External Manufacturing Interface
Approximately 50% of production within the fill finish arena is contracted outside the license holder – in this workstream, we explore processes at the interface between license holders and contract manufacturers of drug product.
How is quality maintained across the process of transferring your product to an external partner?
There is variation in the way clients specify and request the information needed from contract manufacturers of drug product and conversely, there is variation in the way contract manufacturers respond to the requests.
Standardize a process which can be agreed between the client and the contract manufacturing organization (CMO)
The team have a number of goals:
- Standardized processes which can be agreed between the client and the contract manufacturing organization (CMO)
- Optimized use of resources and faster decision making
The implementation of standardized processes will result in fewer deviations, failed batches and failed filters and lead to smoother transition to and execution of the technology transfer process
External Manufacturing Interface deliverables
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