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ICH Quality Plenary Meeting

ICH Quality Plenary Meeting. 10:00 A.M. – Noon 7 June 2004. Scope of this Meeting. Quality Topics Q1, Q3, Q4, Q5, Q8, Q9, QS proposal Focus of this meeting be limited to Q8, Q9, and the QS Scoping Document Other topics be discussed separately

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ICH Quality Plenary Meeting

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  1. ICH Quality Plenary Meeting 10:00 A.M. – Noon 7 June 2004

  2. Scope of this Meeting • Quality Topics • Q1, Q3, Q4, Q5, Q8, Q9, QS proposal • Focus of this meeting be limited to Q8, Q9, and the QS Scoping Document • Other topics be discussed separately • Q1 – Tuesday 8:00 a.m., meeting of the group of experts • Q3AR and Q3BR Q&A (further discussion; When? Who?) • Q4B – “Regulatory Acceptance of Pharmacopeial Interchangeability” • Q5E –Discussions with S&E experts (comments on statements referring to non-clinical and clinical studies)

  3. Meeting Agenda • A brief perspective on Q8 and Q9 • To facilitate and structure our discussion on • General principles and scope of Q8 & Q9 • Understanding the connection and approaches for integration between Q8 and Q9 • Q8 Progress and Next Steps • Q9 Progress and Next Steps • QS Scoping Document – Need, Objective, Scope, Relation to Q8 & Q9, …?

  4. Pharmaceutical Development • Multi-disciplinary complex process • Many choices/approaches for achieving the goal • Both industry and regulators wish to assure that • Decisions are based on science to assure a product will perform its intended function for the required duration within a given environment • This includes designing in the ability to maintain, test, and support the product throughout its total life cycle. • “Building quality in” or “assuring quality is by design” • Quality can not be tested into a product

  5. Opportunity • Over the last two decades we have learned how to solve complex multi-factorial problems • Multivariate empirical methods (e.g., Response Surface Methods) • Systems approaches • New measurement and information technologies • Measurements that can predict performance • Such information is often filtered out of regulatory submissions • “fear” or “regulatory uncertinty” • ICH Q8 can open the door for sharing and utilizing this information

  6. Within the design space only - e.g.,other variables held constant

  7. Predicting Dissolution Dissolution = f (Ex1, Ex2, P1, P2, PS…) Drug Substance Formulation Process Bio PK/PD Disso Test NIR Product Stability Real Time Release

  8. Systems focus • Provides a structured approach • Development efficiency • Use of prior knowledge • Continuous learning • Risk mitigation • Knowledge sharing • Knowledge communication • Efficient and optimal decisions • Industry - Regulators

  9. Drug and disease models use mathematical, statistical and pharmacological concepts to accumulate and quantify knowledge to improve decision-making. Decision-making approaches Traditional Model-based Knowledge Transparent logic Predictive Objective Data Hidden Intuition Empirical Subjective Donald Stanski, FDA

  10. Appropriate Level of Regulatory Scrutiny • All regulators desire to apply an appropriate level of regulatory scrutiny to • Risk/Benefit decisions • Specifications, controls, change management to ensure unchanged performance • In absence of relevant information their decisions reflect available data (unable to generalize reliably)

  11. Current CMC Submissions raw material properties process conditions environmental Data based decisions: No Generalization

  12. Knowledge based decisions: Improved Ability to Generalize Pharmaceutical Development Knowledge raw material properties process conditions environmental Robust process Stable and Bioavailable product

  13. Ability to Generalize… • Provides a basis for assuring appropriate regulatory oversight • Review/assessment decisions • Submission commitments • Communication (Review/Inspection) for appropriate risk coverage • Continuous improvement • Efficiency • Reducing variability

  14. An Example of our (FDA) Current Limited Ability to Generalize .. • Change: Site of Manufacture (no other change) – Modified Release Tablet • No IVIVC • Bioequivalence study, up to 3 batches of accelerated stability data,… PAS • Significant body of data (?) – 1 batch • IVIVC • No BE study, rest the same • Changes in formulation – is the IVIVC still valid? [correlation may not be causal, therefore may not hold]

  15. Ability to Generalize … • Provides a “measure” of process understanding • Provides an objective means to evaluate reliability of data/information/knowledge submitted • Predictive ability • Extent of coverage (design space) and data density • Objective approach for risk coverage (regulatory oversight) • Reliability of generalization – Post approval change management (Review – Inspection – Company QS)

  16. cGMP regulatory oversight ICH Q8 Company’s Quality system Risk Post approval change Process Understanding CMC regulatory oversight ICH Q9

  17. Process Understanding Process Understanding Process Understanding CMC regulatory oversight CMC regulatory oversight CMC regulatory oversight cGMP regulatory oversight cGMP regulatory oversight cGMP regulatory oversight Company’s Quality system Company’s Quality system Company’s Quality system Post approval change Post approval change Post approval change Risk (P/R) Risk Risk ICH Q8 + Q9

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