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.
- 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
- PE 009-17 (Annexes) PIC/S GMP Guide: Annexes
- PI 054-1 How to Evaluate and Demonstrate the Effectiveness of a Pharmaceutical Quality System with Regard to Risk-Based Change Management
- PI 041-1 Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
- PI 038-2 Assessment of Quality Risk Management Implementation
- PI 024-3 Inspection of Biotechnology Manufacturers
- PI 009-4 Inspection of Utilities
- 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
- 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 007-6 Validation of Aseptic Processes
- PE 008-4 Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File
- 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