When drug products, medical devices or cellular and tissue-based products are manufactured, all product batches should be of the same quality as that of the product which is approved. To ensure this, the manufacturing site should have appropriate manufacturing facilities, and the manufacturing process and quality management system should be maintained and controlled properly.
PMDA conducts the following inspections.
GMP inspection
For GMP inspection, PMDA conducts on-site and document- based inspections of manufacturing sites for products classi f ied as “high-r isk,” such as new drugs, biological products or biotechnological products (including foreign manufacturing sites), in order to ascertain whether their manufacturing facilities and manufacturing and quality controls comply with standards such as the Good Manufacturing Practice (GMP), and whether the manufacturing sites have a system for manufacturing products of adequate quality.
PMDA also conducts inspections in relation to accreditation of foreign manufacturers.
QMS inspection
For medical devices and in vitro diagnostics, PMDA conducts on-site and document-based inspections of the registered manufacturing sites (of products under review or approved products) located in Japan or overseas, in order to ascertain whether their manufacturing facilities and manufacturing and quality controls comply with standards such as the Quality Management System (QMS), and whether the manufacturing sites have a system for manufacturing products of adequate quality.
GCTP inspection
PMDA has established a system to inspect manufacturing sites of cellular and tissue-based products located in Japan or overseas, in order to determine whether their manufacturing facilities as well as manufacturing process and quality management system comply with the Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP).
PMDA has also developed a necessary system for inspections on compliance with the standards for buildings and facilities, and for-cause inspections and questioning for cell processing facilities, which will be newly started by the enforcement of the Act on Securing Safety of Regenerative Medicine.