Citing the Need for Pandemic Safety, Malaysia to Permit Remote Inspections of Some Pharmaceutical Plants

With the COVID-19 pandemic making it unsafe to conduct most on-site inspections, regulatory authorities in Malaysia are permitting remote assessments of some pharmaceutical manufacturing facilities outside the country.

Malaysia’s Guidance Document on Foreign GMP Inspection, 7th edition, March 2021, published by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) represents the first time since 1984 that the NPRA is permitting inspections to be conducted remotely.  The new guidance applies only to plants that manufacture compounds through chemical synthesis.

Eligible foreign manufacturers can apply for the desktop assessment only if their manufacturing site has been previously inspected by NPRA representatives and found to meet acceptable standards. No additional processing fees will be charged for the assessments. Successful assessments will be valid for two years. However, if a facility does not meet standards in the remote assessment,  an on-site inspection will be required.