New Version of "ICH Q7 Side-by-Side Comparison" Paperback

The newly published paperback "ICH Q7 Side-by-Side Comparison" compares the requirements of the "ICH Q7 Guideline - GMP for Active Pharmaceutical Ingredients" with the interpretations of the revised "How to do"- Document - APIC's Interpretation of ICH Q7 Guide and "Review form" (Version 15) and explains the requirements of the guideline.

In July 2021, the APIC, a sector group of the European Chemical Industry Council (CEFIC), published the 15th version of the "How to do" Document - Interpretation of ICH Q7 Guide and "Review form" for active substances. Additions and updates were mainly made in

  • Chapter 7 - Materials Management
  • Chapter 8 - Production and In-Process Controls
  • Chapter 10 - Storage and Distribution
  • Chapter 11 - Laboratory Controls
  • Chapter 14 - Rejection and Reuse of Materials and
  • Chapter 17 - Agents, Brokers, Traders, Distributors, Repackers and Relabellers.

These changes and revisions were discussed in detail in the recent news "APIC: Update to the ICH Q7 "How to do" Document".

As a participant of the Live Online ICH Q7 Training Courses, which will be held from 20-24 June 2022, you will receive a complimentary copy of the "ICH Q7 Side-by-Side Comparison" paperback following the event. For more information on the full event agenda, please visit the ICH Q7 Week website.

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