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Emerging Phenomena & Challenges
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.
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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 DrugProduct Operations Lifecycle
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- 7. Raw material Process Product Variables If something wrong here Ithas to appear here
- 8. Process Variables Optimize andset during development Controlled as closely as possible during production
- 9. How Inspector andAssessor Integrate To assess Product Control Strategy To assess Quality by Design To verify Effective Manufacturing Process To examine Change Management System
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- 11. Knowledge & Risk Management Knowledge derives betterunderstanding An iterative process A systematic approach An enabler
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- 13. Knowledge & Risk Management Your knowledge isan 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 toflow, grow and evolve across the lifecycle
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- 17. Quality Metrics Lot Acceptance Rate Product Quality Complaint Rate Right first time Rate Invalidated OOSRate 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 OOSRate 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 OOSRate 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 OOSRate 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 OOSRate 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 OOSRate 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 OOSRate 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 OOSRate APR or PQR on time Rate CAPA Rate Ability to initiate voluntary CAPA
- 25. Lots rejected/total lotsin a year Lot Acceptance Rate
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- 27. Deviated lots/ totallots in a year Right First Time Rate
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- 29. APR triggered CAPA/total number of APRs Corrective & Preventive Action (CAPA) Rate
- 30. Corrective & PreventiveAction (CAPA) Rate 3/30=
- 31. Process capability or performanceindex for each critical quality attribute that triggers a CAPA Ability to initiate voluntary CAPA
- 32. Ability to initiatevoluntary CAPA Cp value
- 33. The number ofbatches for which complaint received/ total number of batches (very specific to the product) Product Quality Complaint Rate
- 34. Product Quality ComplaintRate 6/30=
- 35. Invalidated initial OOStests / total number of tests in a year Invalidated OOS Rate
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- 37. The number ofAPRS 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 PQRon time Rate 05/40=
- 39. Hope you hada good learning Email: cultureofcultivatingknowledge@gmail.com Facebook: Culture of Cultivating Knowledge Thank You