News
| Date | Title |
| September 26, 2023 | GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers (updated) |
Regulations and Guidelines
Regulations
- GMP Ministerial Ordinance (Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs) (English version is under preparation.)
- GQP Ministerial Ordinance (Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices)
- Regulations of Buildings and Facilities of Pharmacies, etc.
- Notification Concerning Partial Amendment of the Ministerial Ordinance on Standards for Manufacturing Control and Quality control for Drugs and Quasi-drugs (April 28, 2021) (English version is under preparation.)
Administrative Notice on Application of PICs GMP Guide
Guideline on Management of Computerized Systems
- Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs (Effective on October 21, 2010)
- Q & A
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
- GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufactures(September 26, 2023)
- Legal authorities of GMP inspections in Japan
Documents for application of GMP inspection
- Documents to be submitted for the application for GMP compliance inspection (Aug.2 ,2023) (English version is under preparation.)
Others