PIC/S · GMP Guide
PIC/S GMP 가이드
의약품실사상호협력기구(PIC/S)가 공개한 GMP 가이드(PE 009) 각 부와 부속서, 관련 가이던스 문서를 발행일 순으로 정리했습니다. 식약처를 포함한 PIC/S 가입 규제기관의 실사 기준과 맞닿아 있는 문서들입니다. 법적 효력과 최신본은 반드시 공식 원문에서 확인하세요.
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PI 006-4 적격성평가 및 밸리데이션에 관한 권고문서
PIC/S Recommendations on Qualification and Validation
- PE 009-18 (Part II) PIC/S GMP Guide (PE 009-18) Part II
- PE 009-18 (Part I) PIC/S GMP Guide (PE 009-18) Part I
- PE 009-18 (Intro) PIC/S GMP Guide (PE 009-18) Introduction
- PE 009-18 (Annexes) PIC/S GMP Guide (PE 009-18) Annexes
- PI 056-1 PIC/S Guidance on Remote Assessments
- PI 057-1 PIC/S Aide-Memoire on Remote Assessments
- PE 009-17 (Intro) PIC/S GMP Guide: Introduction
- PE 009-17 (Part I) PIC/S GMP Guide: Part I — Basic Requirements for Medicinal Products
- PE 009-17 (Part II) PIC/S GMP Guide: Part II — Basic Requirements for Active Pharmaceutical Ingredients
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PE 009-17 (Annexes) PIC/S GMP 부속서
PIC/S GMP Guide: Annexes
- PI 044-1 PIC/S Aide Memoire Inspection of GDP for Medicinal Products in the Supply Chain
- PI 054-1 How to Evaluate and Demonstrate the Effectiveness of a Pharmaceutical Quality System with Regard to Risk-Based Change Management
- PI 055-1 PIC/S Guidance COVID-19 Risk Assessment for Routine On-Site Inspections
- PI 041-1 Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
- PI 008-4 PIC/S Aide Memoire to Inspections of Blood Establishments and Plasma Warehouses
- PE 005-4 PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks
- PI 038-2 Assessment of Quality Risk Management Implementation
- PI 024-3 Inspection of Biotechnology Manufacturers
- PI 009-4 Inspection of Utilities
- PI 028-2 Aide-Memoire on Packaging
- PI 053-1 Questions and Answers on the Implementation of Risk-Based Prevention of Cross-Contamination and Health-Based Exposure Limits
- PI 052-1 Inspection of Health-Based Exposure Limit Assessments and Use in Quality Risk Management
- PI 040-1 Guidance on Classification of GMP Deficiencies
- PI 043-1 Cross-Contamination in Shared Facilities
- PI 047-1 Guidelines on Good Distribution Practice of Active Substances for Medicinal Products for Human Use
- PI 046-1 Guideline on Setting Health-Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities
- PI 045-1 Guidelines on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients
- PI 048-1 Guidance on GMP Inspection Reliance
- PI 010-5 Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects
- PI 039-1 Procedure on Notification of Foreign Inspections
- PE 011-1 PIC/S Guide to Good Distribution Practice for Medicinal Products
- PE 010-4 Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
- PI 037-1 PIC/S Recommendation on Risk-Based Inspection Planning
- PI 007-6 Validation of Aseptic Processes
- PE 008-4 Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File
- PI 031-1 Standard Operating Procedure Team Inspections
- PI 030-1 Inspection of Active Pharmaceutical Ingredients
- PI 011-3 Good Practices for Computerised Systems in Regulated GxP Environments
- PI 006-3 Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation
- PI 005-3 Guidance on Parametric Release
- PI 014-3 Isolators Used for Aseptic Processing and Sterility Testing
- PI 012-3 Recommendation on Sterility Testing
- PI 023-2 Inspection of Pharmaceutical Quality Control Laboratories
- PI 021-2 GMP Particularities for Clinical Trial Products
- PI 025-2 Aide-Memoire on Medicinal Gases
- PI 020-3 Site Master File (SMF) for Plasma Warehouses
- PI 019-3 Site Master File (SMF) for Source Plasma Establishments
- PI 013-3 Standard Operating Procedure PIC/S Inspection Report Format
- PI 002-3 Quality System Requirements For Pharmaceutical Inspectorates
- PI 026-2 Recommendation on the Qualification and Training of Inspectors in the Field of Human Blood Tissues and Cells
