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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

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

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