APIC: Updated ICH Q7 "How to do"- document
Recommendation
19/20 March 2025
Barcelona, Spain
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective
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The latest version (version 17) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs was finalized in November 2024 and published on the APIC (Active Pharmaceutical Ingredients Committee) website in early 2025. It is intended to facilitate the implementation of the ICH Q7 guideline and provides recommendations for its interpretation.
In this version, the responsible task force of the Quality Group of APIC, which is a sector group of the European Chemical Industry Council (CEFIC), has mainly made additions and updates in the chapters (2) Quality Management, (5) Process Equipment, (13) Change Control and in chapter (21) Annex: Q&As linked to the respective sections of ICH Q7, in addition to formal changes.
Chapter (2) Quality Management
In Chapter (2) Quality Management, the changes were made in the subsections 2.1 Principles (2.10, 2.12, 2.14) and 2.2 Responsibilities of the Quality Unit(s) (2.21).Chapter (5) Production Equipment
Most of the changes have been made in Chapter (5) Production Equipment. In addition to formal adjustments, the latest version contains many additions and innovations in the subsections 5.2 Equipment Maintenance and Cleaning, 5.3 Calibration and 5.4 Computerized Systems.Chapter (13) Change Control
In addition to formal changes, the current version of Chapter (13) Change Control now shows adjustments in sections 13.10, 13.11, 13.12, 13.13, 13.14 and 13.15. All other passages of this chapter remain in their previous version. Chapter (21) Annex: Q&As linked to the respective sections of ICH Q7
Chapter (21) Annex: Q&As linked to the respective sections of ICH Q7 poses questions on the respective sections of the document and presents the answers of the “ICH Q7 Q&A Working Group” and the “APIC How to Do Task Force”. Here, the updates were mainly made with regard to Chapter 5 and the first five questions and answers were adapted and revised. The updated version of the “How to do” document - Interpretation of ICH Q7 Guide and “Review form” can be found here.
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