Aging Process, Its Trustable Indicators & Management Strategy in Pharmaceutical Manufacturing
•
0 likes•90 views
Opening Talk
Recommended
Recommended
More Related Content
What's hot
What's hot (19)
Similar to Aging Process, Its Trustable Indicators & Management Strategy in Pharmaceutical Manufacturing
Similar to Aging Process, Its Trustable Indicators & Management Strategy in Pharmaceutical Manufacturing (20)
More from Obaid Ali / Roohi B. Obaid
More from Obaid Ali / Roohi B. Obaid (20)
Recently uploaded
Recently uploaded (11)
Aging Process, Its Trustable Indicators & Management Strategy in Pharmaceutical Manufacturing
- 1. AGING PROCESS Its Trustable Indicators & Management Strategy in Pharmaceutical Manufacturing Roohi B. Obaid, R. Ph., M. Phil. 23 Dec 2017
- 2. Opening Message Lets keep wheel of struggling moving on for Re-learning De- learning Learning
- 14. Testing Specifications Assay Dissolution CU Environmental Specifications Building Mechanics Mfg process
- 15. Testing Specifications Assay Dissolution CU Environmental Specifications Building Mechanics Mfg process Materials
- 16. Testing Specifications Assay Dissolution CU Environmental Specifications Building Etc. etc. Mechanics Mfg process Materials
- 17. Testing Specifications Assay Dissolution CU Environmental Specifications Building Etc. etc. Mechanics Mfg process Materials
- 18. Testing Specifications Assay Dissolution CU Purity Environmental Specifications Building Etc. etc. Mechanics Mfg process Materials
- 19. Testing Specifications Assay Dissolution CU Purity Environmental Specifications Building Etc. etc. Mechanics Mfg process Materials Same
- 20. Testing Specifications Assay Dissolution CU Purity Same Integrity Environmental Specifications Building Etc. etc. Mechanics Mfg process Materials
- 21. Back Mirror
- 23. 1960s-90s, Global companies Unable to manufacture even simple drugs e.g. Moxifloxacin, Atorvastatin, Glimiperide, Paroxetine
- 24. 1960s-90s, Global companies Unable to manufacture even simple drugs e.g. Moxifloxacin, Atorvastatin, Glimiperide, Paroxetine Local companies Could not compete that emerged afterwards in surroundings See neighbours
- 25. 1960s-90s, Global companies Unable to manufacture even simple drugs e.g. Moxifloxacin, Atorvastatin, Glimiperide, Paroxetine Local companies Could not compete that emerged afterwards in surroundings See neighbours Shut down of global facilities e.g. Ciba Geigy, Beecham, Welcome, Pfizer, Wyeth, Pharmacia, Opal, Sanofi
- 26. 1960s-90s, Global companies Unable to manufacture even simple drugs e.g. Moxifloxacin, Atorvastatin, Glimiperide, Paroxetine Local companies Could not compete that emerged afterwards in surroundings See neighbours Shut down of global facilities e.g. Ciba Geigy, Beecham, Welcome, Pfizer, Wyeth, Pharmacia, Opal, Sanofi Companies having moderate or new facilities Not in operation as per capacity Uncertainty prevails
- 28. Case study of Genzyme 15 year old plant, everything going good
- 29. Case study of Genzyme Rapidly growing 15 year old plant, everything going good
- 30. Case study of Genzyme Rapidly growing Approval after approvals 15 year old plant, everything going good
- 31. Case study of Genzyme Rapidly growing Approval after approvals Scale up production 15 year old plant, everything going good
- 32. Case study of Genzyme Rapidly growing Approval after approvals Scale up production Virus in bioreactor identified 15 year old plant, everything going good
- 33. Case study of Genzyme Decontamination Cost, Renovation, Fine … Rapidly growing Approval after approvals Scale up production Virus in bioreactor identified 15 year old plant, everything going good
- 34. Case study of Genzyme Decontamination Cost, Renovation, Fine … Rapidly growing Approval after approvals Scale up production Virus in bioreactor identified 15 year old plant, everything going good SHUT DOWN
- 35. A small warm up exercise to engage everyone Please write key words that create uncertainty at any time leading to stoppage of production and drug shortage For e.g. Maintenance overlook Regulatory emergence Supplier shutdown
- 36. Hear See Smell
- 37. Depreciation HVAC unable to adjust changes Number of incidences High degree of manual activities Equipment spare parts availability State of art questionable High process variability Improper outdated analytics Poor maintenance Equipment age
- 38. Noor Nabi Lodhi Coordinator Zaynab Saaya Coordinator Almas Altaf Coordinator CCK is learning to efficiently disseminate knowledge, generate discussion & make it effective
- 39. Please share key words Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Table 7 Table 8 Table 9 Table 10 Table 11 Table 12
- 40. Table 1 30 to 60 sec please
- 41. Table 2 30 to 60 sec please
- 42. Table 3 30 to 60 sec please
- 43. Table 4 30 to 60 sec please
- 44. Table 5 30 to 60 sec please
- 45. Table 6 30 to 60 sec please
- 46. Table 7 30 to 60 sec please
- 47. Table 8 30 to 60 sec please
- 48. Table 9 30 to 60 sec please
- 49. Table 10 30 to 60 sec please
- 50. Table 11 30 to 60 sec please
- 51. Table 12 30 to 60 sec please
- 52. Thank you very much for your active participation and willingness to generate & manage real time knowledge References: International Documents of global discussions among regulators & subject matter experts from multiple leading industries
- 53. Have a very good day