kandungan contents page · laporan bahagian 11 ... sehingga akhir tahu n 1999, ... issues related...

L A P O R A N T A H U N A N 1 9 9 9 / 1 9 9 9 A N N U A L R E P O R T

Kandungan Mukasurat

Contents Page

Kata - Kata Aluan 1Foreword

Struktur Organisasi 4Organizational Structure

Carta Organisasi 5Organizational Chart

Senarai Jawatan 6List of Posts

Falsafah Organisasi 7Organizational Philosophy

Piagam Pelanggan 8Client’s Charter

Ringkasan Aktiviti BPFK 10Summary of NPCB Activities

Laporan Bahagian 11Divisional Reports

Pelawat-pelawat Antarabangsa 48International Visitors

Puspanita BPFK 50Puspanita NPCB

Kursus / Seminar 51Courses / Seminars

B I R O P E N G A W A L A N F A R M A S E U T I K A L K E B A N G S A A N N 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

1 L A P O R A N T A H U N A N 1 9 9 9 / 1 9 9 9 A N N U A L R E P O R T

KATA-KATA ALUANFOREWORD

Setahun telah berlalu, menandakan lebih 20tahun sejak Biro Pengawalan FarmaseutikalKebangsaan (BPFK) ditubuhkan dan 15 tahunskim pendaftaran ubat-ubatan dilaksanakan diMalaysia. BPFK telah banyak menyumbangkandemi kesihatan awam dengan memastikankualiti, keselamatan dan efikasi ubat-ubatanyang berada di pasaran. Sehingga akhir tahun1999, lebih kurang 24,000 produk telahdidaftarkan dan 1,131 premis dilesenkan.Saya ingin mengambil kesempatan di siniuntuk mengimbas kembali pencapaian-pencapaianBPFK dan meninjau kehadapan ke arahpembangunan kawalan regulatori yang mampan.

Sebagai sekretariat kepada Pihak BerkuasaKawalan Dadah (PBKD), BPFK telah mengukirnama dalam arena regulatori di peringkatantarabangsa. Kejayaan BPFK merupakanhasil kepimpinan, kegigihan dan komitmenpelbagai pihak. Tunjukajar dan sokonganpadu daripada pegawai-pegawai atasan,rakan-rakan setugas dan staf-staf lain sangatsaya hargai dengan penuh keikhlasan.

Dalam usaha kita menjadi sebuah pusatkecemer langan da lam b idang regu la to r ifarmaseutikal, kita hendaklah mempraktikkantahap piawaian yang tinggi dalam amalanregulatori . Dengan perubahan pesat yangberlaku dalam globalisasi pasaran produkfarmaseut ikal , kita perlu meningkatkank e c e k a p a n d a n k e b e r k e s a n a n . K i t a m e s t i

Another year has just whizzed by, markingslightly over 20 years of the establishment ofthe National Pharmaceutical Control Bureauand 15 years of the drug registration era inMalaysia. Indeed, the Bureau has madesigni f icant contributions towards publichealth, by ensuring quality, safety and efficacy,and timely availability of medicinal products.By the end of 1999, approximately 24,000products have been registered and 1,131premises licensed. I would like to take thisopportunity to reflect on the milestonesachieved and to look forward to the newregulatory horizon.

Through the years, the Bureau which servesas the Secretariat to the Drug ControlAuthority ( DCA ) has earned worldwidereputation as an important player in theinternational regulatory arena. The Bureau’ssuccess is a tribute to the guidance, hardwork and commitment of many. The wiseadvice and firm support from my superiors,my colleagues and all staff members are verymuch and sincerely appreciated.

As we strive to be a centre of excellence inpharmaceutical regulatory matters, we mustpursue high standards of regulatory practices.With rapid changes taking place in theglobalization of the market for pharmaceuticalproducts, we need to increase effectivenessand improve efficiency. We must devote ourselvesto cont inual improvements . Es tabl ishing a

N 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 UB I R O P E N G A W A L A N F A R M A S E U T I K A L K E B A N G S A A N

2L A P O R A N T A H U N A N 1 9 9 9 / 1 9 9 9 A N N U A L R E P O R T

berusaha secara berterusan untuk meningkatkanketerampilan. Kita perlu mewujudkan sistemkualiti bagi seluruh organisasi, meningkatkansistem jaringan komputer sediada dan berusahauntuk mencapai pengiktirafan skim antarabangsaiaitu “Pharmaceutical Inspection Co-operationScheme ( PIC/S)”.

Tahun lepas telah menyaksikan beberapapendekatan baru yang positif, dan jalinankerjasama yang erat di antara BPFK danorganisas i -organisas i indust r i . Beberapakumpulan kerja teknikal yang terdiri daripadawakil-wakil industri berkenaan, KementerianKesihatan dan agensi kerajaan lain telahditubuhkan dengan matlamat yang spesifikuntuk membincangkan isu-isu teknikal mengenaipendaftaran dan Amalan Perkilangan B a i k(APB) bagi keluaran farmaseutikal, ubattradisional, produk tambahan khasiat makanandan kosmetik. Kerjasama ini telah menghasilkankejayaan dalam mencapai keputusan yang jitudan penggubalan polisi-polisi yang pragmatik.

Di peringkat antarabangsa, tahun 1999 merupakand e t i k p e r m u l a a n d a l a m u s a h a k i t am e n g h a r m o n i s a s i k a n keperluan dokumen-dokumen teknikal (farmaseutikal) di kalangannegara-negara ASEAN. Tujuan utama usahaini ialah untuk mengatasi masalah sekatanregulatori demi membantu perdagangan keluaran-keluaran berkenaan. Dengan sokongan industrifarmaseutikal, BPFK telah banyak memberisumbangan teknikal dalam menjayakanpenubuhan “ASEAN Consultative Committeefor Standards and Quality (ACCSQ) ProductWorking Group on Pharmaceuticals” dan akanterus memainkan peranan yang aktif untukmencapai matlamat yang ditetapkan.

Beberapa dasar baru telah diperkenalkansepanjang tahun 1999. Antaranya termasukpelesenan pengilang dan pengimport ubat-ubatantradisional, pelaksanaan kajian bioequivalenuntuk beberapa keluaran generik sepertiCaptopril, Nifedipine dan Cyclosporin, keperluanvalidasi proses dan analitikal untuk keluaranjenis suntikan, promosi Amalan Klinikal Baik(GCP) dalam kajian klinikal, pelaksanaanproses pendaftaran yang lebih mudah untukmenggalakkan eksport keluaran tempatanserta menembusi pasaran global, dan keperluanmaklumat nilai jualan untuk keluaran-keluaranberdaftar. Namun demikian, terdapat isu-isula in yang per lu d ikaj i dar i perspekt i fperundangan seperti struktur yuran pendaftaranbaru, pengimportan selari, perbezaan di antaramakanan dan ubat-ubatan, dan pemeriksaanAPB premis luar negara.

quality system for the entire organization,upgrading the existing computer network systemand working towards achieving PharmaceuticalInspection Co-operation Scheme ( PIC/S )recognition are currently our main focus.

Glancing back the past year, we saw positivenew approaches and enhanced co-operationbetween us, the regulators and the variousindustry organizations. Several TechnicalWorking Groups ( TWG ), comprising ofrepresentatives from the relevant industry,Ministry of Health and other governmentagencies, have been set up with specific termsof reference, mainly to discuss technicalissues related to registration and GoodManufacturing Practice of pharmaceuticals,traditional medicines, food supplements andcosmetics. The creation of such partnershipshave led to tangible decisions and formulationof pragmatic policies.

On the international front, 1999 also markedthe commencement of efforts towards harmonizationof common technical documents (pharmaceuticals)among ASEAN countries, primarily aimed atelimination of technical regulatory barriersto facilitate trade. The Bureau with thesupport of the pharmaceutical industry, hasmade considerable technical contribution tothe establishment of ASEAN ConsultativeCommittee for Standards and Quality (ACCSQ)Product Working Group on Pharmaceuticals,and will continue to participate actively toachieve our ultimate goals.

Notable new policies have been made during1999. These include licensing of traditionalmedicines manufacturers and importers,implementation of bio-equivalence studies forselected generics such as captopril, nifedipineand cyclosporin, process and analyt icalval idat ion requirements for in jec tables ,promoting Good Clinical Practice ( GCP ) inclinical studies, developing more streamlinedregistration processes to facilitate export andmarket access, and submission of sale valuesfor registered products. However, there areother issues such as the new fee structure,parallel import, food and drug interface andforeign inspections that need to be furtherreviewed from the legislative perspective.




Memandang kehadapan secara positif, BPFKtelah mengenalpasti arahtuju yang strategikselaras dengan perkembangan kawalan regulatoriantarabangsa. Maka kita perlu memperluaskanperanan kawalan regulatori dalam berbagai-bagaibidang lain. Pendaftaran keatas keluaran kosmetik,keluaran veterinar, peralatan perubatan dan bahanaktif farmaseutikal telah dicadangkan untukdilaksanakan di bawah Rancangan MalaysiaKe-8 (2001-2005). Meskipun kerja-kerja asastelah pun dimulakan, kita perlu berupaya danbersedia berhadapan dengan cabaran-cabaranyang akan ditempohi kelak.

Akhir kata, sekali lagi saya ingin mengucapkanribuan terima kasih kepada ketua-ketua sayayang telah banyak memberikan bimbingandan galakan. Setinggi-tinggi penghargaansaya tujukan kepada semua anggota BPFKyang telah bekerja dengan penuh dedikasi.Semangat kerjasama dan sumbangan baktianda sekalian amatlah penting demi kejayaanmasa hadapan BPFK.

( CHE MOHD. ZIN BIN CHE AWANG )PengarahBiro Pengawalan Farmaseutikal KebangsaanKementerian Kesihatan Malaysia

Looking forward with optimism, we haveidentified our future goals and strategiestowards charting new regulatory directions.Diversifying our role, registration of cosmetics,veterinary medicines, medical devices andactive pharmaceutical ingredients have beentargeted for implementation under the 8thMalaysia Plan ( 2001 - 2005 ). While theground-breaking work has already started,we certainly have a challenging task ahead ofus.

Once again, I would like to thank my superiorsfor their guidance and encouragement. To allmy valued staff, the key to our achievements,reputation and our future success, are yourdedication and the willingness to demonstratecommitment.

( CHE MOHD. ZIN BIN CHE AWANG )DirectorNational Pharmaceutical Control BureauMinistry of Health Malaysia


STRUKTUR ORGANISASIORGANIZATIONAL STRUCTURE OF

BAHAGIAN PERKHIDMATAN FARMASIPHARMACEUTICAL DIVISION

KEMENTERIAN KESIHATAN MALAYSIAMINISTRY OF HEALTH

KETUA PENGARAH KESIHATANDIRECTOR GENERAL OF HEALTH

TIMBALANKETUA PENGARAH KESIHATAN(Penyelidikan & Sokongan Teknikal)

DEPUTYDIRECTOR GENERAL OF HEALTH

(Research & Technical Support)

PENGARAHPERKHIDMATAN FARMASI

DIRECTOR OF PHARMACEUTICAL SERVICES

PENGARAH TIMBALAN TIMBALAN KETUA PEGAWAI 13 TIMBALAN PENGARAHBPFK PENGARAH PENGARAH FARMASI KESIHATAN NEGERI

(Perlesenan & (Pengurusan Farmasi) (Hospital Kuala Lumpur) (Farmasi)

DIRECTOR NPCB Penguatkuasaan)

DEPUTY DEPUTY CHIEF PHARMACIST 13-STATE DEPUTY DIRECTOR DIRECTOR (Kuala Lumpur Hospital) DIRECTORS OF HEALTH

(Licensing & (Pharmaceutical Care) (Pharmacy)Enforcement)




CARTA ORGANISASIORGANIZATIONAL CHART

BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAANNATIONAL PHARMACEUTICAL CONTROL BUREAU

PENGARAHDIRECTOR

Bahagian Penilaian & Bahagian APB & Bahagian Pembangunan Bahagian Surveilans Bahagian Pentadbiran Bahagian AnalisisKeselamatan Ubat Perlesenan Organisasi & Teknologi & Farmakovigilans Ubat

Maklumat

Drug Evaluation GMP & Licensing Organizational Surveillance & Administrative Drug Analysis Division& Safety Division Division Development & Pharmacovigilance Division

Information DivisionTechnology Division

Unit Sekretariat Unit Racun Makmal Kimia Makmal MicrobiologiFarmaseutikal Farmaseutikal

Secretariat Unit Poisons UnitPharmaceutical PharmaceuticalChemistry Lab Microbiology Lab

Unit Bukan Unit Ubat Makmal Makmal TeknologiRacun Tradisional Farmakologi/ Farmaseutikal

Toksikologi

Non Poisons Traditional Pharmacology/ Pharmaceutical Unit Medicines Unit Toxicology Lab Technology Lab

Unit Entiti Unit Kosmetik Unit Piawai Makmal UbatKimia Baru Rujukan Tradisional

New Chemical Cosmetics Unit Reference TraditionalEntity Unit Standards Unit Medicines Lab


SENARAI JAWATAN PADA 31 DISEMBER 1999LIST OF POSTS AS AT 31 DECEMBER 1999

Bil. Nama Jawatan Gred Jawatan(Post)No. Position Grade Bil. Diisi Kosong

No. Filled Vacant

1. Pengarah BPFK JUSA C 1 1 0Director of NPCB

2. Timbalan Pengarah U1 2 2 0Deputy Director

3. Ketua Penolong Pengarah U2 13 12 1Principal Assistant Director

4. Penolong Pengarah U3 50 36 14Assistant Director

5. Penolong Pegawai Perangkaan N6 1 1 0Assistant Statistic Officer

6. Pembantu Farmasi U7 8 7 1Pharmacy Assistant

7. Pembantu Farmasi U8 65 63 2Pharmacy Assistant

8. Pembantu Tadbir N7 1 1 0(Perkeranian/Operasi)Administrative Assistant (Clerical/Operations)

9. Pembantu Tadbir N9 11 9 2(Perkeranian/Operasi)Administrative Assistant (Clerical/Operations)

10. Pembantu Perpustakaan S7 1 1 0Library Assistant

11. Pembantu Tadbir N9 1 1 0(Penyelenggara Stor)Administrative Assistant (Store)

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

13. Pembantu Tadbir N9 2 1 1(Kesetiausahaan)Administrative Assistant(Secretary)

14. Pengawal Keselamatan KP10 3 1 2Security Guard

15. Pembantu Tadbir Rendah (Jurutaip) N11 4 2 2Administrative Assistant (Typist)

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

17. Atendan Kesihatan U16 10 7 3Health Attendant

18. Pembantu Am Rendah N13 2 0 2General Assistant

19. Jaga R11 2 0 2Security Guard

20. Pemandu Kenderaan Bermotor R10 3 2 1Driver

21. Operator Mesin Prosesan Data F9 2 1 1Data Processing Machine Operator

Jumlah (Total) 184 149 35



FALSAFAH ORGANISASI

WAWASAN

Biro Pengawalan Farmaseutikal Kebangsaansebagai pusat kecemerlangan unggul dalambidang regulatori farmaseutikal demi menjaminkesihatan dan kesejahteraan insan sejagat.

MISI

Biro Pengawalan Farmaseutikal Kebangsaanakan memastikan kualiti, keberkesanan dankeselamatan keluaran farmaseutikal melaluiperlaksanaan undang-undang oleh tenagakerja yang terampil dan usahasama strategikke arah peningkatan status kesihatan rakyat.

MATLAMAT

Memastikan bahawa bahan-bahan terapeutikyang dibenarkan di pasaran tempatan adalahselamat, berkesan dan bermutu, serta menentukanbahawa kosmetik-kosmetik yang dibenarkandi pasaran adalah selamat dan bermutu.

STRATEGI

Memastikan kecekapan dan keberkesananorganisasi melalui permodenan dan automasisistem-sistem pejabat, makmal dan pendaftaran,pen in jauan se r t a pemba ikan perkhidmatansecara regular.

Memperkukuhkan aktiviti penguatkuasaanundang-undang berkaitan.

Memastikan suasana kefahaman dua hala dankerjasama berterusan sentiasa wujud antarapihak pengawalan dengan sektor swastamelalui sessi dialog dan bimbingan.

Meningkatkan potensi serta kepakaran personel.

Mewujudkan satu kumpulan tenaga kerja yangberdedikasi dan penuh komitmen melaluimotivasi, penghargaan serta ganjaran yangberpatutan.

Mempergiatkan aktiviti penyelidikan sertameningkatkan kemudahan-kemudahan bagitujuan tersebut.

Mewujudkan suatu suasana yang menggalakkankakitangan bekerja secara berpasukan dengansikap penyayang, serta melaksanakan tugasmasing-masing secara profesional.

ORGANIZATIONAL PHILOSOPHY

VISION

The National Pharmaceutical Control Bureauwill be a centre of excellence in pharmaceuticalregulatory matters to ensure the health andwell-being of mankind.

MISSION

The National Pharmaceutical Control Bureaushall ensure the quality, efficacy and safety ofp h a r m a c e u t i c a l p r o d u c t s t h r o u g h t h eimp lemen ta t i on of the relevant legislationby a competent workforce working togetherin strategic alliance towards improving thehealth of the people.

OBJECTIVE

To ensure that therapeutic substancesapproved for the local market are safe, effectiveand of quality and also to ensure that cosmeticproducts approved are safe and of quality.

STRATEGY

To ensure organiza t ional e f f ic iency ande f f e c t i v e n e s s through modernisation andautomat ion of the o f f ice , laboratory andregistrat ion systems and regular review andimprovement of service.

To strengthen enforcement activity of therelated legislation.

To ensure continuous mutual understandingand cooperation between the regulatory bodyand the private sector through dialogue andguidance.

To upgrade personnel potential and expertise.

To attain a dedicated and fully committedwork force through motivation, appreciationand appropriate remuneration.

To strengthen research activities and upgradefacilities for such purpose.

To create a working environment conducivefor the personnel to work as a team with acaring attitude whilst discharging their dutiesin a professional manner.

MOTTO

UTAMAKAN KUALITI, EFIKASI DAN KESELAMATAN.EMPHASIZE QUALITY, EFFICACY AND SAFETY



PIAGAM PELANGGAN

A. KEWAJIPAN BIRO PENGAWALANFARMASEUTIKAL KEBANGSAANTEMA PIAGAM

Ditujukan khas kepada setiap pelangganyang berurusan dengan BPFK.

1. AM

KEMUDAHAN UNTUK PELANGGAN

i) Setiap pelanggan Biro bolehmendapat perkhidmatan sewajarnya.

ii) Setiap pelanggan yang tergolongdalam keadaan yang memerlukanperhatian segera akan diberilayanan dengan segera.

TARAF PERKHIDMATAN

i) Setiap pelanggan akan dilayandengan baik, mesra, bertimbangrasa, hormat dan ikhlas.

ii) Setiap pelanggan akan diberipe rkh idma tan yang t e rba iksecara profesional.

MAKLUMAT PERKHIDMATAN

Set iap pe langgan bo leh mendapa tpen j e l a san dan na s iha t mengena iperkhidmatan yang diberikan kepadanya.

2. AKTIVITI -PENDAFTARAN

Memastikan bahawa semua keluaranfarmaseutikal yang berdaftar adalahselamat, berkesan dan berkualiti sertamenentukan bahawa kosmetik-kosmetikyang berdaftar adalah selamat.

Semua permohonan akan dinilai denganadil dan saksama berlandaskan kepadaperaturan-peraturan yang berkaitan.

Semua dokumen yang dikemukakanoleh pelanggan akan disimpan dalamkeadaan selamat dan terkawal.

3. AKTIVITI - MAKMAL

Semua ujian makmal akan dijalankandengan adi l dan saksama mengikutpera turan-pera turan dan prosedur-prosedur yang berkaitan.

CLIENT’S CHARTER

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

Exclus ive concern for c l ients whodeal with NPCB.

1. GENERAL

FACILITIES FOR CLIENTS

i) E v e r y c l i e n t o f t h e B u r e a ushall receive the appropriateservice.

ii) E v e r y c l i e n t w h o r e q u i r e simmediate attention shall beserved immediately.

STANDARD OF SERVICE

i) Every cl ient shall be treatedwith courtesy, understanding,respect and sincerity.

ii) Every client shall be given thebest possible professional service.

INFORMATION SERVICE

Every client shall be given explanationand advice on the service provided.

2. ACTIVITY - REGISTRATION

To ensure the sa fe ty , e f f i cacy andquality of all registered pharmaceuticalproducts and the safety of registered cosmetic products.

Al l appl icat ions shal l be evaluatedw i t h f a i r n e s s a n d i m p a r t i a l i t y i naccordance with the relevant regulations.

All documents forwarded by clientsshall be kept in a secure and organizedmanner.

3. ACTIVITY - LABORATORY

All laboratory tests shall be carriedout fairly and impartially in accordancewi th the re levant regula t ions andprocedures.

8



4. AKVITIVI - PENGUATKUASAAN DAN KOMPLIANS

Setiap tindakan penguatkuasaan ke atasmana-mana pelanggaran undang-undangyang dikuatkuasakan akan dilakukand e n g a n a d i l d a n s a k s a m a t a n p adipengaruhi oleh apa-apa kepentingandan prasangka.

Bersedia bekerjasama dengan agensipenguatkuasaan la in dalam perkarayang berkaitan dengan penguatkuasaanubat-ubatan.

5. SETIAP PERMOHONAN YANGL E N G K A P A K A N D I P R O S E S M E N G I K U T J A N G K A M A S ABERIKUT:

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

ii) L e s e n U n t u k P e m b o r o n g ,Pengilang dan Pengimport - tidaklebih dari 3 bulan.

iii) Lesen Baru Untuk Pemborong,Pengilang dan Pengimport - tidaklebih dari 6 bulan.

iv) Pendaftaran.

Peringkat 1 - tidak lebih dari 6 minggu.

Peringkat 2 - tidak lebih dari 4 bulan.

Peringkat 3 - Generik - tdak lebih dari6 bulan.

NCE - tidak lebih dari 12 bulan.

Tambahan Indikasi - tidak lebih dari6 bulan.

v) Laporan Pemeriksaan APB.

Susulan - tidak lebih dari 2 bulan.

Baru/Rutin - tidak lebih dari 3bulan.

vi) Perakuan Keluaran.

Alat Perubatan - t idak lebihdari 2 minggu.Farmaseu t ika l - t idak l eb ihdari 1 bulan.

B. KEWAJIPAN PELANGGAN

B a g i m e m b o l e h k a n p i a g a m i n id i l a k s a n a k a n d e n g a n b e r k e s a n ,pelanggan adalah berkewajipan untuk :

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

(ii) Menggunakan kemudahan-kemudahanyang disediakan secara bertanggungjawab.

4. ACTIVITY - ENFORCEMENT AND COMPLIANCE

Every enforcement action on any offenceunder the law shal l be carr ied outfairly and impartially without influencefrom whatever ves ted in teres t andprejudice.

Ever ready to co-operate with otherenforcement agencies in matters relatedto drug enforcement.

5. EVERY COMPLETE APPLICATIONS H A L L B E P R O C E S S E D I NACCORDANCE TO THE FOLLOWINGTIME-FRAME :

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

ii) L i c e n c e F o r W h o l e s a l e r s , 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 than 6 months.

NCE - not more than 12 months.

Additional Indications - not more than 6 months.

v) GMP Inspection Report

Follow-up - not more than 2 months.

New/Routine - not more than3 months.

vi) Product Certificate

Medical Devices - 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 fulfilthe following:-

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

(ii) Use the facilities provided responsibly.



RINGKASAN AKTIVITI BPFK

Aktiviti-aktiviti Biro Pengawalan FarmaseutikalKebangsaan pada amnya termasuk :-

1. Menguatkuasakan skim pendaftaranubat dan kosmetik melalui penilaian datateknikal, ujian makmal, penyelidikan danmaklumat yang diterima daripada badan-badanantarabangsa.

2. Menjalankan ujian analisa, farmaseutik,mikrobiologi, farmakologi serta toksikologike atas ubat-ubatan dan kosmetik untukmenentukan mutu, keberkesanan dan keselamatankeluaran-keluaran tersebut.

3. Menguatkuasakan skim kawalan mutuubat-ubatan di pasaran melalui penyampelanrambang dan menjalankan ujian-ujian analisa.

4. Menguatkuasakan skim pelesenanpengilang, pengimport, pemborong ubat-ubatan, termasuk skim pelesenan untuk percubaanklinikal.

5. Mendorong dan membantu pengilang-pengilang ubat tempatan untuk meningkatkanmutu pengilangan setaraf dengan AmalanPerkilangan Baik yang dianjurkan olehPertubuhan Kesihatan Sedunia.

6. Menguruskan program pemonitorankesan advers ubat dan menganggotai ProgramPemonitoran Ubat Antarabangsa WHO.

7. Menguruskan skim panggilbalik ubat-ubat yang didapati atau dibuktikan merbahayakepada pengguna.

8. Mengendalikan sistem pengumpulandan penyebaran maklumat ubat-ubatan selarasdengan peranannya sebagai Pusat MaklumatUbat Kebangsaan.

9. Menjalankan penyelidikan metodologidan penyelidikan asas untuk tujuan menilaimutu, keberkesanan dan keselamatan ubat-ubatan/kosmetik.

10. Menubuhkan sistem pembentukanpiawai rujukan untuk kegunaan negara ini dannegara jiran melalui skim kerjasama dalambidang farmaseutikal di antara negara-negaraASEAN.

11. Menjalankan latihan bagi pegawai-pegawai farmasi, pegawai-pegawai profesionalla in dan juga pegawai-pegawai separuhprofes ional yang ditempatkan di institusi inidari masa ke semasa melalui skim latihantempatan atau skim kerjasama antarabangsa.

SUMMARY OF NPCB ACTIVITIES

The activities of NPCB are :-

1. To implement the drug and cosmeticregistration scheme through evaluation oftechnical data, laboratory analysis, researchand information received from internationalagencies.

2. To carry out analytical, pharmaceutical,microbiological, pharmacological and toxico-logical tests on drugs and cosmetics todetermine quality, efficacy and safety of suchproducts.

3. To implement the regulatory schemeon quality of pharmaceutical products in themarket through random sampling and carryingout analytical tests.

4. To implement the licensing scheme forpharmaceutical manufacturers, importers andwholesalers including a licensing scheme forclinical trials.

5 . T o e n c o u r a g e a n d a s s i s t l o c a lp h a r m a c e u t i c a l manufacturers to upgrademanufacturing standards to levels equivalent tothe requirements of Good Manufacturing Practiceas recommended by the World HealthOrganisation (WHO).

6. To manage the Adverse Drug ReactionMonitoring Programme and participate in theWHO International Adverse Drug ReactionMonitoring Programme.

7. To manage the product recall schemefor pharmaceutical products which are foundto be substandard or dangerous to consumers.

8. To manage the drug information collectingand disseminating system in line with its roleas a National Drug Information Centre.

9. To carry out research on methodologyand basic research for the purpose of evaluatingquality, efficacy and safety of drugs/cosmetics.

10. To establish a reference standard systemfor use in this country and also for neighbouringcountries through a scheme of cooperation inthe field of pharmaceuticals among ASEANcountries.

11. To carry out training for pharmacists,other professional and semi-professional officerswho are placed in this institution from time totime through l o c a l t r a i n i n g s c h e m e o rin t e rna t i ona l coopera t i ona l scheme.


Laporan BahagianDivisional Reports




Jadual 1: Kutipan Hasil (RM) Table 1: Revenue Until 31.12.1999

Tahun Pendaftaran Lesen Makmal Pemeriksaan Bahan Cetak Lain-lainYear Registration Licences Laboratory Inspection Printed Materials Others

1992 422,965 53,650 308,685 0 0 16,213

1993 759,284 91,951 686,690 4,920 4,920 7,621

1994 911,840 84601 516,805 25,805 9,720 38,610

1995 381,120 99,200 965,110 22,600 52,806 1,520,836

1996 728,253 97,101 963,570 17,700 28,316 14,050

1997 878,050 105,750 797,555 8,800 37,602 28,019

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

Jumlah 5,834,742 819,953 5,473,635 102,575 191,265 1,656,320Total

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 anggotamenikmati upahan gaji bulanan dan tuntutan-tuntutan rasmi dibayar dalam tempoh yangditetapkan. Menguruskan dengan segerasegala keperluan asas dan yang penting.Menguruskan perkhidmatan yang wajib danperlu dikemaskinikan. Mengawal peruntukankewangan supaya sentiasa mencukupi bagimenjamin setiap aktiviti yang dirancang bolehmencapai objektif keseluruhannya.

KEWANGAN

Menguruskan pembayaran upahan dan gajiuntuk 149 anggota :

Gaji bulanan : RM 3,155,200.00

KUTIPAN HASIL

Kutipan hasil diterima daripada pelangganuntuk bayaran pendaftaran ubat-ubatan, ujianmakmal, lesen, perkhidmatan nasihat, jualanbuku-buku panduan dan lain-lain. Jumlahkutipan mengikut disiplin adalah seperti dibawah:-

ADMINISTRATIVE DIVISION

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

OBJECTIVES

To ensure all emoluments and claims are paidwithin the stipulated time. To take immediateaction on basic and urgent matters. To constantlyupdate compulsory records. To oversee thatfinancial allocations are sufficient and toensure that each program and activity meets itsobjective.

FINANCE

Payment to 149 staff members.

Salary : RM 3,115,200.00

REVENUE

Revenue is collected from the public for drugregistration, laboratory tests, licences, advisoryservices, sale of guideline books and others.The breakdown of total revenue is as follows:-



Jadual 2: Tinjauan Belanjawan Table 2: Budget Preview

Peruntukan dan Perbelanjaan Mengurus BPFK (1999)NPCB Operating Allocation and Expenditure

Kod Jenis Peruntukan (RM) Perbelanjaan BakiObjek Perbelanjaan Am Allocation (RM) Expenditure Balance

Object Expenditure Asal Dipinda PerbelanjaanCode Original Amended bersih (RM)

Actual % (RM) %Expenditure

(RM)

10000 Emolumen 3,528,744 3,861,420 4,067,384 105.33 (205,964) 5,33Emolument

20000 Perkhidmatan dan 2,853,000 2,295,000 2,296,633 100.07 (1,633) -BekalanServices and Supply

30000 Aset (Harta Modal) 125,000 175,000 174,955 99.97 44.16 0.02Asset(Property Model)

Jumlah 6,506,744 6,331,420 6,538,972 305.37 (207,552) 5.35Total



BAHAGIAN PENILAIAN DAN KESELAMATAN UBAT

OBJEKTIF

Untuk memastikan semua keluaran berdaftardinilai dari segi kualiti, keselamatan danefikasi.

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

PENCAPAIAN

Permohonan diterima

Sejumlah 43,299 permohonan diterima daritahun 1985 sehingga 1999, dimana 13,545(31.3 %) ubat racun, 9,519 (22.0 %) ubatbukan racun, 18,768 (43.3 %) ubat tradisionaland 1,467 (3.4 %) kosmetik (Jadual 3). Jumlahpermohonan telah meningkat dengan ketaradari 6,448 pada 1986 kepada 20,257 pada1992. Trend yang sama dapat diperhatikanpada 1992 hingga 1999, dimana jumlah permohonanmeningkat sebanyak 53.2 %, kerana permohonanyang banyak untuk ubat tradisional dan kosmetik.

Keluaran didaftarkan

Sejumlah 23,935 keluaran telah didaftarkansehingga 1999, dimana 8,792 ( 36.7 % ) ialahubat racun, 5,942 (24.8 %) ubat bukan racun,7,966 (33.3 %) ubat tradisional dan 1,235 (5.2%) kosmetik (Jadual 4). Jumlah keluaranyang didaftarkan menunjukkan peningkatanbagi semua kategori.

Permohonan ditolak

Sehingga 1999, sejumlah 16,384 permohonanditolak dan ini meliputi kira-kira 37.8% darijumlah permohonan yang diterima. (Jadual 5)

DRUG EVALUATION AND SAFETY DIVISION

OBJECTIVES

To ensure that all registered products havebeen evaluated for quality, safety and efficacy.

To provide technical and administrative supportin all matters pertaining to registration ofproducts.

ACHIEVEMENTS

Applications Received

A total of 43,299 applications were receivedfrom 1985 to 1999, of which received 13,545(31.3 %) were prescription drugs, 9,519 (22.0%) OTC products, 18,768 (43.3 %) traditionalmedicines and 1,467 (3.4 %) cosmetics (Table 3).The number of applications had increasedvery markedly, from 6,448 in 1986 to 20,257in 1992. A similar increasing trend wasobserved from 1992 to 1999, where the numberof applications had gone up by almost 53.2 %,mainly due to the enormous number of traditionalmedicines and cosmetics applications.

Products Registered

A total of 23,935 products had been registeredby 1999, of which 8,792 registered( 36.7 % )are prescription drugs, 5,942 (24.8 %) OTCs,7,966 (33.3 %) traditional medicines and1,235 (5.2 %) cosmetics (Table 4). The numberof products registered display increasingtrends for all categories.

Applications rejected

Up until 1999, a total of 16,384 applicationshad been re jec ted and th is representsapproximately 37.8 % of the total number ofapplications received. (Table 5)




Jadual 3 : Permohonan Untuk Pendaftaran, 1985 - 1999Table 3 : Applications Received For Registration, 1985 - 1999

Tahun Ubat racun Ubat bukan racun Ubat tradisional Kosmetik Jumlah TahunanKumulatif

Year Prescription OTC products Traditional Cosmetics Total Annualdrugs medicines Cumulative

1985 9 - - - 9 9

1986 6,439 - - - 6,439 6,448

1987 824 56 - - 880 7,328

1988 702 2,532 - - 3,234 10,562

1989 664 2,750 - - 3,414 13,976

1990 528 597 - - 1,125 15,101

1991 481 305 - 42 828 15,929

1992 150 60 3,973 145 4,328 20,257

1993 376 111 7,059 51 7,597 27,854

1994 400 168 4,080 31 4,679 32,533

1995 440 239 288 58 1,025 33,558

1996 617 671 415 130 1,833 35,391

1997 532 635 668 123 1,958 37,349

1998 587 606 938 277 2,408 39,757

1999 796 789 1,347 610 3,542 43,299

Jumlah 13,545 9,519 18,768 1,467 43,299 43,299Total

Jadual 4 : Bilangan Kumulatif Keluaran Yang Didaftarkan ( 1991 - 1999 )Table 4 :Cumulative Number Of Products Registered ( 1991 - 1999 )

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

drugs medicines

1991 5,332 3,331 - - 8,663

1992 5,862 3,743 - 14 9,619

1993 6,131 3,867 5 109 10,112

1994 6,444 3,954 57 149 10,604

1995 6,691 4,023 339 183 11,236

1996 7,027 4,237 1,852 292 13,408

1997 7,525 4,830 4,347 476 17,178

1998 8,187 5,415 7,819 664 22,085

1999 8,792 5,942 7,966 1,235 23,935

Jumlah 8,792 5,942 7,966 1,235 23,935Total


Jadual 5 : Bilangan Kumulatif Permohonan Yang Ditolak, 1986 - 1999Table 5 : Cumulative Number Of Applications Rejected By The DCA, 1986 - 1999


drugs medicines

1986 955 - - - 955

1987 2,043 - - - 2,043

1988 2,389 329 - - 2,718

1989 2,889 1,083 - - 3,972

1990 3,206 1,318 - - 4,524

1991 3,495 1,585 - - 5,080

1992 3,693 2,127 - 14 5,834

1993 3,770 2,262 0 92 6,124

1994 3,860 2,362 410 98 6,730

1995 3,938 2,592 1,253 98 7,881

1996 4,020 2,783 2,570 98 9,373

1997 4,132 2,963 3,915 98 11,108

1998 4,164 3,065 7,190 98 14,517

1999 4,186 3,125 8,975 98 16,384

Jumlah 4,186 3,125 8,975 98 16,384Total

Permohonan yang dibatalkan atau ditarik balik

Sehingga 1999, sejumlah 5,108 permohonandibatalkan atau ditarik-balik, dan ini meliputi1925 (37.7 %) ubat racun, 909 (17.8 %) ubatbukan racun, 2208 (43.2 %) ubat tradisional dan66 (1.3 %) kosmetik (Jadual 6). Jumlah keluaranyang dibatalkan atau ditarik-balik adalah 11.8% daripada jumlah permohonan yang diterima.

Applications Cancelled or Withdrawn

Up until 1999, a total of 5,108 applications hadbeen cancelled or withdrawn, which consistedof 1925 (37.7 %) prescription drugs, 909(17.8 %) OTCs, 2208 (43.2 %) traditionalmedicines and 66 (1.3 %) cosmetics (Table 6).The total number of products cancelled or with-drawn represents about 11.8 % of the totalnumber of applications received.



Rayuan

Jumlah rayuan yang diterima pada 1999adalah 370 berbanding dengan 522 pada 1998dan 388 pada 1997.

Entiti kimia baru

Dar i 1985 h ingga 1999 , se jumlah 1 ,051permohonan diterima untuk keluaran entitikimia baru (Rajah 1). Daripada jumlah ini,668 (63.5%) telah diluluskan, 275 (26.2%)ditolak dan 38 (3.6%) tertangguh.

Tempatan vs. Import

Sebanyak 42.0 % (10,128) daripada jumlahkeluaran yang didaftarkan adalah dikilangkan ditempatan, sementara 58.0 % (13,807) adalahdiimport. Keluaran tempatan dan import yangdidaftarkan dari 1991 sehingga 1999,mengikut kategori berlainan diilustrasikanpada Jadual 7.

Appeals

The number of appeals received in 1999 was370, as compared to 522 in 1998 and 388 in1997.

New chemical entities

From 1985 to 1999, a total of 1,051 applications were received for products classified as newchemical entities (Figure 1). Out of these, 668(63.5 %) had been approved, 275 (26.2 %)rejected and 38 (3.6 %) deferred.

Local vs. Import

About 42.0 % (10,128) of the total number ofproducts registered are locally-manufactured,while 58.0 % (13,807) are imported. Locallymanufactured and imported products registeredfor the period between 1991 to 1999, according todifferent categories, are cumulatively illustratedin Table 7.


Jadual 6 : Permohonan Yang Dibatalkan /Ditarikbalik, 1989 - 1999Table 6 : Applications Cancelled/Withdrawn, 1989 - 1999

Tahun Ubat racun Ubat bukan racun Ubat tradisional Kosmetik Jumlah TahunanKumulatif

Year Prescription OTC products Traditional Cosmetics Total Annualdrugs medicines Cumulative

1989 166 0 - - 166 166

1990 114 0 - - 114 280

1991 103 37 - - 140 420

1992 0 15 - - 15 435

1993 6 0 0 - 6 441

1994 9 28 0 - 37 478

1995 39 59 0 - 98 576

1996 59 62 0 - 121 697

1997 62 76 0 - 138 835

1998 0 23 595 - 618 1,453

1999 1,367 609 1,613 66 3,655 5,108

Jumlah 1,925 909 2,208 66 5,108 5,108Total


Jadual 7 : Jumlah Kumulatif Produk Tempatan Dan Import ( 1991 - 1999 )Table 7 : Cumulative Number Of Locally Manufactured And Imported Products Registered ( 1991 - 1999 )


drugs medicines

Local Import Local Import Local Import Local Import Local Import

1991 1,602 3,730 1,750 1,581 - - - - 3,352 5,311

1992 1,760 4,102 1,983 1,760 - - 2 12 3,745 5,874

1993 1,867 4,264 2,032 1,835 1 4 22 87 3,922 6,190

1994 1,951 4,493 2,081 1,873 17 40 22 127 4,071 6,543

1995 2,041 4,650 2,083 1,940 145 194 22 161 4,291 6,945

1996 2,213 4,814 2,202 2,035 950 942 72 220 5,437 8,011

1997 2,347 5,178 2,475 2,355 2,300 2,047 72 404 7,194 9,984

1998 2,602 5,585 2,755 2,660 4,246 3,573 106 558 9,709 12,376

1999 2,781 6,011 3,052 2,890 4,098 3,868 197 1,038 10,128 13,807

Jumlah 8,792 5,942 7,966 1,235 23,935Total

0

200

400

600

800

1000

1200

85-91

431

188

101

0

1992

8

48

30

0

1993

2

34

35

3

1994

60

48

7

8

1995

47

36

18

1

1996

52

37

11

0

1997

127

87

39

4

1998

114

61

15

11

1999

140

129

19

11

Jumlah

1051

668

275

38

Rajah 1: Status Pendaftaran Keluaran Entiti Kimia Baru 1985 - 1998Figure 1: Registration Status Of New Chemical Entities, 1985 - 1998

TerimaReceivedLulusApproved

TolakRejectedTangguhDeferred



Semenjak 1999, peratusan nisbahantara produk tempatan dan produk importuntuk ubat racun adalah 32:68 seperti datadalam Jadual 5. Bagi ubat bukan racun, peratusankeluaran tempatan adalah lebih tinggi sepertimana ditunjukkan dalam nisbah 51:49.Peratusan untuk ubat tradisional adalah 51:49,menunjukkan peratusan keluaran yang dikilangtempatan adalah lebih tinggi manakala peratusannisbah kosmetik pula adalah 16:84.

Merujuk kepada jumlah produk tempatanyang didaftarkan (n = 10,128) seperti padaJadual 5, 2,781 (27.5 %) adalah ubat racun, 3,052(30.1 %) ubat bukan racun, 4,098 (40.5 %) ubattradisional dan 197 (1.9%) kosmetik. Untukproduk import, berdasarkan kepada jumlahyang didaftarkan (n = 13,807), 6,011 (45.1 %)adalah ubat racun, 2,890 (21.5 %) ubat bukanracun, 3,868 (28.9 %) ubat tradisional dan 1,038(4.5 %) kosmetik (Rajah 2).

As of 1999, the percentage ratiobetween locally manufactured and importedproducts for prescription drugs is in the order of32:68 as shown by data in Table 5. For OTCproducts the percentage of locally manufacturedproducts is slightly higher as indicated by aratio of 51:49. The percentage ratio for tra-ditional medicines is shown to be 51:49, indi-cating a higher proportion of locally manu-factured products whereas the percentage ratiofor cosmetics is 16:84.

Based on the total number of locally-manu-factured products registered (n = 10,128) aspresented in Table 5, 2,781 (27.5 %) areprescription drugs, 3, 052 (30.1 %) OTCproducts, 4,098 (40.5 %) traditional medicinesand 197 (1.9%) cosmetics. For importedproducts, based on the total number registered(n = 13,807), 6,011 (45.1 %) are prescriptiondrugs, 2,890 (21.5 %) OTC products, 3,868(28.9 %) traditional medicines and 1,038 (4.5%) cosmetics (Figure 2).

50454035302520151050

Racun Bukan racun Ubat Tradisional KosmetikPrescription drugs OTC products Traditional Medicines Cosmetics

Tempatan ImportLocal Imported

27.5

45.1

30.1

21.5

40.5

28.9

1.9 4.5

Rajah 2: Produk berdaftar - Tempatan vs Import, 1999Figure 2: Registered Products - Local vs. Imported, 1999



Kebenaran Eksport

Pengeluaran sijil perakuan keluaran farmaseutikal[certificates of pharmaceutical products(CPP)] dan sijil perakuan penjualan bebas[certificates of free sale (CFS)] untuk alatanperubatan, untuk kebenaran mengeksport,telah bertambah sejak 1987 and 1992.Sejumlah 12,657 CPP dan 4,552 CFS telahdikeluarkan sejak 1999 (Rajah 3).

Sumber Produk

Senarai untuk 50 negara pengeluar produkyang didaftarkan oleh PBKD menunjukkanMalaysia berada di tangga teratas (Jadual 6).10 negara pengeluar utama ialah China,Amerika Syarikat, Australia, England,Germany, Indonesia, Switzerland, Thailand,India dan France. Negara-negara ini meliputilebih kurang 73.0 % (10,074) daripada jumlahkeluaran import (13,807). Produk yang diimportdari negara-negara ASEAN seperti Indonesia,Thailand, Singapore, dan Philippines meliputihampir 12.2 % (1,678).

5 negara pengeluar utama bagi keluaran ubatracun, ubat bukan racun, ubat tradisional dankosmetik ditunjukkan pada Rajah 4. Malaysiamerupakan pengeluar utama keluaran ubatracun, ubat bukan racun dan ubat tradisional,sementara Germany ialah pengeluar utamakeluaran kosmetik.

Export Authorisation

Issuance of certificates of pharmaceuticalproducts (CPP) and certificates of free sale(CFS) for medical devices, for export authorisation,had increased steadily since 1987 and 1992respectively. A total of 12,657 CPP and 4,552CFS had been issued up to 1999 (Figure 3).

Sources of Products

Listing of 50 different origins of productsregistered by the DCA products shows thatMalaysia is ranked topmost (Table 6). The top10 leading foreign sources include China,United States of America (USA), Australia,England, Germany, Indonesia, Switzerland,Thailand, India and France. Together theyaccount for approximately 73.0 % (10,074) ofour total imports (13,807). Products importedfrom neighbouring ASEAN countries, whichinclude Indonesia, Thailand, Singapore, andPhilippines constitute nearly 12.2 %(1,678).

The 5 leading sources for prescription drugs,OTC products, traditional medicines and cosmeticsare illustrated in Figure 4. Malaysia is theleading source for prescription drugs, OTCs andtraditional medicines, while Germany is theleading source for cosmetics.

0

5000

10000

15000

1987

158

-

1988

242

-

1990

393

-

1991

532

-

1992

561

192

1993

827

257

1994

943

263

1995

1502

278

1996

1590

372

1997

1865

652

1998

2049

864

1999

1700

1679

Jumlah

12657

4552

Rajah 3: Pengeluaran Sijil Perakuan Keluaran Farmaseutikal dan Sijil Perakuan Penjualan Bebas 1987 - 1999

Figure 3: Issuance of Certificate of Pharmaceutical Product andCertificate of Free Sale, 1987 - 1999

CPP

CFS



45004000350030002500200015001000500

0

Racun Bukan racun Ubat Tradisional KosmetikPrescription Drug OTC Traditional Medicines Cosmetics

Rajah 4: Pengeluar Utama Produk Berdaftar, 1999Figure 4: Leading Sources For Registered Products, 1999

Malaysia China Amerika Syarikat Australia England Germany Indonesia Switzerland

2781

408

3052

116

4098

114

Jadual 8: Sumber Produk Yang Berdaftar Dengan PBKD, 1999Table 8: Sources Of Products Registered By The DCA, 1999

Kategori KeluaranCategories of Products

Bil. Sumber Ubat Ubat bukan Ubat Kosmetik Jumlahracun racun tradisional

No. Source Prescription OTC Traditional Cosmetics Total Drugs Products Medicines

1 MALAYSIA 2,781 3,052 4,098 197 10,128

2 CHINA 8 22 2231 - 2,261

3 U.S.A 408 502 477 144 1,531

4 AUSTRALIA 495 445 328 127 1,395

5 GERMANY 597 213 30 231 1,071

6 ENGLAND (U.K.) 658 311 16 28 1,013

7 INDONESIA 112 116 334 172 734

8 SWITZERLAND 486 111 9 - 606

9 THAILAND 259 259 3 53 574

10 INDIA 223 86 165 4 478

11 FRANCE 302 93 14 2 411

12 ITALY 194 60 4 86 344

13 CANADA 222 41 19 34 316

14 BELGIUM 204 28 6 56 294

15 TAIWAN 128 42 108 - 278

16 JAPAN 110 79 15 41 245

17 SINGAPORE 134 95 14 - 243


Kategori KeluaranCategories of Products

Bil. Sumber Ubat Ubat bukan Ubat Kosmetik Jumlahracun racun tradisional

No. Source Prescription OTC Traditional Cosmetics Total Drugs Products Medicines

18 IRELAND 129 69 - - 198

19 SWEDEN 118 47 23 - 188

20 CYPRUS 168 18 - - 186

21 SOUTH KOREA 110 32 36 - 178

22 DENMARK 149 23 - - 172

23 SPAIN 90 14 - 55 159

24 HOLLAND 94 27 2 5 128

25 PHILIPPINES 80 47 - - 127

26 HUNGARY 100 19 - - 119

27 FINLAND 74 13 2 - 89

28 AUSTRIA 62 8 2 - 72

29 NEW ZEALAND 41 1 20 - 62

30 SLOVENIA 38 9 - - 47

31 YUGOSLAVIA 35 3 - - 38

32 NORTH KOREA 32 - 1 - 33

33 POLAND 26 4 - - 30

34 JORDAN 24 - 4 - 28

35 PORTUGAL 15 6 - - 21

36 GREECE 20 - - - 20

37 NORWAY 7 12 - - 19

38 S. AFRICA 13 5 1 - 19

39 REP. CZECH 16 - - - 16

40 EGYPT - 12 3 - 15

41 TURKEY 9 3 - - 12

42 SCOTLAND 8 3 - - 11

43 CHILE 7 - - - 7

44 PAKISTAN 2 3 - - 5

45 REP. SLOVAK - 5 - - 5

46 MEXICO 3 1 - - 4

47 ICELAND - 2 - - 2

48 BANGLADESH - 1 - - 1

49 BULGARIA - - 1 - 1

50 PANAMA 1 - - - 1

Jumlah 8,792 5,942 7,966 1,235 23,935Total




BAHAGIAN APB DAN PERLESENAN

OBJEKTIF

Objektif utama bahagian ini ialah untukmemas t ikan p remis peng i l ang ke lua ranfa rmaseu t ika l dan ubat-ubatan tradisionalmematuhi keperluan Amalan PerkilanganBaik ( APB ). Bahagian ini juga bekerjasamadengan Unit Penguatkuasa Farmasi Negeridalam memastikan premis pengimport danpemborong mematuhi keperluan AmalanPenstoran Baik ( ASB ).

AKTIVITI-AKTIVITI

Bahagian ini menjalankan aktiviti-aktivitiseperti berikut :

Memeriksa premis pengilang, pengimportdan pemborong keluaran-keluaran berdaftarMemproses permohonan dan mengeluarkanlesen pengilang, pengimport dan pemborong keluaran-keluaran berdaftarMengeluarkan senarai tambahan keluaran-keluaran berdaftarMenilai pelan susun-atur premis pengilang keluaran berdaftarMemberi khidmat nasihat dan bimbingankepada industri berkenaan dalam aspek APB, ASB dan perlesenan.Menganjur kursus latihan APB untuk industri farmaseutikal dan tradisionalserta pelawat-pelawat luar negaraMengadakan perbincangan teknikal dengan industri farmaseutikal untuk meningkatkan tahap APB premis pengilang tempatanMengumpul maklumat berkaitan industri farmaseutikal dan tradisionalMengeluarkan Perakuan APB dan mengesahkan salinan dokumen-dokmenberkaitan lesen

PENCAPAIAN

Pemeriksaan APB

Sebanyak 120 pemeriksaan APB telahdijalankan pada tahun 1999, berbanding dengan111 pada tahun 1998. Pemeriksaan tersebutmeliputi 23 premis pengilang keluaran racun,24 keluaran bukan racun, 73 ubat tradisional ,1 kosmetik dan 1 keluaran veterinar.Pencapaian ini adalah 20 % melebihi sasaranyang ditetapkan dan menunjukkan peningkatansebanyak 8.1 % daripada jumlah pemeriksaantahun 1998. Rajah 5 menunjukkan bilanganpemeriksaan APB yang dijalankan daripada1995 hingga 1999.

GMP AND LICENSING DIVISION

OBJECTIVES

The main objective of this division is toensure that pharmaceutical and traditionalmedicine manufacturing premises adhere tothe requirements of Good ManufacturingPractice ( GMP ). This division also co-operateswith State Pharmacy Enforcement Units toensure that the premises of importers andwholesalers adhere to Good Storage Practice( GSP ).

ACTIVITIES

This division carries out the following activi-ties :

Inspection of premises for manufacturers,importers and wholesalers of registeredproductsProcessing of licence applications formanufacturers, importers and wholesalers of registered productsIssuance of additional lists of registeredproductsEvaluat ion o f lay-out p lans for manufacturing premises for registeredproductsAdvisory service to relevant industrieson technical aspects regarding GMP, GSP and licensingTraining courses for pharmaceutical and traditional medicines industries and also overseas visitorsTechnical discussions with pharmaceuticalindustries to upgrade the GMP standardof local manufacturing premisesCollection of information related to pharmaceutical and traditional industriesIssuance of GMP certificates and endorsement of licence related documents

ACHIEVEMENTS

GMP Inspection

A total of 120 inspections were conducted in1999 as compared with 111 in 1998. Theseinspections included 23 premises for scheduledpoisons manufacturers, 24 non-scheduledpoisons, 73 traditional medicines, 1 cosmeticand 1 veterinary medicine. This achievementis 20% more than the targeted output and itshows an increase of 8.1 % performance output,as compared to the output for 1998. Figure 5shows the number of GMP inspections carriedout since 1995 until 1999.


Rajah 5: Pemeriksaan APB Premis Pengilang, 1995-1999Figure 5: GMP Inspection Of Manufacturing Premises, 1995 - 1999

Rajah 6: Kadar Pertumbuhan Premis Berlesen, 1988-1999Figure 6: Growth Rate of Licensed Premises, 1988 - 1999

120 (1999) 108 (1995)

334 (1996)214 (1997)

111(1998)

Penilaian Pelan Premis Pengilang

Sejumlah 62 pelan susun-atur premis pengilangbaru dan sediada telah dinilai, termasuk 4premis pengilang keluaran racun, 4 keluaranbukan racun, 47 ubat tradisional , 6 kosmetikdan 1 farmasi hospital. Pencapaian ini telahmenurun 55.4 % berbanding dengan bilangantahun 1998.

Dari segi kadar pertumbuhan premis berlesen,Rajah 6 menunjukkan bahawa kadar pertumbuhanbagi jumlah premis adalah 5.8 % bagi tahun1999 berbanding 15.7 % pada tahun 1998.

Evaluation of Manufacturing Premises Lay-outPlans

A total of 62 lay-out plans for new and existingmanufacturing premises were evaluated,which included 4 premises of scheduled poisonsmanufacturers, 4 non-scheduled poisons, 47traditional medicines, 6 cosmetics and 1 hospitalpharmacy unit. This shows a 55.4% drop, ascompared to 1998.

With respect to growth rates of licensedpremises, Figure 6 shows the growth profilefor 1988 until 1999, whereby the growth for1999 is 5.8 %, as compared to 15.7 % for1998.

150

100

50

0

50

1988

17.4

8

16.1

13.5

Manufacturer

Importer

Wholesaler

Total

1989

-7.4

-12.6

-16.1

-14.2

1990

32

9.6

23.2

19.7

1991

0

-4.4

-4.3

-3.9

1992

30.3

23

77

56

1993

6.9

20.6

116.8

84.5

1994

28.3

-1.55

2.2

-0.5

1995

5.08

-11

15.6

10.9

1996

19.4

40.7

-22.8

-12.5

1997

43.2

-7.6

1.2

3.3

1998

37.7

74.1

11.8

15.7

1999

30.1

3.1

-0.9

5.8



. . .

. . .

. . .

. . .

. . .


Khidmat Nasihat

Pada tahun 1999 sebanyak 196 khidmat nasihatdan bimbingan telah diberikan kepada pengi-lang atau pengusaha, berbanding dengan 185pada tahun 1998 dan 140 pada tahun 1997.Daripada jumlah yang dicapai, 15 adalahberkaitan APB keluaran racun, 8 bukan racun,153 ubat tradisional, 5 kosmetik, 1 peralatanperubatan, 7 keluaran veterinar dan 7 berkaitanASB. Rajah 7 menunjukkan bilangan khidmatnasihat yang diberikan daripada tahun 1997hingga 1999.

Advisory Service

In 1999, a total of 196 advisory services weregiven to the relevant industries, as comparedto 185 in 1998 and 140 in 1997. For 1999, 15of them were related to premises of scheduledpoisons, 8 non-scheduled poisons, 153 traditionalmedicines, 5 cosmetics, 1 medical device, 7veterinary medicines and 7 related to GSP.Figure 7 shows the statistic from 1997 to1999.

200

180

160

140

120

100

80

60

40

20

01990

140

1998

185

1999

196

1999

7

7

1

5

153

8

15

Rajah 7: Khidmat Nasihat APBFigure 7: GMP Advisory Service

TotalGSP

Veterinary

Medical Device

Cosmetic

Traditional

OTC

Scheduled Poison



Pemprosesan Lesen

Lesen Pengilang

Sebanyak 237 permohonan lesen pengilangtelah diproses pada tahun 1999, berbanding148 pada tahun 1998 dan 100 pada tahun1997. Daripada jumlah ini, 63 adalah permohonanbaru manakala 174 lagi adalah pembaharuan.Pencapaian ini adalah sebanyak 2.37 kaliganda sasaran yang ditetapkan.

Lesen Pengimport

B a g i l e s e n p e n g i m p o r t , s e b a n y a k 3 0 5pe rmohonan telah diterima dan diproses.Daripada jumlah ini, 73 adalah permohonanbaru dan 232 pembaharuan. Bilangan permohonandidapati telah meningkat berbanding 255 padatahun 1998 dan 171 pada tahun 1997.Pencapaian ini juga adalah 22 % melebihisasaran yang ditetapkan.

Lesen Pemborong

Bilangan permohonan lesen pemborong yangdiproses juga telah meningkat kepada 985,dimana 69 adalah permohonan baru dan 918pembaharuan. Pencapaian ini adalah 40 %melebihi sasaran yang ditetapkan.Peningkatan ini begitu ketara sekali berbandingjumlah 705 pada tahun 1998 dan 642 padatahun 1997.

Data mengenai jumlah lesen yang diprosesdaripada tahun 1995 hingga 1999 dipaparkandalam Rajah 8. Pada keseluruhan, statistikini menunjukkan bahawa jumlah lesen yangdiproses telah meningkat tahun demi tahun.

Licence Processing

Manufacturers Licence

A total of 237 applications for manufacturerslicences were processed in 1999, compared to148 in 1998 and 100 in 1997. From this totalnumber, 63 applications are new applica-t ions whereas the remaining 174 arerenewals. This performance achievement is2.37 times more than the targeted output.

Importers Licence

A total of 305 applications were received andprocessed for importers license. From thistotal, 73 applications are new applications,whereas the remaining 232 are renewals. The num-ber of applications has increased significantly, com-pared to 255 in 1998 and 171 in 1997. The 1999performance achievement is 22% more thanthe targeted output.

Wholesalers Licence

The number of applications processed forwholesalers license has increased to 985,whereby 69 of them are new applications and918 are renewals. This achievement shows40% more than the targeted output specification.The increase is significant, as compared with705 in 1998 and 642 in 1997.

The overall statistic for processing of licensesfrom 1995 until 1999 is presented in Figure 8.On the whole, it shows that the number oflicenses processed had increased year byyear.

1999

1998

1997

1996

1995

0 500 1000 1500 2000

1995

719

544

113

62

1996

827

596

159

72

1997

916

642

171

103

1998

1108

705

255

148

1999

1527

985

305

237

TotalWholesaler

Importer

Manufacturer

Rajah 8: Pemprosesan Lesen, 1995-1999Figure 8: Processing Of Licences, 1995 - 1999



Premis Berlesen

Rajah 9 menunjukkan jumlah premis berlesendaripada tahun 1987 sehingga 1999. Jumlahbilangan premis bagi tahun 1999 telahmeningkat kepada 1,131 berbanding 1,076pada tahun 1998.

Licensed Premises

Figure 9 shows the number of licensedpremises from 1987 until 1999. For 1999, thenumber has increased to 1,131 as comparedto 1,076 in 1998.

Rajah 10 menunjukkan taburan geografimengikut negeri premis-premis berlesen bagitahun 1999. Negeri Selangor mencatatkanjumlah yang tertinggi, diikuti oleh WilayahPersekutuan dan Pulau Pinang.

Rajah 11 menunjukkan bilangan premispengilang berlesen mengikut kategori bagitahun 1999, dimana 55 adalah pengilangfarmaseutikal, 131 pengilang tradisional dan 4pula pengilang kosmetik, menjadikan jumlahkeseluruhan sebanyak 190.

Figure 10 shows the geographical distributionof licensed premises according to states for1999. Selangor recorded the highest number,followed by Wilayah Persekutuan and PulauPinang.

Figure 11 shows the total number of 190licensed manufacturers according to categoriesfor 1999, whereby 55 are pharmaceutical, 131traditional medicines and 4 cosmetics.

Rajah 9: Bilangan Premis Berlesen, 1987-1999Figure 9: Number Of Licensed Premises, 1987 - 1999

800

1000

600

400

200

0

1988

27

95

180

302

1987

23

88

155

266

Importer

Manufacturer

Wholesaler

Total

1989

25

83

151

259

1990

33

91

186

310

1991

33

87

178

298

1992

43

107

315

465

1993

46

129

683

858

1994

59

127

668

854

1995

62

113

772

947

1996

74

159

596

829

1997

106

147

603

856

1998

146

256

674

1076

1999

190

264

677

1131



Rajah 10: Taburan Geografi Premis Berlesen, 1999Figure 10: Geographical Distribution Of Licensed Premises, 1999

300

350

200

250

100

50

150

0

Ked

19

4

23

46

Joh

26

9

56

91

Manufacturer

Importer

Wholesaler

Total

Kel

5

1

38

44

Mel

15

2

19

36

NS

3

1

10

14

Phg

0

0

29

29

Prk

16

8

76

100

Prs

1

0

1

2

PP

24

21

67

112

Sab

0

2

72

74

Swk

3

6

88

97

Sel

61

131

110

302

Trg

1

0

23

24

WP

16

79

56

167

Rajah 11: Kategori Premis Pengilang Berlesen, 1999Figure 11: Categories Of Licensed Manufacturing Premises, 1999

60

70

40

50

20

10

30

0

Ked

3

16

19

Joh

5

20

1

26

Pharmaceutical

Traditional

Cosmetic

Total

Kel

1

4

5

Mel

2

13

15

NS

1

2

3

Phg

0

0

0

Prk

3

13

16

Prs

0

1

1

PP

10

13

1

24

Sab

0

0

0

Swk

0

3

3

Sel

26

34

1

61

Trg

0

1

1

WP

4

11

1

16



Senarai Tambahan Keluaran Berdaftar

Jumlah permohonan yang diproses pada tahun1999 adalah sebanyak 314 dan melibatkansebanyak 1,928 produk, berbanding 343permohonan dan 1,844 produk pada tahun1998. Walaupun bilangan permohonan didapatitelah menurun tetapi bilangan produk telahmeningkat. Statistik bagi tahun 1998 dan1999 digambarkan dalam Rajah 12.

Additional Lists for Registered Products

The total number of applications that wereprocessed in 1999 was 314 and they includeda total of 1,928 registered products, as comparedwith 343 applications and 1,844 products in1998. Although the number of applicationsshows decrease, the total number of productshas actually increased. Statistics for 1998and 1999 are shown in Figure 12.

Pertukaran Pemegang Lesen

Sebanyak 47 permohonan pertukaranpemegang lesen telah diproses, di mana 9adalah untuk pengilang, 11 pengimport dan27 pemborong. Bilangan yang dicapai adalah38.2 % lebih daripada tahun 1998. Statistikbagi tahun 1997 hingga 1999 dipaparkandalam Rajah 13.

Change of Licence Holder

A total of 47 applications for change oflicence holders were processed, whereby 9were manufacturers, 11 importers and 27wholesalers. The number of applicationsprocessed is 38.2% more than that for 1998.Statistics for 1997 to 1999 are presented inFigure 13.

Rajah 12: Pengeluaran Senarai Tambahan Produk, 1998-1999Figure 12: Issuance Of Additional Registered Product List 1998 - 1999

2500

2000

1500

1000

500

0

1844 1928

314343

1998 1999

Application Product



Rajah 13: Permohonan Pertukaran Pemegang, 1997 - 1999Figure 13: Application For Change Of Holder, 1997 - 1999

60

50

40

30

20

10

01997 1998 1998 1999 1999

Manufacturer Importer Wholesaler Total

9

11

27

47

34

56 14

8

12

Perakuan APB Untuk Tujuan Eksport

Pada tahun 1999 jumlah perakuan APB yangdikeluarkan adalah sebanyak 119, berbanding124 pada tahun 1998 dan 80 pada tahun 1997(Rajah 14) . Sijil berkenaan adalah baginegara-negara seperti Vietnam, Hong Kong,Filipina, Brazil, Cambodia, Bahrain, Qatar,United Arab Emirates, Namibia, Peru,Myanmar, Indonesia, Singapore, Australia,Iraq, Oman, Poland, Saudi Arabia, Barbados,Slovakia, Tanzania, Thailand, Taiwan,Bulgaria, Egypt, Pakistan, Sri Lanka,Maldives, Canada, Papua New Guinea,Dominican Republic, Yemen, Khazakhstan,China, Honduras, Lithuania, Malta, India,Brunei Darussalam, Romania dan Kenya.

GMP Certification

In 1999, the total number of GMP certificatesissued was 119, as compared with 124 in 1998and 80 in 1997 (Figure 14). These certificatesare for countries such as Vietnam, HongKong, Philippines, Brazil, Cambodia,Bahrain, Qatar, United Arab Emirates,Namibia, Peru, Myanmar, Indonesia,Singapore, Australia, Iraq, Oman, Poland,Saudi Arabia, Barbados, Slovakia, Tanzania,Thailand, Taiwan, Bulgaria, Egypt, Pakistan,Sri Lanka, Maldives, Canada, Papua NewGuinea, Dominican Republic, Yemen,Khazakhstan, China, Honduras, Lithuania,Malta, India, Brunei Darussalam, Romaniaand Kenya.



140

120

100

80

60

40

20

0

124 119

80

1997 1998 1999

Rajah 14: Permohonan Sijil APB, 1997-1999Figure 14: Application Of GMP Certificates, 1997-1999


Tindakan Punitif

Pihak Berkuasa Kawalan Dadah ( PBKD )telah menggantung sementara lesen pengilangbagi 5 premis farmaseutikal kerana gagalmematuhi keperluan APB. Pada tahun 1998,sebanyak 3 premis telah digantung lesenpengilangan dan 6 premis pula pada tahun1997.

Dialog Dengan Industri

Bahagian ini telah menyelaraskan beberapasessi dialog dengan persatuan-persatuanindustri termasuk Persatuan Ubat TradisionalMelayu Malaysia ( PURBATAMA ),Malaysian Organisation of PharmaceuticalIndsutries ( MOPI ) dan Federation ofMalaysian Manufacturers - MalaysianCosmetic and Toiletries Industry Group ( FMM MCTIG. ).

Punitive Actions

In 1999 , manufac tur ing l i cences for 5pharmaceut ical premises were temporarilysuspended because of major non-compliancesto GMP. In 1998, 3 manufacturing premiseswere temporarily suspended, compared to 6suspensions in 1997.

Dialogues with Industries

This division coordinated dialogue sessionswith industry associations such as thePersatuan Ubat Tradisional Melayu Malaysia(PURBATAMA), Malaysian Organization ofPharmaceutical Industries (MOPI) and theFederation of Malaysian Manufacturers-Malaysian Cosmetic and Toiletries IndustryGroup (FMM- MCTIG).


Satu kumpulan kerja teknikal yang dikenalisebagai Pharmaceutical GMP TechnicalWorking Group ( TWG ) telah ditubuhkanuntuk membincang isu-isu dan mengatasimasalah-masalah berkaitan APB farmaseutikal.Kumpulan ini telah mengenalpasti beberapaaspek seperti program latihan APB bercorakmodul untuk jangka panjang termasuk aspekkawalan mutu, keperluan validasi, penggunaangaris panduan APB European Commission ( Eudralex ) dan lain-lain isu yang berkaitan.

Usahasama Dengan Unit PenguatkuasaFarmasi Negeri (UPFN)

Satu program usahasama dengan setiap UPFNtelah dijalankan khususnya untuk membantudalam menjalankan pemeriksaan APB bagipremis pengilang ubat tradisional. SebuahSkim Inspektorat Kebangsaan yang melibatkanlebih kurang 30 orang pemeriksa sertapemeriksa kontrak APB telah ditubuhkan dibawah naungan Bahagian PerkhidmatanFarmasi. Seramai 14 orang pemeriksa kontrak,seorang dari setiap UPFN telah dilantik untukmenyertai inspektorat ini.

Pertubuhan Pusat Industri Farmaseutikal

Pembinaan pusat tersebut yang merangkumikawasan ki lang contoh, ruangan sumbermaklumat dan ruangan untuk pameran telahdilaksanakan, walaupun terpaksa dibuatsecara berperingkat. Cadangan untuk rangkaiansistem komputer, khusus untuk pusat tersebuttelah dikemukakan untuk pertimbangan pihakberkenaan.

Permohonan Untuk Menjadi AhliPharmaceutical Inspection Co-operationScheme (PIC/S)

Dua orang pegawai dari bahagian ini telahmenghadiri seminar PIC/S 1999 yangdiadakan di Oxford, United Kingdom, sebagailangkah permulaan untuk menjalin hubungandan memahami lebih mendalam syarat-syaratkemasukan PIC/S. Permohonan untuk menjadiahli PIC/S telah mula-mula dikemukakanpada bulan Oktober 1999. Beberapa dokumenberkaitan termasuk Manual Kualit i telahdisediakan. Malaysia juga telah menjemputwakil PIC/S untuk menyampaikan ceramahmengenai peranan dan aktiviti PIC/S padaSeminar Regulatori Farmaseutikal danKosmetik 1999 yang diadakan pada bulanOktober 1999.

A Pharmaceutical GMP Technical WorkingGroup ( TWG ) was established in 1999 todiscuss pertinent issues and resolve problemsrelated to pharmaceutical GMP. This TWGhas already identified a few areas of interestsuch as quality control, validation requirements,adoption of European Commission (Eudralex)GMP Guidelines and other relevant technicalissues.

Co-Operation With State PharmacyEnforcement Units

The National Inspectorate Scheme comprisingof about 30 GMP inspectors and sub-contractinspectors was established under thePharmaceutical Services Division, Ministryof Health Malaysia. A total of 14 inspectors,one f rom each s ta te was appoin ted assub-contrac t GMP auditors. The aim of suchco-operation was to work together in carryingout inspect ions of t radi t ional medicinemanufacturing premises throughout thecountry.

Establishment of Pharmaceutical IndustryCentre

The proposed pro jec t inc ludes a mockmanu fac tur ing facility, an informationresource section and an exhibition area. Dueto financial constraints, the physical constructionof the centre was undertaken in stages. Thefunding for the proposed computer isednetworking system for the centre has alreadybeen submitted to the relevant department forconsideration and approval.

Application To Be A Member of ThePharmaceutical Inspection Co-operationScheme (PIC/S)

Two officers from this division attended thePIC/S 1999 Seminar that was held in Oxford,United Kingdom in September 1999. This wasan initial step towards establishing a closeworking relationship and also to understandfurther about the conditions for being a memberof PIC/S. Malaysia’s application to be amember of PIC/S was first submitted inOctober 1999. Several documents includingthe GMP Quality Manual were presented toPIC/S. Malaysia also invited a representativefrom PIC/S to present a paper on the role andactivities of PIC/S at the Pharmaceutical andCosmetic 1999 Regulatory Seminar that washeld in October 1999.



Garis Panduan APB Kosmetik

Kumpulan Kerja Teknikal APB Kosmetik telahmenyediakan draf garis panduan berkenaandalam dua bahasa. Draf dokumen berkenaanjuga telah dikemukakan kepada AseanConsulatative Committee for Standards andQuality ( ACCSQ ) Product Working Groupfor Cosmetic untuk dipertimbangkan danditerima-pakai sebagai Garis Panduan APBKosmetik ASEAN.

Kajian Semula Garis Panduan Fail IndukPengilang

Bahagian ini telah mengkaji semula garis panduanberkenaan Edisi Pertama ( Oktober 1994 ),agar selaras dengan keperluan PIC/S. DrafEdisi Kedua yang disediakan juga memuatkanterjemahan dalam Bahasa Malaysia, khususnyauntuk diguna-pakai o leh pengi lang ubatt radis ional .

Persediaan Untuk ISO 9000

Selaras dengan usaha BPFK untuk mendapatkanpensijilan ISO 9000 yang diperakui olehSIRIM, bahagian ini juga telah menyediakanprosedur-prosedur kualiti yang berkaitan denganskop pemeriksaan dan pelesenan termasukManual Kualiti.

Kajiselidik Industri Farmaseutikal danTradisional

Satu kajiselidik yang bertujuan untukmengkaji perkembangan industri farmaseutikaldan tradisional tempatan termasuk pengilangdan pengimport telah dijalankan. Aspek-aspekseperti hak milikan, nilai pelaburan, nilaijualan, nilai eksport, nilai import, pelaburanuntuk R & D, pelaburan untuk peralatan,bilangan personel, perbelanjaan untuk latihan,aktiviti kontrak dan lain-lain telah dikaji.

Kursus-kursus yang dianjurkan

Bahagian ini telah bekerjasama denganJabatan Kesihatan Negeri Sabah dan Sarawakdan membantu dalam menganjurkan SeminarUbat Tradisional yang diadakan di Sabah danSarawak pada bulan April 1999. Pada bulanMei dan Jun, bahagian ini telah menyelaraskanbeberapa program latihan termasuk 11bengkel validasi anjuran bersama denganMOPI di mana sejumlah 510 peserta industridan BPFK telah menghadiri program ini.

Bahagian ini juga telah mengelolakan kursusAPB selama 4 hari pada bulan Ogos,September dan Oktober untuk 12 PegawaiPenguatkuasa Farmasi Negeri. Pegawai-pegawai berkenaan telah dilantik sebagaipemeriksa kontrak APB khususnya untukpremis pengilang tradisional.

Cosmetic GMP Guidelines

The Cosmetic GMP Technical Working Grouphas completed the draft guidelines in two separatelanguages. The draft document has also beenpresented to the Asean ConsultativeCommittee for Standards and Quality(ACCSQ) Product Working Group forCosmetics for consideration and adoption asthe ASEAN Cosmetic GMP Guidelines.

Revised Guidelines For Site Master File

The Guidelines for Site Master File, FirstEdition (October 1994) was reviewed to meetthe requirements of PIC/S. The draft for theSecond Edition was also translated intoBahasa Malaysia, in view of extending theira p p l i c a t i o n s t o t r a d i t i o n a l m e d i c i n emanu fac ture r s .

Preparation for ISO 9000

In tandem with NPCB’s efforts to obtain theISO 9000 Cer t i f i ca t ion by S IRIM, th i sdivision has prepared quality procedures relevantto the scope of inspection and licensing.

Survey of Pharmaceutical and TraditionalIndustries

A survey was conducted to study the developmentof the local pharmaceutical and traditionalindustries. Various aspects such as ownerships,investment values, sales values, export values,import values, investments in R & D, investmentsfor equipment, number of personnel, expendituresfor training, contract activities and others areincluded in the survey.

Courses Conducted

This division has worked together with theSabah and Sarawak State Health Departmentsin organizing the Traditional MedicineSeminar, held in Sabah and Sarawak in April1999. In May and June, a series of 11 validationworkshops were jointly organized with MOPI,whereby a total of 510 participants from theindustries and NPCB attended.

This division also conducts GMP courses,duration of 4 days in August, September andOctober for State Pharmacy EnforcementOfficers. These officers were appointed asGMP sub-contract inspectors to assist mainlyin inspection of traditional medicine manufacturingpremises.



RANCANGAN UNTUK TAHUN 2000

Usahasama Pemeriksaan APB

Usahasama dengan UPFN dan BPKP, BAUdan BSF akan terus dipergiatkan untukmemantapkan Skim Inspektorat Kebangsaand a n m e n i n g k a t k a n p e m a n t a u a n d a n penguatkuasaan skim pelesenan, khususnyauntuk premis pengilang ubat tradisional.

Pusat Industri Farmaseutikal

L a n g k a h - l a n g k a h a k a n d i a m b i l u n t u kmengubahsuai dan melengkapkan infrastrukturdengan kemudahan-kemudahan asas termasukperabot, peralatan pejabat dan lain-lain agarpusat berkenaan dapat berfungsi sebagai pusatbimbingan industri tempatan sepertimanayang dirancangkan. Jawatan-jawatan baruuntuk membolehkan pusat berkenaan beroperasidengan licin akan dipohon.

Permohonan Keahlian PIC/S

Permohonan menggunakan format baru sertadokumen-dokumen sokongan yang berkaitanakan dimajukan kepada Urusetia PIC/S.Kerjasama serta hubungan erat dengan PIC/Sakan diperkukuhkan. Program latihan untukpemeriksa dan pemeriksa kontrak APB akandijalankan untuk meningkatkan kecekapandalam bidang pemeriksaan selaras denganpiawaian antarabangsa.

Harmonisasi Kosmetik ASEAN

Bagi aspek APB, usaha-usaha gigih perludiselaraskan dengan industri kosmetik tempatanserta pihak-pihak berkuasa negara-negaraASEAN lain untuk mewujudkan satu garispanduan APB kosmetik yang sesuai untukdiguna-pakai oleh semua negara ASEAN,dibawah program ACCSQ ( Cosmetic ).

Latihan APB Bercorak Modul

Program latihan APB untuk jangka panjangakan dirangka dan modul-modul yang sesuaiakan dikenalpasti untuk meningkatkankecekapan dan keterampilan personel-personelyang terlibat dalam bidang pengeluaran dankawalan mutu disektor industri. Projek iniakan dikelolakan bersama dengan MOPI.

PLANS FOR YEAR 2000

GMP Inspection Co-Operation

Co-operation between various divisions withinNPCB and State Pharmacy Enforcement Unitswill be enhanced to strengthen the NationalInspectorate Scheme and to further strengthenenforcement of the licensing scheme, especiallyfor traditional medicine manufacturingpremises.

Pharmaceutical Industry Centre

Further steps will be taken to furnish the centrewith basic facilities such as furniture, officeequipment and other miscellaneous items toenable the centre to function as a guidancecentre for the local industries. New posts forpersonnel will be put up to enable the centreto operate smoothly.

Application of PIC/S Membership

The new application format together withother supporting documents will be submittedto the PIC/S Secretariat. Co-operation andclose working relationship with PIC/S will bestrengthened. Training programmme for GMPinspectors and sub-contract inspectors will beconducted to improve their capability in thefield of inspection, in accordance with inter-national standards.

ASEAN Cosmetic Harmonization

With regards to GMP, the cosmetic industriesand ASEAN regulatory authorities need towork hand in hand to establish and adopt theASEAN Cosmetic GMP Guidelines that issuitable for all ASEAN countries, as proposedunder the ACCSQ (Cosmetic) programme.

GMP Modular Training

A well-planned and long term GMP trainingprogramme, based on appropriate moduleswill be conducted to increase the skill andcapabilities of personnel involved in productionand quality control in the industry sector.This programme will be jointly organized withMOPI.



BAHAGIAN SURVEILANS DAN FARMAKOVIGILANS

OBJEKTIF

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

PENCAPAIAN

Sepanjang tahun 1999, program surveilanstelah menyaksikan peningkatan sebanyak128.9% dalam jumlah sampel keluaran untuktujuan kajian kualiti berbanding pada tahun1998. Julat dan bilangan sampel keluaranuntuk tujuan surveilans telah meningkat denganadanya kerjasama pegawai unit penguatkuasafarmasi negeri dimana dengan mereka membantudalam pungutan sampel keluaran daripadapremis pemegang lesen disemua negeri.

Manakala program pemonitoran kesan adversubat telah berjaya mencapai satu peningkatanbaru iaitu dengan penambahan sebanyak45.1% dalam jumlah laporan yang diterimasepanjang tahun 1999 berbanding dengantahun sebelumnya.

Kesedaran mengenai kepentingan kualiti kelu-aran oleh pihak pengguna juga telah menye-babkan peningkatan dalam bilangan aduankeluaran yang telah diterima.

SURVEILLANCE &PHARMACOVIGILANCE DIVISION

OBJECTIVE

The objective of the Surveillance andPharmacovigilance Division is to ensure thatproducts registered by the Drug ControlAuthority are safe, efficacious and meet theestablished standards of quality.

ACHIEVEMENTS

During the year 1999, the survei l lanceprogramme saw a 128.9% increase in thenumber of products sampled for quality testingas compared to 1998. The range and number ofproducts sampled for surveillance wasincreased through the assistance of the statepharmacy enforcements officers who supplementedthe activities of the surveillance officers bycol lec t ing samples of products from thepremise of the registration holders throughoutthe country.

The adverse drug reac t ions moni tor ingprogramme also achieved new heights withan increase of 45.1% in the number of reportsreceived in 1999 as compared to the previousyear.

Awareness of this division also appears tohave increased as demonstrated by the risingnumber of product complaints which werereceived.

0

500

1000

1500

2000

1996

531

530

55

1997

602

602

97

1998

714

603

111

1999

1635

875

151

Rajah 15: Aktiviti Surveilans Figure 15: Surveillance Activities

No. of products sampled

No. of ADR reports received

No. of complaints received



Penyiasatan terhadap semua keluaran yangterdapat di premis 4 syarikat jualan langsungtelah diadakan bersama dengan bantuan daripadapegawai Unit Penguatkuasa Farmasi NegeriSelangor.

Surveilans

Sejumlah 1635 keluaran berdaftar yang digunakandi Malaysia telah dikaji sepanjang programini dan 1584 keluaran tersebut telah dihantarke makmal untuk diuji. Didapati daripada1083 keluaran yang telah diuji sepanjangtahun ini, 204 sampel keluaran telah gagalmemenuhi kriteria yang ditetapkan (Rajah 16).

Inspection of all products available at thepremises of 4 direct selling companies wereconducted together with the assistance of theSelangor state pharmacy enforcement officers.

Surveillance

A total of 1635 products registered for use inMalaysia were sampled through this programmeof which a total of 1584 products were sentfor laboratory testing. 204 samples out of1083 products tested during the year failed tothe meet the accepted standards (Figure 16).

Panggilbalik

Arahan telah dikeluarkan untuk membuatpanggilbalik terhadap 113 kelompok keluarandimana 14 daripadanya merupakan keluaranracun berjadual, 7 adalah persediaaan bukanracun dan 92 adalah keluaran tradisional.Manakala 35 keluaran lagi (21-racun, 13-OTC, 1-tradisional) telah dipanggilbaliksecara sukarela oleh pemegang pendaftarankeluaran berdasarkan aduan yang diterimaterhadap keluaran tersebut.

Recalls

Instructions were issued for the recall of 113batches of products of which 14 were productscontaining scheduled poisons, 7 were over-the-counter preparations and 92 were traditionalmedicines. 35 other products (21-poisons; 13-OTC;1-traditional) were recalled voluntarilyby the product registration holders mainlybased on product complaints.

Lulus (Pass)81% Gagal

(Fail)19%

Rajah 16: Keputusan Ujian Sampel Surveilans Figure 16: Test Results Of Surveillance Samples

Racun (poison) 3%

Bukan Racun(OTC) 4%

Ubat Tradisional 12%(TraditionalMedicine)


Pemonitoran ADR

Dibawah program pemonitoran ADR, didapatipeningkatan yang menggalakkan dalam bilanganlaporan kesan advers ubat yang diterimasepanjang 1999 berbanding dengan tahun-tahun yang sebelumnya (Rajah 17).

Sejumlah 15 ceramah/taklimat telah diadakandi beberapa tempat di seluruh negara sebagaisatu usaha untuk memberi kesedaran mengenaikepentingan program pemonitoran ADR danlaman web MADRAC (www.madrac.gov.my/madrac)yang mana ia telah digunakan untuk menyebarkanmaklumat berkaitan dengan isu keselamatanubat. Laman web ini juga menyediakan satuperkhidmatan yang efektif untuk menerimalaporan secara “on-line” dan penjelasan bolehdibuat secara terus kepada pelapor. Terdapatsejumlah 150 laporan telah dihantar menerusilaman web ini.


ADR Monitoring

Under the ADR monitoring programme, therewas a marked increase in the number ofadverse drug reaction reports received in1999 as compared to previous years. (Figure 17)

A total of 15 talks were conducted in severalparts of the country in an effort to createawareness of the ADR monitoring program meand the MADRAC homepage(www.madrac.gov.my/madrac) which is beingused to disseminate information pertaining todrug safety issues. The homepage has servedas an effective means for receiving reports ascorrespondance and clarifications can bemade almost immediately with the reporters.A total of 150 ADR reports were submittedthrough the homepage.

Tahun (Year) 1995 1996 1997 1998 1999

Jumlah (Total) 35 37 32 93 148

Kategori 35 20 93(Category)(A/X/T)

A= Racun (Poisons); X=OTC; T= Ubat Tradisional (Traditional Medicine)

Jadual 9: Panggilbalik KeluaranTable 9: Product Recalls (directive and voluntary)

0

200

400

600

800

1000

1987

10

1988

38

1989

40

1991

150

1992

216

1993

263

1994

233

1995

400

1996

530

1998

603

1999

875

Rajah 17: Pemonitoran ADR: Kadar Laporan 1987-1999 Figure 17: ADR Monitoring: Reporting Rate 1987-1999

No. of Reports



Rajah 18 meninjukkan bilangan laporan yangditerima daripada pelbagai negeri dan didapatibahawa sebahagian besar laporan yang diterimaadalah daripada Hospital Besar KualaLumpur.

Usaha telah dijalankan untuk menggalakkanpenglibatan daripada pelbagai bidang untukmempertingkatkan kadar laporan ADRdimana sebelum ini kebanyakan laporanadalah daripada doktor dari sektor awam.Hasil daripada tindakan ini, satu peningkatanyang positif dalam bilangan laporan ADRtelah diterima daripada ahli farmasi dan sektorswasta menerusi usaha dar ipada indust r ifarmaseut ikal (Rajah 19).

Latihan

Satu lawatan sehari ke Unit Kosmetik,Kementerian Kesihatan Singapura telah diadakan untuk mengkaji sistem surveilans bagipemonitoran kualiti dan keselamatan keluarankosmetik.

K u r s u s l a t i h a n p e m o n i t o r a n A D R y a n gdikelolakan oleh Uppsala Monitoring Centre diSweden telah diikuti oleh Abida Syed Haq.

The reporting rate from the various states isas shown in Figure 18 with the highest numberof reports being submitted from the KualaLumpur General Hospital.

Efforts were made to encourage a multidisciplinaryapproach to improve the reporting rate ofADRs which previously relied mainly ondoctors in the public sector. As a result ofthis, an increase in ADR reporting by pharmacistsand the private sector through the efforts ofthe pharmaceutical industry was seen (Figure 19).

Training

A one-day visit to the Cosmetic Unit, Ministryof Health Singapore was conducted to studythe surveillance system for monitoring thequality and safety of cosmetic products.

The training course on ADR monitoringorganised by the Uppsala Monitoring Centrein Sweden was attended by Abida Syed Haq.

Rajah 18: Kadar Laporan Berdasarkan NegeriFigure 18: Reporting Rate by State 1999

0

7

2 43 3

1 4 9

1 0 3

5 837

8 2

39 4 5

1 7 324 8

1 9 4

3

2 0

4 0

6 0

8 0

1 0 0

1 2 0

1 4 0

1 6 0

1 8 0

2 0 0



RANCANGAN UNTUK MASA DEPAN

Bahagian ini bercadang untuk memperkembangkanlagi peranannnya dalam pengurusan surveilansuntuk semua keluaran kosmetik dan veterinarselepas ia didaftarkan bermula pada tahun2000.

Menjelang tahun 2000 ini juga, satu sistemyang lebih baik telah dirangka dengan ker-jasama daripada pihak Pusat Kesihatan Umumuntuk melaksanakan surveilans peristiwaadvers yang berlaku selepas setiap immu-nisasi.

Selain daripada itu, satu edisi terbaru mengenaipanduan kerja terhadap sistem pemonitoranADR juga telah dirancang untuk diperkenalkanpada tahun tersebut.

FUTURE PLANS

The surveillance division will expand its roleto conduct surveillance of cosmetics andveterinary products after registration of theseproducts begins in the year 2000.

An improved system for surveillance ofadverse events following immunisation in col-laboration with the Public Health Division isbeing planned for the year 2000.

A new edition of the manual on ADR monitoringis also being planned to be produced in theyear 2000.

0

200

400

600

800

1987

10

0

0

00

1988

32

3

2

10

1989

36

2

2

00

1990

39

1

4

00

1991

87

12

51

00

1992

129

6

81

00

1993

193

2

68

00

1994

191

9

33

00

1995

303

27

70

00

1996

419

40

61

00

1997

473

62

51

016

1988

469

61

44

1811

1999

607

141

66

547

Rajah 19: Sumber LaporanFigure 19: Source Of Reports

Governmentdoctors

Pharmacists

Private practitioners

Industry

University



BAHAGIAN ANALISIS UBAT

OBJEKTIF

Bahagian Analisis Ubat (BAU) meneruskanperanan yang efektif dalam kawalan kualitiproduk yang merupakan satu komponen pentingdalam penilaian produk farmaseutikal. Ujianyang dijalankan meliputi ujian-ujian kimia,f i z i ka l , m ik rob io log i , f a rmako log i dant o k s i k o l o g i , yang merangkumi berbagai-bagai jenis ujian seperti ujian identifikasi,berjenis-jenis ujian had, penentuan kandunganbahan dalam produk dan juga penelitian kepadapelbagai parameter prestasi dosis. Kriteriauntuk penerimaan keputusan ujian berasaskankepada farmakopia, spesifikasi dalaman atauhad/spesifikasi pengilang.

PENCAPAIAN

Pencapaian BAU bagi tahun 1999diringkaskan seperti berikut.

Beban Kerja

Sepanjang tahun 1999, BAU telah mengujisebanyak 4583 sampel (Rajah 20) dan menjalankan27235 ujian (Rajah 23). Berbanding denganpencapaian di tahun 1998, bilangan sampelyang diuji telah menurun sebanyak 6.9%sementara bilangan ujian yang dilakukant e l a h m e n i n g k a t s e b a n y a k 1 4 . 9 % . K o sp e n g a n a l i s a a n yang diterima juga telahberkurangan sebanyak 34.3% dengan hanyaRM 500,541 dipungut untuk tahun 1999.

DRUG ANALYSIS DIVISION

OBJECTIVE

Drug Analysis Division (DAD) continues toplay an effective role in quality controlassessment of products which constitute animportant component of pharmaceutical productevaluation. The tests conducted include chemical,physical, microbiological, pharmacologicaland toxicological, covering various typessuch as identification tests, the various limittests, quantitation of the content in the productand a l so assess ing the var ious dosageperformance parameters. Acceptance criteriaare based on pharmacopoeial, in-house ormanufacturers limits and specifications.

ACHIEVEMENTS

The achievements o f DAD in 1999 aresummarised as follows:-

Workload

Throughout the year 1999, DAD had analyseda total of 4583 samples (Figure 20) whichgenerated a total of 27235 tests (Figure 23). Incomparison to the achievement in 1998, thenumber of samples analysed were reduced by6.9% while the number of tests done wereincreased by 14.9%. The collection of analyticalfees had been reduced by 34.3% with onlyRM 500,541 collected for the year 1999.

12000

10000

8000

6000

4000

2000

0

Rajah 20: Bilangan Sampel DiujiFigure 20: Number Of Samples Tested

1069811337

8517

7472

9987

71416343 6623

4922 4583



Rajah 21: Jenis Sampel DiterimaFigure 21: Types Of Samples Received

RayuanAppeal 7%

Unit Penguatkuasa Farmasi Pharmacy Enforcement2%

PendaftaranRegistration28%

AduanComplaint3%

PengawasanSurveillance60%

Rajah 22: Perbandingan Sampel Ubat Tradisional Dengan Sampel Lain

Figure 22: Traditional Medicine Versus Other Samples

Sampel Ubat TradisionalTraditional MedicineSamples39%Lain

Others61%

40000

35000

30000

25000

20000

15000

10000

5000

0

Rajah 23: Bilangan Ujian DijalankanFigure 23: Number of Tests Done

28370

25949

2327924519

19776

32566

35017

28649

23710

27236


. . .

. . .

. . .

. . .

. . .

. . .

. . .


Rajah 24: Protokol Penganalisaan DiterimaFigure 24: Analytical Protocols Received

199923.9%

199628.6%

199722.3%

199825.2%

Penilaian tatacara dan protokol ujian

Sebanyak 984 protokol penganalisaan telahditerima pada tahun 1999. Terdapat penurunansebanyak 5.3% jika dibandingkan denganjumlah terimaan pada tahun 1998 (Rajah 24).

Pemeriksaan premis untuk pematuhan APB

Empat belas pemeriksaan Amalan PerkilanganBaik (APB) telah dilakukan ke atas premis-premis pengilang farmaseutikal tempatan danini adalah lebih tinggi dari bilangan yangdilaporkan pada tahun 1998 (lapan premis).

Piawai Rujukan

Di tahun 1999 sejumlah 198 piawai rujukan(ASEAN/BPFK) telah dibekalkan kepadajabatan kerajaan dan ini merupakan penurunankepada jumlah yang dilaporkan di tahun 1998oleh kerana BPFK t idak per lu membuatpembekalan ke badan-badan kerajaan luarnegera di tahun 1999. Walaupun begitu terda-pat peningkatan jualan tempatan piawairujukan di tahun 1999 (329) berbanding denganjualan yang dibuat dalam tahun 1998 (181).

GLP ASEAN

BAU telah berjaya mengendalikan kursusGLP peringkat ASEAN pada 23-24 November1999 dengan penglibatan Dr. David Mooresebagai penasihat jangka pendek WHO.

The evaluation of testing methods and analyticalprotocols

984 analytical protocols were received in1999 which showed a decrease of 5.3% fromthe number received in 1998 (Figure 24).

Premise inspection for GMP compliance

Fourteen GLP inspections were done on thelocal pharmaceutical manufacturing premisesand this was higher than the number reportedin 1998 (eight premises)

Reference standards

In 1999 a total of 198 reference standards(ASEAN/NPCB) were supplied to governmentdepartments. The figure was lower than the1998 report (884) since in 1999 NPCB wasnot r equ i r ed t o s end any s t andard t oo ther government bodies overseas. Howeverthere was an increase in the standards soldlocally in 1999 (329) compared to sales madein 1998 (181).

ASEAN GLP

DAD had successfully conducted an ASEANGLP course from 23th till 24th November1999 with the participation of Dr. DavidMoore as a WHO short-term consultant.


. . .

. . .

. . .

. . .


Pencapaian Profesional

Tahun 1999 melihat penglibatan profesionalahli BAU yang lebih aktif berbandingpenglibatan di tahun 1998. Mr. Lai Lim Sweetelah menghadiri Mesyuarat ke 17 ASEANWorking Group on Technical Cooperation inPharmaceuticals di Bangkok, Thailand pada24-26 Mac 1999. Dr. Sulaikah V.K. Moideentelah menjadi penasihat jangka pendek WHOdibidang kawalan mutu farmaseutikal (aspekmikrobiologi) di Vietnam dan menghadirimesyuarat ke 105 Sesssion of the EuropeanPharmacopoeia Commission yang masing-masing diadakan di Strasbourgh NegaraPerancis pada 9-29 Mei and 23-25 November1999.

Puan Yogeswary Markandoo, Dr. Sulaikah, EnJaafar Lassa, En. Tan Ann Ling and PuanHasenah Ali menyampaikan syarahan di semi-nar mengenai “Kursus pengenalan jaminankualiti ubat-ubat traditional” yang diadakandi Palace of Golden Horses Kuala Lumpurpada 15-16 Jun 1999. En Jaafar telahmenyumbangkan satu kertas kerja“Kepastian mutu ubat-ubat tradisional” dalamsatu seminar di FRIM Kuala Lumpur pada 22-23 Jun 1999.

Pematuhan ISO 9000

BAU memandang serius pematuhan ini danterlibat dalam penyediaan dokumen yangberkaitan dengan prosedur pemprosesan kerjadan pengurusan makmal.

Lain-lain aktiviti

Satu ujian kualitatif ubat beta antagonis yangboleh ditambah sebagai campur palsu kepadamakanan binatang telah berjaya dibangunkan.

Lima alat baru iaitu Karl Fischer Autotitrator,satu sistem ion kromatografi, satu AutomatedDissolution Apparatus, satu Gradient HPLCdan satu Sistem Pemonitoran Pirogen telahditauliahkan pada tahun 1999.

Professional achievements

In 1999 there was a more active professionalinvolvement of DAD’s personnel as comparedto the involvement seen in 1998. Mr. Lai LimSwee attended the 17th Meeting of the ASEANWorking Group on Technical Cooperation inPharmaceuticals in Bangkok, Thailand on 24-26th March 1999. Dr. Sulaikah V.K. Moideenhad served as a WHO short-term consultantfor the microbiological quality control ofpharmaceuticals in Vietnam and attended ameeting on the 105th Sesssion of theEuropean Pharmacopoeial Commission heldin Strasbourgh France on 9-29th May and 23-25th November 1999 respectively.

Puan Yogeswary Markandoo, Dr. Sulaikah, EnJaafar Lassa, En. Tan Ann Ling and PuanHasenah Ali gave lectures in a seminar on“Kursus pengenalan jaminan kualiti ubat-ubat traditional” held at the Palace ofGolden Horses Kuala Lumpur from 15-16thJune 1999. En Jaafar presented a paper on“Kepastian mutu ubat-ubat tradisional” in aseminar at FRIM Kuala Lumpur on 22-23thJune 1999.

Compliance to ISO 9000

DAD was seriously involved in preparing thedocumentation relating to work procedureand laboratory management.

Other activities

A test for detection of beta antagonist drugswhich can be found as adulterants of the animalfeeds was successfully developed.

Five new instruments namely a Karl FischerAutotitrator, an ion chromatography system,an automated Dissolution Apparatus, a gradientHPLC and a pyrogen monitoring system werecomissioned in 1999.

43

BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN NATIONAL PHARMACEUTICAL CONTROL BUREAU

L A P O R A N T A H U N A N 1 9 9 9 / 1 9 9 9 A N N U A L R E P O R T44

RANCANGAN UNTUK MASA DEPAN

BAU akan sentiasa bersedia untuk menghadapicabaran baru bagi melengkapkan danmeningkatkan keupayaan agar dapat terlibatsecara aktif dan efektif dalam melaksanakanfasa-fasa pendaftaran yang berikutnya.Sejajar dengan status BPFK sebagai pusatkolaboratif WHO dalam bidang regulatori danpengawasan mutu, beberapa plan strategiktelah dirangkakan untuk BAU yang diperjelaskanseperti berikut:

Melengkapkan BAU secara total dengan aspekyang berkaitan dengan pematuhan ISO 9000and Amalan Baik Makmal.

Bekerjasama dengan Bahagian Farmakovigilansagar BAU dapat menjalankan ujian kawalanmutu yang dapat merangkumi aspek yangmelibatkan perbandingan keluaran generikdengan keluaran asal.

Mengendalikan kursus kawalan mutu untukpengeluar ubat tradisional tempatan yangberhajat untuk mendapatkan pengetahuan“hands-on” dalam pengujian ubat tradisional.

Mengendalikan kursus validasi analitikaluntuk kakitangan BAU dan pengeluar tempatan.

FUTURE PLANS

DAD shall continue to provide professionalservices in the field of pharmaceutical analysis.DAD shall be in a position to accept newchallenges and be able to play an active andeffective role in the implementation of thefuture phases of registration exercise. In tandemwith the status of NPCB as a WHO collaboratingcentre in regulatory control, several strategicplan of action are scheduled and they are asfollows:

To complete the implementation of ISO 9000and GLP to DAD.

Involved in collaborative work with theP h a r m a c o v i g i l a n c e s e c t i o n t o e n a b l ecomparisons of generic preparations withtheir market leaders be made, in quality controltesting aspects.

To conduct quality control training course(s)for the local traditional manufacturer seekinghands-on experience in the testing of traditionalproducts.

To provide a training course on analyticalvalidation to the evaluators of DAD and to themanufacturers.



BAHAGIAN PEMBANGUNAN ORGANISASI DAN TEKNOLOGI MAKLUMAT (POTM)

OBJEKTIF

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

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

Menyebarkan maklumat-maklumat ubat kepadaorganisasi-organisasi dalam sektor awam danswasta.

PENCAPAIAN

Untuk mencapai objektif-objektif tersebut,beberapa aktiviti telah dijalankan oleh bahagianini seperti berikut :-

perkhidmatan maklumat ubat danmaklumat am tentang pendaftaran ubat-ubatanperkhidmatan perpustakaanpengkelasan keluaranpenerbitan

Perkhidmatan Maklumat Ubat dan MaklumatAm

Bahagian POTM telah menjawab 1027 pertanyaansepanjang tahun 1999 dari sektor awam danswasta (Rajah 25). Kebanyakan daripadapertanyaan tersebut adalah berkenaan statuspendaftaran keluaran-keluaran farmaseutikal,prosedur pendaftaran ubat-ubatan, indikasikeluaran, keberkesanan dan kesan adversubat/keluaran (Rajah 26) .

Perkhidmatan Perpustakaan

Perpustakaan ini mempunyai hampir 950 buahbuku, termasuk farmakopia-farmakopia utamada r i pe lbaga i nega ra l ua r . Se l a in i t u ,pe rpus t akaan ini juga melanggan 45 jenisjurnal/buletin ubat, Micromedex dan InternationalPharmaceutical Abstract. Perpustakaan inidibuka kepada kakitangan BPFK sahaja.Ahli-ahli farmasi di bawah KementerianKesihatan boleh memohon untuk menggunakankemudahan-kemudahan di perpustakaan ini.

ORGANIZATIONAL DEVELOPMENTAND INFORMATION TECHNOLOGYDIVISION (OD & IT)

OBJECTIVE

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 improvethe standard 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 to organizationswithin the public and private sectors.

ACHIEVEMENTS

In order to achieve the above objectives, sev-eral activities undertaken by this division areas follows :-

drug information service and information on drug registrationlibrary serviceproduct classificationpublications

Drug Information Service and Informationon Drug Registration

The OD & IT division responded to 1027inquiries in 1999 from both the public andprivate sectors (Figure 25). The majority ofthe inquiries were on dosage, indications,efficacy, adverse drug reactions, registrations ta tus o f pharmaceutical products and drugregistration procedures (Figure 26).

Library Service

The library has about 950 books, includingthe major pharmacopoeias from variouscountries. Besides that, it subscribes to 45journals/drug bulletins, Micromedex andInternational Pharmaceutical Abstracts. Thelibrary is open to the staff of the institutiononly. Pharmacists in the Ministry of Healthmay, by request, make use of the library facilities.

BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN NATIONAL PHARMACEUTICAL CONTROL BUREAU


0

200

400

600

800

1000

1200

1991

345

1992

363

1993

245

1994

474

1995

552

1996

688

1997

729

1998

707

1999

1027

Rajah 25: Bilangan Pertanyaan Diterima Dari 1991 - 1999Figure 25: Number Of Enquiries Received From 1991 - 1999

Bil. Pertanyaan

Rajah 26: Jenis Pertanyaan Yang Diterima Pada Tahun 1999Figure 26: Types Of Enquiries Received In 1999

Status PendaftaranRegistration Status175

Indikasi / Indication 66

Formula KeluaranProduct Formulation10

Kesan AdversAdverse Reaction29

InteraksiInteraction20

FarmakologiPharmacology16

PembekalSupplier56

Keadaan Penyakit Disease Condition14

Maklumat Am KeluaranGeneral ProductInformation198

Efikasi TerapeutikTherapeutic Efficacy36

Lain-lainOthers407


. . .

. . .

. . .

. . .

. . .

. . .

. . .

. . .

. . .

. . .

. . .

Pengelasan Keluaran

Bahagian ini bertanggungjawab ke atas semuapertanyaan berkenaan dengan klasifikasi kelu-aran-keluaran “borderline”, sama ada kelu-aran-keluaran itu perlu didaftar atau tidak.Antara 955 keluaran yang diterima untukpengkelasan dalam tahun 1999, 600 keluaranmerupakan butiran-butiran yang tidak perludidaftar, seperti peralatan-peralatan perubatan,keluaran-keluaran penjagaan kulit, supplemenmakanan (dalam bentuk jus/minuman), kelu-aran-keluaran “food-based” dan herba-herbamentah.

Baki 355 keluaran telah dikelaskan sebagaiperlu didaftarkan.

Penerbitan

Penerbitan-penerbitan yang berikut telahdihasilkan dan diedarkan organisasi-organisasidalam sektor awam dan swasta sepanjangtahun 1999.

(i) Berita Ubat-Ubatan (3 keluaran)

(ii) Pekeliling Maklumat Ubat (12 keluaran)

(iii) Monograf Ubat (17 keluaran)

(iv) Q Bulletin (1 keluaran)

(v) Laporan Tahunan (1 keluaran)


Product Classification

This division handles all queries pertainingto classification of “borderline products”, asto whether they are registrable or not. Out ofthe 955 products received for classification in1999, 600 products were non-registrable itemssuch as medical devices, skin care products, food supplements in the form of juices/drinks,food-based products and raw herbs.

The remaining 355 products were classifiedas registrable.

Publications

The following publications were producedand distributed to organisations in the publicand private sector in 1999.

(i) Drug Control Authority Newsletter (3 issues)

(ii) Drug Information Circular (12 issues)

(iii) Drug Monograph (17 issues)

(iv) Q Bulletin (1 issue)

(v) Annual Report (1 issue)



PELAWAT-PELAWAT ANTARABANGSA

INTERNATIONAL VISITORS

Tarikh Pelawat ObjektifDate Visitors Objective

11.1.1999 until 3.3.1999 Two WHO Fellows from Attachment Training onBangladesh: Quality Control of * Mr. Haque Mozammel Essential Drugs* Mr. Das Ranjit Kumar

25.1.1999 WHO Fellow from Ministry Of Temporary Advisor-SouthHealth & Welfare of Japan: East Asian Regions &* Mr. Akira Hamada Western Pacific

8.2.1999 until 1.3.1999 WHO Fellow from Bangladesh: Training on Quality* Mr. Md. Ruhul Amin Management in

Pharmaceutical

23.3.1999 until 22.4.1999 WHO Fellow from MCA: As a Consultant Good* Dr. David Moore Laboratory Practice (GLP)

3.5.1999 until 29.5.1999 Three WHO Fellows: Training on Drug Quality* Mr. Sun Lei (from China) Control* Ms. Prey Yean (from Ministry

of Health of Cambodia)* Ms. Vongsavanh Insixiengmay

(from Ministry of Health ofLaos)

10.5.1999 until 25.5.1999 WHO Fellow from Ministry of Training on DrugHealth and Social Welfare of RegistrationMongolia:* Ms. Zulzaga Zuzaan

24.5.1999 until 27.5.1999 Three WHO Fellows from Training on National DrugVietnam: Policy Programme* Mrs. Le Thi Nga* Ms. Chu Thi Tuyet* Mr. Luu Minh Triet

1.6.1999 until 30.6.1999 Three WHO Fellows from Training on Local Mongolia: Production & Methodology* Mrs. Gunjar Dolgormaa* Mr. Terbish Bayaraa* Dr/Mrs. Gendenjamts

7.6.1999 until 23.7.1999 Three WHO Fellows from Training on Methods toVietnam: Organize and Run Drug* Mr. Nguyen Duc Bon Information Centres* Mr. Tran Cuc* Dr/Miss Hoang Thanh Mai


Tarikh Pelawat ObjektifDate Visitors Objective

19.7.1999 until 30.7.1999 Two Officers from Pharmacy In House Training onBoard, Tanzania: Adverse Drug Reactions* Mr. Henry Irunde Monitoring & Drug * Mr. N. A Msuye Information Services

2.8.1999 until 27.8.1999 WHO Fellows from Vietnam: Study Tour on Drug Quality* Ms. Hoang Thai Phuong Cac Control by Non-* Ms. Budjav Tavanjin (from Pharmacopoeial Methods

Mongolia)

5.10.1999 until 8.10.1999 Dra Rahmaniar Brahim from Comparative Study on theIndonesia: Drug Information System(SEAMIC Travel ResearchFellowship)

8.10.1999 until 12.10.1999 Miss Charunee Krisanaphan Study Tour on Drug Controlfrom Thailand: System(SEAMIC Travel ResearchFellowship)




PUSPANITA BPFK

Puspanita BPFK 1999 yang diterajui oleh 19orang ahli jawatankuasa telah berjaya menjalanibeberapa aktiviti-aktiviti yang telah dapatdimanfaatkan oleh ahli-ahlinya yang berjumlahseramai 96 orang.

Aktiviti-aktiviti yang dijalankan keseluruhannyamerangkumi aspek sukan, sosial, kebajikandan pendidikan. “Hari Kesihatan dan Anda“yang telah diadakan pada bulan Jun 1999 telahberjaya memberi kesedaran dan keprihatinanahli-ahli tentang permakanan seimbang dangaya hidup yang sihat. Sukan “out-door” dan“in-door” seperti badminton, ping-pong, carrom,darts dan lain-lain sememangnya menjadikegemaran ahli-ahli sepanjang tahun.Beberapa ceramah yang berbentuk pendidikandan kebajikan juga telah didedahkan kepadaahl i -ahl i semua. Untuk menambahkanpengetahuan yang berkaitan dengan masak-memasak beberapa sessi demonstrasi masakanjuga telah dijalankan.

Sepanjang tahun 1999, selain dari hasil yurantahunan, pendapatan Puspanita BPFK adalahhasil dari diantaranya jualan tapak pasaria,keuntungan jualan kueh hari raya/makananbeku dan komisyen tempahan kasut.

Pada tahun 1999 juga , Puspani ta te lahdiperuntukkan satu bilik oleh pihak pengurusanuntuk penyimpanan harta-harta tetapPuspanita dan perkakas permainan “in-door”seperti carrom dan darts.

Puspanita BPFK masih dapat mempertahankankesinambungan kegiatan dan aktiviti-aktivitinyadisebabkan hasil dari kerjasama dan komitmen dikalangan ahli jawatankuasa dan sokonganpadu yang berterusan dari ahli-ahli semua.Diharap pada tahun yang berikutnya, semuaahli akan terus bergiat demi memperjuangkanPuspanita BPFK khasnya.

“ WANITA SEPAKAT NEGARAMENINGKAT “

PUSPANITA NPCB

In 1999 Puspanita BPFK consisted of 19committee members and 96 ordinary members.

Several activities covering sports, social welfareand education were held. “Health and You”Day organized in June 1999 created theawareness of members towards the importanceof a balanced diet and a healthy lifestyle.Educational and welfare talks were also held.Cooking demonstrations were conducted forthose interested in enhancing their culinaryskills

Throughout the year, out-door and in-doorsports such as badminton, table tennis, carromand darts were the favourite activities.

The revenue collection for Puspanita BPFKwas derived from the yearly membership feeand earnings from ‘pasaria’ sites, sale ofcakes/frozen food and commission from thesale of shoes.

In 1999, Puspanita was allocated a room bythe management to store Puspanita’s fixedassets and sports equipment.

Up to the end of the year, Puspanita BPFKwas able to continue its activities for the benefitof its members due to the cooperation andstrong commitment from its committee membersand continued support from all its members.


51

Kursus / SeminarCourses / Seminars


Kursus / Latihan Yang DihadiriCourses / Training for Staff

Nama Pegawai Kursus Tarikh Tempat AnjuranName Course / Training Date Place Sponsors

Che Mohd Zin 1. 2 n d IFMA Asian Regulatory 2-3 Mac 1999 Singapura IFPMA & SAPIChe Awang Conference

2. APEC workshop on the Food/ 29 Nov-3 Dis 1999 Bangkok, Thailand A P E C3. 9 t h International Conference of 26 - 29 April 1999 Berlin, German ICRDA

Drug Regulatory Authorities4. Lawatan sambil belajar ke 30 Jun-1 Julai 1999 Singapura KKM

‘Cosmetic Control Unit’Singapura.

5. First Meeting of ACCSQ-Product 6-7 September 1999 Kuala Lumpur KKM & Jabatan Standard Working Group on Pharmaseutical Malaysia

6. Second Meeting of ACCSQ- 8-9 September 1999 Kuala Lumpur KKM & Jabatan StandardProduct Working Group on MalaysiaCosmetics

7. Seminar Regulatori 1999 19-20 Oktober 1999 Petaling Jaya BPFK/MOPI/PhAMA/ FMM-MCTIG/CTFA

Hasnah Ismail 1. 2nd IFPMA Asian Regulatory 2-3 Mac 1999 IFPMA & SAPI SingapuraConference

2. Pharmaceutical GMP Training 19-20 Mei 1999 BPFK, KKM & MOPI BPFKAnalytical Validation

3. Pharmaceutical GMP Training 24-25 Mei 1999 BPFK, KKM & MOPI BPFK- Process Validation

4. Lawatan sambil belajar ke ‘Cosmetic 30 Jun-1 Julai 99 KKM SingapuraControl Unit’ Singapore

5. Persidangan Penguatkusaan Akta 27 Julai 1999 Bahagian Perkhidmatan Langkawi, KedahUbat (Iklan dan Penjualan) 1956 Farmasi KKM

6. First Meeting of ACCSQ-Product 6-7 September 99 KKM & Jabatan Kuala LumpurWorking Group on Cosmetics Standard M’sia

7. Second Meeting of ACCSQ- 6-7 Sept 1999 Kuala Lumpur KKM & Jabatan Product Group on Cosmetics Standarad Malaysia

8. Mesyuarat Penyediaan Polisi 15-17 Sept 1999 Port Dickson, N. Sembilan KKMPerubatan Tradisional/Komplimentari Kebangsaan

9. Seminar Regulatori 1999 19-20 Oktober 1999 Petaling Jaya BPFK/MOPI/PhMA10.Commonwealth Working 4 November 1999 Kuala Lumpur KKM

Group on TraditionalComplementary Medicine

11.Kursus Komputer Microsoft 6-9 Disember 1999 Petaling Jaya BPFKAccess 97 (beginner,Intermediate & Advance)

Nama Pegawai Kursus Tarikh Anjuran TempatName of Officer Course Date Sponsor Place

Fudziah Ariffin 1. Bengkel “Improving The Availablity 31 Mac - 2 April 1999 KKM Awana, Genting HighlandsOf Pain Releif Drugs”

2. Bengkel ISO 9000 10 - 14 Mei 1999 BPFK A Farmosa Resort, Melaka3. Process Validation Workshop 19 - 20 Mei 1999 BPFK BPFK, Petaling Jaya4. Analytical Method Validation 24 - 25 Mei 1999 BPFK BPFK, Petaling Jaya5. Bengkel Odit Dalaman Untuk 6 - 8 Julai 1999 Bahagian Farmasi Kem. Permai Park Inn, Kuala Terengganu

Perkhidmatan Farmasi Kesihatan Malaysia6. Bengkel “ Clinical Trials 18 - 19 Ogos 1999 Eli Lilly (M) Sdn Bhd Sunway Resort, Sungai Way

Methodology, Critical Appraisaland Meta-analysis”

7. First Meeting of ACCSQ Product 6 - 7 September 1999 KKM Hotel Concorde, Kuala LumpurWorking Group on Pharmaceutical

8. Mesyuarat Penyediaan Polisi 15 - 17 September 1999 KKM Avillion Village Resort, Port DicksonPerubatan Tradisional/KomplimentariKebangsaan

9. Seminar Pendidikan Berterusan -Drug 27 - 28 September 1999 Universiti Sains Malaysia USM, Pulau PinangRelated Clinical Trials

10. Pharmaceutical & Cosmetic Regulatory 19 - 20 October 1999 BPFK Subang Sheraton,SubangSeminar

11. The 11 th Meeting of the parties to the 29 Nov - 3 Disember 1999 Jabatan Alam Sekitar, Kem. Beijing, ChinaMontreal Protocol Sains, Teknologi dan Alam

Sekitar

Arpah Abas 1. Bengkel MS ISO 9000 10 - 14 Mei 1999 BPFK A Farmosa Resort, Melaka2. Process Validation Workshop 17 - 18 Mei 1999 BPFK BPFK, Petaling Jaya3. Pharmaceutical & Cosmetic Regulatory 19 - 20 October 1999 BPFK Subang Sheraton, Subang

Seminar4. First Meeting of ACCSQ Product 6 - 7 September Kem. Kesihatan Malaysia Hotel Concorde, Kuala Lumpur

Working Group on Pharmaceutical5. Microsoft Access 97 6 - 8 Disember 1999 BPFK Bandar Sunway, Petaling Jaya6. WHO Training on Assessment of 29 Nov - 3 Disember 1999 WHO/BFAD Philippines Manila, Philippines

Application for Marketing Authorised(Generics)

Mazuwin 1. Bengkel Pelaksanaan MS ISO 9000 10 - 14 April 1999 BPFK A Farmosa Resort, MelakaZainal Abidin 2. Process Validation Workshop 17 - 18 Mei, 1999 BPFK BPFK, Petaling Jaya

3. Pharmaceutical & Cosmetic Regulatory 19 - 20 October 1999 BPFK Subang Sheraton, SubangSeminar

4. Good Laboratory Practice Seminar 23 - 24 November 1999 BPFK BBPFK

Nama Pegawai Kursus Tarikh Anjuran TempatName of Officer Courses Date Coordinator Place

Zainab Md. Yusuf 1. Bengkel Perlaksanaan MS ISO 10-14 Mei 1999 B P F K Alor Gajah9000 BPFK

2. Latihan Komputer Kursus Excel 97 15 November 1999 B P F K Bandar Sunway, PJ-Beginning

3. Persidangan QAP farmasi 16-19 Nov 1999 Bhg. Perkhidmatan MelakaFarmasi

Mohd Tarmizi 1. Latihan Komputer Kursus Excel 97 15 November 1999 B P F K Bandar Sunway, PJ- Beginning

Napsah Mahmud 1. Bengkel Perlaksanaan MS ISO 9000 10-14.5.1999 INTAN A’Famosa Resort Hotel, Melaka2. Pharmaceutical GMP Training 26-27.5.1999 B P F K B P F K

Process Validation Workshop3. First Meeting of ACCSQ Product 6-7.9.1999 KKM Hotel Concorde, Kuala Lumpur

Working on Pharmaceuticals4. Mesyuarat Penyediaan Polisi 15.9.1999 KKM Avillion Village Resort, Port Dickson

Perubatan Tradisional/KomplementariKebangsaan

5. Dialog Penasihat Antara Bangsa 1-2.11.1999 MARDI/KKM Hotel Diamond Puteri, Kota Bharu(International Advisory Panel)untuk Pembangunan Herba IndustriMalaysia

6. Commonwealth Working Group on 4.11.1999 KKM Mandarin Oriental, Kuala LumpurTraditional/Complementary Medicine

Rosilawati Ahmad 1. Bengkel Perlaksanaan MS ISO 9000 10-14.5.1999 INTAN A’Famosa Resort, Melaka2. Seminar Regulatori Farmaseutikal 19-20.10.1999 BPFK, PhAMA, MOPI, Hotel Subang Sheraton, Petaling Jaya

dan Kosmetik 1999 CTFA, FMM-MGTIC Selangor3. Commonwealth Working Group on 4.11.1999 KKM Mandarin Oriental, Kuala Lumpur

Traditional/Complementary Medicine 4. Seminar Good Laboratory Practice 23-24.11.1999 BAU (BPFK)& WHO BPFK5. Kursus Komputer-Microsoft Access 6-9.12.1999 BPFK New Horizons Computer Learning

97, Beginner, Intermediate, Advanced Centre

Ainul Salhani 1. Kursus Komputer-Microsoft Access 97 2-5.11.1999 BPFK New Horizons Computer LearningBeginner, Intermediate, Advanced Centre

2. Kursus Komputer- Microsoft Excel 9, 15.11.1999 BPFK New Horizons Computer LearningBeginner Centre

Asnida Mat Daud 1. Kursus Pengenalan Perkhidmatan 10-11.1999 Bahagian Perkhidmatan De Palma Inn, Shah Alam, SelamgorFarmasi


Zambin Rokiah 1. Computer (Microsoft Access) 1-4.11.99 BPFK Horizon Computer Learning CentreAbdul Rashid

Zawiyah 1. Computer (Microsoft Access) 6-8.12.99 BPFK Horizon Computer Learning CentreAbdul Wahab

Tan Lie Sie 1. National Seminar on Regulation 1 April 1999 FMM-MCTIG Shah Alamand Registration of Cosmetics &Toiletries

2. Bengkel Perlaksanaan MS ISO 9000 10-14 Mei 1999 BPFK Alor GajahB P F K

3. Pharmaceutical GMP Training 19-20 Mei 1999 NPCB/MOH/MOPI Petaling JayaAnalytical Validation


5. APEC Workshop on the Food/Drug 9-13 Ogos 1999 BPFK Canberra,Australia6. ACCSQ Product Working Group 6-7 Sept 1999 Jabatan Standard Kuala Lumpur

on Pharmaceuticals7. Seminar Regulatori Farmaseutikal 19-20 Okt 1999 BPFK Subang Jaya, PJ

& Kosmetik 19998. Latihan Komputer Kursus Excel 97 15 November 1999 BPFK Bandar Sunway, PJ

- Beginning9. Latihan Komputer Kursus Excel 97 18 November 1999 BPFK Bandar Sunway, PJ

- Advanced10. APEC Workshop on the Food/Drug 27-3 Disember 1999 AusAID Bangkok, Thailand

Interface11. Latihan Komputer Kursus 6-9 Disember 1999 BPFK Bandar Sunway,PJ

Access 97- Beginning, Intermediate& Advanced

Mazli Muhamad 1. Bengkel Perlaksanaan MS ISO 9000 10-14 Mei 1999 BPFK Alor GajahB P F K


3. Pharmaceutical GMP Training 24-25 Mei 1999 NPCB/MOH/MOPI Petaling JayaValidation

4. Seminar Regulatori Farmaseutikal 19-20 Okt 1999 BPFK Subang Jaya, PJ& Kosmetik 1999

5. GLP Seminar 23-24 Nov 1999 BPFK Petaling Jayas


Shukri 1. Computer (Microsoft Access - 6-9.12.99 BPFK Horizon Computer LearningMohd Arif Beginner, Intermediate & Advance)

Soleha Che Ros 1. Latihan Amali Dispensing Jan-Jun 1999 KKM H K L

Talip Tawil 1. Bengkel Perlaksanaan ISO 10-14.5.99 Intan/BPFK A Famosa Resort, Melaka2. Computer (Microsoft Access) Nov 1999 BPFK Horizon Computer Learning Centre3. Seminar on GLP 23-24.11.99 W H O BPFK

Tan Ann Ling 1. Microbiology: from manual to 29.4.99 Fischer Scientific PJ Hiltonautomation

2. Analytical spectroscopy 4.5.99 Bruker AXS Holiday Villa, PJ3. Bengkel Perlaksanaan ISO 10-14.5.99 Intan/BPFK A Famosa Resort, Melaka4. Analytical Validation 17-18.5.99 BPFK/MOPI BPFK5. Process Validation 19-20.5.99 BPFK/MOPI BPFK6. Seminar Regulatori Farmaseutikal 19-20.10.99 BPFK/MOPI/CTFA/ Sheraton Hotel, PJ

& Kosmetik Pharma/MCTIG7. Seminar GLP 23-24.11.99 W H O BPFK8. Computer (Micorosoft Word, Excel Nov & Dis 1999 BPFK Horizon Computer Learning Centre

& Advance)

Yogeswary 1. Bengkel Perlaksanaan ISO 10-14.5.99 Intan/BPFK A Famosa Resort, MelakaMarkandoo 2. Analytical Spectroscopy 4.5.99 Bruker AXS Holiday Villa, PJ

3. Analytical Validation 17-18.5.99 BPFK/MOPI BPFK4. Process Validation 26-27.5.99 BPFK/MOPI BPFK5. International Pharmacy Symposium 21-22.5.99 Persendirian Kota Kinabalu6. Seminar Regulatori Farmaseutikal 19-20.10.99 BPFK/MOPI/CTFA/ Sheraton Hotel, PJ

& Kosmetik Pharma/MCTIG7. Computer (Microsoft Words, Nov & Dis 1999 BPFK Horizon Computer Learning Centre

Excel 7 Access)8. Seminar on GLP 23-24.11.9 W H O BPFK

Zaini 1. Latihan Amali Dispensing Jan - Jun 1999 KKM H K LJamaluddin 2. Pengurusan keselamatan dan 25.8.99 Prime Consistence Sdn Bhd BPFK

kebakaran bangunan3. Seminar on Sympatec’s Particle 10.12.99 Interscience Sdn Bhd PJ Hilton

Measurement4. Computer (Microsoft Words) 10.11.99 BPFK Horizon Computer Learning Centre


Noraida Mohd. 11. Persidangan QAP Farmasi 16-19.12.99 Bahagian Farmasi Makhota Century Hotel, MelakaZainoor 12. Seminar on GLP 23-14.11.99 W H O BPFK

13. Meeting of ASSQC on cosmetics 8-9.9.99 Jabatan Standard Malaysia Concord Hotel, KL

Mohd Nasir 1. Waters Vision 2000 6.5.99 Research Instrument Hyatt Saujana Hotel , PJHashim 2. Bengkel Perlaksanaan ISO 10-14.5.99 Intan/BPFK A Famosa Resort, Melaka

3. Analytical Validation 17-18.5.99 BPFK/MOPI BPFK4. Process validation 24-25.5.99 BPFK/MOPI BPFK5. Computer (Microsoft Words, Nov 1999 BPFK Horizon Computer Learning Centre

Excel & Access)

Norzehan 1. Latihan Amali Dispensing Jan-Jun 1999 KKM H K LYusoff

Nirmala Devi 1. Seminar on laser scattering 31.3.99 Mecomb Malaysia Petaling Jayaparticle size distribution

2. Computer (Microsoft Word) 11.11.99 BPFK Horizon Computer Learning Centre

Oh Lay Eng Computer (Microsoft Access) 6-9.12. 99 BPFK Horizon Computer Learning Centre

Ong Chui Eng Computer (Microsoft Excel) 18.11.99 BPFK Horizon Computer Learning Centre

Pang Moy Yong Ion Chromatography 19 & 22.3.99 Research Instrument

Ropidah Yaacob 1. Seminar on lase scattering particle 31.3.99 Mecomb Malaysia Petaling Jayasize distribution

2. Computer (Microsoft Words) 10.11.99 BPFK Horizon Computer Learning Centre

Rosni Sharif Computer (Microsoft Words) 10.11.99 BPFK Horizon Computer Learning

Rusnah Rejab Latihan Amali Dispensing Julai-Dis 1999 KKM H K L

Selvaraja 1. Regulation of vaccines 5-12.5.99 W H O Canberra, AustraliaSeerangam 2. Process validation 17-18.5.99 BPFK/MOPI BPFK

3. Analytical validation 26-27.5.99 BPFK/MOPI BPFK4. Quality assurance of live attenuated 26.9.99-27.10.9 W H O Bandung, Indonesia

polio and measles vaccine5. Seminar on GLP 23-24.11.9 W H O BPFK6. Computer (Microsoft - Word, 3,5,12,16.11.99, BPFK Horizon Computer Learning

Excel & Access) 18.11.99


Kamsah Marjan Computer (Microsoft Access) 6-7.12.99 BPFK Horizon Computer Learning Centre

Latifah Mhd Computer (Microsoft Word) 10.11.99 BPFK Horizon Computer Learning CentreTap

Lee Lian Chee Water Visions 2000 6.5.99 Research Instrument Hyatt Saujana, PJ

Lim Kah Hun Ion Chromatography 19 & 22.3.99 Research Instrument BPFK

Low Mooi Ling Computer (Microsoft - Excel Nov 1999 BPFK Horizon Computer Learning Centre& Access)

Jaafar Lassa 1. Bengkel Perlaksanaan ISO 10-15.5.99 Intan/BPFK A Farmosa, Melaka2. Analytical Validation 19-20.5.99 BPFK/MOPI BPFK3. Process Validation 26-27.5.99 BPFK/MOPI BPFK4. Bengkel Audit Dalaman 6-8.7.99 Bahagian Farmasi Kuala Trengganu

(Perkhidmatan Farmasi)

Mior Zamri 1. Ion Chromatography 19 & 22.3.99 Research Instrument BPFKMior Ahmad

Mohd Harian 1. Computer (Microsoft Word 10 & 18.11.99 BPFK Horizon Computer Learning CentreAhmad & Excel)

Mohd Noor 1. Latihan Amali Dispensing Jun - Dis 1999 BPFK H K LNurudin

Noraida Mohd 1. Chemical assay on the 18-29.1.99 W H O Bangkok, ThailandZainoor production of regional reference

substance 2. Ion chromatography 19 & 22.3.99 Research Instrument BPFK3. Bengkel Perlaksanaan ISO 10-14.5.99 Intan/BPFK A Famosa Resort, Melaka4. Karl Fischer (GLP Approach) 5.8.99 Mettler Toledo Mettler Toledo, Petaling Jaya5. Analytical Validation 26-27.5.99 MOPI/BPFK BPFK6. Process Validation 31.5.99-1.6.99 MOPI/BPFK BPFK7. Seminar regulatori farmaseutikal 19-20.10.99 BPFK/MOPI/CTFA/ Sheraton Hotel, PJ

& kosmetik Pharma/MCTIG8. National seminar on regulation of 1.4.99 CTFA/BPFK Concord Hotel, Shah Alam

cosmetic 9. HPLC training 1-5.7.99 Research Instrument Research Instrument

10.Computer (Microsoft Word Nov 1999 BPFK Horizon Computer learning& Access)


Dr. Sulaikah 1. Seminar on regulation of 1.4.99 CTFA/BPFK Concorde Hotel, Shah AlamV.K. Moideen cosmetic and toiletries

2. Microbiology: from manual to 29.4.99 Fischer Scientific PJ Hiltonautomation

3. Process Validation 31.5.99 & 1.6.99 BPFK/MOPI B P F K4. Quality Assurance of Live 26.9.99-27.10.99 WHO/JICA Bandung Indonesia

Attenuated Polio and Measles Vaccine

5. Computer (Microosoft Words, Nov & Dis 1999 B P F K Horizon Computer Learning CentreExcel & Access)

6. Meeting of the ACCSQ on 6-7 Sept 1999 Jabatan Standard Malaysia Concord Hotel, KLPharmaceuticals

7. Meeting of the ACCSQ on cosmetics 8-9 Sept 1999 Jabatan Standard Malaysia Concord Hotel, KL

Faridah Malek 1. Waters Vision 2000 Seminar 6.5.99 Research Instrument Hyatt Saujana Hotel, PJ2. Process Validation 17-18.5.99 BPFK/MOPI B P F K3. Analytical Validation 26-27.5.99 BPFK/MOPI B P F K4. First Meeting of ASSOC on 6-7.9.99 Jabatan Standard Malaysia Concord Hotel KL

Pharmaceuticals & Cosmetics5. Seminar Regulatori Farmaseutikal 19-20.10.99 BPFK/MOPI/CTFA/ Sheraton Hotel PJ

& Kosmetik Pharma/MCTIG6. Seminar on GLP 23-24.11.99 B P F K B P F K7. Computer (Microsoft Words, Nov 1999 B P F K Horizon Computer Learning Centre

Excel 7 Access)

Hasenah Ali 1. Standardisation of Traditional 15.3.99 - 14.4.99 W H O Beijing, ChinaMedicine

2. Bengkel Perlaksanaan ISO 10 - 14.5.99 Intan/BPFK A Famosa Resort, Melaka 3. Process Validation 17-18.5.99 BPFK/MOPI B P F K4. Analytical validation 19-20.5.99 BPFK/MOPI B P F K5. Waters Vision 2000 6.5.99 Research Instrument Hyatt Saujana Hotel, PJ6. Karl Fischer (GLP Approach) 5.8.99 Mettler Toledo Mettler Toledo, PJ7. First Meeting of ASSQC on 6-7.9.99 Jabatan Standard Malaysia Concord Hotel, KL

Pharmaceuticals8. Mesyuarat Penyediaan Polisi 15-17.9.99 BPFK/IMR/BPPK Avilion Hotel, Port Dickson

Perubatan Traditional/komplementari9. Seminar Regulatori farmaseutikal 19-20.10.99 BPFK/MOPI/CTFA/ Sheraton Hotel, PJ

& kosmetik Pharma/MCTIG10.Seminar on GLP 23-24.11.99 W H O B P F K11.Computer (Microsoft Excel Nov 7 Dis 1999 B P F K Horizon Computer Learning Centre

& Access)


Absah Awang 1. Kursus Keselamatan dan Kebakaran 25.8.99 Prime Consistense Sdn Bhd BPFKbangunan

2. Seminar on Sympatec’s 10.2.99 Interscience PJ HiltonParticle Measurement

3. Karl Fischer (GLP Appraoch) 5.8.99 Mettler Toledo Mettler Toledo

Ani Abdullah 1. Bengkel Perlaksanaan ISO 10-14.5.99 BPFK A Famosa Resort, Melaka2. Anti-inflammatory: Invitro tests 1-30.6.99 W H O University of Uppsala, Sweden

of herbal extracts3. Seminar Regulatori farmaseutikal 19-20.10.99 BPFL/MOPI/CTFA/Pharma/MCTIG Sheraton Hotel, PJ

& kosmetik4. Persidangan QAP Farmasi 16-19.11.99 Bahagian Farmasi KKM Mahkota Century Hotel, Melaka5. Seminar on GLP 23-24.11.99 W H O BPFK6. Computer (Microsoft Word& Nov & Dis 1999 BPFK Horizon Computer Learning Centre

Access )

Chan Sek Neo 1. Latihan Amali Dispensing Jan-Jun 1999 KKM H K L2. Karl Fischer (GLP Approach) 5.8.99 Mettler Toledo Mettler Toledo, PJ3. Computer (Microsoft Excel) Nov 1999 BPFK Horizon Computer Learning Centre4. Seminar on Sympatec’s Particle 10.12.99 Interscience Sdn Bhd PJ Hilton

Measurement

Chan Lai Peng 1. Training on ASEAN Reference 4-15.10.99 W H O Nonthanburi, ThailandSubstances (Microbiological Assay)

Chua Wone 1. Seminar on Sympatec’s Particle 10.12.99 Interscience Sdn Bhd PJ HiltonTying Measurement

Sulaiman 1. ISO 9000 Workshop 9 - 14 Mei 1999 BPFK A’Famosa, MelakaAhmad 2. Process Validation 24 - 25 Mei 1999 BPFK & MOPI BPFK

3. PIC/SSeminar - Non Technical 6 Sept - 10 Sept PIC/S, MCA, UK Oxford UniversityAspect 1999

4. Towards Effective 26 Okt 1999 SIRIM & DSM Pan Pacific GlenmarieStandardisation

5. Regulatory Seminar 1999 19 - 20 Okt 1999 BPFK & industri Subang Sheraton6. GLP Seminar 23 - 24 Nov 1999 BPFK & WHO BPFK


Kadariah Ali 1. ISO 9000 Workshop 9 - 14 Mei 1999 A’Famosa, Melaka BPFK

2. Analytical Validation 17 - 18 Mei 1999 BPFK BPFK & MOPI

3. Process Validation 19 - 20 Mei 1999 BPFK BPFK & MOPI

4. ACCSQ Pharmaceutical 6 - 7 Sept 1999 Concorde Hote l , KL DSM

5. Bengkel Polisi Perubatan 15 - 17 Sept 1999 Avilion Resort, KKMKomplimentari dan Port DicksonTradisional

6. Seminar Regulatori 1999 19 - 20 Okt 1999 Subang Sheraton BPFK & industri

7. Seminar GLP Seminar 23 - 24 Nov 1999 BPFK BPFK & industri

8. Kursus komputer 6 - 10 Dis 1999 Bandar Sunway BPFK

Wan Othman 1. ISO 9000 Workshop 9 - 14 Mei 1999 A’Famosa, Melaka BPFK

2. Analytical Validation 31 Mei - 1 Jun 1999 BPFK BPFK & MOPI

3. ACCSQ Cosmetic 8 - 9 Sept 1999 Concorde Hotel DSM

4. Regulatory Seminar 1999 19 - 20 Okt 1999 Subang Sheraton BPFK & industry associations

5. GMP Workshop 16 - 30 Nov 1999 Beijing, China W H O

6. Course in Computer 6 - 10 Dis 1999 Bandar Sunwa BPFK


Rosnani M. Ghazali 1. Bengkel ISO 900 10-14 Mei 1999 Melaka INTAN2. Seminar Regulatori Farmasiutikal 19-20 Okt 1999 Subang Jaya BPFK

dan Kosmetik 19993. Kursus Komputer Microsoft Word 11-12 Nov. 1999 Subang Jaya BPFK

97 (Intermediate & Advanced)

Siti Aisah Bahari 1. Kursus Pengenalan Jaminan 15-16 July 1999 Hotel Palace of The BPFKKualiti Ubat-ubatan Tradisional Golden Horses

2. Seminar Regulatori, 19-20 Okt 1999 Subang Sheraton BPFK/PHAMA/MOPI/Farmaseutikal & Kosmetik 1999 CTFA/FMM/MCTIG

Nurulfajar 1. Seminar Regulatori, 1-3 1999 Subang Jaya BPFKMohd. Jamid Farmaseutikal & Kosmetik 1999 5 Nov 1999

2. Kursus Komputer Microsoft

Eishah A. Rahman 1. Process Validation 31 May - 1 Jun 1999 BPFK BPFK & MOPI2. Analytical Validation 26 - 27 May 1999 BPFK BPFK & MOPI3. Medicinal Plants - 22 - 23 June 1999 FRIM FRIM

Quality Herbal Products For Healthy Living

4. Global Harmonisation Task 27 June - 2 Julai 1999 Maryland, USA CDRH & US FDAForce

5. PIC/S - 1999 Seminar 6 Sept - 10 Sept 1999 Oxford University PIC/S, MCA, UKNon Technical Aspect

6. GMP Course in Vaccines 18 Oct - 5 Nov 1999 MBL, Boston, USA WHO & USAID7. GLP Seminar 23 - 24 Nov 1999 BPFK BPFK & WHO


Ramli Zainal 1. 2nd Forum on Harmonized 15-16 Mac 1999 Manila ACCSQRegulatory Systems for Cosmetics

2. National Seminar on Regulation 1 April 1999 Shah Alam FMM-MCTIGand Registration of Cosmetics& Toiletries

3. Bengkel ISO 9000 10-14 April 1999 Melaka INTAN4. Pharmaceutical GMP Training 17-18 Mei 1999 BPFK BPFK

on Process Validation5. Bengkel Audit Dalaman Untuk 6-8 Julai 1999 Kuala Terengganu Bhg Farmasi

Perkhidmatan Farmasi6. 1st Meeting of ACCSQ of PWG 6-7 Sept 1999 Kuala Lumpur ACCSQ/DSM

on Pharmaceutical7. 2nd Meeting of ACCSQ of PWG 8-9 Sept 1999 Kuala Lumpur ACCSQ/DSM

on Cosmetic8. Mesyuarat penyediaan Polisi 15-17 Sept 1999 Port Dickson KKM

Perubatan Tradisional/Komplementari Kebangsaan

9. Seminar Regulatori 1999 19-20 Okt 1999 Subang Jaya BPFK

Anis Talib 1. National Seminar on Regulation 1 April 1999 Shah Alam FMM-MCTIGand Registration of Cosmetic &Toiletries

2. Bengkel Perlaksanaan MS ISO 10-14 Mei 1999 Melaka BPFK9000

3. Seminar Regulatori 19-20 Oktober 1999 Subang Jaya BPFKFarmaseutikal dan Kosmetik 1999

4. Good Laboratory Practice 23-24 Nov 1999 BPFK BPFK5. Kursus Komputer MS Excell 97 15-18 Nov 1999 Subang Jaya BPFK

(Beginner/Intermediate/advanced)

Zuraida Abdullah 1. Bengkel Perlaksanaan MS ISO 10-14 Mei 1999 Melaka BPFK9000

2. 2nd Meeting of ACCSQ of PWG 8-9 Sept 1999 Kuala Lumpur ACCSQ/DSMon Cosmetic

3. Persidangan QAP Farmasi 1999 16-19 Nov 1999 Melaka BPFK4. Kursus Komputer MS Acess 97 6-9 Dec 1999 Subang Jaya BPFK


Zawiah Zainal 1. ISO 9000 Workshop 9 - 14 Mei 1999 A’Famosa, Melaka BPFK2. Analytical Validation 19 - 20 Mei 1999 BPFK BPFK & MOPI3. Process Validation 24 - 25 Mei 1999 BPFK BPFK & MOPI4. Induction Course 17 - 31 Julai 1999 Air Keroh D’Village, KKM

Melaka5. Computer Access 1,2,3,5 Nov 1999 Bandar Sunway BPFK6. Pharmacist Induction 10 - 12 Nov 1999 Shah Alam Bhg. Farmasi

Course7. Pharmacy QAP Conference 16 - 19 Nov 1999 Melaka Bhg. Farmasi8. GLP Seminar 23 - 24 Nov 1999 BPFK BPFK

Dalila Abd Wahid Course in Computer Nov 1999 Bandar Sunway BPFK

Normah Ali Course in Computer Nov 1999 Bandar Sunway BPFK

Tang Poh Yoong Course in Computer Nov 1999 Bandar Sunway BPFKMicrosoft Words dan Excel

kandungan contents page · laporan bahagian 11 ... sehingga akhir tahu n 1999, ... issues related...

Documents