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

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3.1 General principles Q11 3.1.1 DS Quality link to Drug product 3.1.2 Process development tools: Quality risk management Knowledge management 6
Q11: Approaches to development • ICH Q8 recognizes that “Strategies for product development vary from company to company and from product to product. The approach to, and extent of, development can also vary and should be outlined in the submission.” These concepts apply equally to the development of the drug substance manufacturing process. An applicant can choose either a traditional approach or an enhanced approach to drug substance development, or a combination of both. 7
Page 1 and 2: Q11 Development and manufacture of
Page 3 and 4: What’s new? • This guideline de
Page 5: • DS = Drug substance • DS = De
Page 9 and 10: Q11 Development and manufacture of
Page 11 and 12: CQA’s with the reference to speci
Page 13 and 14: Q11: Manufacturing process developm
Page 15 and 16: Material attributes and process par
Page 17 and 18: Q11: design space • For chemical
Page 19 and 20: Volume 15 14 13 12 11 10 9 8 -20 Q1
Page 21 and 22: Isomerization Stage - Reaction Surf
Page 23 and 24: Design space for manufacturing proc
Page 25 and 26: Q1: Description of Manufacturing Pr
Page 27 and 28: Selection of Starting Materials for
Page 29 and 30: Q11: Control Strategy 29
Page 31 and 32: Process Validation / Evaluation •

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

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