National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued an updated guidance document on foreign GMP inspection in August 2021.
The main update is regarding the “GMP Distant Assessment (DiA)” for foreign production facilities, which is effective from the 1st of September 2021. The DiA, which consists of Remote Inspection (RI), will replace on-site foreign GMP inspection during the COVID-19 pandemic when border closure/travel restrictions are still in place.
The DiA is only applicable to all foreign GMP inspection applications pending for on-site inspection. Foreign manufacturers eligible for GMP Desktop Assessment (GDA) work process are excluded from DiA as the GMP status of the manufacturer shall be confirmed following the completion of GDA.
The Remote Inspection includes documentation review, followed by virtual inspection. The documentation will be used by GMP inspector(s) for evaluation and the correspondences with these inspector(s) shall be shared in written form via email or on a document-sharing platform. For the virtual inspection, video chat, screen-sharing, or other means of real-time communication will be used. The guidance document mentions that the virtual inspection may include a virtual tour of aspects of the manufacturer, video communication and interview.
The payment structure for DiA consists of the processing fee and inspection fee, whereby the fees are RM5,000 and RM20,000 respectively. The GMP validity for Remote Inspection is 2 years, as compared to the 3-year validity for on-site inspections.
More details can be found in:
- “Guidance Document: Foreign GMP Inspection, 8th Edition, September 2021”: https://www.npra.gov.my/easyarticles/images/users/1133/Guidance-Document-Foreign-GMP-Inspection-_Sep-2021_8th-Ed.pdf
- “Frequently Asked Questions (FAQs) on Foreign GMP Inspections During COVID-19 Pandemic”: https://www.npra.gov.my/index.php/en/component/sppagebuilder/915-faq-gmp-foreigncovid.html