Update of the "ICH Q7 Side-by-Side Comparison" Booklet
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The newly published 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 16) and explains the requirements of the guideline.
At the end of October 2022, APIC, a sector group of the European Chemical Industry Council (CEFIC), published the 16th 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:
- (1) Introduction
- (6) Documentation and Records
- (10) Storage and Distribution
- (12) Validation
All participants of the ICH Q7 Training Courses, which will be held November 21-25, 2022, 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.
