PICS-GMP
PICS全般
- 【PIC/S加盟国リスト】List of PIC/S Participating Authorities
- 【PIC/S-GMPとGDP質疑応答】PICS-GMP and GDP FAQ Guide
- 【PIC/S概要】PIC/S GMP Guide (Introduction)
PICS-GMP
- 【PIC/S製剤GMP】PIC/S GMP Guide (Part I: Basic Requirements for Medicinal Products)
- 【PIC/S原薬GMP】PIC/S GMP Guide (Part II: Basic Requirements for Active Pharmaceutical Ingredients)
- 【PIC/S付属書】PIC/S GMP Guide (Related Annexes)
- Annex 1 【無菌医薬品の製造】 (Manufacture of sterile medicinal products)
- Annex 2A 【ヒト用先端医療医薬品ATMPsの製造】 (Manufacture of advanced therapy medicinal products for human use)
- Annex 2B 【ヒト用生物学的医薬品（原薬及び製剤）の製造】(Manufacture of biological medicinal substances and products for human use)
- Annex 3 【放射性医薬品の製造】 (Manufacture of radiopharmaceuticals)
- Annex 4 【動物用医薬品（免疫学的医薬品を除く）の製造】 (Manufacture of veterinary medicinal products other than immunologicals)
- Annex 5 【動物用免疫学的医薬品の製造】 (Manufacture of immunological veterinary medical products)
- Annex 6 【医療用ガスの製造】 (Manufacture of medicinal gases)
- Annex 7 【植物性医薬品の製造】 (Manufacture of herbal medicinal products)
- Annex 8【原料及び包材のサンプリング】 (Sampling of starting and packaging materials)
- Annex 9 【液剤、クリーム剤及び軟膏剤の製造】(Manufacture of liquids, creams and ointments)
- Annex 10 【定量噴霧式吸入剤の製造】 (Manufacture of pressurised metered dose aerosol preparations for inhalation)
- Annex 11 【コンピュータ化システム】 (Computerized systems)
- Annex 12 【医薬品製造における電離放射線の利用】 (Use of ionising radiation in the manufacture of medicinal products)
- Annex 13 【治験用医薬品の製造】 (Manufacture of investigational medicinal products)
- Annex 14 【ヒト血液及びヒト血漿由来医薬品の製造】 (Manufacture of medicinal products derived from human blood or plasma)
- Annex 15 【クオリフィケーション及びバリデーション】 (Qualification and validation)
- Annex 16 【オーソライズドパーソンによる認証及びバッチ出荷判定】 (Authorised person and batch release)
- Annex 17 【リアルタイムリリース試験及びパラメトリックリリース】 (Real Time Release Testing and Parametric Release)
- Annex 18 【原薬】[GMP Guide for active pharmaceutical ingredients]
- Annex 19 【参考品及び保存サンプル】 (Reference and retention samples)
- Annex 20 【品質リスクマネジメント】 (Quality risk management)***
- Appendix I: Risk Management Methods and Tools
- Appendix II: Potential Applications For Quality Risk Management
PICS-GMP参考通知
品質システム関係
- 【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
- 【GDP】PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products
- 【GDP】PIC/S Guidelines on GDP of Active Substances for Human Use
- 【GDP】PIC/S Aide Memoire Inspection of GDP for Medicinal Products in the Supply Chain
- 【CS】Good Practices for Computerised Systems in Regulated GXP Environments
- 【当局報告】Guidance on Classification of GMP Deficiencies
- 【パラメトリックリリース】Guidance on Parametric Release
- 【医療機関における製品調製】Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
- 【データインテグリティ／DI】PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
- 【品質システム】Aide Memoire on Assessment of Quality Risk Management (QRM) Implementation
製造管理・工程管理関係
- 【原料】PIC/S Guidelines on Excipient GMP Risk Assessment
- 【無菌製造】Validation of Aseptic Processes
- 【無菌製造】Technical Interpretation of Revised Annex 1 to PIC/S GMP Guide
- 【バリデーション】Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation
- 【血液製剤】PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks
- 【アイソレータ】Isolators Used for Aseptic Processing and Sterility Testing
- 【治験薬】Aide Memoire on GMP Particularities for Clinical Trial Products
- 【コンタミ】Aide-Memoire on Cross-Contamination in Shared Facilities
- 【医療用ガス】Aide-Memoire on Medicinal Gases
- 【包装】Aide-Memoire on Packaging
- 【COVID-19】PIC/S Guidance COVID-19 Risk Assessment for Routine On-Site Inspections
品質管理関係
- 【COVID-19】PIC/S Guidance COVID-19 Risk Assessment for Routine On-Site Inspections
- 【GDP】PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products
- 【GDP】PIC/S Guidelines on GDP of Active Substances for Human Use
- 【暴露限界】PIC/S Guideline on Exposure Limits
- 【曝露限界】Aide Memoire on the Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management
- 【暴露限界】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’
- 【無菌試験】Recommendation on Sterility Testing
PICS-Site Master File 関係の通知
- 【SMF】Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF)
- 【SMF】Site Master File (SMF) for Plasma Warehouses
- 【SMF】Site Master File (SMF) for Source Plasma Establishments
PICS査察関係の通知
- 【査察官要件】Recommendation on the Qualification and Training of Inspectors in the Field of Human Blood Tissues and Cells
- 【査察計画】PIC/S Recommendation on Risk-Based Inspection Planning
- 【血液製剤】PIC/S Aide Memoire to Inspections of Blood Establishments and Plasma Warehouses
- 【原薬】Aide-Memoire on the Inspection of Active Pharmaceutial Ingredients (APIs)
- 【バイオ製品】Aide Memoire on Inspection of Biotech
- 【品質管理】Aide Memoire on Inspection of Quality Control Laboratories
- 【ユーティリティ】Aide-Memoire Inspection of Utilities
- 【査察官用_当局間連携】Guidance on GMP Inspection Reliance
- 【査察官用_チェックリスト】PIC/S Audit Checklist
- 【査察官用_チェックリストガイド】PIC/S Audit Checklist - Interpretation Guide
- 【査察官用_PICS加入】PIC/S Guidelines for Accession
- 【査察官用_PICS加入前手順】PIC/S Guidelines for the Pre-Accession Procedure
- 【査察官用_品質欠陥】Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects
- 【査察官用_査察通知】Procedure on Notification of Foreign Inspections
- 【査察官用_品質システム】Quality System Requirements For Pharmaceutical Inspectorates
- 【査察官用_質問票】Questionnaire for Assessment
- 【査察官用_スキーム】Revised PIC/S Scheme
- 【査察官用_報告書】Standard Operating Procedure PIC/S Inspection Report Format
- 【査察官用_チーム査察】Standard Operating Procedure Team Inspections