Presentation ICH Q8 annex QbD- november 2008
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Pharmaceutical Development: ICH Q8 - QbD
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Presentation ICH Q8 annex QbD- november 2008
- 2. REGULATORY STATUS : STEP 3 ? DATE FOR COMING INTO OPERATION ? FINAL APPROVAL BY CHMP May 2008 DEADLINE FOR COMMENTS November 2007 TRANSMISSION TO INTERESTED PARTIES November 2007 TRANSMISSION TO CHMP
- 12. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (4) Manufacturing Implementation Process Scale-up & Tech Transfer Process Development Formulation Development Role of Quality Risk Management Risk Management Product quality control strategy Risk Control Risk Assessment Process design space Process Understanding Excipient & drug substance design space Product/prior Knowledge Risk Assessment Continual improvement Process History Risk Review
- 14. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (6)
- 15. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (7) Response surface plot of dissolution as a function of two parameters of a granulation operation. Dissolution above 80% is desired. Example Of Presentation Of Design Space
- 16. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (7) Response surface plot of dissolution as a function of two parameters of a granulation operation. Dissolution above 80% is desired. Example Of Presentation Of Design Space