Booklet "ICH Q7 Side-by-Side Comparison" updated
Recommendation
Tuesday, 23 September 2025 13.00 - 17.00 h
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The booklet "ICH Q7 Side-by-Side Comparison" compares the requirements of the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" to the interpretations of the revised "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" (Version 17) and explains the requirements of the guideline.
Beginning of 2025, the APIC, a sector group of the European Chemical Industry Council (CEFIC), published the 17th version of the "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" for active pharmaceutical ingredients. The main additions and updates were made to the following chapters:
(2) Quality Management
(5) Production Equipment
(13) Change Control
(21) Annex: Q&As linked to the respective sections of ICH Q7
All participants of the ICH Q7 Training Courses, which will be held from 30 June until 04 July 2025 in Copenhagen, Denmark, will receive a free copy of the "ICH Q7 Side-by-Side Comparison" booklet. For more information on the full event agenda, please visit the ICH Q7 Week website.
