ICH_Q7_How_To_Do_第14版中英文翻译件.docxVIP

ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE GMPs for APIs: “How to do” Document Interpretation of the ICH Q7 Guide Version 14 (Update November 2020) Cefic/APICHow to do-DocumentPage PAGE Cefic/APIC How to do-Document Page PAGE 22 of 104 ICHQ7 How to DO v. 14Version ICHQ7 How to DO v. 14 Version 14 Table of Contents目录 (Revised chapters in this Version are highlighted in blue)此版本中修订的章节以蓝色字体突出显示 1 Introduction (update: January 2018) 2 Quality Management (update: August 2018) 3 Personnel (update: January 2019) 4 Buildings and Facilities (update: January 2020) 5 Process Equipment (update: July 2017) 6 Documentation and Records (update: August 2016) 7 Materials Management (update co-shipment samples: January 2019) 8 Production and In-Process Controls (update 8.15: August 2016) 9 Packaging and Identification Labelling of APIs and Intermediates (update: August 2018) 10 Storage and Distribution (General update: December 2014, update 10.20: August 2016) 11 Laboratory Controls (update: November 2020) 12 Validation (update: August 2016) 13 Change Control (update: January 2017) 14 Rejection and Reuse of Materials (update: August 2018) 15 Complaints and Recalls (update: November 2020) 16 Contract Manufacturers (incl. Laboratories) (update: November 2020) 17 Agents, Brokers, Traders, Distributors, Repackers, and Relabellers (update: January 2020) 18 Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 19 APIs for Use in Clinical Trials (January 2020) Glossary (please refer to the original Q7-guideline for any definitions) ICH Q7 QA “how to do” attachment added (update: January 2017) Chapter 1 Introduction第1章 介绍 Objective目的 Historical Background历史背景 When the initiative was taken by PIC/S at the Canberra meeting in September 1996 to draft a globally harmonised Good Manufacturing Practices (GMP) guide for the Production of Active Pharmaceutical Ingredients (APIs), the recommendation was made that this should essentially be a “what to do”, rather than a “how to d