GMP・PIC/S GMP Guide (Part I: Basic Requirements for Medicinal Products) 
・PIC/S GMP Guide (Part II: Basic Requirements for Active Pharmaceutical Ingredients) 
・PIC/S GMP Guide (Related Annexes)
変更管理PIC/S Recommendation How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management
バリデーションValidation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation
品質リスクマネジメントAide Memoire on Assessment of Quality Risk Management (QRM) Implementation
不純物管理PIC/S Guideline on Exposure Limits (PDE)
逸脱管理PIC/S Guidance on classification of GMP deficiencies
製造管理Questions and Answers (Q&A) on the Implementation of Risk-Based Prevention of Cross-Contamination in Production and ‘Guideline on Setting Health-Based Exposure Limits (HBEL) for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities’
原料管理PIC/S GMP Guide (Related Annexes) Annex 8 Sampling of starting and packaging materials
PIC/S Guidelines on Excipient GMP Risk Assessment
GMP監査PIC/S Recommendation on Risk-Based Inspection Planning
Aide Memoire on Inspection of Biotech
Aide Memoire on Inspection of Quality Control Laboratories
Aide-Memoire on the Inspection of Active Pharmaceutial Ingredients (APIs)
無菌管理Isolators Used for Aseptic Processing and Sterility Testing
Validation of Aseptic Processes
Recommendation on Sterility Testing
Technical Interpretation of Revised Annex 1 to PIC/S GMP Guide
CSVGood Practices for Computerised Systems in Regulated GXP Environments
Data IntegrityPIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
貯法・使用期限・安定性試験Stability testing for applications for variations to marketing authorisation
Stability testing of existing active ingredients and related finished products
In-use stability testing of human medicinal products
Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form)
Declaration of storage conditions for medicinal products particulars and active substances (Annex)
包装Aide-Memoire on Packaging

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