonanmelibatkan 1,844 produk pada tahun 1998.Rajah 8 menunjukkan statistik bagi pengeluaransenarai tambahan produk untuk tahun 1998hingga 2001.

LICENCE PROCESSING

Manufacturer’s Licence

A total of 247 manufacturer’s licences wereprocessed in 2001 compared to 289 in 2000, 237in 1999, 148 in 1998 and 100 in 1997. From thistotal number, 26 are new applications whereasthe remaining 221 are renewals.

Importer’s Licence

A total of 330 applications were received andprocessed for import licence. From this total, 41applications are new applications and 289 arerenewal. The number of applications hasdecreased significantly, compared to 424 in2000, 305 in 1999, 255 in 1998 and 171 in 1997.The number of application has decreased by22.2 % from the previous year.

Wholesaler’s Licence

The number of application processed forwholesaler’s licence was 774, whereby 73 werenew applications and 701 renewals. The numberof applications processed increased by 6.3% ascompared in 2000.

Additional Lists for Registered Products

The total number of applications processed in2001 was 255 and these include 937 products. In2000, the number of applications was 299 andthese include 1,228 products compared with 314applications and 1,928 products in 1999, 343applications and 1,844 products in 1998. Figure8 shows statistic for issuance of additionalregistered product list for the year 1998 until2001.


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Rajah 7 : Pemprosesan LesenFigure 7 : Processing of Licences

1995 - 2001

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Pertukaran Pemegang Lesen

Bagi tahun 2001, sebanyak 24 permohonanpertukaran pemegang lesen telah diproses dimana 3 adalah untuk pengilang, 8 pengimportdan 13 pemborong. Bilangan yang dicapai telahmeningkat 4.3% berbanding tahun 2000.Statistik bagi permohonan pertukaranpemegang lesen bagi tahun 1998 hingga 2001adalah seperti yang ditunjukkan dalam Rajah 9.

Change of Licence Holder.

In 2001, a total of 24 applications for change oflicence holder were processed, whereby 3 weremanufacturers, 8 importers and 13 wholesalers.The number of achievements was increased to4.3% as compared in 2000. Statistics for changeof holder for the year 1998 until 2001 isillustrated in Figure 9.


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Rajah 8 : Senarai Tambahan Keluaran BerdaftarFigure 8 : Issuance Of Additional Registered Product List

1998 - 2001

Rajah 9 : Permohonan Pertukaran Pemegang LesenFigure 9 : Application for Change of Holder

1998 - 2001

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Perakuan APB Untuk Tujuan Eksport

Pada tahun 2001, jumlah perakuan APB yangdikeluarkan adalah sebanyak 151 berbanding181 pada tahun 2000, 101 pada tahun 1999, 124pada tahun 1998 dan 80 pada tahun 1997.Perakuan ini adalah untuk negara-negaraseperti Albania, Barbados, Botswana, Brazil,Brunei, Bulgaria, Kemboja, China, Costa Rica,Denmark, Mesir, Ethiopia, Honduras, HongKong, India, Iraq, Jordan, Kenya, Korea, Kuwait,Laos, Libya, Lithuania, Malawi, Maldives, Malta,Mauritius, Mexico, Morocco, Myanmar, NewZealand, Nigeria, Oman, Papua New Guinea,Filipina, Poland, Arab Saudi, Sierra Leone,Singapura, Slovakia, Sri Lanka, Afrika Selatan,Surinam, Taiwan, Tanzania, Thailand, Turki,Uganda, Venezuela, Vietnam, Yaman danZambia.

Tindakan Punitif

Pihak Berkuasa Kawalan Dadah (PBKD) telahmenggantung sementara lesen pengilang bagi 2premis pada tahun 2001 berbanding 4 padatahun 2000, 5 pada tahun 1999, 3 pada tahun1998 dan 6 pada tahun 1997.

TWG GMP

Kumpulan kerja teknikal (TWG) GMP telahmenganjurkan 4 bengkel latihan APB bercorakmodul untuk industri farmaseutikal. Bidang-bidang yang diliputi adalah seperti berikut :

GMP Certification

In 2001, the total number of GMP certificatesissued was 151, as compared with 181 in 2000,101 in 1999, 124 in 1998 and 80 in 1997. Thesecertifications are for countries such as Albania,Australia,Barbados,Botswana, Brazil, Brunei,Bulgaria, Cambodia, China, Costa Rica,Denmark, Egypt, Ethiopia, Honduras, HongKong, India, Iraq, Jordan, Kenya, Korea, Kuwait,Laos, Libya, Lithuania, Macau, Malawi, Maldives,Malta, Mauritius, Mexico, Morocco, Myanmar,New Zealand, Nigeria, Oman, Papua NewGuinea, Philippines, Poland, Saudi Arabia, SierraLeone, Singapore, Slovakia, Sri Lanka, SouthAfrica, Sudan, Suriname, Taiwan, Tanzania,Thailand, Turkey, Uganda, Venezuela, Vietnam,Yemen, and Zambia.

Punitive Actions

DCA has temporarily suspended manufacturer’slicences or part of manufacturing lines for twopremises in 2001 compared with 4 in 2000, 5 in1999, 3 in 1998 and 6 in 1997.

TWG GMP

The GMP Technical Working Group (TWG) hasconducted four training workshop in GMP modularfor local pharmaceutical industries (similar modules asin the previous year). The modules carried out were:


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Rajah 10 : Permohonan Perakuan Amalan Perkilangan Baik (APB)Figure 10 : Application of Good Manufacturing Pratice (GMP) Certificates

1997 - 2001

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Module 1 – Quality Assurance and GMP Auditing

Module 2 – GMP Documentation and Records

Module 3 – Introduction to Good Laboratory Practices

Module 4 – GMP for Utilities & Services

Seminar APB

Latihan dokumentasi untuk pengilang ubattradisional telah diadakan di Langkawi, Kedahpada 25 – 26 April 2001 dengan dibantu olehPURBATAMA Northern Branch. Satu seminarmengenai ‘Current Good ManufacturingPractices for Pharmaceuticals’ juga telahdiadakan. Seminar ini dikendalikan oleh Mr.Alan Duff, juruaudit dari TGA Australia dengankerjasama MOPI (Malaysian Organisation ofPharmaceutical Industries).

Permohonan Untuk Menjadi Ahli PIC/S

Pada 12 – 16 Mac 2001, satu delegasi seramaienam juruaudit dari PIC/S, yang diketuai olehpengerusinya, Mr. Bob Tribe, Mr. Daniel Brunnerdan delegasi dari United Kingdom, Switzerland,Republik Slovak dan Singapura telah datanguntuk menilai Sistem Kualiti APB dan prosedurpemeriksaan. Delegasi tersebut juga telahmembuat pemerhatian ke atas juruaudit APB(BPFK) semasa pengauditan empat premiskilang. Secara keseluruhannya, para juruauditberpuas hati dengan sistem kualiti dan mutupengauditan yang dilakukan.Walaubagaimanapun, masih terdapat sedikitkelemahan yang perlu diperbaiki dan diambiltindakan sebelum diterima menjadi ahli PIC/S.

Dalam ‘Mesyuarat Rasmi Jawatankuasa PIC/S’ diPrague, Republik Czech pada 21 – 25 Mei 2001,mereka mengambil keputusan untuk menerimaMalaysia sebagai ahli PIC/S mulai 1 Januari 2002,dengan syarat Malaysia haruslah mengambilbeberapa langkah untuk memperbaiki semuakelemahan yang dikenalpasti melalui auditterdahulu.

Audit susulan telah dijalankan oleh duajuruaudit yang diketuai oleh Mr. Bob Tribe,pengerusi PIC/S dan Mr. Sia dari Singapura

Module 1 – Quality Assurance and GMP Auditing

Module 2 – GMP Documentation and Records

Module 3 – Introduction to Good Laboratory Practices

Module 4 – GMP for Utilities & Services

GMP Seminar

Documentation training for traditionalmedicine manufacturers was conducted inLangkawi, Kedah on 25 – 26 April 2001 with theassistance of PURBATAMA Northern Branch, fortraditional manufacturers. A seminar on CurrentGood Manufacturing Practices forpharmaceuticals was also conducted by Mr. AlanDuff, Senior Auditor of TGA Australia with theco-operation of Malaysia Organization ofPharmaceutical Industries (MOPI).

Application of Pharmaceutical InspectionCooperation Scheme - PIC/S Membership

On 12 – 16 March 2001, a delegate of sixauditors from PIC/S, lead by its chairman Mr. BobTribe, PIC/S Secretary, Mr. Daniel Brunner anddelegates from United Kingdom, Switzerland,Slovak Republic and Singapore evaluated ourGMP Quality System and inspectionprocedures.The delegates observed our GMPauditors during the auditing of fourmanufacturing premises. Overall they werequite satisfied with our quality system and thestandard of auditing but there were still someweaknesses that we had to improve and takeaction before we become a member.

During the PIC/S Committee of Official Meetingin Prague, Czech Republic on 21 - 25 May 2001,the committee decided to admit Malaysia as amember of PIC/S from 1 January 2002, providedthat Malaysia take the necessary action on allthe weaknesses from previous audit.

Follow-up audit by a delegate of two auditorslead by Mr. Bob Tribe, chairman of PIC/S and Mr.Sia from Singapore. Our auditors conducted the


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semasa juruaudit BPFK mengendalikanpemeriksaan ke atas dua premis. Mereka amatberpuas hati dengan langkah-langkah yangdiambil untuk memperbaiki kelemahan sertapeningkatan dalam tahap/mutu pengauditantersebut.

Dalam ‘Mesyuarat Rasmi Jawatankuasa PIC/S Ke-13’ di Geneva pada 27 dan 28 November 2001,pengerusi PIC/S dengan rasminya telahmengumumkan bahawa Malaysia telah diterimasebagai ahli PIC/S yang ke-26 mulai 1 Januari2002.

Garispanduan APB Kosmetik

Deraf akhir ‘Garispanduan APB Kosmetik’ telahdibincangkan ketika ‘ASEAN ConsultativeCommittee for Standard and Quality (ACCSQ)Cosmetic Product Working Group’ di Ho ChiMinh, Vietnam. Anggota ASEAN telah bersetujuuntuk menggunakannya sebagai ‘GarispanduanKosmetik ASEAN’.

Seminar Mengenai Pendaftaran Kosmetik

Bahagian ini juga terlibat dalam seminar yangdianjurkan bersama dengan Unit Kosmetikuntuk memupuk kesedaran mengenaikeperluan pendaftaran, Amalan PerkilanganBaik (APB) untuk kosmetik dan dokumentasilain. Ia meliputi Sabah dan Sarawak.

Juruaudit Kontrak

Latihan APB telah disediakan kepada PegawaiPenguatkuasa, Unit Penguatkuasa Negeri yangseterusnya akan dilantik sebagai juruauditkontrak. Kerjasama dengan Unit PenguatkuasaNegeri telah dipertingkatkan melaluipemeriksaan bersama yang dijalankan ke ataspengilang ubat tradisional, farmaseutikal danOTC.

PERANCANGAN UNTUK TAHUN 2002

Latihan APB Farmaseutikal Bercorak Modul

Program latihan APB bercorak modul akanbermula pada Februari dan berakhir pada Jun2002. Program ini dikelolakan bersama denganMOPI.

audit on two premises. They were veryimpressed and satisfied with the actions takenon the weaknesses and improvements on thestandard of the audit.

On the 13th PIC/S Committee Official Meeting inGeneva on 27 and 28 November 2001, theChairman officially announced that Malaysia isaccepted as 26th member of PIC/S starting from1 January 2002.

Cosmetic GMP Guidelines

The final draft of Cosmetic GMP Guidelines wasdiscussed during ASEAN ConsultativeCommittee for Standard and Quality (ACCSQ)Cosmetic Product Working Group in Ho ChiMinh City, Vietnam. Principly ASEAN membersagreed to adopt it as ASEAN CosmeticGuidelines.

Cosmetic Registration Awareness Road Show

This division was also involved in the road showtogether with Cosmetic Unit to create theawareness on the requirement of registration,requirement of GMP for cosmetic and otherdocumentation. It covered central, northern,southern region, Sarawak and Sabah.

Contract Auditor

GMP training was provided to chosen EnforcementOfficers of the State Enforcement Unit who werelater appointed as Contract Auditors. The co-operation with the State Enforcement Unit wasenhanced by joint inspection in the pre-licensinginspection of traditional medicine manufacturers,pharmaceutical and over-the-counter (OTC)manufacturers.

PLANS FOR YEAR 2002.

GMP Modular Training

The GMP modular training will start in Februaryand ends in June 2002. This program is jointlyorganized with MOPI.


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Module 5 – GMPs for Equipment, Cleaning and Computerized System

Module 6 – Process Validation, Plan and Protocol

Module 7 - Facility, Materials and Environment Control

Module 8 - Process Control- Manufacturing and Packaging

Module 9 - Staff Development and GMP Training

Pusat Industri Farmaseutikal

Menjalankan pengubahsuaian terakhir ke atasPusat Industri Farmaseutikal dan melengkapkaninfrastruktur pusat ini dengan perabot danbahan-bahan pameran. Setelah lengkap, pusatini akan menjadi pusat rujukan bagi semuapengilang-pengilang.

Keahlian PIC/S

Oleh kerana Malaysia akan menjadi ahli PIC/Smenjelang 1 Januari 2002, BPFK akan terlibat didalam pelbagai aktiviti PIC/S seperti mesyuarat,seminar, bengkel latihan, pemeriksaan bersamadan sebagainya. Sebagai ahli baru, Malaysiadigalakkan untuk menyertai seberapa banyakaktiviti yang dianjurkan bagi memastikanbahawa Malaysia memainkan peranan yangaktif sebagai ahli PIC/S.

Bengkel Dokumentasi APB untuk PengilangUbat Tradisional

Bengkel mengenai dokumentasi sangatberguna kepada pengilang-pengilang ubattradisional. Pertubuhan atau badan-badanberkenaan akan diminta untuk bersama-samamengelolakan bengkel-bengkel tersebut untukahli-ahli mereka dan lain-lain.

ASEAN Pharmaceutical Harmonization

Sebagai ahli negara-negara ASEAN, Malaysiatelah menyumbang dan memainkan perananyang aktif di dalam “harmonization of ASEANPharmaceutical”. Sebagai ahli PIC/S pula,Malaysia akan memainkan peranannya dalammemastikan bahawa keperluan semasa APBselaras dengan garispanduan antarabangsa.

Module 5 – GMPs for Equipment, Cleaning and Computerized System

Module 6 – Process Validation, Plan and Protocol

Module 7 - Facility, Materials and Environment Control

Module 8 - Process Control- Manufacturing and Packaging

Module 9 - Staff Development and GMP Training

Pharmaceutical Industry Centre

To carry out final renovation of thePharmaceutical Industry Centre, to equip thecentre with furniture and exhibits. Whencompleted, the centre will be a reference centrefor manufacturers.

PIC/S Members

As Malaysia will be a member of PIC/S by 1January 2002, we will be involved in a lot ofPIC/S activity such as meetings, seminars,training, joint inspections and others. Malaysiaas a new member is encouraged to join as manyactivities as possible to ensure that we play anactive role as a member.

GMP Documentation Workshop for TraditionalMedicines Manufacturers

The workshop on documentation will be veryuseful for traditional medicine manufacturers.The respective organization or bodies will beasked to jointly organize the workshops fortheir members and others.

ASEAN Pharmaceutical Harmonization

Malaysia as a member of ASEAN Nation hadcontributed and plays an active part in theharmonization of ASEAN Pharmaceutical. As amember of PIC/S, Malaysia will play its part inensuring that the current GMP requirement willharmonize with the international guidelines.


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BAHAGIAN SURVEILANS DANFARMAKOVIGILANS

OBJEKTIF

Objektif Bahagian Surveilans danFarmakovigilans adalah untuk memastikansecara berterusan bahawa semua keluaran yangberdaftar dengan Pihak Berkuasa KawalanDadah adalah selamat, berefikasi danmemenuhi tahap kualiti yang diiktiraf.

PENCAPAIAN

Secara kesimpulan, pencapaian bahagian initerbahagi kepada tiga aktiviti utama iaitusurveilans rutin, penyiasatan ke atas aduanmengenai produk dan pemonitoran profilkeselamatan produk seperti yang ditunjukkandalam Gambarajah 1.

SURVEILANS

Untuk tahun 2001, 1487 sampel keluaranberdaftar di Malaysia telah diambil untuksurveilans. Walaupun ini hanya mewakili 5.5%jumlah produk yang berdaftar dibawah PBKD, iamemberi satu petanda ukur yang memuaskanterhadap kualiti produk yang terdapat di dalampasaran tempatan.

Kesemua sampel yang diambil dibawahprogram surveilans ini dihantar ke BahagianAnalisis Ubat untuk dianalisa. Ujian ke atasproduk yang mengandungi racun berjadual(ubat preskripsi) dan persediaan bukan racundijalankan mengikut protokol analisa terkiniyang dikemukakan oleh pengilang. Ujian keatas ubat-ubatan tradisional dijalankanberpandukan ujian yang ditetapkan, contohnya,ujian-ujian untuk pencemaran mikrob dankulat, logam berat serta ujian-ujianfarmaseutikal asas.

SURVEILLANCE &PHARMACOVIGILANCE DIVISION

OBJECTIVES

The objectives of the Surveillance andPharmacovigilance Division are to ensure thatproducts registered by the Drug ControlAuthority (DCA) are safe, efficacious and meetthe established standards of quality.

ACHIEVEMENTS

The achievements of this division aresummarised under the three main activitiesconducted i.e. routine surveillance, investigationof product complaints and the monitoring ofthe safety profile of products as shown in Fig.1.

SURVEILLANCE

During the year 2001, a total of 1487 registeredproducts were sampled for quality testing.Although this represents only approximately5.5% of the total number of products registeredby the DCA, it gives a fairly good reflection ofthe quality of products available on the localmarket.

All the samples picked up under the surveillanceprogram were sent to the Drug Analysis Divisionfor testing. Testing of products containingscheduled poisons (prescription drugs) and over-the-counter drugs were carried out inaccordance to the latest protocols of analysissupplied by the manufacturers. Testing oftraditional medicines was done in line with theestablished tests for this group of products i.e.testing for microbial and fungal contamination,heavy metals and basic test pharmaceuticaltests.


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Figure 1 : Workload under the activities of surveilance, investigation ofproducts complaints of activities and ADR monitoring

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Disebabkan lebihan dari tahun sebelumnya,keputusan daripada makmal adalah untuk 1536keluaran. Analisis kadar kegagalan keluaranyang telah diuji berdasarkan kategori keluaranditunjukkan pada Gambarajah 2.

PANGGILBALIK

Bukan kesemua produk yang gagal ujianmakmal memerlukan panggilbalik. Sekiranyakegagalan ujian tersebut tidak mempengaruhikualiti produk secara ketara, surat amarandikemukakan kepada pemegang pendaftaran.Arahan telah dikeluarkan untuk membuatpanggilbalik terhadap 100 kelompok keluarandimana 9 adalah keluaran racun berjadual, 6persediaan bukan racun dan 85 keluarantradisional. 22 keluaran lagi (13 – racun; 7 –bukan racun; 2 – tradisional) telahdipanggilbalik secara sukarela oleh pemegangpendaftaran keluaran berdasarkan aduan yangditerima terhadap keluaran tersebut.

Tiada panggilbalik yang begitu serius yangmenghendaki panggilbalik Paras I atau II. Semuapanggilbalik adalah panggilbalik Paras III, TahapB iaitu dilakukan dalam tempoh 30 hari dansehingga tahap peringkat penjualan/pembekalan kepada pelanggan.

Due to a spillover from the previous year, resultswere received rom the laboratory for 1536products. An analysis of the failure rate ofproducts tested by category of products isshown in Fig.2.

RECALLS

Not all products which fail the laboratory testsare required to be recalled. Where the testsfailed are deemed not to significantly affect thequality of products, warning letters are issued tothe registration holders. Instructions were issuedfor the recall of 100 batches of products ofwhich 9 were products containing scheduledpoisons, 6 were over-the-counter preparationsand 85 were traditional medicines. 22 otherproducts (13 - poisons; 7 - OTC; 2 - traditional)were recalled voluntarily by the productregistration holders mainly based on productcomplaints (Table 1).

There were no recalls which were seriousenough to warrant a Degree I or Degree II recall.All recalls were Degree III recalls i.e. carried outover period of 30 days and were done up toLevel B which is up to the point of distribution.


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Table 1: Product Recalls (directive + voluntary)

Year 1996 1997 1998 1999 2000 2001

Total No. 37 32 93 148 148 122of Recalls

Category NA NA NA 35 20 93 32 17 99 22 13 87(A/X/T)

A=Poisons; X=OTC; T=Traditional

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ADUAN TERHADAP KELUARAN BERDAFTAR

Bilangan aduan terhadap keluaran berdaftarbertambah ke 124 Keluaran aduan dalam tahun2001 berbanding 110 aduan dalam tahun2000.

Tindakan susulan telah diambil untukmenyelesaikan aduan-aduan ini dalam tempoh6 minggu dalam lebih dari 90% kes.

PEMONITORAN ADR

Terdapat sedikit peningkatan dalam jumlahlaporan kesan advers ubat yang diterima dalamtahun 2001, iaitu sebanyak 811 laporanberbanding dengan 794 laporan dalam tahun2000 (Gambarajah 3).

Bilangan laporan yang diterima daripadapelbagai negeri ditunjukkan pada Gambarajah4 dengan jumlah laporan tertinggi yangdihantar adalah dari Hospital Kuala Lumpur dannegeri Selangor.

PRODUCT COMPLAINTS

The number of product complaints forregistered products increased in 2001 with atotal of 124 complaints being received ascompared to 110 in the previous year.

Action was taken to resolve these complaintswithin 6 weeks in more than 90% of the cases.

ADR MONITORING

The number of adverse drug reactions reportsreceived increased slightly in 2001 as a total of811 reports were received as to 794 in 2000(Fig. 3).

The reporting rate of the various states is asshown in Figure 4 with the highest number ofreports being submitted from the Kuala LumpurGeneral Hospital and from the state of Selangor.


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Rajah 3 : Bilangan Laporan DiterimaFigure 3 : Number of ADR reports Received

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ANALYSIS OF ADRs BY REPORTING STATES

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Usaha telah dijalankan untuk menggalakkanpenglibatan daripada pelbagai bidang untukmempertingkatkan kadar laporan ADR di manasebelum ini banyak bergantung kepada doktordari sektor awam.

PERJAWATAN

Terdapat beberapa perubahan ketara dalamperjawatan di bahagian ini. Oleh keranakenaikan pangkat, Pn. Nik Noriah Nik Husseintelah meninggalkan bahagian ini manakala En.Kamaruzaman melanjutkan pendidikan denganmengikuti program Ijazah Kedoktoran.

Pn. Mazlin Mastar, Pn. Sathikala dan Pn. SurianiIbrahim menyertai bahagian ini untukmenggantikan pegawai-pegawai tersebut sertauntuk mengisi satu jawatan yang baru dibentukakibat bebanan kerja yang kian meningkat.

LATIHAN

Selaras dengan hasrat Biro PengawalanFarmaseutikal Kebangsaan untuk melaksanakansistem kualiti sejajar dengan standard ISO 9001,pegawai-pegawai farmasi bahagian ini telahdiberikan latihan dalam ISO 9001.

Sejajar dengan pelaksaan pendaftaran untukbarangan kosmetik, pegawai-pegawai farmasibahagian ini turut menyertai BengkelPendaftaran Kosmetik yang dikendalikanbersama oleh BPFK dan industri kosmetik.

Pn. Abida Haq telah menyertai "DIA-TGAFellowship Program on Post-Market Vigilance ofTherapeutic Goods" di Australia selama 10 hari.

PRESENTAS

Selaras dengan polisi Biro PengawalanFarmaseutikal Kebangsaan untuk memberilatihan kepada industri dan menyebarkanmaklumat kepada pengguna terakhir, bahagianini terlibat di dalam penyampaian beberapakertas pada pelbagai forum dalam topikberkaitan dengan surveilans dan pemonitorankeselamatan ubat.

Pn. Abida Haq juga telah memberi satupresentasi bertajuk "Monitoring TraditionalMedicines: The Malaysian Experience" padamesyuarat "24th Annual Meeting of NationalCentres Participating in the WHO Program forDrug Safety Monitoring" di New Zealand.

PERANCANGAN

Selain dari surveilans rutin, bahagian surveilansjuga merancang untuk menjalankan surveilansberdasarkan isu-isu khusus contohnya‘pengskrinan’ ubat-ubatan tradisional untukadulterasi.

Program latihan ADR khususnya untuk hospitalsedang dirancang demi mempertingkatanpelaporan ADR daripada hospital danmeningkatkan penglibatan farmasi hospitaldalam program ini.

Efforts were made to encourage a multidisciplinaryapproach to improve the reporting rate of ADRswhich previously relied mainly on doctors in thepublic sector. In 2001, there was a slight increase inthe number of ADRs reported by doctors from theprivate sector. Unfortunately, the number of ADRsreported by doctors from government hospitalsdecreased slightly but there was a slight increase inthe number of reports submitted by pharmacists.There was no significant difference in themonitoring of ADRs by pharmaceutical industry in2001 as compared to 2000 (Fig.5).

STAFFING

The year 2001 saw some changes in this divisionwith several significant changes to staffing. Pn. NikNoriah Nik Husein left the division as a result of apromotion and Mr. Karamruzaman left to do aPhD.

Pn. Mazlin Mastar, Pn. Sathikala and Pn. SurianiIbrahim joined this division to replace the officerswho left and to fill a new post which was createdin view of the increasing workload.

TRAINING

As the National Pharmaceutical Control Bureauwas to implement a quality system in complianceto ISO 9001 standards, the pharmacists under thisdivision were given training on ISO 9001.

In view of the implementation of the registrationfor cosmetics, the pharmacists also attended theCosmetic Registration road shows which wereconducted conjointly by NPCB and the cosmeticsindustry.

Pn. Abida Haq attended the DIA-TGA FellowshipProgram on Post-Market Vigilance of TherapeuticGoods in Australia.

PRESENTATIONS

In line with the National Pharmaceutical ControlBureau’s policy to provide training for the industryand to disseminate information to end-users, thisdivision was involved in presenting several papersat various forums on topics pertaining tosurveillance and drug safety monitoring.

Pn. Abida Haq also gave a presentation entitiled"Monitoring Traditional Medicines: the MalaysianExperience" during the 24th Annual Meeting ofNational Centres Participating in the WHOProgram for Drug safety Monitoring in NewZealand.

FUTURE PLANS

Besides the routine surveillance of registeredproducts, the surveillance division plans to conductsurveillance based on specific issues such asscreening of selected traditional medicines foradulteration.

An ADR training program especially for hospitals isbeing planned in a move to improve the reportingof ADRs from hospitals and also to increase theinvolvement of hospital pharmacists in thisprogram.


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BAHAGIAN ANALISIS UBAT

PENGAWALAN MUTU UBAT

Bahagian Analisis Ubat (BAU) meneruskanperanan yang efektif dalam kawalan kualitiproduk yang merupakan satu komponenpenting dalam penilaian produk farmaseutikal.Produk yang diterima merangkumi produkuntuk permohonan pendaftaran, pengawasanmutu ubat di pasaran ke atas keluaranberdaftar, kes-kes aduan untuk keluaranberdaftar dan sampel dari penguatkuasaan.Ujian yang dijalankan meliputi ujian-ujiankimia, fizikal, mikrobiologi, farmakologi dantoksikologi, yang merangkumi berbagai-bagaijenis ujian seperti ujian identifikasi, berbagaijenis ujian had, penentuan kandungan bahandalam produk dan juga penelitian kepadapelbagai parameter prestasi dosis. Kriteriauntuk penerimaan keputusan ujian berasaskankepada farmakopia, spesifikasi dalaman atauhad/spesifikasi pengilang yang diluluskan.

PENCAPAIAN

Pencapaian BAU bagi tahun 2001 adalah sepertiberikut:

BEBAN KERJA

Pengujian sampel

Sepanjang tahun 2001, BAU telah mengujisebanyak 4,626 sampel (Rajah A) danmenjalankan 28,096 ujian (Rajah B). Berbandingdengan pencapaian di tahun 2000, bilangansampel yang diuji telah menurun sebanyak16.5% sementara bilangan ujian yang dilakukanjuga menurun sebanyak 17.7%.

DRUG ANALYTICAL DIVISION

QUALITY CONTROL

Drug Analytical Division (DAD) continues to playan effective role in quality control assessment ofproducts which constitute an importantcomponent of pharmaceutical productevaluation. The products received includesamples submitted for registration, registeredproducts submitted for post marketingsurveillance, complaint samples andenforcement samples. The tests conductedinclude chemical, physical, microbiological,pharmacological and toxicological, coveringvarious types such as identification tests, thevarious limit tests, quantitation of the contentin the product and also assessing the variousdosage performance parameters. Acceptancecriteria are based on pharmacopoeia, in-houseor approved manufacturers’ limits andspecifications.

ACHIEVEMENT

The achievements of DAD in 2001 aresummarised as follows :

WORKLOAD

Analysis of samples

Throughout the year 2001, DAD had analysed atotal of 4626 samples (Figure A) whichgenerated a total of 28,096 tests (Figure B). Incomparison to the achievement in 2000, thenumber of samples analysed has decreased by16.5% while the number of tests done were alsodecreased by 17.7%.


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Rajah A: Bilangan Sampel DiujiFigure A: (Number of Samples Tested)

12000

10000

8000

6000

4000

2000

0

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

1069811337

8517

7472

9987

71416343 6623

4922 4583

5539

4626


Rajah A : Bilangan Sampel DiujiFigure A : Number of Samples Tested

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Jenis-jenis ujian yang dilakukan bolehdikategorikan sebagai ujian had mikrobial(MLT), kimia, logam berat (As,Hg,Pb,Cd),pengecaian, pelarutan, steriliti, endotoksinbakteria, dan lain-lain seperti toksisiti, biokimia,biologikal, bilangan partikel, esei antibiotik.Pecahan ujian-ujian tersebut diilustrasikandalam Rajah C.

Jenis sampel yang di terima

Jenis sampel yang diterima diperjelaskan dalamRajah D. Untuk sampel pendaftaran yangditerima, perbandingan keluaran tradisionaldan bukan tradisional diilustrasikan dalamRajah E dan perbandingan keluaran import dantempatan digambarkan dalam Rajah F.

The types of tests done can be categorized asmicrobial limit test (MLT), chemical, heavymetals (As, Hg, Pb, and Cd), disintegration,dissolution, sterility, bacterial endotoxin andothers such as toxicity, biochemical, biological,particle counts and antibiotic assay. Thebreakdown of the tests done is illustrated inFigure C.

Types of sample received

The types of samples received are illustrated inFigure D. With respect to registration samplesreceived, a comparison between traditional andnon-traditional samples is indicated in Figure Eand comparison between imported and locally-manufactured samples is illustrated in Figure F.


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Rajah B: Bilangan Ujian DijalankanFigure B: (Number of Tests Done)

40000

35000

30000

25000

20000

15000

10000

5000

0

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001


Rajah C: Jenis ujian yang dianalisaFigure C: Type of Tests Analysed

Pengecaian(4%)

Disintengration(4%)

Pelarutan(2%)

Dissolution(2%)

Lain-lain(1%)

Others(1%)

Logam Berat(14%)

Heavy Metals(14%)

Kimia(26%)

Chemicals(26%)

Had Mikrobial(50%)

Microbial Limit(50%)

Bakteria(1%)

Endotoksin(1%)

Steriliti(2%)

Sterility(2%)


Rajah B : Bilangan Ujian DijalankanFigure B : Number of Test Done

Rajah C : Jenis ujian yang dianalisaFigure C : Type of Tests Analysed

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Sampel gagal ujian

Penganalisaan terhadap keputusan ujianmenunjukkan bahawa 10.2% daripada jumlahujian telah gagal (Rajah G) dan ini menunjukkanpeningkatan sebanyak 1.7% dari tahun 2000.

BAU telah melantik Therapeutic GoodsAdministration (TGA) Laboratories Australia danSirim QAS Sdn. Bhd. sebagai makmal ketigauntuk menjalankan ujian yang gagal untuksampel-sampel pengawasan mutu ubat di

Failed samples

Additionally analysis of the test results hasshown that 10.2% of the tests done had failedlaboratory tests (Figure G). This showed anincreased of 1.7% from year 2000 figure.

DAD had appointed Therapeutic GoodsAdministration (TGA) Laboratories Australia andSirim QAS Sdn. Bhd. as third laboratory torepeat the test on the failed market surveillancesamples. Four failed samples had been sent to


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Rajah D: Jenis Sampel DiterimaFigure D: Types of Samples Received

Unit PenguatkuasaanFarmasi & lain-lain

(2%)Pharmacy

Enforcement Unitand others

(2%)

Pengawasan(54%)

Surveillance(54%)

Pendaftaran(43%)

Registration(43%)

Aduan(1%)

Complaint(1%)


Rajah E: Perbandingan Sampel Ubat TradisionalDengan Sampel Lain

Figure E: Traditional Medicine Versus Other Samples

Sampel UbatTradisional

(45%)TraditionalMedicineSamples

(45%)Lain(55%)Others(55%)

Rajah F: Perbandingan Keluaran Import dan TempatanFigure F: Imported Versus Local Samples

KeluaranTempatan

(36%)Local

Samples(36%)

KeluaranImport(64%)

ImportedSamples

(64%)

Rajah G: Perbandingan Ujian dan Gagal PenganalisaanFigure G: Number of Tests Which Passed Versus

Number of Tests Which Failed Analysis

Bilangan ujiangagal

penganalisaan(10.2%)

Number oftests failing

analysis(10.2%)

Bilangan ujianlulus

penganalisaan(89.8%)

Number oftests passed

analysis(89.8%)


Rajah D : Jenis Sampel DiterimaFigure D : Type of Samples Received

Rajah E : Perbandingan Sampel UbatTradisional Dengan Sample Lain

Figure E : Traditional Medicine Versus OtherSample

Rajah F : Perbandingan Keluaran Import dan TempatanFigure F : Imported Versus Local Samples

Rajah G : Perbandingan Ujian dan Gagal PenganalisaanFigure G : Number of Tests Which Passed Versus Number

of Tests Which Failed Analysis

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pasaran. Empat sample yang gagal telah dihantar ke TGA atas persetujuan syarikatberkenaan untuk ujian ulangan dan keputusanyang di perolehi dari TGA juga gagal.

Pungutan hasil dari pengujian sampel

Oleh kerana bilangan ujian yang dijalankanmenurun, maka kos pengujian yang diperolehijuga telah menurun iaitu sebanyak 12.8% daritahun 2000 dengan pungutan sebanyak RM460,880.00 untuk tahun 2001.

Penilaian tatacara pengujian dan data validasi

Sebanyak 900 protokol penganalisaan telahditerima pada tahun 2001. Terdapatpeningkatan sebanyak 23.3% jika dibandingkandengan bilangan protokol pada tahun 2000. Inimencerminkan penambahan terhadappermohonan pendaftaran untuk keluaran difasa 1 dan 2. Penilaian protokol pada tahun2001 yang dapat diselesaikan kurang dari satubulan dikekalkan ditahap peratusan yang tinggiiaitu 97.7%, juga mematuhi petunjuk QAP.

Menjalankan Pemeriksaan Amalan PerkilanganBaik

BAU masih aktif memberi khidmat sokongandalam pemeriksaan Amalan Perkilangan Baik (APB)dalam aspek Amalan Makmal Baik. Dalam tahun2001, sebanyak 35 pemeriksaan (APB) untuk aspekmengenai Amalan Makmal Baik telah dilakukan keatas premis pengilang farmaseutikal tempatan danini adalah lebih tinggi dari bilangan yangdilaporkan pada tahun 2000 (11 pemeriksaan).

Pada bulan Mac 2001, empat orang pemeriksadari BAU telah terlibat dalam menjalankanpemeriksaan Amalan Perkilangan Baik dalamaspek Amalan Makmal Baik untuk tujuanmendapatkan pengiktirafan PIC/S. Berikutnyapada bulan Oktober 2001, dua orang pemeriksadari BAU juga telah terlibat dalam pemeriksaanyang serupa.

Piawai Rujukan

Pada tahun 2001, sejumlah 349 vial piawairujukan (ASEAN/BPFK) telah dibekalkan kepadajabatan kerajaan dan ini merupakanpeningkatan kepada jumlah pada tahun 2000(237 vial). Selain daripada itu, terdapatpeningkatan untuk jumlah piawai yang dijualkepada industri tempatan (470 vial pada tahun2001 berbanding dengan 446 vial pada tahun2000). Dalam tahun 2001 juga, sebanyak 215vial telah dijual ke luar negara sepertiCambodia, Bangladesh, Nepal dan Indonesia.Pungutan yang diperolehi daripada jualanpiawai rujukan adalah sebanyak RM59,822.50.50.

TGA with the company’s agreement and theresults from TGA are in accordance with DAD'sresults.

Collection from the analysis of samples

Since the number of tests done was decreasedhence the collection of analytical fees had alsobeen decreased by 12.8% with RM 460,880.00collected for the year 2001.

The evaluation of analytical protocols

900 analytical protocols were received in 2001. Thefigure showed an increase of 23.3% whencompared to the number received in 2000. Thisreflects an increase in the applications forregistration of products in phase 1 and phase 2 ofthe registration exercise. However in the year 2001,the protocol evaluation which was completed inless than one month has been maintained at highpercentage that is 97.7%, which also complied withthe NPCB QAP indicator.

Good Manufacturing Practice (GMP) Inspection

DAD continues to be active in GMP inspectionsfor Good Laboratory Practice (GLP) aspect. In2001, 35 GMP inspections were conducted onlocal pharmaceutical manufacturing premises.The figure showed an increased as compared toyear 2000 (11 inspections).

In March 2001, four auditors from DAD wereinvolved in GLP inspection for the purpose ofPIC/S certification. In October 2001, two auditorswere involved for the same purpose but theinspections were done on differentpharmaceutical manufacturing premises.

Reference Standards

In year 2001, a total of 349 reference standards(ASEAN/NPCB) were supplied to governmentdepartments and this figure reflects an increaseto the number reported in 2000 (237 vial). Therewas also an increase in the standards sold locally(470 vial compared to 446 vial in 2000). In year2001, a total of 215 vials were sold to foreigncountries namely Cambodia (189), Bangladesh(4), Nepal (4) and Indonesia (18). Total collectionfor year 2001 was of RM 59, 822.50.


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Latihan Yang Dikendalikan Oleh BAU

BAU telah menganjurkan bengkel ‘Evaluation ofAnalytical Method Validation Data‘ dari 11 Ogos2001 hingga 18 Ogos 2001 di manafasilitaturnya adalah Mr. Paul Sidhu dariTherapeutic Goods Administration (TGA)Australia. Para peserta terdiri daripada semuaPegawai Farmasi dari BAU manakala beberapapegawai dari bahagian lain di BPFK hanyamenghadiri sesi hari pertama sahaja. Tiga orangpeserta dari luar negara juga turut mengikutibengkel tersebut. Mereka adalah Dini PraptiKaryani dan Mirawati dari National Agency ofDrug and Food Control, Indonesia dan Mdm.Nam Nivanna dari National Laboratory for DrugQuality Control, Combodia.

Dalam tahun 2001, BAU telah memberi latihandalam aspek kawalan mutu kepada empatkumpulan pelatih dari luar negara dan satukumpulan pelajar Farmasi dari UKM. Merekatelah menjalani latihan sangkutan di makmal-makmal di BAU mengikut jadual yang telahdisediakan. Mereka adalah :

1. Mr. Farrouqe Ahmad, WHO Fellow dari Ministry of Health and Family Welfare, Government of Bangladesh (29 Januari 2001- 10 Februari 2001)

2. Mrs. Dorj Ulziidulam, WHO Fellow dari Mongolia (7 Mei 2001 – 1 Jun 2001)

3. Awg. Hj. Zulkiflee bin Hj. Mohammad dan Awg. Hj. Saifulbahri bin Hj. Mohsin, dari Bahagian Perkhidmatan Farmasi, Kementerian Kesihatan, Negara Brunei Darussalam (3 September 2001 – 5 Oktober 2001)

4. Mrs. Mery Meiya Mahajan dari Nepal dan Miss Rahima Khaitun dari Bangladesh (17 September 2001 – 29 September 2001)

5. Kumpulan pelajar Farmasi Tahun 3, Universiti Kebangsaan Malaysia (19 Mac 2001 – 6 April 2001)

Satu kumpulan pelajar Farmasi Tahun Akhir,Universiti Malaya telah melawat BAU pada 28Ogos 2001 sebagai salah satu daripada programlawatan sambil belajar mereka.

Latihan Untuk Kakitangan

BAU dengan kerjasama Fisher Scientific (M) S/Btelah menganjurkan seminar bertajuk‘Fundamental of Gas Chromatography‘ pada 12Jun 2001 bertempat di Dewan Anggerik BPFKuntuk semua Pembantu Farmasi yang bertugasdi BAU.

Trainings conducted by DAD and co-operationwith the industry

DAD had conducted a workshop on Evaluationof Analytical Method Validation Data from 11thtill 18th August 2001 with Mr. Paul Sidhu fromTGA Australia as a facilitator. Participants consistof officers from DAD, while a few officers fromother divisions of NPCB attended the firstsession on the first day. There were threeparticipants from the neighbouring ASEANcountries. They were Ms. Dini, Mrs. PraptiKaryani and Mirawati from National Agency ofDrug and Food Control, Indonesia and Mdm.Nam Nivanna from National Laboratory forDrug Quality Control, Cambodia.

In year 2001, DAD has given training in qualitycontrol aspects to three groups of trainees fromoversea and one group of Pharmacy studentsfrom UKM. They were attached to variouslaboratories in DAD according to the schedulewhich had been prepared for them. They were:

1. Mr. Farruque Ahmad, WHO Fellow from Ministry of Health and Family Welfare, Government of Bangladesh (29th January till 10th February 2001)

2. Mrs. Dorj ULziidulam, WHO Fellow from Mongolia (7th Mei till 1st Jun 2001)

3. Awg. Hj. Zulkiflee bin Hj. Mohammad and Awang Hj. Saifulbahri bin Hj. Mohsin from Bahagian Perkhidmatan Farmasi, Kementerian Kesihatan, Negara Brunei Darussalam

4. Mrs. Mery Meiya Mahajan from Nepal and Miss Rahima Khaitun from Bangladesh (17 September 2001 – 29 September 2001)

5. Third year Pharmacy Students, University Kebangsaan Malaysia (19th Mac till 6th April 2001)

A group of final year Pharmacy students fromUniversity Malaya visited DAD on 29 August2001 as part of their study tour program.

Training for DAD staff

DAD and Fisher Scientific (M) Sdn. Bhd. hadjoinedly organized a one day seminar onFundamental of Gas Chromatography on 12thJun 2001 held at Dewan Anggerik NPCB. For thesecond time, DAD and NIOSH organized acourse on Safety Use of Chemicals for DAD staff


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Untuk kali kedua, BPFK dengan kerjasamaNIOSH telah menganjurkan kursus KeselamatanDalam Penggunaan Bahan Kimia untukkakitangan BAU pada 19 – 20 Jun 2001 diDewan Anggerik BPFK. Satu kumpulan, 20orang Pembantu Farmasi telah menghadiriseminar dua hari pada 27 hingga 28 Ogos 2001yang dikendalikan oleh SUCXes Laboratory,University Malaya bertajuk ‘Basic and Principlesof HPLC in Pharmaceuticals Analysis’ di DewanAnggerik BPFK.

Pematuhan ISO 9002

BAU seperti bahagian-bahagian lain di BPFK,telah diaudit oleh Sirim QAS Sdn. Bhd. untuktujuan pensijilan MS ISO 9002 pada 18 April2001 hingga 20 April 2001. Sebelum itu sebagaipersediaan, BAU telah diaudit oleh sekumpulanaudit dalaman sebanyak dua kali.

Ahli baru BAU

BAU mengalu-alukan kedatangan 3 orangPegawai Farmasi dan 2 orang Pembantu Farmasibaru iaitu Cik Ida Syazrina Ibrahim, Cik AzrinaHassan, En. Othman Ahmad dan Puan ZuriatiNawi, Cik Rohaiza bt Zaitun masing-masing.

Mesyuarat Di luar Negeri

Timbalan Pengarah BAU, Pn. Hasiah bteAbdullah telah menghadiri ‘The 4th Meeting ofACCSQ Products Group on Pharmaceuticals’ diBali, Indonesia pada 27 hingga 28 September2001. Beliau adalah ketua delegasi bagiMalaysia untuk mesyuarat ini dan telahmembentangkan laporan aktiviti yangdikoordinasikan oleh Malaysia mengenai‘Administrative Data for RegistrationSubmission’.

Ketua Penolong Pengarah Makmal Farmakologi/ Toksikologi, En. Selvaraja, telah menghadiri‘Conference on Advancing Science andElimination of the Use of Laboratory Animals’ diHolland, Amsterdam pada 12 – 14 November2001. En. Selvaraja juga telah menghadiri ‘The4th Meeting of ACCSQ Products Group onPharmaceuticals’ di Bali, Indonesia pada 27 – 28September 2001. Beliau bertindak sebagaipemerhati dalam mesyuarat tersebut.

which was held from 19th till 20th Jun 2001 atDewan Anggerik NPCB. A group of PharmacyAssistant from DAD attended a two day seminaron the 27th till 28th August 2001 on Basic andPrinciples of HPLC in Pharmaceutical Analysisconducted by SUCXes Laboratory of UniversityMalaya.

Compliance to ISO 9002

DAD had been audited by Sirim QAS Sdn. Bhd.for compliance audit in view of MS ISO 9002certification from the 18th till 20th April 2001.Prior to the compliance audit, DAD had beenaudited twice by the internal audit group.

New members of DAD

DAD welcomes three new Pharmacists and twonew Pharmacy Assistants namely Cik IdaSyazrina Ibrahim, Cik Azrina Hassan, En. OthmanAhmad and Puan Zuriati Nawi, Cik Rohaiza btZaitun respectively.

Meetings abroad

Deputy Director DAD, Pn. Hasiah bte Hj.Abdullah, attended ‘The 4th Meeting of theACCSQ Products Group on Pharmaceuticals’ on27th September till 28th September 2001 in Bali,Indonesia. She was the Chief delegate for thismeeting and had delivered an activity reportcoordinated by Malaysia on ‘AdministrativeData for Registration Submission’.

Principle Assistant Director, Pharmacology /Toxicology Laboratory, En. Selvaraja Seerangam,had attended a ‘Conference on AdvancingScience and Elimination of the Use ofLaboratory Animals’ in Amsterdam, Holland on12 – 14 November 2001. He was an observer at"The 4th Meeting of the ACCSQ Products Groupon Pharmaceuticals’ on 27th till 28th September2001 in Bali, Indonesia.


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Rancangan Untuk Masa Depan

BAU akan bersedia untuk menghadapi cabaranbaru bagi melengkapkan dan meningkatkankeupayaan agar dapat terlibat secara aktif danefektif dalam melaksanakan fasa-fasapendaftaran yang berikutnya. Rancangan yangdijadualkan untuk tahun 2002 adalah sepertiberikut:

a) Memulakan kajian mengenai pengesanan racun berjadual dalam ubat tradisional

b) Memulakan kajian pencirian bahan tumbuhan dalam ubat tradisional

c) Terlibat dalam penyediaan "Malaysian Herbal Monograph - Volume 2" yang akan dicetak pada akhir tahun

d) Meneruskan kerjasama diantara negara ASEAN dengan mengambil bahagian dalam pengeluaran piawai rujukan ASEAN melalui ujian kolaboratif ke atas piawai rujukan yang dicadangkan

e) Menghadiri kursus "ASEAN Group Training of GMP for Biologicals" di Indonesia

f) Penswastaan ujian untuk keluaran di peringkat kedua permohonan pendaftaran

g) Mendapatkan peruntukan khas di bawah dasar baru untuk pembelian alat-alat makmal tambahan dan untuk unit piawai rujukan

h) Meneruskan usaha mengadakan latihan berterusan untuk Pegawai Farmasi baru dan Pembantu Farmasi di BAU untuk aspek yang melibatkan penggunaan komputer, keselamatan makmal dan latihan dalam bidang kromatografi, spektroskopi dan mikrobiologi

i) Memulakan proses penstrukturan semula BAU ke arah keberkesanan dan kelicinan proses kerja

j) Ke arah pematuhan farmakopia untuk pengendalian dan pelabelan mikroorganisma dengan mengambil kira "passage number" untuk mikrooganisma yang digunakan dalam ujian validasi dan menggantikan Ps. aeruginosa dan E. coli kepada strain yang terkini

k) Terlibat dalam pembangunan sistem komputer baru (QUEST 2) untuk modul BAU

Future plans

DAD shall work towards preparing it for newchallenges and be able to play an active andeffective role in the implementation of futurephases of registration exercise. Several strategicplans of actions are scheduled for the year 2002and they are as follows :

a) Embarking on research in the detection of schedule poisons in traditional medicines.

b) Embarking on research in thecharacterization of herbal ingredients in traditional medicines.

c) Involving itself in the preparation of "Malaysian Herbal Monograph – Volume 2" which is scheduled to be printed at the end of the year.

d) Continuing with the collaboration amongst ASEAN countries in the production of ASEAN reference material through collaborative testing of the suggested reference materials.

e) Attending a course on "ASEAN Group Training of GMP for Biologicals" in Indonesia.

f) Privatization of laboratory testing of products at the second stage of registration.

g) Acquiring special funding under the "one off project" for purchase of additional laboratory equipment and for reference standard unit.

h) Continuing the effort to provide a continuous training to new Pharmacists and Laboratory Assistants in DAD in aspects involving the use of computer, laboratory safety and training in the field of chromatography, spectroscopy and microbiology.

i) Starting the restructuring process for DAD as a move towards more effective and smooth work process.

j) Working towards compliance to pharmacopoeial requirement for the management and labeling of microorganisms by considering "passage number" for the microorganisms that are used in validation tests and the replacement of Ps. aeruginosa and E. coli with the current strain.

k) Involving itself in the development of computer system (QUEST 2) for DAD module.


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BAHAGIAN PEMBANGUNANORGANISASI DAN TEKNOLOGI

MAKLUMAT (POTM)

OBJEKTIF

Memberi perkhidmatan maklumat ubat yangberkesan kepada personel-personel yangterlibat dalam penilaian keluaran-keluaranfarmaseutikal/kosmetik dan pegawai-pegawaiyang terlibat dalam rawatan pesakit bagimeningkatkan lagi mutu perkhidmatankesihatan di negara ini.

Memberi perkhidmatan penerangan kepadaorang awam berkenaan dengan pendaftarankeluaran-keluaran farmaseutikal dan kosmetik.

Menyebarkan maklumat-maklumat ubatkepada organisasi-organisasi dalam sektorawam dan swasta.

PENCAPAIAN

Perkhidmatan Maklumat Ubat dan MaklumatAm

Sepanjang tahun 2001, Bahagian POTM telahmenjawab 1576 pertanyaan dari sektor awamdan swasta. Kebanyakan daripada pertanyaantersebut adalah berkenaan status pendaftarankeluaran-keluaran farmaseutikal, pendaftarankosmetik, prosedur pendaftaran ubat-ubatandan pembekal keluaran-keluaran yang telahdidaftarkan.

Pengelasan Keluaran

Bahagian ini bertanggungjawab ke atas semuapertanyaan berkenaan dengan klasifikasikeluaran-keluaran "borderline", sama adakeluaran-keluaran itu perlu didaftar atau tidak.Antara 681 keluaran yang diterima untukpengelasan dalam tahun 2001, 344 keluaranmerupakan butiran-butiran yang tidak perludidaftar, seperti peralatan-peralatan perubatan,keluaran-keluaran penjagaan kulit, suplemenmakanan (dalam bentuk jus/minuman),keluaran-keluaran "food-based" dan herba-herba mentah.

Baki 337 keluaran telah dikelaskan sebagaiperlu didaftarkan.

Penerbitan

Penerbitan-penerbitan yang berikut telahdihasilkan dan diedarkan kepada organisasi-organisasi dalam sektor awam dan swastasepanjang tahun 2001.

ORGANISATIONAL DEVELOPMENTAND INFORMATION

TECHNOLOGY DIVISION

OBJECTIVES

To provide an effective drug information serviceto officers who are involved in evaluation ofdrugs/cosmetics and also to officers who areinvolved in patient care in order to improve thestandard of health services in the country.

To provide an effective information service tothe public with regards to the registration ofpharmaceutical products and cosmetics.

To disseminate drug information toorganisations within the public and privatesectors.

ACHIEVEMENTS

Drug Information Service and GeneralInformation on Drug Registration

In the year 2001, the OD & IT division respondedto 1576 enquiries from both the public andprivate sectors. The majority of the inquirieswere on registration, status of pharmaceuticalproducts, registration of cosmetics, registrationprocedures and suppliers of registered products.

Product Classification

This division handles all queries pertaining toclassification of "borderline products", as towhether they are registrable or not. Out of the681 products received for classification in 2001,344 products were non-registrable items such asmedical devices, contact lens care solution, skincare products, food supplements in the form ofjuices/drinks, food-based products and rawherbs.

The remaining 337 products were classified asregistrable products, and were mainly dietarysupplements containing traditional ingredients.

Publications

The following publications were produced anddistributed to organisations in the public andprivate sector in 2001.


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(i) Berita Ubat-Ubatan (3 keluaran)

(ii) Pekeliling Maklumat Ubat (12 keluaran)

(iii) Monograf Ubat (12 keluaran)

(iv) Laporan Tahunan (1 keluaran)

Penerbitan-penerbitan di atas juga bolehdidapati di laman web BPFK iaitu diwww.bpfk.gov.my.

Perkhidmatan Perpustakaan

Perpustakaan ini mempunyai hampir 1547 buahbuku, termasuk farmakopia-farmakopia utamadari pelbagai negara. Selain itu, perpustakaanini juga melanggan 32 jenis jurnal/buletin ubat,Micromedex dan International PharmaceuticalAbstract. Perpustakaan ini dibuka kepadakakitangan BPFK sahaja. Ahli-ahli farmasi dibawah Kementerian Kesihatan boleh memohonuntuk menggunakan kemudahan-kemudahandi perpustakaan ini.

Dalam tahun 2001, perpustakaan inidiperuntukkan sebanyak RM 5,000 di bawahprogram SEAMIC (South East Asian MedicalInformation Centre) untuk membeli buku-bukuperubatan.

Pelawat-pelawat antarabangsa dan delegasi keBPFK pada tahun 2001 adalah seperti berikut:-

(i) Drug Control Authority Newsletter (3 issues)

(ii) Drug Information Circular (12 issues)

(iii) Drug Monograph (12 issues)

(iv) Annual Report (1 issue)

The above publications are also posted onNPCB’s website www.bpfk.gov.my.

Library Service

The library has about 1547 books, including themajor pharmacopoeias from various countries.Besides that, it subscribes to 32 journals/drugbulletins, Micromedex and InternationalPharmaceutical Abstracts. The library is open tothe staff of the institution only. Pharmacists inthe Ministry of Health may, by request, makeuse of the library facilities.

In the year 2001, the library was allocated RM5,000 under the SEAMIC (South East AsianMedical Information Centre) program topurchase medical books.

International Visitors and Delegations to NPCB

The following people visited NPCB in year 2001:-


DATE: 11-02-03

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Nama Negara Tarikh Tujuan Lawatan

Mr. Farruque Ahmad Bangladesh 29 January – WHO Fellow - Laboratory Director, 10 February Quality System Analysis inMinistry of Health and Relation to Drug TestingFamily Welfare

Mr. Robert Tribe Australia 12-16 March PIC/S Assessment VisitPIC/S Chairman to MalaysiaTGA Australia

Mr. Sia Chong Hock Singapore 12-16 March PIC/S Assessment VisitPIC/S Member to Malaysia

Dr. Ludevit Martinec Slovak Republic 12-16 March PIC/S Assessment VisitPIC/S Member to Malaysia

Mr. Daniel Brunner Geneva 12-16 March PIC/S Assessment VisitPIC/S Secretary, Geneva to Malaysia

00284-03 BPFK Adment 3/31/03 3:09 PM


DATE: 11-02-03

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Dr. Gordon Munro United Kingdom 12-16 March PIC/S Assessment VisitPIC/S member from Medicines to MalaysiaControl Agency, London

Dr. Matteo Schaffhauser Switzerland 12-16 March PIC/S Assessment VisitPIC/S Member to Malaysia

Mrs. Dorj Ulziidulam Mongolia. 7 May – 1 June WHO Fellow - Training Programin Quality Control of Pharmaceuticals

The Honourable Kiribati. 10 May Official VisitBaraniko MooaMinister of HealthKiribati

Pham Dinh Hien Vietnam 14 – 17 May Drug Management CourseNgugen Nhu ChinhNgo Pham KienPham Thi Trinh ThuenNgugen Thi HiepMinistry of Health

Dr. Nguyen Xuan Chinh Vietnam 8 August Program on HealthMrs. Nguyen Thi Bieh Hai Legislation DevelopmentMr. Mai Thi HienMr. Le Truc PhuongMrs. Trinh Thi Le TramMinistry of Health

Dr. Torres Philippines 10 August Discussion on CosmeticDirector, RegistrationBureau of Food and Drug Administration, Manila

He Di Ung Phu Run Cambodia 24 August Official VisitSecretary of StateMinistry of Health

Dr. Nuth Sokhom As aboveAs above As above

Dr. Chieng Phana As aboveDepartment of Drug and Food, Ministry of Health

Dr. Cheng Doran As above

Ph. Heng HuotAs aboveChief of Drug Regulation Bureau

00284-03 BPFK Adment 3/31/03 3:09 PM


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Ms. Rahima Khatun Bangladesh 3 – 29 WHO Fellow – ProgramBacteriologist, September in PharmacyDrug Testing LaboratoryInstitute of Public Health

Mrs. Mery Maiya Maharjan Nepal 3 – 29 WHO Fellow – ProgramAssistant Quality Controller, September on Development of SecondaryRoyal Drug Research Reference Standards and Laboratory Quality Assurance of

Biological Products

Dr. Sabah N. Salim Iraq 3 September Official VisitTechnical Affairs DivisionMinistry of Health Baghdad

Dr. Raed A. Sultan Iraq 3 September Official VisitPharmacist, KIMADIAMinistry of Health

Dr. Boonchii Somboonsuk Thailand 8 September Discussion on ImplementationDeputy Secretary General, of MS ISO 9002Food and Drug Administration, Ministry of Public Health

Mr. Wattana Akraethalin As above As above As aboveDirector, Medical Devices Control Division,Food and Drug Administration, Ministry of Public Health

Ms. Siriphan Eamrungroj As above As above As aboveMedical Devices Control Division, Food and Drug Administration, Ministry of Public Health

Mrs. Wimonwan As above As above As aboveWitayapiboonMedical Device Control Division, Food and Drug Administration, Ministry of Public Health

Mrs. Suchada Trisarnsri As above As above As aboveMedical Devices Control Division, Food and Drug Administration, Ministry of Public Health

00284-03 BPFK Adment 3/31/03 3:09 PM


DATE: 11-02-03

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The Honourable Mr. Allan Solomon Island 18 September Official VisitPaul, Minister of Health

Dr. George Malefoasi Solomon Island 18 September As aboveSecretary, Health Care Division, Ministry of Health

Hjh. Siti Mariam Jaafar Brunei 26 September Discussion on TrainingPrincipal Pharmaceutical Darussalam of PharmacistsChemist, Pharmaceutical Services Department, Ministry of Health

Mr. Rosni Jair Brunei 26 September As aboveSenior Pharmaceutical DarussalamChemist

Mr. Chong Chee Kiong Brunei 8 - 19 October Training in DrugScientific Officer, Drug Darussalam RegistrationQuality Control Section, Pharmaceutical Services Department, Ministry of Health

Ms. Jamilah H. Metussin Brunei As above Training in DrugPharmaceutical Chemist, Darussalam RegistrationPharmaceutical Services Department, Ministry of Health

Ms. Zanatul Aini Haji Zainin Brunei As above WHO Fellow – TrainingPharmaceutical Chemist, Darussalam in Drug RegistrationDrug Quality Control Section, Pharmaceutical Services Department, Ministry of Health

Mr. Robert Tribe Australia 29 – 31 October 2nd PIC/S Assessment VisitPIC/S Chairman

Mr. Sia Chong Hock Singapore 20 – 31 October 2nd PIC/S Assessment VisitPIC/S Member

Mr. M. N. Dauramanzi Zimbabwe 12 - 16 Attachment to NPCBDirector General, NovemberMedicines Control Authority

Ms. G. N. Mahlangu Zimbabwe As above As aboveDirector of Medicines Control, Medicines Control Authority

00284-03 BPFK Adment 3/31/03 3:09 PM


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Mr. P. S. Mutsigwa Zimbabwe As above As aboveDirector of Finance,Medicines Control Authority

Mr. Derek Rochford Belgium 26 November Discussion & Update onChairman, Proposed RegulationsInternational Affairs, for Medical DevicesEuropean Commission in Malaysiafor Medical Devices

Ms. Jolynn Lim Singapore 26 November As aboveBoston Scientific Asia Pacific

Mr. Lam Thanh Nghi Vietnam 10 – 11 Attachment – DrugPharmacist, December Information & ADR MonitoringDrug Administration of Vietnam

Mrs. Tran Tuyet Quy Vietnam 10 – 11 Attachment – DrugPharmacist, December Information & ADR MonitoringThe Pharmaceutical Journal

Mrs. Nguyen Thi Phuong Vietnam 10 – 11 Attachment – DrugCham, Pharmacist, Expert December Information & ADR Monitoringof Department of Therapy

Mr. Nguyen Duy Than Vietnam 10 – 11 Attachment – DrugPharmacist, Vice Director December Information & ADR Monitoringof Yen Bai Health Bureau

Mrs. Nguyen Thi Dai Phong Vietnam 10 – 11 Attachment – DrugPharmacist, Bach Mai Hospital December Information & ADR Monitoring

Ms. Tran Thi Le Ha Vietnam 10 – 11 Attachment – DrugPharmacist, Hanoi December Information & ADR MonitoringHealth Bureau

Mr. Nguyen Manh Pha Vietnam 10 – 11 Attachment – DrugPharmacist, DIC Hanoi December Information & ADR MonitoringPharmaceutical College

Mrs. Pham Thi Minh Chau Vietnam 10 – 11 Attachment – DrugADPC Office, The Drug December Information & ADR MonitoringAdministration of Vietnam

Mrs. Cao Thi Mai Phuong Vietnam 10 – 11 Attachment – DrugPharmacist, December Information & ADR MonitoringPharmacopoeia Committee

Mr. Cao Xuan Son Vietnam 10 – 11 Attachment – DrugPharmacist, December Information & ADR MonitoringUong Bi General Hospital

00284-03 BPFK Adment 3/31/03 3:09 PM


DATE: 11-02-03

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DATE: 11-02-03

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gg

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a –

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2001

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anas

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mb

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gan

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an S

isa

Klin

ikal

27

.9.2

001

B

PFK

BPF

K

Has

enah

Ali

Lati

han

HPL

C L

C-1

0VP

20 –

21.

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01B

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BPF

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inar

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est

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elo

pm

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on

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, 16

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001

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ha

An

alyt

ical

(M

) Sd

n. B

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ace

of

the

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no

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her

mo

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, Ser

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inar

on

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ula

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ced

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s Fo

r 17

.4.2

001

BPF

KB

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ary

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du

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ical

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BPF

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lato

ry S

emin

ar 2

001

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/Ph

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tel S

her

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ang

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fact

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23

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s (C

GM

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ISO

170

25 a

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001

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KK

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13

– 1

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2001

BPF

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DATE: 11-02-03

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Far

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Mal

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001

17 –

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/Ph

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2001

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ang

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edic

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9 –

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KM

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OH

ote

l Eas

tin

, Pe

talin

g J

aya

Und

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an IS

O 9

001:

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05

– 6.

11.2

001

Nev

ille

Cla

rke

Ho

tel P

arkr

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l,K

. Lu

mp

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28.

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115

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2001

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g

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rsu

s K

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ISO

900

06.

11.2

001

BPF

KB

PFK

Lati

han

Pen

gg

un

aan

"Pe

rso

nn

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rote

ctiv

e 28

.12.

2001

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DATE: 11-02-03

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Nat

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001

17 –

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/Ph

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A/M

OPI

Ho

tel S

her

ato

n,

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ang

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a

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gu

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Far

mas

i24

– 2

7.7.

2001

Bah

agia

n F

arm

asi

Pah

ang

Wo

rksh

op

On

Eva

luat

ion

of

An

alyt

ical

13

– 1

7.8.

2001

BPF

KB

PFK

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n D

ata

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gu

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ian

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, Sab

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min

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001

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.200

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Med

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pu

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tel E

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.J

Lati

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gg

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a -

Car

a Pe

mb

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Sis

a27

.9.2

001

Rad

icar

eB

PFK

Klin

ikal


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

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KU

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30

.10.

2001

Sart

ori

us

Hot

el S

unw

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goon

, P.J

PDA

Tec

hn

ical

Rep

ort

No

. 26

Lati

han

Pen

gg

un

aan

"Pe

rso

nn

el P

rote

ctiv

e 28

.12.

2001

BPF

KB

PFK

Equ

ipm

ent"

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Mh

d. T

apTh

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ical

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inin

g f

or

AX

an

d

4.9.

2001

BPF

KB

PFK

MX

Bal

ance

Lati

han

Pen

gg

un

aan

"Pe

rso

nn

el P

rote

ctiv

e 28

.12.

2001

BPF

KB

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ipm

ent"

Lim

Kah

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per

atio

n o

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stru

men

t an

d C

lass

-VP

20 –

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nin

g

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ent

on G

C, G

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Tech

nolo

gy16

.4.2

001

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ha

An

alyt

ical

(M

) Sd

n. B

hd

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ote

l Pal

ace

of

the

/ Th

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o F

inn

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stin

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lden

Ho

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, Se

ri K

emb

ang

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Mio

r Za

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ior

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ain

ing

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BPF

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C, G

CMS

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gy16

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001

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alyt

ical

(M

) H

ote

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gg

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2001

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DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

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MA

PEG

AW

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KU

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nolo

gy16

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001

An

alyt

ical

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) Sd

n. B

hd

. /H

ote

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ace

of

the

Ther

mo

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an A

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.10.

2001

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are

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d.

Ho

tel H

yatt

Reg

ency

Sa

uja

na,

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ban

g

Mo

hd

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i b. N

awi

Bas

ic a

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Pri

nci

ple

s o

f H

PLC

in

27 –

28.

8.20

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es L

abo

rato

ry, U

M

BPF

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arm

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hd

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asic

an

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rin

cip

les

of

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C in

27

– 2

8.8.

2001

SUC

Xes

Lab

ora

tory

, UM

BPF

KPh

arm

aceu

tica

l An

alys

is

Mu

ham

mad

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ir

Sem

inar

Ko

smet

ik1.

11.2

001

BPF

KB

PFK

b. H

ash

imFu

nd

amen

tals

of

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Ch

rom

ato

gra

ph

y12

.6.2

001

Fish

er S

cien

tifi

c (M

) Sd

n. B

hd

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PFK

The

3rd

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tern

atio

nal

Co

ng

ress

of

the

12 –

15.

11.2

001

USM

/APA

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WH

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Bay

view

Bea

ch R

eso

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Asi

a Pa

cifi

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ssoc

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edic

al T

oxic

olog

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– 8.

11.2

001

Nat

. Poi

son

Cent

re/ K

KM

Pen

ang

Inte

rnal

Qu

alit

y A

ud

it7

– 8.

11.2

001

BPF

K /N

evill

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lark

eB

PFK

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 –

18.

7.20

01B

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/Ph

AM

A/M

OPI

Ho

tel S

her

ato

n,

Sub

ang

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a

The

Pro

du

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001

Alp

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An

alyt

ical

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) Sd

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ote

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Tech

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log

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mo

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in U

SAG

old

en H

ors

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DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

AW

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KU

RSU

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Sun

way

Lag

oon,

P.J

PDA

Tec

hn

ical

Rep

ort

No

. 26

Lati

han

Pen

gg

un

aan

"Pe

rso

nn

el

28.1

2.20

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PFK

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men

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KC

hro

mat

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rap

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mal

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evi

Ku

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s Pe

ng

enal

an IS

O 9

001:

2000

6.11

.200

1B

PFK

BPF

K

No

raid

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2001

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PFK

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min

ar o

n M

od

ern

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pro

ach

to

9.

3.20

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Ho

tel P

an P

acif

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LA

sth

ma

Man

agem

ent

Sem

inar

on

Reg

ula

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Pro

ced

ure

s fo

r 17

.4.2

001

BPF

KB

PFK

Vet

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ary

Prod

ucts

in S

ome

Maj

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ount

ries

No

rhan

a b

t A

hm

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asic

an

d P

rin

cip

les

of

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C in

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– 2

8.8.

2001

SUC

Xes

Lab

ora

tory

, UM

BPF

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arm

aceu

tica

l An

alys

is

Oh

Lay

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as C

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mat

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inar

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2001

BPF

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ote

l Eas

tin

, P. J

aya

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han

Pen

gg

un

a u

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ir C

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.200

1R

adic

are

BPF

K

Sem

inar

men

gen

ai k

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-ker

ja K

on

sess

i 19

.7.2

001

Rad

icar

eB

PFK

ole

h S

IHA

T

LAL

Sem

inar

200

115

.10.

2001

Ch

oic

e-C

are

Sdn

. Bh

d.

Ho

tel H

yatt

Reg

ency

Sa

uja

na,

Su

ban

g

Ku

rsu

s K

esed

aran

ISO

900

06.

11.2

001

BPF

KB

PFK

Theo

ry &

Pra

ctic

al T

rain

ing

fo

r A

X

4.9.

2001

BPF

KB

PFK

and

MX

Bal

ance

Lati

han

Pen

gg

un

aan

"Pe

rso

nn

el P

rote

ctiv

e 28

.12.

2001

BPF

KB

PFK

Equ

ipm

ent"


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

AW

AI

KU

RSU

STA

RIK

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Sem

inar

Ko

smet

ik 2

001

10.1

0.20

01B

PFK

Ho

tel S

her

ato

n,

Sub

ang

Jay

a

Ku

rsu

s K

esed

aran

ISO

900

06.

11.2

001

BPF

K/N

evill

e C

lark

eB

PFK

Au

dit

Ku

alit

i Dal

aman

7 –

8.11

.200

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/Nev

ille

Cla

rke

BPF

K

Rap

id ID

Sys

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fo

r B

acte

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12.1

1.20

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-BIO

S Sd

n. B

hd

.H

UK

M, K

ual

a Lu

mp

ur

Lati

han

Pen

gg

un

a u

ntu

k G

C15

.11.

2001

Rad

icar

eB

PFK

Lati

han

Pen

gg

un

aan

"Pe

rso

nn

el P

rote

ctiv

e 28

.12.

2001

BPF

KB

PFK

Equ

ipm

ent"

Oth

man

b. A

lias

Lati

han

Pen

gg

un

a u

ntu

k "A

ir C

on

dit

ion

er"

13.7

.200

1R

adic

are

BPF

K

Sem

inar

men

gen

ai k

erja

-ker

ja K

on

sess

i 19

.7.2

001

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icar

eB

PFK

ole

h S

IHA

T

Theo

ry &

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ctic

al T

rain

ing

fo

r A

X a

nd

4.

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BPF

KM

X B

alan

ce

Lati

han

Pen

gg

un

a –

Car

a Pe

mb

uan

gan

27

.9.2

001

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icar

eB

PFK

Sisa

Klin

ikal

Ku

rsu

s K

esed

aran

ISO

900

06.

11.2

001

BPF

KB

PFK

Ku

rsu

s A

ud

it K

ual

iti D

alam

an7

– 8.

11.2

001

BPF

KB

PFK

Lati

han

Pen

gg

un

aan

"Pe

rso

nn

el P

rote

ctiv

e 28

.12.

2001

BPF

KB

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ipm

ent"


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

AW

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2001

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ance

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idat

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30.1

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rto

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P.J

PDA

Tec

hn

ical

Rep

ort

No

. 26

Lati

han

Pen

gg

un

a u

ntu

k G

C15

.11.

2001

Rad

icar

eB

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Lati

han

Pen

gg

un

aan

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rso

nn

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rote

ctiv

e 28

.12.

2001

BPF

KB

PFK

Equ

ipm

ent"

Ro

hai

za b

t. Z

ain

un

Theo

ry &

Pra

ctic

al T

rain

ing

fo

r A

X

4.9.

2001

BPF

KB

PFK

and

MX

Bal

ance

Lati

han

Pen

gg

un

a u

ntu

k G

C15

.11.

2001

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icar

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PFK

Lati

han

Men

gg

un

akan

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rso

nn

el P

rote

ctiv

e 28

.12.

2001

BPF

KB

PFK

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ipm

ent"

Ro

han

i bt.

Ram

liO

per

atio

n o

f In

stru

men

ts o

f C

lass

VP

20 –

21.

2.20

01B

PFK

BPF

KSo

ftw

are

Trai

nin

g

Late

st D

evel

opm

ent

on G

C, G

CMS

Tech

nolo

gy16

.4.2

001

Alp

ha

An

alyt

ical

(M

) Sd

n B

hd

Pa

lace

of

The

Go

lden

/ Th

erm

o F

inn

igan

Au

stin

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Ho

rses

, Sri

Kem

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gan

Ru

snah

bt.

Rej

abK

urs

us

Bas

ics

and

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nci

ple

s o

f H

PLC

in

27 –

28.

8.20

01SU

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es L

abo

rato

ry, U

MB

PFK

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mac

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An

alys

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ctic

al T

rain

ing

fo

r A

X a

nd

13

.7.2

001

BPF

KB

PFK

MX

Bal

ance

Salm

ah b

t. M

oh

d. Z

ahid

Sem

inar

Bio

log

ical

Ind

icat

or

11.1

.200

1B

PFK

BPF

K

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ry &

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ctic

al T

rain

ing

fo

r A

X4.

9.20

01B

PFK

BPF

Kan

d M

X B

alan

ce


DATE: 11-02-03

CPANTONE 730 CV

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. Sam

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Pers

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nel

28

.12.

2001

BPF

KB

PFK

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Selv

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10

.1.2

001

BPF

KB

PFK

per

mo

ho

nan

Mal

aysi

a ke

PIC

/s

1st.

Nat

iona

l Con

fere

nce

on T

rans

fusio

n M

ediu

m27

– 3

1.3.

2001

Pusa

t D

arah

Neg

ara

Ho

tel H

ilto

n, K

. Lu

mp

ur

Sem

inar

on

OH

SAS,

180

0:19

9911

.4.2

001

SIR

IMSh

ah A

lam

Wo

rksh

op

on

Eva

luat

ion

of

An

alyt

ical

13

– 1

7.8.

2001

BPF

KB

PFK

Met

ho

d V

alid

atio

n D

ata

Mes

y. &

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inar

4th

Mee

tin

g o

f A

SEA

N

25 –

29.

9.20

01W

HO

Bal

i, In

do

nes

iaC

on

sult

atio

n C

om

mit

tees

fo

r St

and

ard

&

Qu

alit

y Pr

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Wo

rkin

g G

rou

p

Co

nfe

ren

ce o

n A

dva

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ng

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ence

an

d

12 –

14.

11.2

001

WH

OA

mst

erd

am, H

olla

nd

Elim

inat

ion

of

the

Use

of

Lab

ora

tory

An

imal

Seth

iara

m a

/l Se

rip

alB

eng

kel K

e-em

pat

Kaw

alan

Do

pin

g

22.8

.200

1K

KM

IMR

Suka

n S

ea k

e 21

, Kl 2

001

Shu

kri M

oh

d. A

riff

Late

st D

evel

opm

ent

on G

C, G

CMS

Tech

nolo

gy16

.4.2

001

Alp

ha

An

alyt

ical

(M

) Sd

n. B

hd

.H

ote

l Pal

ace

of

Go

lden

/ Th

erm

o F

inn

igan

Au

stin

USA

Ho

rses

, Ser

i Kem

ban

gan


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

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MA

PEG

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KU

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STA

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.Se

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dic

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.1.2

001

BPF

KB

PFK

Mo

idee

nIn

tern

atio

nal

GM

P C

ou

rse

(Mo

du

le 7

)21

– 2

3.3.

2001

BPF

K/M

OPI

BPF

K

Go

od

Clin

ical

Pra

ctic

e W

ork

sho

p9

– 11

.4.2

001

BPF

K/E

li Li

llyH

ote

l Sh

erat

on

,Su

ban

g J

aya

Sem

inar

on

Saf

ety

in t

he

Use

of

Ch

emic

als

19 –

20.

6.20

01B

PFK

/NIO

SHB

PFK

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 –

18.

7.20

01B

PFK

/Ph

AM

A/M

OPI

Ho

tel S

her

ato

n,

Sub

ang

Jay

a

ISO

170

25 &

GLP

/GM

P fo

r A

nal

ytic

al

25.7

.200

1A

gile

nt

Tech

no

log

ies/

KK

MH

ote

l Sh

erat

on

,La

bo

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Sub

ang

Jay

a

Wo

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op

on

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luat

ion

of

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alyt

ical

13

– 1

7.8.

2001

BPF

KB

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Met

ho

d V

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atio

n D

ata

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al T

rial

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on

fere

nce

24 –

26.

9.20

01K

KM

Sun

way

Lag

oo

nR

eso

rt H

ote

l

Sem

inar

Ko

smet

ik 2

001

1.11

.200

1B

PFK

BPF

K

Hj.

Supa

iman

b. M

at S

omLa

tih

an P

eng

gu

na

– C

ara

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bu

ang

an

27.9

.200

1R

adic

are

BPF

KSi

sa K

linik

al

Lati

han

Pen

gg

un

aan

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son

nel

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tect

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2.20

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PE)’

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bd

. Ham

idPh

arm

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p26

.4.2

001

Mec

om

b T

ech

no

log

ies

Ho

tel S

her

ato

n

Sub

ang

Jay

a


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

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MA

PEG

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row

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or

the

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ahru

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nd

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ple

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PLC

27 –

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01B

PFK

BPF

K

Au

dit

Ku

alit

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aman

7 –

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.200

1R

adic

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BPF

K

Lati

han

Pen

gg

un

a u

ntu

k G

C15

.11.

2001

Rad

icar

eB

PFK

Lati

han

Pen

gg

un

aan

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rso

nn

el P

rote

ctiv

e 28

.12.

2001

BPF

KB

PFK

Equ

ipm

ent"

Tan

An

n L

ing

Fun

dam

enta

l of

Gas

Ch

rom

ato

gra

ph

y12

.6.2

001

Fish

er S

cien

tifi

c (M

) Sd

n. B

hd

.B

PFK

Wo

rksh

op

on

Eva

luat

ion

of

An

alyt

ical

13

– 1

7.8.

2001

BPF

KB

PFK

Met

ho

d V

alid

atio

n D

ata

Filt

er V

alid

atio

n:P

DA

Tec

hn

ical

Rep

ort

No

. 26

30.1

0.20

01Sc

hm

idt

Scie

nti

fic

Sdn

. Bh

d.

Hot

el S

unw

ay L

agoo

n, P

.J

Prin

cip

le o

f G

LP &

An

alyt

ical

Met

ho

d

19 –

20.

11.2

001

BPF

K /

MO

PIH

ote

l Pan

Pac

ific

V

alid

atio

n, M

icro

bio

log

ical

GLP

Gle

nm

arie

Yam

Ch

au Y

itH

PLC

Cla

ss V

P So

ftw

are

Trai

nin

g &

19

– 2

0.2.

2001

BPF

KB

PFK

Op

erat

ion

of

Inst

rum

ent

Ben

gke

l Per

tam

a K

awal

an D

op

ing

Su

kan

16

.5.2

001

KK

MIM

RSe

a ke

21,

Kl 2

001

Ben

gke

l Ke-

emp

at K

awal

an D

op

ing

11

.7.2

001

KK

MIM

RSu

kan

Sea

ke

21, K

l 200

1

Ben

gke

l Ke-

emp

at K

awal

an D

op

ing

22

.8.2

001

KK

MIM

RSu

kan

Sea

ke

21, K

l 200

1


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

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Mar

kan

do

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EU L

egis

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on

fo

r th

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arm

aceu

tica

l 23

.1.2

001

MA

TRA

DE/

Euro

pea

n B

usi

nes

sH

ote

l Hilt

on

, P. J

aya

Ind

ust

ryIn

form

atio

n/B

PFK

Sem

inar

on

Reg

ula

tory

Pro

ced

ure

s fo

r 17

.4.2

001

BPF

KB

PFK

Vet

erin

ary

Pro

du

cts

in s

om

e m

ajo

r co

un

trie

s

Sem

inar

on

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cin

es5.

2.20

01B

PFK

BPF

K

IT in

Ph

arm

acy

Prac

tice

an

d P

roje

ct 2

001

28.4

.200

1M

PSH

ote

l Su

nw

ay L

ago

on

Up

dat

e an

d F

ollo

w-U

p

ICP-

MS-

ole

h P

erki

n E

lmer

9.5.

2001

Perk

in E

lmer

Ho

tel S

her

ato

n,

Sub

ang

Jay

a

Fun

dam

enta

ls o

f G

as C

hro

mat

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rap

hy

12.6

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1Fi

sher

Sci

enti

fic

(M)

Sdn

. Bh

d.

BPF

K

Val

ue

Bas

ed L

ead

ersh

ip9

– 11

.7.2

001

KK

MH

ote

l Aw

ana,

Lan

gka

wi

Sem

inar

on

saf

ety

in t

he

use

of

chem

ical

s19

– 2

0.6.

2001

BPF

K/N

IOSH

BPF

K

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 –

18.

7.20

01B

PFK

Ho

tel S

her

ato

n,

Sub

ang

Jay

a

Wo

rksh

op

on

Eva

luat

ion

of

An

alyt

ical

13

– 1

7.8.

2001

BPF

KB

PFK

Met

ho

d V

alid

atio

n D

ata

Zain

i bt.

Jam

alu

din

Theo

ry &

Pra

ctic

al T

rain

ing

fo

r A

X

4.9.

2001

BPF

KB

PFK

and

MX

Bal

ance

Lati

han

Pen

gg

un

a u

ntu

k G

C15

.11.

2001

BPF

KB

PFK

Lati

han

Pen

gg

un

aan

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rso

nn

el P

rote

ctiv

e 28

.12.

2001

BPF

KB

PFK

Equ

ipm

ent"


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

AW

AI

KU

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bin

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G

as C

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mat

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rap

hy

Sem

inar

9.5.

2001

Fisc

her

Scie

ntif

ic (

M) S

dn. B

hd.

East

in H

ote

l, P.

Jay

a

Ab

d. R

ash

id

Zura

ik b

. Mu

staf

faLa

tih

an P

eng

gu

na

un

tuk

GC

15.1

1.20

01R

adic

are

BPF

K

Lati

han

Pen

gg

un

aan

"Pe

rso

nn

el

28.1

2.20

01B

PFK

BPF

K

Pro

tect

ive

Equ

ipm

ent"

Has

nah

bt.

Ism

ail

3rd

Mee

tin

g o

f th

e A

CC

SQ P

-PW

G o

n

5 –

7 Fe

bru

ari

2001

ASE

AN

Sek

reta

riat

Ho

Ch

i Min

h C

ity,

Phar

mac

euti

cals

Vie

tnam

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 &

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Sher

aton

Sub

ang,

P. J

aya

& F

MM

-MC

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4th

Mee

tin

g o

f th

e A

CC

SQ-P

-PW

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n

25 -

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epte

mbe

r 20

01A

SEA

N S

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tari

atB

ali,

Ind

on

esia

Phar

mac

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cals

an

d r

elat

ed e

ven

t

Nat

ion

al D

rug

Po

licy

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rksh

op

9 –

12 O

kto

ber

200

1M

OH

, W

HO

East

in H

ote

l

Inte

rnat

ion

al C

ou

rse

on

Dru

g P

olic

ies

29 O

kt –

9 N

ov

2001

WH

OJo

gja

kart

a, In

do

nes

iaIs

sues

in D

evel

op

ing

Co

un

trie

s


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

AW

AI

KU

RSU

STA

RIK

HA

NJU

RA

NTE

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TN

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E


Ro

han

i bt.

Ism

ail

Sem

inar

"EU

Leg

isla

tio

n f

or

the

23 M

ac 2

001

Mat

rad

e &

EB

IC M

alay

sia

Peta

ling

Jay

aPh

arm

aceu

tica

l In

du

stry

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Sem

inar

on

Reg

ula

tory

Pro

ced

ure

s fo

r 17

Ap

ril 2

001

BPF

KB

PFK

, P. J

aya

Vet

erin

ary

Pro

du

cts

in S

om

e M

ajo

r C

ou

ntr

ies

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 -

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Sher

aton

Sub

ang,

P. J

aya

& F

MM

-MC

TIG

Wo

rksh

op

on

Intr

od

uct

ion

to

th

e 13

Og

os

2001

BPF

KB

PFK

An

alyt

ical

Met

ho

d V

alid

atio

n

2nd

Inte

rnat

ion

al C

on

gre

ss/1

3th

VA

M

27 –

30

Og

os

2001

VA

M, S

AM

PAM

, MEV

A, U

PM

The

Min

es,

Co

ng

ress

CV

A-A

ust

ralia

/Oce

ania

Reg

ion

V

ET, A

LUM

NI,

CV

AK

ual

a Lu

mp

ur

Sym

po

siu

m

Asi

a Pa

cifi

c C

linic

al T

rial

s C

on

fere

nce

24 –

26

Sept

embe

r 200

1K

KM

& A

cad

emy

of

Med

icin

es,

Ban

dar

Su

nw

ay, P

. Jay

a M

alay

sia

Sem

inar

Ko

smet

ik1

No

vem

ber

200

1B

PFK

BPF

K

Ku

rsu

s A

ud

it K

ual

iti D

alam

an7

– 8

No

vem

ber

200

1B

PFK

BPF

K

Ro

snan

i bt.

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 –

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

ASh

erat

on S

uban

g, P

. Jay

aM

oh

d. G

haz

ali

& F

MM

-MC

TIG

Hea

lth

Tech

nolo

gy A

sses

smen

t Tr

aini

ng C

ours

e27

– 3

0 O

go

s 20

01K

KM

Mic

asa

Ho

tel,

Joh

or

Bah

ru

Asi

a Pa

cifi

c C

linic

al T

rial

s C

on

fere

nce

24 –

26

Sept

embe

r 20

01K

KM

& C

olle

ge

of

Phys

icia

ns

Sun

way

Ho

tel,

P. J

aya

Sem

inar

Ko

smet

ik10

Okt

ob

er 2

001

BPF

KSh

erat

on S

uban

g, P

. Jay

a


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

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KU

RSU

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BPF

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MA

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PI, C

TFA

Sh

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uban

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. Jay

a&

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th

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nal

ytic

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Og

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2001

BPF

KB

PFK

Met

ho

d V

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atio

n

2nd

Inte

rnat

ion

al C

on

gre

ss/1

3th

VA

M

27 –

30

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os

2001

VA

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, MEV

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PMTh

e M

ines

, K. L

um

pu

rC

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ss C

VA

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ia R

egio

nV

ET, A

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it K

ual

iti D

alam

an7

– 8

No

vem

ber

200

1B

PFK

BPF

K

Sem

inar

Ko

smet

ik 2

001

1 N

ove

mb

er 2

001

BPF

KB

PFK

Nu

rulf

ajar

bt.

Sem

inar

on

Vac

cin

es5

Feb

ruar

i 200

1B

PFK

BPF

KM

oh

d. J

amid

Sem

inar

on

Reg

ula

tory

Pro

ced

ure

s fo

r1

Ap

ril 2

001

BPF

KB

PFK

Vet

erin

ary

Pro

du

cts

in S

om

e M

ajo

r C

ou

ntr

ies

Ku

rsu

s B

iro

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aneg

ara

(In

du

ksi)

10 –

12

Mei

200

1B

iro

Tat

aneg

ara,

Jab

atan

K

ole

j Lat

ihan

Tel

eko

mPe

rdan

a M

ente

riK

uch

ing

, Sar

awak

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 –

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Sher

aton

Sub

ang,

P. J

aya

& F

MM

-MC

TIG

Wo

rksh

op

on

Intr

od

uct

ion

to

th

e 13

Og

os

2001

BPF

K &

Th

erap

euti

c G

oo

d

BPF

KA

nal

ytic

al M

eth

od

Val

idat

ion

Ad

min

istr

atio

n A

ust

ralia

Phar

mac

y Sc

ien

tifi

c C

on

fere

nce

200

122

– 2

3 O

kto

ber

200

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rsat

uan

Far

mas

i Mal

aysi

a,

Sum

mit

Ho

tel,

P. J

aya

Un

iver

siti

Mal

aya

Sem

inar

Ko

smet

ik 2

001

1 N

ove

mb

er 2

001

BPF

KB

PFK

Ku

rsu

s A

ud

it K

ual

iti D

alam

an7

– 8

No

vem

ber

200

1B

PFK

BPF

K


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

AW

AI

KU

RSU

STA

RIK

HA

NJU

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mac

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Pers

idan

gan

Far

mas

i 200

1 –

Mo

der

n

9 M

ac 2

001

KK

M, M

PSPa

n P

acif

ic H

ote

l, A

pp

roac

h t

o M

anag

emen

t o

f A

sth

ma

K. L

um

pu

r

Sem

inar

"EU

Leg

isla

tio

n f

or

the

23 M

ac 2

001

Mat

rad

e &

EB

ICH

ilto

n H

ote

l, P.

Jay

aPh

arm

aceu

tica

l In

du

stry

1st

Nat

ion

al T

ran

sfu

sio

n M

edic

ine

27 –

31

Mac

200

1K

KM

, Pu

sat

Dar

ah N

egar

a,

Hilt

on

Ho

tel,

P. J

aya

Co

nfe

ren

ce 2

001

Mal

aysi

an B

loo

d

Tran

sfu

sio

n S

oci

ety

Qu

alit

y M

anag

emen

t in

Mal

aysi

an

2 –

4 M

ei 2

001

KK

M,

Mal

aysi

an T

ran

sfu

sio

nPu

sat

Dar

ah N

egar

aB

loo

d S

ervi

ces

Blo

od

So

ciet

y

Mes

yuar

at "

Co

un

cil f

or

TRIP

s –

Acc

ess

to

19 –

21

Jun

200

1W

TOG

enev

a, S

wit

zerl

and

Esse

nti

al M

edic

ine"

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 &

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Sher

aton

Sub

ang,

P. J

aya

& F

MM

-MC

TIG

Ben

gke

l "V

alu

e-B

ased

Lea

der

ship

" u

ntu

k 9

– 11

Ju

lai 2

001

PPF,

KK

MA

wan

a Po

rto

Mal

ai,

peg

awai

-peg

awai

Far

mas

i, K

KM

Lan

gka

wi

Wo

rksh

op

on

Intr

od

uct

ion

to

th

e A

nal

ytic

al

13 O

go

s 20

01B

PFK

BPF

KM

eth

od

of

Val

idat

ion

4th

Mee

tin

g o

f th

e A

CC

SQ-P

-PW

G o

n

25–2

9 Se

ptem

ber

2001

ASE

AN

Sek

reta

riat

Bal

i, In

do

nes

iaPh

arm

aceu

tica

ls a

nd

Rel

ated

Eve

nt

Nat

ion

al D

rug

Po

licy

Wo

rksh

op

9 –

11 O

kto

ber

200

1K

KM

, WH

OEa

stin

Ho

tel,

P. J

aya

Phar

mac

y Sc

ien

tifi

c C

on

fere

nce

200

120

– 2

3 O

kto

ber

200

1M

PS, U

MSu

mm

it H

ote

l, P.

Jay

a

Sem

inar

Ko

smet

ik1

No

vem

ber

200

1B

PFK

BPF

K

Ben

gke

l "Im

plic

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of

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bal

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ion

an

d

12–1

3 N

ove

mb

er 2

001

KK

MG

ran

d S

easo

ns,

M

ult

ilate

ral T

rad

e A

gre

emen

ts o

n H

ealt

h

K. L

um

pu

rC

are

Serv

ices


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

AW

AI

KU

RSU

STA

RIK

HA

NJU

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bas

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-PW

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n

5 –

7 Fe

bru

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001

ASE

AN

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Ch

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ity,

Ph

arm

aceu

tica

lsV

ietn

am

1st

Nat

ion

al T

ran

sfu

sio

n M

edic

ine

27 –

31 M

ac 2

001

Pusa

t D

arah

Neg

ara

Ho

tel H

ilto

n K

. Lu

mp

ur

Co

nfe

ren

ce 2

001

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 &

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Sher

aton

Sub

ang,

P. J

aya

& F

MM

-MC

TIG

1st

AH

WP

Tech

nic

al C

om

mit

tee

& W

ork

sho

p6

– 7

Sep

tem

ber

200

1H

ealt

h S

cien

ces

Au

tho

rity

,Sh

erat

on S

uban

g, P

. Jay

aSi

ng

apo

re

4th

Mee

tin

g o

f th

e A

CC

SQ P

-PW

G o

n

25 –

29

Okt

ob

er 2

001

ASE

AN

Sek

reta

riat

Bal

i, In

do

nes

iaPh

arm

aceu

tica

ls a

nd

Rel

ated

Eve

nt

Phar

mac

y Sc

ien

tifi

c C

on

fere

nce

200

122

– 2

3 O

kto

ber

200

1M

PS, U

MSu

mm

it H

ote

l, P.

Jay

a

Sem

inar

Ko

smet

ik1

No

vem

ber

200

1B

PFK

BPF

K

Maz

uwin

Bt.

Zain

al A

bidi

nG

oo

d C

linic

al P

ract

ice

Wo

rksh

op

9 –

11 A

pr

2001

BPF

K &

Eli

Lilly

(M

) Sd

n. B

hd

.Sh

erat

on S

uban

g, P

. Jay

a

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 &

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Sher

aton

Sub

ang,

P. J

aya

& F

MM

-MC

TIG

Wo

rksh

op

on

Intr

od

uct

ion

to

th

e 13

Og

os

2001

BPF

KB

PFK

An

alyt

ical

Met

ho

d V

alid

atio

n

Asi

a Pa

cifi

c C

linic

al T

rial

s C

on

fere

nce

24-2

6 Se

pte

mb

er 2

001

KK

M &

Aca

dem

y o

f M

edic

ines

,Su

nw

ay H

ote

l, P.

Jay

aM

alay

sia

Suh

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h b

t. A

bu

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arSe

min

ar K

osm

etik

1 N

ove

mb

er 2

001

BPF

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PFK

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ouse

Tra

inin

g - K

efah

aman

ISO

900

0:20

006

No

vem

ber

200

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BPF

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DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

AW

AI

KU

RSU

STA

RIK

HA

NJU

RA

NTE

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ATE

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Feb

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i 200

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PFK

BPF

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Pers

idan

gan

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mas

i 200

1 –

Mo

der

n

9 M

ac 2

001

KK

M, M

PSPa

n P

acif

ic K

. Lu

mp

ur

Ap

pro

ach

to

Man

agem

ent

of

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a

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inar

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Leg

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tio

n f

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the

23 M

ac 2

001

Mat

rad

e, E

BIC

Hilt

on

, P. J

aya

Phar

mac

euti

cal I

nd

ust

ry

Ben

gke

l "V

alu

e-B

ased

Lea

der

ship

" 9

– 11

Ju

lai 2

001

PPF,

KK

MA

wan

a Po

rto

Mal

ai,

un

tuk

peg

awai

-peg

awai

Far

mas

i, K

KM

Lan

gka

wi

Sem

inar

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ula

tori

Keb

ang

saan

200

117

– 1

8 Ju

lai 2

001

BPF

K, P

hA

MA

, MO

PI, C

TFA

Sh

erat

on, S

uban

g, P

. Jay

a&

FM

M-M

CTI

G

Asi

a Pa

cifi

c C

linic

al T

rial

s C

on

fere

nce

24–2

6 Se

ptem

ber

2001

KK

M &

Co

lleg

e o

f Ph

ysic

ian

,Su

nw

ay H

ote

l, P.

Jay

aA

cade

my

of M

edic

ine

of M

alay

sia

Sem

inar

Ko

smet

ik1

No

vem

ber

200

1B

PFK

BPF

K

Ase

an D

irec

t Se

llin

g C

on

fere

nce

- A

DSC

15 N

ove

mb

er 2

001

Salih

in R

amli

Man

agem

ent

Pala

ce o

f G

old

en H

ors

es,

Sdn

. Bh

d.

K. L

.B

asm

iah

bt.

Md

. Isa

Sem

inar

on

Vac

cin

es5

Feb

ruar

i 200

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PFK

BPF

K

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idan

gan

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mas

i 200

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od

ern

9

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dan

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satu

an F

arm

asi

Ho

tel P

an P

acif

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Ap

pro

ach

to

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agem

ent

of

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hm

aM

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sia

K. L

um

pu

r

Sem

inar

On

Reg

ula

tory

Pro

ced

ure

s fo

r 1

Ap

ril 2

001

BPF

KB

PFK

Vet

erin

ary

Pro

du

cts

in S

om

e M

ajo

r C

ou

ntr

ies

Ku

rsu

s B

iro

Tat

aneg

ara

(In

du

ksi)

10 –

12

Mei

200

1B

iro

Tat

aneg

ara,

Jab

atan

K

ole

j Lat

ihan

Tel

eko

m,

Perd

ana

Men

teri

Ku

chin

g, S

araw

ak

Sem

inar

Reg

ula

tori

K

eban

gsa

an 2

001

17 –

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Sher

aton

, Sub

ang,

P. J

aya

& F

MM

-MC

TIG

Sem

inar

on

"Dru

g A

buse

Pre

vent

ion

Act

ivit

ies

12 S

epte

mb

er 2

001

Ag

ensi

Dad

ah K

eban

gsa

anH

ote

l Pan

Pac

ific

, K

. Lu

mp

ur

Asi

a Pa

cifi

c C

linic

al T

rial

s C

on

fere

nce

24–2

6 Se

ptem

ber

2001

KM

& C

olle

ge

of

Phys

icia

n,

Sun

way

Ho

tel,

P. J

aya

Aca

dem

y of

Med

icin

e of

Mal

aysia

Sem

inar

Ko

smet

ik

2001

10 O

kto

ber

200

1B

PFK

Sher

aton

Sub

ang,

P. J

aya

Phar

mac

y Sc

ien

tifi

c C

on

fere

nce

200

122

– 2

3 O

kto

ber

200

1U

M, M

PS &

Bhg

.Far

mas

i Sel

ango

rH

otel

Sum

mit,

Sub

ang

Jaya

In-H

ouse

Tra

inin

g on

Inte

rnal

Qua

lity

Aud

itin

g7

– 8

No

vem

ber

200

1B

PFK

BPF

K

Ase

an D

irec

t Se

llin

g C

on

fere

nce

- A

DSC

15 N

ove

mb

er 2

001

Salih

in R

amli

Man

agem

ent

Pala

ce o

f G

old

en H

ors

esSd

n. B

hd

.


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

AW

AI

KU

RSU

STA

RIK

HA

NJU

RA

NTE

MPA

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iyat

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bt.

Se

min

ar K

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mb

er 2

001

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KB

PFK

Dah

alan

@ D

amu

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urs

us

Kes

edar

an IS

O 9

000

6 N

ove

mb

er 2

001

BPF

KB

PFK

Ram

li b

in Z

ain

alTa

klim

at H

alal

11 J

anu

ari 2

001

CTF

AP.

Jay

a

4th

Mee

tin

g A

CC

SQ-C

osm

etic

Pro

du

ct

8 –

9 Fe

bru

ari 2

001

AC

CSQ

Ho

Ch

i-M

inh

Cit

y,

Wo

rkin

g G

rou

pV

ietn

am

Takl

imat

Pen

gg

un

aan

Ko

d A

TC14

Feb

ruar

i 200

1B

PFK

BPF

K

Beng

kel P

engu

rusa

n K

ewan

gan

dan

Beka

lan

1 –

4 M

ei 2

001

Baha

gian

Per

khid

mat

an F

arm

asi

Lan

gka

wi

Nat

ion

al R

egu

lato

ry S

emin

ar

17 –

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Sher

aton

Sub

ang,

P. J

aya

(Sci

enti

fic

Co

mm

itte

e)&

FM

M-M

CTI

G

Beng

kel P

engu

rusa

n IT

Far

mas

i24

– 2

7 Ju

lai 2

001

Baha

gian

Per

khid

mat

an F

arm

asi

Ch

erat

ing

, Pah

ang

Kur

sus K

eutu

han

Peng

urus

an F

arm

asi

25 –

27 Se

ptem

ber 2

001

Baha

gian

Per

khid

mat

an F

arm

asi

Ko

ta B

har

u

Stra

teg

ic T

ran

sfo

rmat

ion

of

Pub

lic E

nte

rpri

se5

No

vem

ber

200

1A

rth

ur

An

der

sen

Ku

ala

Lum

pu

r

An

is b

t. T

alib

3rd

Mee

tin

g o

f th

e A

CC

SQ-P

PWG

on

5

– 7

Feb

ruar

i 200

1A

CC

SQH

o C

hi M

inh

Cit

y,Ph

arm

aceu

tica

lsV

ietn

am

4rd

Mee

ting

of th

e A

CCSQ

-PPW

G o

n Co

smet

ics

8 –

9 Fe

bru

ari 2

001

AC

CSQ

Ho

Ch

i Min

h C

ity,

V

ietn

am

Co

nfe

ren

ce o

n F

un

ctio

nal

Fo

od

–10

– 1

1 A

pri

l 200

1U

niv

ersi

ti P

utr

a M

alay

sia

Ren

aiss

ance

Pal

m

late

st d

evel

op

men

tG

ard

en,

Putr

a Ja

ya


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

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MA

PEG

AW

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KU

RSU

STA

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ida

bt.

Ab

du

llah

Co

nfe

ren

ce o

n F

un

ctio

nal

Fo

od

–

10 –

11

Ap

ril 2

001

Un

iver

siti

Pu

tra

Mal

aysi

aRe

naiss

ance

Pal

m G

arde

n,la

test

dev

elo

pm

ent

Putr

a Ja

ya

Sem

inar

on

Reg

ula

tory

Pro

ced

ure

s 17

Ap

ril 2

001

BPF

KB

PFK

for

Vet

erin

ary

Pro

du

cts

Sem

inar

Reg

ula

tori

Keb

ang

saan

200

117

– 1

8 Ju

lai 2

001

BPF

K, P

hA

MA

, MO

PI, C

TFA

Sh

erat

on S

uban

g, P

. Jay

a&

FM

M-M

CTI

G

Wo

rksh

op

on

Intr

od

uct

ion

to

th

e 13

Og

os

2001

BPF

KB

PFK

An

alyt

ical

Met

ho

d V

alid

atio

n

Sale

ha

bt.

Mo

hd

. Ew

anW

ork

sho

p o

n E

valu

atio

n o

f Ef

fica

cy o

f 27

– 3

1 M

ac 2

001

WH

OB

ang

kok,

Th

aila

nd

An

ti-M

alar

ial D

rug

s

Ku

rsu

s m

ener

aju

i per

ub

ahan

22 –

25

Mei

200

1IN

TAN

INTA

N, B

uki

t K

iara

Clin

ical

Tri

al C

on

fere

nce

24 –

27

Sept

embe

r 200

1M

OH

Co

lleg

e o

f Ph

ysic

ian

Sun

way

Res

ort

, P. J

aya

3rd

Inte

rnat

ion

al C

on

gre

ss12

– 1

5 N

ovem

ber 2

001

APA

MT

Pula

u P

inan

g

Ass

essm

ent

of

Ap

plic

atio

n f

or

Mar

keti

ng

3

– 7

Dis

emb

er 2

001

WH

OM

anila

, Ph

illip

pin

esA

uth

ori

zati

on

of

Mu

ltis

ou

rce

Dru

gs

Ro

sila

wat

i bt.

Ah

mad

Post

Co

nfe

ren

ce W

ork

sho

p –

27

Sep

tem

ber

200

1K

KM

& C

olle

ge

of

Phys

icia

ns,

IM

R, K

. Lu

mp

ur

Clin

ical

Tri

al in

Her

bal

Med

icin

e R

esea

rch

Aca

dem

y of

Med

icin

e of

Mal

aysia

Nat

ion

al R

egu

lato

ry S

emin

ar17

– 1

8 Ju

lai 2

001

BPF

K, P

hA

MA

, MO

PI, C

TFA

Sh

erat

on S

uban

g, P

. Jay

a&

FM

M-M

CTI

G

Sem

inar

Tu

mb

uh

an-t

um

bu

han

Ub

atan

24

– 2

5 Ju

lai 2

001

FRIM

(Ins

titut

Per

huta

nan

Mal

aysia

)FR

IMd

an B

erar

om

a 20

01

Sem

inar

Co

mp

lem

enta

ry H

ealt

hca

re6

– 7

Sep

tem

ber

200

1K

KM

, UM

dan

Tra

ns

Ever

tPW

TC, K

. Lu

mp

ur


DATE: 11-02-03

CPANTONE 730 CV

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iza

Om

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min

ar o

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Reg

ula

tory

Pro

ced

ure

s fo

r 17

Ap

ril 2

001

BPF

KB

PFK

Vet

erin

ary

Pro

du

cts

in S

om

e M

ajo

r C

ou

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Sem

inar

Reg

ula

tori

Keb

ang

saan

17 –

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Sher

aton

Sub

ang,

P. J

aya

& F

MM

-MC

TIG

Sem

inar

Tu

mb

uh

an-t

um

bu

han

Ub

atan

24

– 2

5 Ju

lai 2

001

FRIM

(In

stit

ut

Perh

uta

nan

FR

IMd

an B

erar

om

a 20

01M

alay

sia)

Wo

rksh

op

on

Intr

od

uct

ion

to

th

e 13

Og

os

2001

BPF

KB

PFK

An

alyt

ical

Met

ho

d V

alid

atio

n

Ku

rsu

s Pe

ng

enal

an IS

O 9

001-

2000

6 N

ove

mb

er 2

001

BPF

KB

PFK

Ku

rssu

s A

ud

it D

alam

an7

– 8

No

vem

ber

200

1B

PFK

BPF

K

Asn

ida

bt.

Mat

Dau

dSe

min

ar o

n V

acci

nes

5

Feb

ruar

i 200

1B

PFK

BPF

K

On

-lin

e Ed

uca

tio

n: W

hat

to

Exp

ect

16 M

ac 2

001

Intr

amed

icin

e U

SAIM

R(C

on

tin

ou

s M

edic

al E

du

cati

on

)

Ku

rsu

s B

iro

Tat

aneg

ara

10 –

12

Mei

200

1B

iro

Tat

aneg

ara,

Jab

atan

Ko

lej L

atih

an T

elek

om

Perd

ana

Men

teri

Ku

chin

g, S

araw

ak

Ku

rsu

s In

du

ksi k

hu

sus

bag

i Ku

mp

ula

n

13 –

26

Mei

200

1K

KM

Ho

tel G

ran

d C

on

tin

enta

lPe

ng

uru

san

dan

Pro

fesi

on

alK

uch

ing

, Sar

awak

Sem

inar

Reg

ula

tori

Keb

ang

saan

17 –

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Sher

aton

Sub

ang,

P. J

aya

& F

MM

-MC

TIG

Sem

inar

EU

Leg

isla

tio

n o

n H

erb

al

11 S

epte

mb

er 2

001

MA

TRA

DE,

Eu

rop

ean

Bu

sin

ess

PWTC

K. L

um

pu

rM

edic

inal

Pro

du

cts

Info

rmat

ion

Cen

tre

(EB

IC)

Asi

a-Pa

cifi

c C

linic

al T

rial

s C

on

fere

nce

24 –

26

Sept

embe

r 200

1K

KM

& C

olle

ge

of

Phys

icia

n,

Sun

way

Ho

tel,

P. J

aya

Aca

dem

y of

Med

icin

e of

Mal

aysia

Clin

ical

Tri

al in

Her

bal

Med

icin

e R

esea

rch

27 S

epte

mb

er 2

001

KK

M &

Co

lleg

e o

f Ph

ysic

ian

, IM

R K

. Lu

mp

ur

Aca

dem

y of

Med

icin

e of

Mal

aysia

Phar

mac

y Sc

ien

tifi

c C

on

fere

nce

200

122

– 2

3 O

kto

ber

200

1M

PS, U

M &

Bhg

.Far

mas

i Sel

ango

rSu

mm

it H

ote

l, P.

Jay

a

Sem

inar

Ko

smet

ik1

No

vem

ber

200

1B

PFK

BPF

K

Ku

rsu

s A

ud

it K

ual

iti D

alam

an7

– 8

No

vem

ber

200

1B

PFK

BPF

K


DATE: 11-02-03

CPANTONE 730 CV

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MA

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AW

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KU

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RIK

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NJU

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Ram

li b

t. A

bd

. Gh

ani

Thir

d IF

PMA

Asi

an R

egu

lato

ry S

emin

ar20

– 2

2 M

ac 2

001

IFPM

A/W

HO

Ban

gko

k, T

hai

lan

d

GC

P W

ork

sho

p (

org

aniz

er)

9 –

11 A

pri

l 200

1B

PFK

, Eli

Lilly

Sher

aton

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el, S

uban

g Ja

ya

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nfe

ren

ce o

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& D

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alit

ion

fo

r TB

2

– 4

Mei

200

1C

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, USM

/Glo

bal

Alli

ance

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lau

Pin

ang

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g D

ev. i

n A

sia

for

TB D

rug

Bri

dg

ing

Stu

dy

Co

nfe

ren

ce24

– 2

6 M

ei 2

001

APE

C/D

OH

Tai

wan

Taip

ei, R

OC

Evid

ence

-Bas

ed V

acci

no

log

y22

– 2

3 Ju

n 2

001

MO

H/M

LFM

anda

rin H

otel

, K. L

umpu

r

Nat

ion

al R

egu

lato

ry S

emin

ar

17 –

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Hot

el Sh

erat

on Su

bang

, P. J

aya

(Sci

enti

fic

Co

mm

itte

e)&

FM

M-M

CTI

G

GLP

Sem

inar

(o

rgan

izer

)25

Ju

lai 2

001

BPF

K/U

MM

C/A

gile

nt

Tech

Hot

el Sh

erat

on Su

bang

, P. J

aya

Trai

nin

g o

n In

t. P

ract

ice

for

Dru

g

3 –

21 S

epte

mb

er 2

001

WH

O/T

DR

Pro

gra

mC

anb

erra

/Syd

ney

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istr

atio

n o

n N

CE

Asi

a-Pa

cifi

c C

linic

al T

rial

s C

on

fere

nce

24

Sep

tem

ber

200

1M

OH

/CP,

AM

MSu

nw

ay H

ote

l, P.

Jay

aW

ork

sho

p (

org

aniz

er)

AP

Clin

ical

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als

Co

nfe

ren

ce25

– 2

6 Se

ptem

ber

2001

MO

H/C

P, A

MM

Sun

way

Ho

tel,

P. J

aya

(sci

enti

fic

com

mit

tee)

Thir

d In

t. C

on

gre

ss o

f A

P o

f M

edic

al

12 –

15

Nov

embe

r 20

01U

SM/M

OH

/WH

OPu

lau

Pin

ang

Toxi

colo

gy

(sp

eake

r/A

JK)


DATE: 11-02-03

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E


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riza

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min

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acci

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5 Fe

bru

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001

BPF

KB

PFK

1st

Nat

ion

al T

ran

sfu

sio

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edic

ine

27 –

31

Mac

200

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sat

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ah N

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, K. L

um

pu

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on

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nce

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1

Sem

inar

on

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egu

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ry P

roce

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res

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pri

l 200

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BPF

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eter

inar

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oduc

ts in

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e M

ajor

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ntri

es"

Sem

inar

on

Blo

od

Pro

du

cts

8 M

ei 2

001

Pusa

t D

arah

Neg

ara

Pusa

t D

arah

Neg

ara

Evid

ence

-Bas

ed V

acci

no

log

y Sy

mp

osi

um

22 –

23

Jun

200

1K

KM

Man

dar

in O

rien

tal H

ote

l, K

. Lu

mp

ur

Nat

ion

al R

egu

lato

ry S

emin

ar 2

001

17 –

18

Jula

i 200

1B

PFK

, Ph

AM

A, M

OPI

, CTF

A

Ho

tel S

her

ato

n S

ub

ang

, &

FM

M-M

CTI

GP.

Jay

a

Pre-

Co

nfe

ren

ce W

ork

sho

p: N

ew D

rug

24

Sep

tem

ber

200

1K

KM

Sun

way

Lag

oo

n R

eso

rt ,

Ap

plic

atio

n in

Mal

aysi

a: A

sia

Paci

fic

Clin

ical

P.

Jay

aTr

ial C

on

fere

nce

200

1

4th

Mee

tin

g o

f th

e A

CC

SQ P

-PW

G o

n

25 –

29

Sept

embe

r 200

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SEA

N S

ekre

tari

atB

ali,

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on

esia

Phar

mac

euti

cals

an

d R

elat

ed E

ven

t

Phar

mac

y Sc

ien

tifi

c C

on

fere

nce

200

122

– 2

3 O

kto

ber

200

1M

PS, U

MSu

mm

it H

ote

l, P.

Jay

a

Sem

inar

Ko

smet

ik1

No

vem

ber

200

1B

PFK

BPF

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In-H

ouse

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inin

g on

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rnal

Qua

lity

Aud

itin

g7

– 8

No

vem

ber

200

1B

PFK

BPF

K


DATE: 11-02-03

CPANTONE 730 CV

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MA

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AW

AI

KU

RSU

STA

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ruar

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esp

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mat

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tel P

an P

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asi &

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um

pu

r

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inar

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egu

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ry P

roce

du

res

for

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pri

l 200

1B

PFK

BPF

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eter

inar

y Pr

oduc

ts in

Som

e M

ajor

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ntri

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inar

on

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loo

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rod

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s"8

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200

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sat

Dar

ah N

egar

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sat

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ah N

egar

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Wo

rksh

op

on

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alu

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f A

nal

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go

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idat

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a"

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inar

on

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g A

buse

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vent

ion

Act

ivit

ies"

12 S

epte

mb

er 2

001

Ag

ensi

Dad

ah K

eban

gsa

anH

ote

l Pan

Pac

ific

, K

. Lu

mp

ur

Asi

a Pa

cifi

c C

linic

al T

rial

s C

on

fere

nce

24 –

26

Sept

embe

r 200

1K

KM

& A

cad

emy

of

Med

icin

es,

Sun

way

Res

ort

Ho

tel,

Mal

aysi

aP.

Jay

a

Sem

inar

Ko

smet

ik 2

001

10 O

kto

ber

200

1B

PFK

, CTF

A

& F

MM

-MC

TIG

Sher

ato

n H

ote

l, P.

Jay

a

Sam

bu

tan

Har

i Q 2

001

1 N

ove

mb

er 2

001

KK

MH

ote

l Cit

itel

, Mid

Val

ley,

K

.L

Ku

rsu

s "K

esed

aran

ISO

900

0"6

No

vem

ber

200

1B

PFK

BPF

K

Ku

rsu

s "A

ud

it K

ual

iti D

alam

an"

7 –

8 N

ove

mb

er 2

001

BPF

KB

PFK


DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

NA

MA

PEG

AW

AI

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DATE: 11-02-03

CPANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM


DATE: 11-02-03

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AKTIVITI-AKTIVITI BPFK SEPANJANG TAHUN 2001ACTIVITIES OF NPCB THROUGHOUT THE YEAR 2001

Ahli Pihak Berkuasa Kawalan Dadah

Mesyuarat PihakBerkuasa Kawalan Dadah

National Regulatory Seminar 2001

PI C/S accessment

PANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM


DATE: 11-02-03

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Demonstasi masakan oleh Pn. Zaidah - Puspanita

Majlis Penganugerahan Perkhidmatan Cemerlang

Pasaria Puspanita

Pelawat dari Zimbabwe

PANTONE 730 CV

00284-03 BPFK Adment 3/31/03 3:09 PM

00284-03 bpfk adment - npra.gov.my · status ms iso 9002 di mana ini membawa maksud semua prosedur...

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