Training Session on Good Manufacturing Practices of the 21st Century
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GMP Intent & Cases - Part 1/4
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Training Session on Good Manufacturing Practices of the 21st Century
- 1. GMP Intent & Cases (Part 1/4) Training Session by OR Centre for Quality Sciences Obaid Ali & Roohi B. Obaid Good Manufacturing Practices (GMP) of the 21st Century 04 April 2021, Hotel Marriott Karachi
- 3. Welcome Training on GMP of the 21st Century 04 April 2021, Hotel Marriott Karachi
- 4. It reflects the views and understanding of presenter & may not be construed to represent the views or policies of organization or association to which speaker has ties Documents of US-FDA, Review Scientific Articles are used to construct presentation Disclaimer Reference
- 7. Drug …. Contamination …. Mix up
- 12. Batch J – 093 Series of deaths
- 18. • Some employee had not been properly trained • Records were not adequately secured • Established testing procedures were not being followed • Measures intended to prevent contamination or mix up was found to be deficient April 2020
- 19. • Astra Zeneca ingredients • Spoiled enough raw vaccine up to 15 million doses April 2021 Recently mix up/contaminated
- 20. ? What is assumed What is expected Let’s see ….
- 21. Safe, efficacious & have correct identity Assume … …. Drugs are
- 22. Deliver the same performance as claimed Assume … …. Drugs will
- 23. Perform consistently over shelf life Assume … …. Drugs will
- 24. Made in a manner that ensure quality Assume … …. Drugs are
- 25. be available when needed Assume … …. Drugs will
- 26. You have a batch of one drug. Samples of drug from the same batch are picked for testing. It qualifies all attributes upon testing. Testing was done by third party. Can the same be safely used? Yes No
- 27. Lets challenge the thinking process
- 28. Use Reason If you weigh and add correct quantity of material Do you think testing for assay is required?
- 30. Use Reason If you weigh and add correct quantity of material Do you think testing for assay is required?
- 31. Lets share thoughts Testing is sufficient Testing is not sufficient For Quality
- 32. Lets share thoughts Testing is sufficient Testing is not sufficient For Quality
- 33. Lets share thoughts Testing is sufficient Testing is not sufficient For Quality
- 34. The drug which is tested, is not given to patient & the drug which is given to patient is not tested Please Remember
- 35. The drug which is tested, is not given to patient & the drug which is given to patient is not tested Please Remember
- 37. ? Intent of GMP Regulation Let’s see ….
- 39. Consistency Epileptic, cardiac, Antibiotic MIC, asthma, streptokinase, dobutamine….
- 40. Contamination Penicillin, Cytotoxic, Microbial ….
- 41. Mix-Up Strength, batch, product, process …
- 42. What is GMP? It is a set of Regulatory Methodology to inspect manufacturing practices of the drugs
- 43. What GMP Does?
- 44. What GMP Does? Protects Integrity & Quality of manufactured product intended for human use
- 45. What GMP Does? Ensures that products are consistently produced & controlled
- 46. GMP Provides
- 48. GMP Assures
- 49. GMP Assures Identity, quality & strength of drugs Correct procedures are followed Timely documented Reviewed before release
- 50. Quality cannot be observed by every one and/or by naked eye Quality cannot be tested in a laboratory but has to be built in to the product We know We know
- 51. If a drug is manufactured in GMP environment & qualifies all tests, is it sufficient for quality or something remains?
- 53. Pure Consistent Zero Mix Up DRUG 1 2 3 Batch after Batch Within Batch Time after Time
- 54. GMP Elements Premises Equipment Personnel Materials Documentation Qualification & Validation Etc.
- 56. GMP System Indicators & Attributes Complaints Recall Investigations & CAPA Internal Audits Reviews Change Management Supplier Qualification Risk Management Deviations Master Maintenance Plan Master Validation Plan Master Training Plan Calibration
- 57. GMP System Indicators & Attributes Complaints Recall Investigations & CAPA Internal Audits Reviews Change Management Supplier Qualification Risk Management Deviations Master Maintenance Plan Master Validation Plan Master Training Plan Calibration
- 58. Quality Safety Efficacy Identity Purity Strength
- 59. Good Manufacturing Practices (GMP) of the 21st Century To transform pharmaceutical manufacturing we have to identify inherent misconceptions and improve ability to understand science
- 60. Thanks