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Presentation ICH Q8 annex QbD- november 2008

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Pharmaceutical Development: ICH Q8 - QbD

Pharmaceutical Development: ICH Q8 - QbD


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  • 1.
    • Pharmaceutical Development
    • Mohamad Haitham Ayad
    • 2008
    ICH Q8 Annex
  • 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.
    • WHY
    • ICH Q8 ANNEX
    • ?
  • 4. THE WALL STREET JOURNAL Septembre 3, 2003
    • Pharmaceutical manufacturing techniques lag behind those of potato-chip and laundry soap makers
  • 5. APPROACHES TO PHARMACEUTICAL DEVELOPMENT (1)
    • MINIMAL APPROACH :
    • Empirical development often conducted one variable at a time
    • Fixed manufacturing process
    • Off-line analysis
    • Drug product quality controlled by intermediate and end product testing
    • Reactive life cycle management
  • 6. APPROACHES TO PHARMACEUTICAL DEVELOPMENT (2)
    • ENHANCED, QUALITY BY DESIGN APPROACH (QbD) :
    • A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
  • 7. APPROACHES TO PHARMACEUTICAL DEVELOPMENT (3)
    • QUALITY BY DESIGN APPROACH (QbD) :
    • Multivariate expeiments to understand product and process
    • Adjustable manufacturing process within design space
    • PAT Tools
    • Drug product quality ensured by risk-based control strategy
    • Continual improvement live cycle management
  • 8. ADVANTEGES OF QUALITY BY DESIGN APPROACH
    • Higher level of assurance of product quality
    • Cost saving and efficiency for industry and regulators
      • Increase efficiency of manufacturing process and reduce manufacturing cost and product rejects
      • Minimize/eliminate potential compliance actions, costly penalties and recalls
      • Enhance opportunities for first cycle approval
      • Streamline post approval manufacturing changes and regulatory processes
      • Opportunities for continual improvement
  • 9. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (1)
    • 1) TARGET PRODUCT PROFILE
    • Dosage form and route of administration
    • Dosage form strength
    • Therapeutic moiety realise and pharmacokinetic characteristics (ex : dissolution profil)
    • Drug product quality criteria (ex : sterility, purity)
  • 10. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (2)
    • 2) CRITICAL QUALITY ATTRIBUTES (CQA)
    • Physical, chemical, biological, or microbiological property that should be within an appropriate limit to ensure the product quality.
    • Potenial CQA can be identified from target product profile and prior knowledge.
    • CQAs are used to guide product development.
  • 11. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (3)
    • 3) LINKING MATERIAL AND PROCESS ATTRIBUTE TO CQA BY USING RISK ASSESSMENT
    • Risk assessment tools can be used to identify and rank parameters with potential to have impact on product quality.
  • 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. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (5)
    • 4) DESIGN SPACE
    • linking the process inputs and CQA to establish the appropriate process parameters
  • 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. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (8)
    • 5) CONTROL STRATEGY
    • A control strategy is designed to consistently ensure product quality.
  • 18. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (9)
    • ELEMENTS OF A CONTROL STRATEGY CAN INCLUDE THE FOLLOWING:
    • • Control of input material attributes (e.g., drug substance, excipients, primary packaging materials) based on an understanding of their impact on processability or product quality
    • • Product specification(s)
    • • Controls for unit operations that have an impact on downstream processing or end-product quality (e.g., the impact of drying on degradation, particle size distribution of the granulate on dissolution)
    • • In-process or real-time release in lieu of end-product testing
    • • A monitoring program (e.g., full product testing at regular intervals) for verifying multivariate prediction models .
  • 19. PHARMACEUTICAL DEVELOPMENT STEPS ACCORDING TO QbD (10)
    • 6) PRODUCT LIFECYCLE MANAGEMENT
    • AND CONTINUAL IMPROVEMENT
    • A design space provides the applicant flexibility to optimize and adjust a process as managed under their quality system