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C
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
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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
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
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KATA–KATA ALUANDARIPADA PENGARAH
MESSAGE FROM THEDIRECTOR
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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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DATE: 11-02-03
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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
3. Pegawai FarmasiPharmacist U2 19 19 0
4. Pegawai FarmasiPharmacist U3 44 39 5
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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DATE: 11-02-03
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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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DATE: 11-02-03
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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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DATE: 11-02-03
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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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16 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
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
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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.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
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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
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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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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DATE: 11-02-03
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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
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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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.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
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Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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).
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
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Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
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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.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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:
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
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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.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
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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.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
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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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DATE: 11-02-03
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Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
Figure 1 : Workload under the activities of surveilance, investigation ofproducts complaints of activities and ADR monitoring
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34 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
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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DATE: 11-02-03
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Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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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35L 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
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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Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
Rajah 3 : Bilangan Laporan DiterimaFigure 3 : Number of ADR reports Received
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36 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
Selang
orKL
Perak
Joho
r
Paha
ng
Sarawak
Saba
h
N.Sem
bilan
P.Pina
ng
Tereng
ganu
Keda
h
Kelantan
Melak
a
Labu
an
Putra
jaya
Perlis
194
157
112
126
149
106
114112
103
81
39
47
20
88
82
39
4846
43
32
41
53
33 3432
35
58
38
24 24 24
29
45
18
37
27
24
1917 16
7
30 0 1
98
3
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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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DATE: 11-02-03
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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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DATE: 11-02-03
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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
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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%)
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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%)
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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%)
Sumber: Biro Pengawalan Farmaseutikal KebangsaanSource : National Pharmaceutical Control Bureau
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:-
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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
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Nama Negara Tarikh Tujuan Lawatan
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
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Nama Negara Tarikh Tujuan Lawatan
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
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Nama Negara Tarikh Tujuan Lawatan
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
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Nama Negara Tarikh Tujuan Lawatan
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
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00284-03 BPFK Adment 3/31/03 3:09 PM Page 55
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
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00284-03 BPFK Adment 3/31/03 3:09 PM Page 59
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58 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
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2001
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 60
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11
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2001
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 61
NA
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60 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
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An
alyt
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(M
) Sd
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hd
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no
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mo
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lden
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 62
NA
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gg
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 63
NA
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DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 64
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 65
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 66
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 67
NA
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 68
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 69
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2001
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
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NA
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001
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her
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saf
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chem
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2001
BPF
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 73
NA
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2001
Fisc
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M) S
dn. B
hd.
East
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Jay
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
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cad
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
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NA
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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
Tat
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
1Pe
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
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 76
NA
MA
PEG
AW
AI
KU
RSU
STA
RIK
HA
NJU
RA
NTE
MPA
TN
AM
E O
F O
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ERC
OU
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SD
ATE
SPO
NSO
RPL
AC
E
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Fud
ziah
bt.
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tin
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f th
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CC
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-PW
G o
n5
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Feb
ruar
i 200
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SEA
N S
ekre
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o C
hi M
inh
Cit
y,
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mac
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tnam
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idan
gan
Far
mas
i 200
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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
atio
ns
of
Glo
bal
isat
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
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 77
NA
MA
PEG
AW
AI
KU
RSU
STA
RIK
HA
NJU
RA
NTE
MPA
TN
AM
E O
F O
FFIC
ERC
OU
RSE
SD
ATE
SPO
NSO
RPL
AC
E
76 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
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t. A
bas
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tin
g o
f th
e A
CC
SQ P
-PW
G o
n
5 –
7 Fe
bru
ari 2
001
ASE
AN
Sek
reta
riat
Ho
Ch
i Min
h C
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
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nw
ay H
ote
l, P.
Jay
aM
alay
sia
Suh
aila
h b
t. A
bu
Bak
arSe
min
ar K
osm
etik
1 N
ove
mb
er 2
001
BPF
KB
PFK
In-H
ouse
Tra
inin
g - K
efah
aman
ISO
900
0:20
006
No
vem
ber
200
1B
PFK
BPF
K
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 78
NA
MA
PEG
AW
AI
KU
RSU
STA
RIK
HA
NJU
RA
NTE
MPA
TN
AM
E O
F O
FFIC
ERC
OU
RSE
SD
ATE
SPO
NSO
RPL
AC
E
77L 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
Tan
Lie
Sie
Sem
inar
on
Vac
cin
es5
Feb
ruar
i 200
1B
PFK
BPF
K
Pers
idan
gan
Far
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
Ast
hm
a
Sem
inar
"EU
Leg
isla
tio
n f
or
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
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
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
1B
PFK
BPF
K
Pers
idan
gan
Far
mas
i 200
1- M
od
ern
9
Mac
200
1K
KM
dan
Per
satu
an F
arm
asi
Ho
tel P
an P
acif
ic,
Ap
pro
ach
to
Man
agem
ent
of
Ast
hm
aM
alay
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
.
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 79
NA
MA
PEG
AW
AI
KU
RSU
STA
RIK
HA
NJU
RA
NTE
MPA
TN
AM
E O
F O
FFIC
ERC
OU
RSE
SD
ATE
SPO
NSO
RPL
AC
E
78 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
Som
iyat
on
bt.
Se
min
ar K
osm
etik
1 N
ove
mb
er 2
001
BPF
KB
PFK
Dah
alan
@ D
amu
riK
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
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 80
NA
MA
PEG
AW
AI
KU
RSU
STA
RIK
HA
NJU
RA
NTE
MPA
TN
AM
E O
F O
FFIC
ERC
OU
RSE
SD
ATE
SPO
NSO
RPL
AC
E
79L 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
Zura
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
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
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NA
MA
PEG
AW
AI
KU
RSU
STA
RIK
HA
NJU
RA
NTE
MPA
TN
AM
E O
F O
FFIC
ERC
OU
RSE
SD
ATE
SPO
NSO
RPL
AC
E
80 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
Syal
iza
Om
arSe
min
ar o
n "
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
ntr
ies"
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
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 82
NA
MA
PEG
AW
AI
KU
RSU
STA
RIK
HA
NJU
RA
NTE
MPA
TN
AM
E O
F O
FFIC
ERC
OU
RSE
SD
ATE
SPO
NSO
RPL
AC
E
81L 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
Dr.
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
Hot
el, S
uban
g Ja
ya
Co
nfe
ren
ce o
n R
& D
Co
alit
ion
fo
r TB
2
– 4
Mei
200
1C
DR
, USM
/Glo
bal
Alli
ance
Pu
lau
Pin
ang
Dru
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
Reg
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
Tri
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)
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
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NA
MA
PEG
AW
AI
KU
RSU
STA
RIK
HA
NJU
RA
NTE
MPA
TN
AM
E O
F O
FFIC
ERC
OU
RSE
SD
ATE
SPO
NSO
RPL
AC
E
82 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
No
riza
m b
t. Ib
rah
imSe
min
ar o
n V
acci
nes
5 Fe
bru
ari 2
001
BPF
KB
PFK
1st
Nat
ion
al T
ran
sfu
sio
n M
edic
ine
27 –
31
Mac
200
1Pu
sat
Dar
ah N
egar
aH
ote
l Hilt
on
, K. L
um
pu
rC
on
fere
nce
200
1
Sem
inar
on
"R
egu
lato
ry P
roce
du
res
for
17 A
pri
l 200
1B
PFK
BPF
KV
eter
inar
y Pr
oduc
ts in
Som
e M
ajor
Cou
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
1A
SEA
N S
ekre
tari
atB
ali,
Ind
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
K
In-H
ouse
Tra
inin
g on
Inte
rnal
Qua
lity
Aud
itin
g7
– 8
No
vem
ber
200
1B
PFK
BPF
K
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 84
NA
MA
PEG
AW
AI
KU
RSU
STA
RIK
HA
NJU
RA
NTE
MPA
TN
AM
E O
F O
FFIC
ERC
OU
RSE
SD
ATE
SPO
NSO
RPL
AC
E
83L 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
No
rhay
ati b
t. H
anaf
iah
Sem
inar
on
Vac
cin
es5
Feb
ruar
i 200
1B
PFK
BPF
K
Pers
idan
gan
Far
mas
i 200
1 (R
esp
irat
ori
)9
Mac
200
1B
ahag
ian
Per
khid
mat
an
Ho
tel P
an P
acif
ic,
Farm
asi &
MPS
K. L
um
pu
r
Sem
inar
on
"R
egu
lato
ry P
roce
du
res
for
17 A
pri
l 200
1B
PFK
BPF
KV
eter
inar
y Pr
oduc
ts in
Som
e M
ajor
Cou
ntri
es"
Sem
inar
on
"B
loo
d P
rod
uct
s"8
Mei
200
1Pu
sat
Dar
ah N
egar
aPu
sat
Dar
ah N
egar
a
Wo
rksh
op
on
"Ev
alu
atio
n o
f A
nal
ytic
al
13 O
go
s 20
01B
PFK
BPF
KM
eth
od
Val
idat
ion
Dat
a"
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 –
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
JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
CPANTONE 730 CV
00284-03 BPFK Adment 3/31/03 3:09 PM Page 85
NA
MA
PEG
AW
AI
KU
RSU
STA
RIK
HA
NJU
RA
NTE
MPA
TN
AM
E O
F O
FFIC
ERC
OU
RSE
SD
ATE
SPO
NSO
RPL
AC
E
84 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
Ch
uah
Sie
w K
him
Sem
inar
Sta
tus
Terk
ini P
erke
mb
ang
an
12 M
ac 2
002
JIC
A /K
KM
Ren
aiss
ance
Pal
mPe
ratu
ran
Mak
anan
dan
Dad
ahG
ard
en H
ote
l, Pu
traj
aya
Pers
idan
gan
Akt
a d
an P
erat
ura
n A
hli
Farm
asi
19 -
21
Mac
200
2B
hg
. Far
mas
i KK
MH
ote
l Aw
ana
Port
o
Mal
ai, L
ang
kaw
i
Wo
rksh
op
on
Co
mm
un
icat
ion
Ski
lls in
2
- 5
Ap
ril 2
002
Jab
atan
Kes
ihat
an N
eger
i Ph
arm
aceu
tica
l Car
eK
edah
Clin
ical
Ph
arm
acy
Co
nfe
ren
ce "
Lip
id a
nd
14
- 1
7 A
pri
l 200
2B
hg
. Far
mas
i KK
M/M
PS/
A’ F
amo
sa R
eso
rt,
Pain
Man
agem
ent"
Pfiz
erM
elak
a
Ku
rsu
s "P
har
mac
y U
pd
ates
" u
ntu
k 15
- 1
6 M
ei 2
002
Jab
atan
Kes
ihat
anH
otel
Gra
nd C
onti
nent
al,
Peg
awai
Far
mas
iN
eger
i Pah
ang
Ku
anta
n
1st
Nat
ion
al C
on
fere
nce
on
Lif
e Sc
ien
ces
on
21
- 2
2 M
ei 2
002
KK
M/C
olle
ge
of
Phys
icia
ns,
Mal
aysi
a In
tern
atio
nal
"Gen
om
ics
and
Hea
lth
Imp
licat
ion
s fo
r A
cad
emy
of
Med
icin
e o
fEx
hib
itio
n &
Co
nve
nti
on
Mal
aysi
aM
alay
sia
Cen
tre
K. L
um
pu
r.
Clin
ical
Ph
arm
acy
Sem
inar
on
CN
S-R
elat
ed
4 Ju
lai 2
002
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DATE: 11-02-03
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
DATE: 11-02-03
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AKTIVITI-AKTIVITI BPFK SEPANJANG TAHUN 2001ACTIVITIES OF NPCB THROUGHOUT THE YEAR 2001
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PANTONE 730 CV
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JOB NO.: 00284-03DTP : YF Image-s: 3050LPI/˚ : 150/45˚
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PANTONE 730 CV
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