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;
- NATIONAL GMP INSPECTIONS
- FOREIGN GMP INSPECTIONS
- GDP INSPECTIONS
1. Will the GDP inspection be conducted during the COVID-19 pandemic in Malaysia?
Yes, GDP inspection will be conducted on licensed importers / wholesalers either on-site (on-site) or remotely.
2. What are the differences between the above mentioned GDP inspection mechanisms?
3. Is my company allowed to choose the mechanism for GDP inspection?
For any further enquiries / information, kindly refer to:
- Frequently Asked Questions: Good Distribution Practice (GDP) through the following link https://www.npra.gov.my/index.php/en/faqs-compliance-and-licencing/faqs-gdp-inspection.html
- Officers-on-duty via email: saeb@npra.gov.my
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:
- PEMERIKSAAN APB DALAM NEGARA
- PEMERIKSAAN APB LUAR NEGARA
- PEMERIKSAAN AEB
1. Adakah pemeriksaan AEB akan dijalankan sepanjang tempoh pandemik COVID-19 di Malaysia?
Ya, pemeriksaan AEB akan dijalankan ke atas premis pengimport / pemborong berlesen sama ada secara lapangan (on-site) atau jarak jauh (remote).
2. Apakah perbezaan di antara mekanisma pemeriksaan AEB yang tersebut di atas?
3. Adakah syarikat saya dibenarkan untuk memilih mekanisma pemeriksaan AEB?
Untuk sebarang pertanyaan / maklumat lanjut, sila rujuk:
- Soalan Lazim : Amalan Pengedaran Baik (AEB) melalui pautan https://www.npra.gov.my/index.php/en/faqs-compliance-and-licencing/faqs-gdp-inspection.html
- Pegawai bertugas melalui e-mel: saeb@npra.gov.my
