Unit 14: Technology Transfer
Technology transfer ensures seamless movement of manufacturing and analytical processes between development and production or across sites. It involves planning, documentation, risk assessment, and validation to maintain product quality and regulatory compliance.
Definition
Technology transfer is the process of transferring manufacturing processes, analytical methods, and knowledge from development to commercial production or between manufacturing sites.
It ensures that the receiving unit can reproduce the product consistently and in compliance with regulatory requirements. Technology transfer is critical for scale-up, site changes, and product lifecycle management.
Key Points
WHO and GMP guidelines govern technology transfer
Includes process, analytical, and documentation transfer
Requires risk assessment and validation
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