Report of the PMDA-ATC GCTP Inspection Training for NPRA

Two Good Manufacturing Practice (GMP) inspectors from the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia, visited Japan from September 14 to 16 to enhance their insight onGood Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP) Compliance Inspection and joined the inspection conducted by the PMDA. This training was conducted in cooperation with NIPRO CORPORATION to help them learn PMDA inspection methods on regenerative medicine manufacturers. To make the training fruitful, a preliminary briefing by the Office of Manufacturing Quality for Drugs was arranged prior to the inspection, and a conclusive session including lectures on related topics was held after the inspection to deepen their understanding of the GCTP inspection.
The PMDA continues to provide training opportunities and contributes to the capacity building of the NPRA to improve patient access to medical products in Asia.