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

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<strong>Q11</strong>: Controls strategy • 6.1.1 Approaches to Developing Control strategy • 6.1.2 Consideration in Developing a Control Strategy 30
Process Validation / Evaluation • PV is the documented evidence that process, operated within established parameters can perform effectively and reproducibly a drug substance… • To be performed before commercialization. • When should be repeated? - When manufacturing process changes have a place: scale up, changes in RM, equipment etc. • Continuous process verification vs. traditional process validation (<strong>ICH</strong> Q8) 31
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 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: Q11: Control Strategy 29

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

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