ICH Q11 Presentation by Alex Weisman - The Israel Chapter of PDA

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Q11 Development and manufacture of Drug product: Chemagis overview • Founded in 1987, Chemagis is a subsidiary of Perrigo Israel (PIL) , Israel's second largest pharmaceutical conglomerate and part of the Perrigo Group. • Chemagis develops, produces and markets an extensive line of high-quality Active Pharmaceutical Ingredients (APIs) mainly for generic pharmaceutical industries. • Its products comply with the exacting regulatory requirements of leading health authorities. 2
What’s new? • This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in CTD sections 3.2.S.2.2 – 3.2.S.2.6. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance. 3
Page 1: Q11 Development and manufacture of
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Page 7 and 8: Q11: Approaches to development •
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Page 11 and 12: CQA’s with the reference to speci
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Page 15 and 16: Material attributes and process par
Page 17 and 18: Q11: design space • For chemical
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Page 21 and 22: Isomerization Stage - Reaction Surf
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Page 27 and 28: Selection of Starting Materials for
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Page 31 and 32: Process Validation / Evaluation •

ICH Q11 Presentation by Alex Weisman - The Israel Chapter of PDA

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