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

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Q11: Linking MA and Process parameters to DS CQAs • The manufacturing process development program should identify which material attributes (e.g., of raw materials, starting materials, reagents, solvents, process aids, intermediates) and process parameters should be controlled. Risk assessment can help identify the material attributes and process parameters with the potential for having an effect on drug substance CQAs. Those material attributes and process parameters that are found to be important to drug substance quality should be addressed by the control strategy 14
Material attributes and process parameters vs. CAQ’s of DS • Raw materials, reagents, solvents, catalysts used for DS production; Traditional approach – works not bad for the generic industry: Example 1: Process related impurity – N-Alkyl Cilostazol, Example 2: Reagent related impurity – S-methyl Fluticasone Example 3: RM/process related impurity - D- Cetirizine 15
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: Q11: Manufacturing process developm
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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