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Technology transfer is the structured process of transferring a validated manufacturing process, along with its associated documentation, including the Master Batch Record, from one site or scale to another, such as from a development lab to commercial manufacturing, or between two commercial facilities.
When the receiving site uses a compatible EBR system, technology transfer can include migrating the digital MBR and its associated process parameters directly, reducing the risk of transcription errors that can occur when process details are manually re-entered into a new site's documentation from scratch.
A product manufactured at a development site is transferred to a commercial contract manufacturer. Because both sites use compatible EBR platforms, the digital MBR, including its embedded critical process parameters and specifications, is transferred and adapted for the new site's equipment, rather than being rebuilt manually from a paper document.
Not necessarily. It depends on whether the receiving site uses the same or a compatible EBR platform; if not, the MBR and related documentation must be rebuilt within the new site's system.
Ensuring process parameters and equipment differences between sites are properly accounted for. A process validated on one scale or equipment set doesn't automatically perform identically on another without careful evaluation.
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