TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
TECHNOLOGY TRANSFER OF STERILE PROPDUCTS - IIR
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Technology Transfer Process<br />
1. Quality Agreement/Project Scope Document<br />
(joint document)<br />
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Project overview<br />
Process description and Process flow diagram (PFD),<br />
Design basis<br />
Overall schedule and Milestones<br />
Budget tracking mechanism<br />
Project execution mechanism<br />
Decision matrix: Who makes what decisions?<br />
Technology Transfer strategy (details in TTD)<br />
Location of facilities and areas to be used at CMO<br />
Materials matrix: Purchase, Storage, Testing<br />
Testing matrix: RM, DS, DP, Components<br />
Failure communication and investigation, Change Control<br />
Audit Support (PAI/GMP Inspection)<br />
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