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

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Design space for purification and crystalline form control • DS a proprietary purification method was developed. • The API character- • Hardly soluble in any “conventional” organic solvents • Easily decomposes in water and in protic solvents (as MeOH). • To get the pure material, very polar and high boiling point solvents • had to be chosen (e.g. DMF, DMAA), DMF found to be the best choice for purification. • However… residual DMF (CQA), found to be difficult to remove • We have found during defining of the design space of crystallization parameters, by DOE, that crystallization at lower temperatures and volumes enable to remove the DMF later on, by drying, to get in spec material. 18
Volume 15 14 13 12 11 10 9 8 -20 Q11: DS 2 Contour Plot of DMF vs Volume, Temp -15 -10 -5 Temp 0 5 DMF < 200 200 – 300 300 – 400 400 – 500 500 – 600 600 – 700 700 – 800 > 800 19
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: Q11: design space • For chemical
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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