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

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Traditional approach • Typical CQA’s: DS quality = safety, potency, strength, purity; - Genotoxic impurities directly effect safety; - Crystalline form and PSD can effect potency (bioavailability can be sufficiently different for the different forms of PSD of the same DS ); - Related substances, residual solvents etc. directly effects the purity; CQA’s are important not only with the reference to quality, but to with the reference to the DS markets. 10
CQA’s with the reference to specific markets Desired DS quality may sufficiently varies within territory: Example 1 : EP/USP description of DS: white to off white is acceptable; Japan – off white will not pass!!!! Example 2: Related substances level: for same DS approved in EC with ICH limits, FDA requested 0.05% /0.10% as exceeding 2g/day – obesity problem in US !!! 11
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: Q11 Development and manufacture of
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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