Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Presentation ICH Q8 annex QbD- november 2008

3,727 views

Published on

Pharmaceutical Development: ICH Q8 - QbD

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>

×