FAQ : GMP Foreign Covid

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

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NATIONAL GMP INSPECTIONS FOREIGN GMP INSPECTIONS 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?

Remote Inspection will commence from 1st September 2021.

2.1 What is Remote Inspection?
Remote Inspection includes documentation review and followed by virtual inspection in which:

2.1.1 Documentation (e.g., filing commitments, site description, and key procedures) is requested by GMP inspectors for further evaluation. Requests and responses to questions are shared in written form (e.g., via email or on a document-sharing platform).

2.1.2 In addition to sharing documentation as in any other Remote Inspection, virtual inspection utilizes technologies such as live or real-time streaming video, screen-sharing, or other means of real-time communication. Virtual inspection
may include virtual tour of aspects of the manufacturer, video communications and interviews.

2.2 How does NPRA perform GMP inspection through Remote Inspection?
Below is the summary of Remote Inspection process:

2.2.1 The assigned GMP inspector(s) will communicate with the manufacturer on the
arrangement of the inspection and the list of documents required for evaluation. The GMP inspector(s) in-charge may also forward invoice for inspection fee calculated based on the number of inspector/ assessors and the duration of the Remote Inspection days to be conducted. [Note: The full amount of inspection fee must be paid upfront before the GMP inspector(s) proceed with the process of Remote Inspection.]

2.2.2 The GMP inspector(s) will prepare the inspection/ document evaluation agenda
based on the inspection type.

2.2.3 The GMP inspector(s) will evaluate the documentation provided by the manufacturer.

2.2.4 The GMP inspector(s) may further communicate with the manufacturer’s
representative to request additional documents. Total correspondence with company shall be limited to 3 correspondences.

2.2.5 The GMP inspector(s) will notify company regarding the virtual inspection date. Virtual inspection will be conducted through an online platform according to the inspection agenda prepared by the GMP inspector(s).

Opening Meeting.
Outcome of documentation evaluation and further discussion/ document requested if it is deemed necessary.
The manufacturer conducts a virtual tour on the facility.
Closing Meeting.

2.2.6 An inspection report will be forwarded to the manufacturer.

2.2.7 The manufacturer is required to submit Corrective and Preventive Action Report (CAPA) based on the GMP deficiencies reported.

2.2.8 The GMP inspector(s) receives and evaluates CAPA report forwarded by the manufacturer.

2.3 What hardware is required or recommended for a virtual inspection? The basic requirements for a virtual inspection are as follows:

2.3.1 Computer: All participants must have devices with a reliable internet connection
of a speed that matches the requirements of the technological tools and communications platforms intended to be used.

2.3.2 Webcam or conference camera: A videoconferencing camera or a camera builtin
to the computer can be used.

2.3.3 Audio: Computer audio must be suitable. The speakers and microphone for each
participant should be of appropriate quality.

2.3.4 Intranet or virtual private network (VPN) connectivity at manufacturer: The manufacturer should test connectivity from all locations involved with the inspection, including those of key staff participating remotely, prior to the start
date to ensure that all software applications will be accessible.

2.3.5 Scanner can be helpful in all types of virtual inspections as the manufacturer may
be required to prepare documents for sharing.

2.4 What is the most suitable process for sharing documentation in a Remote Inspection? In a virtual inspection, what is the most suitable process for conducting interviews and providing virtual tours of the facility?

All communication channels must be agreed by both parties and provide the appropriate level of protection for the exchange of confidential and sensitive information. Regardless of the technological tools selected, it is essential that all participants test and become familiar with the tools in advance of the inspection. In addition, access to documentsharing platform and virtual inspection platform should be revoked immediately 15 working days after end of inspection by the host (GMP inspector or manufacturer).

2.4.1 Sharing documentation The manufacturer should prepare documents in digital format. Documents shared electronically should be:

Formatted to be as a readable Portable Document Format (PDF).
Provided in a clearly organized manner, consistent with the document request.
Identified in a way that enables the inspector to understand each document’s contents from its title or file name without having to open the document.
The options for sharing documentation range from secured email to secured cloud storage solutions restricted to specific participants and made available only during the inspections.
The document sharing platform should provide the appropriate level of security while also allowing auditors to easily locate, review, and annotate documents.
Documents also can be shared in real time during the virtual inspection through the video communication platform.
Documents also might be shipped through traditional mail or courier services, either in paper form or on electronic storage media.
The manufacturer should ensure that any electronic files are accessible by the inspector.

2.4.2 Virtual inspection

Video communication platforms can be used during many aspects of a virtual inspection, including chat, video- and audio-conferencing. Examples are Microsoft Teams, Cisco WebEx, and Zoom.
Care should be taken to ensure that the camera produces a stable picture that is easy to view.
Additional audio tools may be necessary for the person operating the camera during the virtual tour.
In areas of the facility where the Wi-Fi signal may not be strong enough to broadcast a live virtual tour, consider whether it might be useful to install devices to amplify the signal or prepare a pre-recorded video.
No recordings are allowed throughout the inspection process.

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:

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

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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

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PEMERIKSAAN APB DALAM NEGARA PEMERIKSAAN APB LUAR NEGARA 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?

Remote Inspection akan dilakukan ke atas pengilang luar negara bermula 01 September 2021.

2.1 Apakah yang dimaksudkan dengan Remote Inspection?
Kaedah Remote Inspection merangkumi penilaian dokumen dan disusuli dengan
pemeriksaan secara maya di mana:

2.1.1 Pemeriksa akan menghubungi syarikat untuk mengemukakan dokumen yang diperlukan seperti maklumat pengilang, prosedur utama dan lain-lain
bagi tujuan penilaian lanjut. Dokumen dan sebarang maklum balas akan dikongsikan melalui emel atau document-sharing platform.

2.1.2 Setelah penilaian dokumen berakhir, satu pemeriksaan secara maya akan
dilakukan dengan menggunakan kemudahan teknologi maklumat (IT) seperti real-time streaming video, screen-sharing atau sebarang bentuk komunikasi masa nyata yang bersesuaian. Pemeriksaan secara maya akan
merangkumi pemeriksaan ke atas premis dan aktiviti pengilangan di samping menemu duga pihak pengilang bagi mendapatkan maklumat lanjut.

2.2 Bagaimanakah pemeriksaan APB secara Remote Inspection dijalankan?

Berikut adalah proses kerja bagi Remote Inspection:

2.2.1 Pemeriksa yang telah dilantik akan menghubungi pihak pengilang untuk perancangan pemeriksaan dan mengemukakan senarai dokumen yang diperlukan. Sekiranya perlu, pemeriksa akan mengemukakan kadar caj
bayaran pemeriksaan berdasarkan bilangan pemeriksa dan jumlah hari yang terlibat dengan Remote Inspection. [Nota: Bayaran fi pemeriksaan perlu dijelaskan oleh pihak pengilang
sebelum Remote Inspection dijalankan.]

2.2.2 Pemeriksa akan menyediakan agenda pemeriksaan berdasarkan jenis pemeriksaan yang akan dijalankan.

2.2.3 Pemeriksa akan menilai dokumen yang dikemukakan oleh pihak pengilang.

2.2.4 Pemeriksa akan menghubungi pihak pengilang sekiranya dokumen/ maklumat tambahan diperlukan. Jumlah koresponden bersama pihak pengilang adalah dihadkan kepada 3 koresponden sahaja.

2.2.5 Pemeriksa akan memaklumkan pihak pengilang berkaitan tarikh pemeriksaan yang dijadualkan untuk dijalankan secara maya. Pemeriksaan secara maya akan dilakukan menggunakan aplikasi komunikasi atas talian berdasarkan agenda pemeriksaan yang telah disediakan.

1. Mesyuarat pembukaan.
2. Pemakluman hasil semakan dokumen dan perbincangan lanjut sekiranya memerlukan maklumat tambahan.
3. Pemeriksaan secara maya ke atas fasiliti dan aktiviti pengilangan.
4. Mesyuarat penutup.

2.2.6 Laporan pemeriksaan akan dimajukan kepada pihak pengilang.

2.2.7 Pihak pengilang perlu memberikan maklum balas melalui laporan Corrective Action Preventive Action (CAPA) untuk kesemua penemuan yang dilaporkan di dalam laporan pemeriksaan.

2.2.8 Pemeriksa akan menerima dan menilai maklum balas CAPA yang dikemukakan.

2.3 Apakah cara yang sesuai untuk berkongsi dokumen dan menjalankan pemeriksaan secara maya bagi kaedah Remote Inspection?

Semua saluran komunikasi yang akan digunakan perlu dipersetujui oleh kedua-dua pihak (pemeriksa dan pihak pengilang) dan mempunyai tahap keselamatan yang
baik memandangkan maklumat / dokumen yang dikongsikan adalah sensitif dan sulit. Selain itu, semua pihak yang terlibat dengan pemeriksaan perlu menguji semua peralatan IT dan aplikasi atas talian yang akan digunakan sebelum pemeriksaan di samping membiasakan diri dengan peralatan dan aplikasi berkenaan. Semua akses kepada document-sharing platform dan aplikasi atas talian yang digunakan untuk pemeriksaan secara maya perlu dibatalkan oleh host (pemeriksa atau pihak pengilang) selepas 15 hari bekerja daripada tarikh pemeriksaan tamat.

2.3.1 Perkongsian dokumen

Pihak pengilang perlu menyediakan semua dokumen secara elektronik dengan mengambil kira perkara-perkara berikut:

1. Format dokumen perlu dalam bentuk readable Portable Document Format (PDF).
2. Dokumen yang dikemukakan perlu dikongsikan mengikut urutan senarai dokumen yang diminta oleh pemeriksa.
3. Tajuk dokumen yang dikongsi perlu dinyatakan dengan jelas supaya pemeriksa boleh memahami isi setiap dokumen daripada tajuk tanpa perlu membuka dokumen berkenaan.
4. Perkongsian dokumen boleh dilakukan melalui emel atau sebarang aplikasi atas talian yang boleh dipercayai dan terhad kepada peserta tertentu ketika pemeriksaan.
5. Document-sharing platform yang digunakan perlu mempunyai tahap keselamatan yang baik dan juga membolehkan pemeriksa menyemak dokumen dengan mudah.
6. Dokumen boleh dikongsikan secara masa nyata semasa pemeriksaan secara maya dengan menggunakan aplikasi atas talian yang bersesuaian.
7. Pihak pengilang boleh mengemukakan dokumen di dalam bentuk hardcopy atau softcopy (pendrive atau compact disk) melalui pos atau khidmat kurier kepada pemeriksa.
8. Pihak pengilang perlu memastikan semua dokumen di dalam bentuk digital / elektronik boleh diakses oleh pemeriksa.

2.3.2 Pemeriksaan secara maya

1. Aplikasi atas talian seperti Microsoft Teams, Cisco WebEx dan Zoom boleh digunakan untuk tujuan pemeriksaan secara maya.
2. Pihak pengilang perlu memastikan kamera yang digunakan berupaya untuk memaparkan gambar atau video yang berkualiti.
3. Peralatan audio tambahan perlu disediakan untuk personel yang mengendalikan kamera semasa pemeriksaan dilakukan ke atas kawasan dan aktiviti pengilangan.
4. Pihak pengilang boleh mempertimbangkan pemasangan peralatan yang membantu untuk menguatkan isyarat internet di kawasan pengilangan yang mempunyai liputan internet yang lemah. Selain itu, pre-recorded video boleh disediakan oleh pihak syarikat untuk memaparkan kawasan atau aktiviti pengilangan di kawasan berkenaan.
5. Aktiviti penrekodan

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?

7. Apakah bayaran fi yang terlibat dalam Remote Inspection?

Untuk sebarang pertanyaan / maklumat lanjut, sila rujuk:

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

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

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

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