Pmda - Pharmaceuticals and Medical Devices Agency

Reviews and Related Services

GMP compliance inspection


Date Title
September 26, 2023 GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers (updated)


Regulations and Guidelines



Administrative Notice on Application of PICs GMP Guide


Guideline on Management of Computerized Systems


Guidance on the Manufacture of Sterile Pharmaceutical Products


SMF(Site Master File) template

This SMF template was discussed at APAC (Asia Partnership Conference of Pharmaceutical Associations) meeting with Asian regulatory authority such as Indonesia, South Korea, Taiwan and Thailand and we reached conclusion to promote usage of this template. This is a reference to the manufacturing sites to prepare the SMF. Whenever you apply this SMF template to your manufacturing sites, please modify this to the present condition of your sites.

Overview Guidances and Notifications concerning GMP compliance inspection

Overview Guidance of GMP Compliance Inspection


Documents for application of GMP inspection



Quality Assurance Activities

Publication of Inspectional observations
Observed Regulatory Attention / Notification of GMP Elements (Orange Letters)