Emerging Phenomena & Challenges
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The document discusses emerging challenges related to ICH Q8 and Q10 implementation, including increased risk and non-compliance due to process variability. It also discusses how quality inspectors and assessors can evaluate product control strategy, quality by design, manufacturing processes, and change management systems. The rest of the document focuses on knowledge management, data integrity, and quality metrics as indicators of operational reliability and quality culture. Key quality metrics discussed include lot acceptance rate, product quality complaint rate, right first time rate, invalidated OOS rate, APR/PQR on time rate, CAPA rate, and ability to initiate voluntary CAPA.
Emerging Phenomena & Challenges
- 1. Emerging Phenomena & Challenges on ICH Q8 & Q10 Obaid Ali Civil Service Officer / Deputy Director, DRAP Member ISPE, PDA
- 2. Drug Substance Operations Pharmaceutical Development Technology Transfer Commercial Manufacturing Drug Product Operations Lifecycle
- 7. Raw material Process Product Variables If something wrong here It has to appear here
- 8. Process Variables Optimize and set during development Controlled as closely as possible during production
- 9. How Inspector and Assessor Integrate To assess Product Control Strategy To assess Quality by Design To verify Effective Manufacturing Process To examine Change Management System
- 11. Knowledge & Risk Management Knowledge derives better understanding An iterative process A systematic approach An enabler
- 13. Knowledge & Risk Management Your knowledge is an asset to your organization & approaches exist to manage as such Your knowledge is a key enabler & can help your organization realize the purpose behind effective PQS
- 14. Knowledge & Risk Management Knowledge needs to flow, grow and evolve across the lifecycle
- 15. Data Integrity
- 16. Quality Metrics Quality Metrics Indicator of operational reliability Quality Culture
- 17. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 18. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 19. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 20. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 21. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 22. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 23. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 24. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOS Rate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 25. Lots rejected/total lots in a year Lot Acceptance Rate
- 27. Deviated lots/ total lots in a year Right First Time Rate
- 28. 38/355= Right First Time Rate
- 29. APR triggered CAPA/ total number of APRs Corrective & Preventive Action (CAPA) Rate
- 30. Corrective & Preventive Action (CAPA) Rate 3/30=
- 31. Process capability or performance index for each critical quality attribute that triggers a CAPA Ability to initiate voluntary CAPA
- 32. Ability to initiate voluntary CAPA Cp value
- 33. The number of batches for which complaint received/ total number of batches (very specific to the product) Product Quality Complaint Rate
- 34. Product Quality Complaint Rate 6/30=
- 35. Invalidated initial OOS tests / total number of tests in a year Invalidated OOS Rate
- 37. The number of APRS within 30 days of annual due date / the total number of products produced during the year APR or PQR on time Rate
- 38. APR or PQR on time Rate 05/40=
- 39. Hope you had a good learning Email: cultureofcultivatingknowledge@gmail.com Facebook: Culture of Cultivating Knowledge Thank You