TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

More documents

Recommendations

Info

Biopharmaceutical Supply Chain – Global Perspective BeneFix (Recomb. Factor IX) Supply Chain (from BioPharm International, Oct 2004) 14
Phases In Evolution of Production Site Transfer and Technology Transfer Early Phase Definition of the Process Implementation Phase Design and Construction Late Phase Qualification, Validation, and Operation (a) Feasibility study Process description Process Flow diagram Equipment List Engineering design (Conceptual, preliminary, And detailed design) Equipment procurement P&Ids Construction FAT Installation Commissioning Validation (IQ, OQ) Equipment qualification SOPs Production Documentation Preproduction runs Comparability protocol Consistency lots (b) Demonstrate Develop Infrastructure to Demonstrate ability understanding operate the process to operate the process of the process 15
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: Needs for Technology Transfer Reaso
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 and 24: Technology Transfer Process 2. Tech
Page 25 and 26: Technology Transfer Process 3. Vali
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 65 and 66:
Hypothetical Technology Transfer (S
Page 67 and 68:
Page 69 and 70:
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
show all

TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR

Create successful ePaper yourself

Delete template?

Save as template?