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Overview Guidance of GMP Compliance Inspection for Foreign Manufacturers
GMP Compliance Inspection concerning Pharmaceuticals (including APIs)- Documents to be submitted for GMP Compliance Inspection
Documents for application of GMP inspection
- Documents Required by PMDA for the Application of GMP Compliance Inspection Revised Version of Form 1-3 (Effective on January 1, 2011)
[Form1]- [Form3]
- Documentation Required for the Application of Periodic GMP Compliance Inspection (Effective on January 1, 2011)
- Annex1: Documentation Required for Periodic GMP Compliance Inspection
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)
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