1 - GMP June 2022 - CQS.pdf
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This document discusses various aspects of quality control and assurance in pharmaceutical manufacturing. It notes that quality testing only examines a small sample of total production. It questions whether current testing methods are directly linked to ensuring the commitments and effects promised for drugs. The document also discusses the importance of understanding manufacturing processes, the resistance to change, and the risks when contamination occurs. It emphasizes learning objectively from experiences to improve quality control.
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1 - GMP June 2022 - CQS.pdf
- 3. It is our understanding based on little knowledge and experience. Care is sincerely taken to maintain accuracy, however, chances of error may not be ruled out. Nothing here is hypothetical but from the library of real world Disclaimer Obaid Ali & Roohi B. Obaid
- 4. We are blessed as chosen to perform for reducing the pain of patient and enhancing public health Suppose we don’t have antiepileptic drugs tomorrow ….?
- 5. We are blessed as chosen to perform for reducing the pain of patient and enhancing public health Suppose we don’t have antiepileptic drugs tomorrow ….?
- 6. We are blessed as chosen to perform for reducing the pain of patient and enhancing public health Suppose we don’t have cardiovascular drugs tomorrow ….?
- 7. We are blessed as chosen to perform for reducing the pain of patient and enhancing public health Suppose we don’t have antipsychotic drugs tomorrow ….?
- 8. We are blessed as chosen to perform for reducing the pain of patient and enhancing public health Suppose we don’t have anti-infective drugs tomorrow ….?
- 9. Field of pharmaceutical sciences is progressing rapidly and reshaping with enhanced quality and technical approach coupled with innovation Lets catch the signals and try to walk with them …
- 10. which is tested is not used and which is used is not tested Drug
- 12. Lets visualize 10 lac dosage is represented by less than 100 dosage for end product testing Some in process controls are placed and less than 10,000 dosage checked for some attributes Is there any direct link of any test with commitment … No
- 13. Lets visualize 10 lac dosage is represented by less than 100 dosage for end product testing Some in process controls are placed and less than 10,000 dosage checked for some attributes Is there any direct link of any test with commitment … No
- 14. Lets visualize 10 lac dosage is represented by less than 100 dosage for end product testing Some in process controls are placed and less than 10,000 dosage checked for some attributes Is there any direct link of any test with commitment … No ?
- 15. Lets visualize 10 lac dosage is represented by less than 100 dosage for end product testing Some in process controls are placed and less than 10,000 dosage checked for some attributes Is there any direct link of any test with commitment … No ?
- 16. Fair and Responsible Assess ………. Clinical Study Direct
- 17. Fair and Responsible Assess ………. Clinical Study Direct Relative calculate ………. Bioequivalence In Direct
- 18. Fair and Responsible Assess ………. Clinical Study Direct Relative calculate ………. Bioequivalence In Direct Second relative calculation Dissolution In Direct
- 19. Fair and Responsible Assess ………. Clinical Study Direct Relative calculate ………. Bioequivalence In Direct Second relative calculation Dissolution In Direct
- 21. Commercial Manufacturing Identification Assay Content Uniformity Dissolution Impurities Microbial Contamination Label Claim and Promise Therapeutic effect Dosage Side effect Adverse effect Warning, Precautions Interactions
- 22. Commercial Manufacturing Identification Assay Content Uniformity Dissolution Impurities Microbial Contamination Label Claim and Promise Therapeutic effect Dosage Side effect Adverse effect Warning, Precautions Interactions Patient & Physician Expectations Consistency in quality Available & Accessible Hope for relief Absolute safe Government vigilance Company vigilance
- 24. Every defective batch may not necessarily be recalled
- 25. Every defective batch may not necessarily be recalled Every recalled batch may not be necessarily manufactured outside the GMP Zone
- 26. Every defective batch may not necessarily be recalled Understand the …. • Product & Process • Resistance to develop • Resistance to change • Habit of ignorance • Innocent negligence Dive to have deep insight Every recalled batch may not be necessarily manufactured outside the GMP Zone
- 27. Quality? What we feel & What we think?
- 28. Quality? What we feel & What we think? What we know & How we know? What we don’t know and Why we don’t know?
- 29. Quality? What we feel & What we think? Can Quality be linked with Clinical Relevance? What we know & How we know? What we don’t know and Why we don’t know?
- 30. Assay 95 to 105 Bio-Equivalence 80 to 125
- 31. Assay 95 to 105 Bio-Equivalence 80 to 125
- 32. Category X Drug If contaminated with any drug (e.g. OTC or regular use drug) due to innocent mistake in cleaning etc. What may happen
- 33. Category X Drug If contaminated with any drug (e.g. OTC or regular use drug) due to innocent mistake in cleaning etc. What may happen
- 34. Heparin took lives …. GMP of facility was compliant … Compendial specification were in control state What happened and why?
- 35. Iron containing Capsules…. Thousand of batches were questioned … Change of excipient was not studied … Company shut down for two good years. What happened and why?
- 36. What can change the taste of tea? How do we control?
- 37. Education Experience Training 1 2 3 Skill Aptitude
- 41. Process Analytical Technology Multivariate Statistical Process Control PAT MSPC
- 42. How do we learn from our subjective experience objectively
- 43. Between the stimulus and response is your choice, choose wisely
- 44. Thank You