The Version 17 of the “How to do” document – Interpretation of ICH Q7 Guide and “Review form” for APIs was finalized last November and published on the Active Pharmaceutical Ingredients Committee (APIC) website in early 2025.
The document aims to facilitate the implementation of the ICH Q7 guideline and provides recommendations for its interpretation.
In this version, additions and updates have been made in the following chapters:
- Chapter 2 Quality Management
- the changes were made in the subsections 2.1 Principles (10, 2.12, 2.14) and 2.2 Responsibilities of the Quality Unit(s) (2.21).
- Chapter 5 Process Equipment
- additions and innovations have been made in subsections: 5.2 Equipment Maintenance and Cleaning, 5.3 Calibration, and 5.4 Computerized Systems
- Chapter 13 Change Control
- updates concern items 10, 13.11, 13.12, 13.13, 13.14, 13.15.
- Chapter 21 ICH Q7 Q&A “how to do” attachment (Questions and Answers linked to the respective sections of ICH Q7)
- some Questions & Answers in Chapter 5 “Process Equipment – Cleaning” have been more clearly interpreted and aligned with the newly published guidelines.
SOURCE: