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Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released guidance on the distant assessment of good manufacturing practices (GMPs) at foreign production facilities.

As per the guidance a company applying with the National Pharmaceutical Regulatory Agency (NPRA) for registration of a medicinal product in Malaysia must provide acceptable evidence to show that the manufacturer of the product follows an internationally accepted standard of Good Manufacturing Practice (GMP) and recognized by the authority in Malaysia.

NPRA is responsible for ensuring all manufacturers of registered products in Malaysia are able to provide acceptable evidence that the manufacturing premises conform to current GMP requirements. Hence, foreign manufacturers are also subjected to GMP conformity assessments through acceptable GMP evidence or GMP inspection.

The current PIC/S Guide to GMP for Medicinal Products and its Annexes have been adopted as the standard used by NPRA to assess the GMP conformity of manufacturers.

The purpose of this guidance is:

  • To provide information on the types of GMP evidence acceptable to the DCA of Malaysia.

  • To provide the requirements for an on-site inspection of manufacturing facility outside Malaysia where GMP evidence of the premise is not available or acceptable to the DCA of Malaysia.

  • To provide guidance on how to apply for an on-site foreign GMP inspection, the eligibility and application for GMP Desktop Assessment (GDA) for foreign manufacturers previously inspected by NPRA.

This guidance applies to all manufacturers of medicinal products located outside Malaysia.

The following are the frequently asked questions related to the management of GMP and GDP Inspections during the period of crisis for industry guidance;


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