FREQUENTLY ASKED QUESTIONS ON GOOD MANUFACTURING PRACTICE (GMP) AND GOOD DISTRIBUTION PRACTICE (GDP) INSPECTIONS BY NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA) DURING COVID-19 PANDEMIC

How does NPRA conduct GMP inspections during COVID-19 pandemic?
The Movement Control Order (MCO) was implemented under Prevention and Control of Infectious Diseases Act 1988 and Police Act 1967 commencing 1th March 2020. With reference to a letter issued by The Chief Secretary to the Government related to the control of infectious diseases (Ref: JPM.KSN.100-2/2/5Jld.3(52); dated 13th March 2020) and a letter related to restrictions on the Ministry of Health (MOH) employees to travel abroad (Ref: KKM.500-6/4/2 JLD 6(57); dated 5th March 2020), NPRA has decided to suspend all national and foreign GMP Inspections which has been scheduled for the year of 2020 until further announcement made by the government.
 
Subsequently, the government announced the implementation of Conditional Movement Control Order (CMCO) which was effective on the 4th May 2020 allowing most economic and social sector in the country to start operating with implementation of strict Standard Operating Procedure (SOP) set by the Ministry.
Due to this unprecedented situation, the following are NPRA’s plan of action to conduct Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) inspections that has been postponed since 18th March 2020.
 
The following are the frequently asked questions related to the management of GMP and GDP Inspections during the period of crisis for industry guidance;
  1. NATIONAL GMP INSPECTIONS
  2. FOREIGN GMP INSPECTIONS
  3. GDP INSPECTIONS
 
1. What is the approach taken by NPRA in managing foreign GMP inspection that had been postponed during this COVID-19 pandemic?

During this interim period, NPRA have implemented mitigation plan for foreign GMP inspection scheduled for the year 2020 to ensure registration process (new registration and/or renewal) are uninterrupted.

 

Where possible, other pathways are being used to facilitate registration process for pending foreign GMP inspection applications including requesting additional information from applicants and existing inspection reports for facility that had been inspected by other competent authorities (e.g. Pharmaceutical Inspection Co-operation Scheme (PIC/S), ASEAN Listed Inspection Services).

 

However, foreign GMP inspection will be resumed once COVID-19 pandemic had subside. Product Registration Holder (PRH) will be informed from time to time regarding re-scheduling of affected foreign GMP inspections. Inspection will be prioritized based on the risk whereby all manufacturing facilities will be evaluated using risk-based approach to determine the need for on-site inspection.

2. How is GMP Inspection being conducted throughout the period of COVID-19 pandemic for foreign manufacturers?
3. If the outcome of the Remote Inspection is Acceptable, will a GMP certificate be issued?
4. What are the timelines to respond to documentation request?
5. Is there any change in foreign GMP inspection application submission flow due to COVID- 19 pandemic?
6. Can PRH submit ‘Borang Permohonan Pemeriksaan APB Luar Negara (BPFK-501)’ for manufacturing facilities located in regions that are impacted by COVID-19 related travel restrictions?
7. What are the fees involve with Remote Inspection?

For any further enquiries / information, kindly refer to:

  1. Frequently Asked Questions (FAQs): Foreign Good Manufacturing Practice (GMP) Inspectionthrough the following link https://www.npra.gov.my/index.php/en/faqs-compliance-and-licencing/faqs-gmp-inspection.html

SOALAN-SOALAN LAZIM BERKENAAN PEMERIKSAAN AMALAN PERKILANGAN BAIK (APB) DAN AMALAN PENGEDARAN BAIK (AEB) OLEH BAHAGIAN REGULATORI FARMASI NEGARA (NPRA) SEMASA PANDEMIK COVID-19

Apakah tindakan yang diambil oleh NPRA semasa pandemik COVID-19?
Selaras dengan pengisytiharan Perintah Kawalan  Pergerakan (PKP) mulai 18 Mac 2020, di bawah Akta Pencegahan dan Pengawalan Penyakit Berjangkit 1988 dan  Akta Polis 1967, surat daripada Ketua Setiausaha Negara No. Rujukan JPM.KSN.100-2/2/5/Jld.3(52) bertarikh 13 Mac 2020 berkenaan Langkah-langkah Menangani Penularan Pandemik (COVID-19) dan surat Arahan Larangan Perjalanan  Anggota KKM ke Luar Negara Semasa Pandemik COVID-19 No. Rujukan KKM.500-6/4/2 JLD 6(57) bertarikh 05 Mac 2020, NPRA telah memutuskan bahawa semua pemeriksaan dalam dan luar negara  yang dijadualkan pada tahun 2020 ditunda sehingga ke satu tarikh yang akan dimaklumkan kelak.
 
Kerajaan kemudiannya mengumumkan Perintah Kawalan Pergerakan Bersyarat (PKPB) yang bermula pada 4 Mei 2020 untuk membolehkan sebahagian besar aktiviti ekonomi dan sosial beroperasi semula secara berhati-hati dan perlu mematuhi prosedur operasi standard (SOP) yang ditetapkan oleh Kementerian Kesihatan Malaysia (KKM).
 
Sehubungan dengan itu, berikut adalah soalan – soalan lazim berkaitan dengan tindakan-tindakan yang diambil oleh NPRA dalam menguruskan pemeriksaan APB dan AEB semasa pandemic COVID-19 untuk rujukan dan panduan pihak industri:
  1. PEMERIKSAAN APB DALAM NEGARA
  2. PEMERIKSAAN APB LUAR NEGARA
  3. PEMERIKSAAN AEB
 
1. Apakah pendekatan yang diambil oleh NPRA dalam pengendalian pemeriksaan APB luar negara yang tertangguh semasa pandemik COVID-19 ini?

NPRA telah mengenal pasti pelan mitigasi bagi pemeriksaan APB premis pengilang luar negara yang telah dijadualkan untuk tahun 2020 bagi memastikan proses regulatori; pendaftaran / pendaftaran semula produk berjalan dengan lancar sewaktu krisis. Pihak pemegang pendaftaran produk [Product Registration Holder (PRH)] yang terlibat akan dihubungi oleh PKKK untuk tindakan selanjutnya.

Pendekatan yang diambil oleh NPRA bagi melancarkan proses pendaftaran produk bagi pemeriksaan luar negara yang tertangguh adalah termasuk mendapatkan maklumat tambahan daripada pihak PRH dan penilaian lanjut ke atas bukti pematuhan APB bagi pengilang luar negara yang pernah diperiksa oleh pihak regulatori berwibawa (Contohnya; Pharmaceutical Inspection Co-operation Scheme (PIC/S), ASEAN Listed Inspection Services).

Walau bagaimanapun, pemeriksaan APB ke atas premis pengilang luar negara tetap akan dijalankan selepas isu pandemik Covid-19 berada dalam keadaan terkawal. Pihak PRH akan dimaklumkan akan penjadualan semula premis-premis yang terlibat yang mana penjadualan semula akan dijalankan berdasarkan penilaian risiko dan keperluan negara.

2. Bagaimanakah Remote Inspection akan dijalankan ke atas pengilang luar negara semasa pandemik COVID-19?
3. Adakah pihak NPRA akan mengeluarkan sijil APB sekiranya keputusan pemeriksaan secara DiA adalah Memenuhi Keperluan APB?
4. Apakah tempoh masa yang diberi oleh pihak NPRA kepada pihak pengilang untuk mengemukakan dokumen / maklum balas?
5. Adakah proses permohonan pemeriksaan APB luar negara berubah ketika pandemik COVID-19?
6. Sekiranya pengilang luar negara terletak di negara yang mempunyai larangan perjalanan disebabkan oleh penularan wabak COVID-19, adakah PRH masih boleh mengemukakan permohonan pemeriksaan APB luar negara bagi pengilang tersebut?
6. Sekiranya pengilang luar negara terletak di negara yang mempunyai larangan perjalanan disebabkan oleh penularan wabak COVID-19, adakah PRH masih boleh mengemukakan permohonan pemeriksaan APB luar negara bagi pengilang tersebut?
7. Apakah bayaran fi yang terlibat dalam Remote Inspection?

Untuk sebarang pertanyaan / maklumat lanjut, sila rujuk:

  1. Frequently Asked Questions (FAQs): Foreign Good Manufacturing Practice (GMP) Inspection melalui pautan https://www.npra.gov.my/index.php/en/faqs-compliance-and-licencing/faqs-gmp-inspection.html

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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