TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

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Technology Transfer Process 3. Validation Protocols Demonstrate consistency at originator site and comparability to recipient site. Done under predefined protocols Provides documented evidence that process operated at recipient /CMO site can consistently manufacture product meeting specifications and other required attributes to demonstrate comparability to reference standard (i.e., approved commercial product or Phase II or III product from another site) 24
Technology Transfer Process 3. Validation Protocols (Master Validation Protocol- PAI) Validation is Drug Product & Manufacturing Site specific for commercialization. Scale is important for commercial products. Facility & Equipment Validation (HVAC, WFI, Clean Steam, Generator, Utility, Sterile Air, Sterile N 2 ) Process Equipment Validation (Tanks, Autoclave, Vial Washer, Stopper Washer, Dry Heat Oven, Lyophilizer, Filler, Dry Heat Tunnel, Capper) Process Validation (Mixing time, Hold time, Loading, Cleaning, Unloading, Capping, Inspection) 25
Page 1 and 2: TECHNOLOGY TRANSFER OF STERILE PROP
Page 3 and 4: Overview Current Status of Pharmac
Page 5 and 6: Status of Pharmaceuticals and Bioph
Page 7 and 8: Late-Stage Biotech Development (Sou
Page 9 and 10: Types of Technology Transfer Origin
Page 11 and 12: Phase IV Typical Drug Development P
Page 13 and 14: Needs for Technology Transfer Reaso
Page 15 and 16: Phases In Evolution of Production S
Page 17 and 18: Schematic to Summarize Technology T
Page 19 and 20: Technology Transfer Process/Phases
Page 21 and 22: Technology Transfer Process 2. Tech
Page 23: Technology Transfer Process 2. Tech
Page 27 and 28: Technology Transfer Process 3. Vali
Page 29 and 30: Technology Transfer Phases 3. Proje
Page 31 and 32: Schematic of Representative Bulk Pr
Page 33 and 34: Schematic of Representative Fill Fi
Page 35 and 36: Aseptic Manufacturing - Isolators V
Page 37 and 38: How to Conduct Technology Transfer
Page 39 and 40: Hypothetical Technology Transfer S
Page 41 and 42: Technology Transfer for Lyo Product
Page 63 and 64: Hypothetical Technology Transfer (S
Page 71 and 72: Using CMO for Technology Transfer
Page 73 and 74: Technology Transfer Essentials Pro
Page 75 and 76:
Technology Transfer Essentials Pro
Page 77 and 78:
Technology Transfer Success Factors
Page 79 and 80:
A Case Study Mixing Validation 79
Page 81 and 82:
Case Study - Mixing Validation •
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Thank you Questions 87
Page 89 and 90:
Strategy for Characterization of Ra
Page 91 and 92:
Air Classification Clean-Area Class
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TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

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