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Presentation ICH Q8 annex QbD- november 2008

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Mohamad Haitham Ayad
Mohamad Haitham Ayad

Pharmaceutical Development: ICH Q8 - QbD

Salud y medicinaEmpresarialesTecnología
1 de 19
[object Object],[object Object],[object Object],ICH Q8 Annex
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
[object Object],[object Object],[object Object]
THE WALL STREET JOURNAL Septembre 3, 2003 ,[object Object]
APPROACHES TO PHARMACEUTICAL DEVELOPMENT (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
APPROACHES TO PHARMACEUTICAL DEVELOPMENT (2) ,[object Object],[object Object]
APPROACHES TO PHARMACEUTICAL DEVELOPMENT (3) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ADVANTEGES OF QUALITY BY DESIGN APPROACH ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (1) ,[object Object],[object Object],[object Object],[object Object],[object Object]
PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (2) ,[object Object],[object Object],[object Object],[object Object]
PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (3) ,[object Object],[object Object]
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
PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (5) ,[object Object],[object Object]
PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (6)
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
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
PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (8) ,[object Object],[object Object]
PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (9) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (10) ,[object Object],[object Object],[object Object]

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Presentation ICH Q8 annex QbD- november 2008

  • 1.
  • 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
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 11.
  • 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
  • 13.
  • 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
  • 17.
  • 18.
  • 19.