Updated version of APIC's "How to do"- Document on GMPs for APIs

Recommendation

Tuesday, 28 May 2024 15.30 - 17.30 h

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Pharmacopoeial Activities, Regulatory Developments and Analytical Testing

In January 2020, the APIC, a sector group of Cefic, published the 13th version of the "How to do"- Document - Interpretation of ICH Q7 Guide and "Review form" on GMPs for APIs.  Amendments and updates have been made in sections "Building and Facilities (4)", "Agents, Brokers, Traders, Distributors, Repackers, and Relabellers (17)" as well as in the section "APIs for use in clinical trials (19)". Now, the paperback "ICH Q7 Side-by- Side Comparison", which lists and compares the "ICH Q7 Guideline- GMP for Active Pharmaceutical Ingredients" with the above-mentioned "How to do"- Document, is available.

This "How to Do" document was written by experts from the European Industry (CEFIC APIC). It is essentially an interpretation of “how to” implement the ICH Q7 Guide based on practical experience. Other relevant publications (e.g. ISPE Baseline Guides, other ICH Guidelines) were taken into account and references included. This document does not intend to provide an exhaustive list of “how to” comply with the requirements and recommendations. It does however provide examples of commonly applied solutions and practical assistance. Along with the ICH Q7 Guide it is a valuable source of information - and side-by-side with the Guide facilitates implementation by providing recommendations for how the requirements can be met and /or interpreted.

As a participant of the Live Online ICH Q7 training courses you will receive a free copy of the paperback. In addition, the contents of the guideline will be explained step by step and practical advice will be given on how to fulfil the requirements of ICH Q7. Further information about the full agenda of the event can be found on the ICH Q7 week website.