The Evolving Quality Expectations & Reshaping Strategy of Controls in Pharmaceutical Manufacturing
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Seminar on "Advanced Pharmaceutical Technology & Practice to Compliance with Challenging Standards" organized by Austar, China & Morgan, Pakistan attended by over hundred participants from different pharmaceutical industries of Karachi & Lahore
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The Evolving Quality Expectations & Reshaping Strategy of Controls in Pharmaceutical Manufacturing
- 1. The Evolving Quality Expectations & Reshaping Strategy of Controls in Pharmaceutical Manufacturing Hotel Pearl Continental, Karachi 26 April 2018 Obaid Ali & Roohi B. Obaid
- 2. This presentation discusses Regulatory Science, nothing more & nothing less Reference: US-FDA Documents / Scientific Articles Personal point of view & nothing to disclose Disclaimer
- 3. Back & side mirror reality Dashboard Story Windscreen Reality
- 4. A lot of Experts Seminars WHO / USP Political Claims Headlines Molecules Conferences
- 5. We know Positioning of Pakistan’s Regulatory Authority Pakistan’s pharmaceutical products
- 6. Some Relative Facts >135 manufacturing facilities approved for GMP by US-FDA Approx. 8 billion USD export/imagine contribution in healthcare system Manufacturing from new to generic drug
- 7. Some Relative Facts US-FDA has multiple offices Expending billions of USD More than 100 inspectors for inspections
- 9. Global Radar & Navigation Missing toxicological studies to qualify an unqualified impurity Unacceptable physical properties for drug product Need full-term stability data to establish expiration dating
- 10. Global Radar & Navigation Failure to identify or include CQAs or methods for controlling them Insufficient data to support use-related risk analysis & any human factors studies assoc. with proposed product Insufficient data to support drug/device compatibility
- 11. Global Radar & Navigation Lack of safety assessment of extractables and leachables, inadequate assessment of extractables and leachables, or submission of that assessment in an unsolicited amendment
- 12. Global Radar & Navigation Data Integrity Culture of Quality
- 13. Trustworthiness / Integrity of Data Data that is reliable Data that is authentic Data that is useable Complete & Accurate Proven to be what it say, it is Can be located, retrieved, presented & interpreted
- 14. Culture of Quality Quality Metrics Lagging Metrics & Leading Metrics
- 15. Lagging Metrics Batch Failure Right First Time OOS Investigation Leading Metrics Quality System Effectiveness Process Capability Quality Culture Index
- 16. Indiscriminative Citations that still revolve around Failing to process/investigate Consumer Complaints Failure to do Annual Product Review Failing to extend their investigation of problem into other lots of products that might or were affected
- 17. Indiscriminative Citations that still revolve around Did not identify, report or investigate the OOS results
- 18. Indiscriminative Citations that still revolve around The lack of reliability and integrity of data is a serious GMP observation that raise concern with all data generated by the company
- 19. Improving Speed & Quality in Drug Manufacturing Continuous Manufacturing as a New Approach has potential to gain popularity in time to come
- 20. Continuous Manufacturing Eliminate manual handling & human error
- 21. Continuous Manufacturing Online monitoring & controls enhance quality
- 22. Continuous Manufacturing Increased efficiency & reduced manufacturing time
- 23. Continuous Manufacturing Smaller equipment & less manufacturing space reduce cost of ….
- 24. Continuous Manufacturing Respond more promptly in case of drug shortage
- 25. Lets keep eye open to make wheel alignment compatible with road and its turning
- 26. Independent / Separate Risk .... Assessment Control New
- 27. Fast public release of New Non Compliance Statement
- 28. No more conditioned GMP with New Non Compliance Statement
- 29. Specific guidance to release New Batches of critical drug products
- 30. Lets move beyond regulatory compliance & explain opportunity to capture unexpected event before it happens Respect & use knowledge, experience, data, pattern, trend & good science to improve efficiency & maintaining culture of quality
- 31. 1/5 Tie with Quality is a Core Value Simple, loud & clear
- 32. 2/5 Setting ethical standards & Training
- 35. 5/5 Hear the gut & ground sound
- 36. Remember Please Meet all requirements of regulatory sciences Prove product understanding (CQAs) Mitigate Risks Provide supporting data
- 37. Remember Please GMP is not complete if you don’t have post marketing surveillance program
- 38. Thank You