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

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Material attributes and process parameters vs. CAQ’s of DS • Quality by Design: A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. (ICH Q8) • The process designed in a way that being within the Critical Process Parameters (CPP) results in producing a material, meeting “Critical Quality Attribute” (CQA) • Every process at its development time should be investigated for: • Kinetics of desired product and impurities formation performed in variable conditions; • Solid state research and crystallization parameterization; • Identification of impurities; • Control of process parameters and MA’s. 16
Q11: design space • For chemical entity design space development, a major focus is knowledge of formation, fate, and purge of impurities through every step of a manufacturing process. It is important to understand the formation, fate (whether the impurity reacts and changes its chemical structure), and purge (whether the impurity is removed via crystallisation, extraction, etc.) as well as their relationship to the resulting impurities that end up in the drug substance as CQAs. All steps (or unit operations) should be evaluated to establish appropriate acceptance criteria for impurities as they progress through multiple process operations 17
Page 1 and 2: Q11 Development and manufacture of
Page 3 and 4: What’s new? • This guideline de
Page 5 and 6: • DS = Drug substance • DS = De
Page 7 and 8: Q11: Approaches to development •
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: Material attributes and process par
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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