Japanese Pharmaceuticals Inspection Guide
is your single source for Japanese GMP regulations and guidances — all translated into English and published by the PMDA — and the resource you need to make your next PMDA inspection successful.
Place your order today and get:
- An overview of the GMP inspection process followed by Japanese inspectors
- The five key systems that will be inspected by PMDA inspectors
- Documents required to be submitted in advance of a PMDA inspection
- Japanese regulations covering warehousing facilities
- Procedures for issuing inspection reports and timelines for responding to PMDA findings
Inspections by Japanese regulators are on the rise, and they won’t wait for you to get ready. The government documents included in Japanese Pharmaceuticals Inspection Guide are:
- The Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-Drugs
- Regulations for Buildings and Facilities of Pharmacies
- The Explanation of Application for Accreditation of Foreign Manufacturers
- GMP Compliance Inspection Concerning Pharmaceuticals (Including APIs)
- Documents to Be Submitted for GMP Compliance Inspection
- Overview Guidance of GMP Compliance Inspection for Foreign Manufacturers
- Documents Required by PMDA for the Application of GMP Compliance
- Inspection Outline of Drug Manufacturing Site (Foreign Manufacturing Site)
- Guidance on Master File System
- A Q&A on the Master File System
Get ready for the PMDA’s visit with Japanese Pharmaceuticals Inspection Guide, priced at $297.
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