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A Talk on Pharmaceutical Quality
This document summarizes a presentation on pharmaceutical quality given at a PPE conference on August 25, 2020. It notes that the pharmaceutical industry in the country is dependent on imports for knowledge, technology, equipment, and materials. It discusses challenges like quality concerns, import alerts, and knowledge crises. It emphasizes that pharmaceutical quality depends on the quality of development and effectiveness of quality management systems. The presentation argues that to ensure quality, errors of omission and commission must be eliminated through quality by design and standard operating procedures. It concludes that leadership should focus on developing others and facilitating continual improvement rather than just aiming for minimum standards.
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A Talk on Pharmaceutical Quality
- 1. Centre for QualitySciences Pharmaceutical Quality Science & Compliance the only way PPE Conference, 25 Aug 2020 Obaid Ali R. Ph., M. Phil., Ph. D.
- 3. No new molecules, Dependenton import for Knowledge, Technology, Equipment, Materials, Excipients, Etc. etc. Poorly sensitized to real time observations & real world evidences 73 years of Independence
- 4. Perfect Success &Perfect Failure Uncertainty, Shortages, Quality Concerns, Import Alerts, Export Restrictions, Knowledge Crisis, Cross-pollination of Myths,
- 5. Based on Quality ofDevelopment Post-marketing Changes Marketing Authorization
- 6. Randomized Controlled Studies PhaseIII Clinical Studies Placebo/Nocebo Effects of real world
- 7. Same Therapeutic Outcome Assurancesin Real World depend upon Quality of Development & Effectiveness of QMS Challenges .. Challenges .. Challenges
- 8. Challenges Abuse, Lack ofAdherence, Availability, Affordability Quality & Authenticity of products
- 9. Challenges Difficulty in listening voicesof patients Uncertainties in the current states
- 10. Evidence is theKey Pharmaceuticals are better than placebo in laboratory & clinical trials
- 11. Real World Development of Humans,Policies, Procedures has to be by design
- 12. Professional Development Why, How& What? Increase awareness How to facilitate self development Self authorship
- 13. Cause & Effectrelationships are self evident Best practices work Cause & Effect relationships are multifactorial, need expertise to understand Good practices work Cause & Effect relationships are not known Research & development are required Cause & Effect relationships are not known Extreme sensitivity to initial conditions Cause & Effect Relationship
- 14. Self assure beforegiving assurance to others How to develop Professionals, Policies, Process, Product
- 15. 21st Century Patient centric Personalizedmedicine Real world evidences
- 16. Learn Conscious thinking with sub-consciousmind Acquired immunity to change Feeling system, Knowing System,
- 17. Education, Training &Experience Practical contact with things in the real world How do you know what you know
- 18. Experience Economy Education &training are necessary but not sufficient Experiential learning is key
- 19. Big Data Our experienceis more important than the material
- 20. Towards Systemic Transformation Weneed to free ourselves from average thinking
- 21. Development Errors of Omissionhave to be eliminated by Quality by Design Error of Commission have to be eliminated in Operation by self authorship of SOPs
- 22. Breaches in Assuranceof Data Integrity A symptom of retarded professional development A symptom of broken system
- 23. BAD-I Why do peoplecheat? Why do we manipulate data? We want to look good & looking good is low order of consciousness
- 24.
- 25. 2013 - 2019 ClassI - 1139 Class II - 8034 Class III - 1070 Unclassified - 40 10284
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- 28. cGMP Issues 905 MicrobialContamination 741
- 29. cGMP Issues 905 MicrobialContamination 741 Stability 606
- 30.
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- 32. Degradation 339 Particulates 302 DataIntegrity 266
- 33.
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- 35. Dissolution 198 Super potent116 Potency Failure 106
- 36. Tablet Injection Solution 169710611501
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- 39. Don’t Use &Don’t Tell Tell us, we will do it Don’t aim at minimum, it will be missed
- 40. CAPA are not ContinualImprovement You can only improve a process when you are in a state of control You can’t improve when it is in need of Corrective & Preventive Actions
- 41. Effective leaders developothers From Looking good to Seeing good
- 42. Centre for QualitySciences Thanks PPE Conference, 25 Aug 2020 Obaid Ali R. Ph., M. Phil., Ph. D.