FAQ : GDP Covid

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

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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?

Perbezaan bagi mekanisma pemeriksaan AEB yang tersebut di atas adalah seperti berikut:

Item	Inspection Mechanism
Item	*On-site*	*Remote*
Method	Field inspection will be conducted on the premises.	Virtual inspection will be conducted on the premises.
Inspection scope	Please refer to Annex 2: General Points to Consider for Auditee in the current GDP Guideline.
Preparation : Before inspection	• The company will be contacted by the inspector (via phone / email) to set the date of inspection. Documents pertaining to the GDP requirement must be prepared by the company and forwarded to the inspector before the inspection.	The company will be contacted by the inspector (via phone / email) to set the date of inspection. Documents pertaining to the GDP requirement must be prepared by the company and forwarded to the inspector before the inspection. The company needs to familiarise with online communication applications such as Skype, Google Meet, etc. upon mutual agreement by both parties.
Preparation: During inspection	Personal protective equipment such as 3-ply face mask and hand sanitiser should be provided at the premises during the inspection. The company must ensure that social distancing, good hygiene practice (frequent use of hand sanitiser / hand washing) are properly implemented and complied within the premises.	The company will have to be ready at least 10-15 minutes before the inspection commencement using an agreed online communication application. The company must be prepared to move within the premises / store using communication equipment such as camera phones if requested by the inspector for verification purposes

3. Is my company allowed to choose the mechanism for GDP inspection?

No, the mechanism for GDP inspection will be determined by NPRA based on defined criteria and its priority will be decided based on the risk of the premises and the products being distributed. The inspection mechanism will be notified to the company by the inspector prior to the 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

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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

Muat turun FAQ

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?

Perbezaan bagi mekanisma pemeriksaan AEB yang tersebut di atas adalah seperti berikut:

Perkara	Mekanisma Pemeriksaan
Perkara	Lapangan (On-site)	*Remote)*
Kaedah	Pemeriksaan secara lapangan dijalankan ke atas premis.	Pemeriksaan secara maya (virtual) dijalankan ke atas premis.
Skop Pemeriksaan	Sila rujuk Annex 2: General Points to Consider for Auditee dalam dokumen Garis Panduan AEB semasa.
Persediaan pihak industri : Sebelum Pemeriksaan	Pihak syarikat akan dihubungi oleh pegawai pemeriksa (telefon / emel) bagi penetapan tarikh pemeriksaan. Dokumen-dokumen berkaitan keperluan AEB perlu disediakan oleh pihak syarikat dan dimajukan kepada pegawai pemeriksa setelah tarikh pemeriksaan ditetapkan.	Pihak syarikat akan dihubungi oleh pegawai pemeriksa (telefon / emel) bagi penetapan tarikh pemeriksaan. Dokumen-dokumen berkaitan keperluan AEB perlu disediakan oleh pihak syarikat dan dimajukan kepada pegawai pemeriksa setelah tarikh pemeriksaan ditetapkan. Pihak syarikat perlu bersedia dengan aplikasi komunikasi seperti Skype, Google Meet, dsb setelah dipersetujui oleh kedua-dua pihak.
Persediaan pihak industri : Semasa Pemeriksaan	Peralatan perlindungan diri seperti topeng muka 3 lapisan (3-ply face mask) dan pensanitasi tangan perlu disediakan di premis syarikat sepanjang tempoh pemeriksaan dijalankan. Pihak syarikat perlu memastikan bahawa amalan penjarakan sosial, penjagaan kebersihan diri yang baik (penggunaan pensanitasi tangan/ membasuh tangan dengan kerap) dipatuhi di premis syarikat.	Pihak syarikat bersedia dalam tempoh 10-15 minit sebelum pemeriksaan dimulakan menggunakan aplikasi komunikasi yang telah dipersetujui. Pihak syarikat perlu bersedia untuk bergerak di dalam kawasan premis syarikat / kawasan stor menggunakan peralatan sokongan komunikasi seperti telefon bimbit berkamera sekiranya diminta oleh pegawai pemeriksa bagi tujuan pengesahan.

3. Adakah syarikat saya dibenarkan untuk memilih mekanisma pemeriksaan AEB?

Tidak, mekanisma pemeriksaan AEB akan ditentukan oleh NPRA berdasarkan kriteria-kriteria tertentu dan keutamaan adalah berdasarkan risiko premis dan produk yang dikendalikan. Mekanisma pemeriksaan yang telah ditetapkan akan dimaklumkan kepada pihak syarikat oleh pegawai pemeriksa sebelum pemeriksaan dijalankan.

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

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