PIC/sのGMP要求事項のリンク集

2023年12月19日 最終更新日時 : 2024年1月29日 GXP station

QMS項目PIC/S
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
CSV・Good Practices for Computerised Systems in Regulated GXP Environments
Data Integrity・PIC/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
参考情報

PICS-GMP guideサイト

カテゴリー
使える情報
タグ
前の記事
FDAのGMP要求事項のリンク集
2023年12月18日
次の記事
EMAのGMP要求事項のリンク集
2023年12月19日