Displaying 1–2 of 2 results for Bikash Chatterjee and Mark Mitchell, Pharmatech Associates

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A Framework for Technology Transfer to Satisfy the Requirements of the New ...

(Article)

In the life of any drug product, the technology transfer of a process is a complex matter, made more complicated by the new definition of the Process Validation (PV) guidance issued by FDA in January 2011.

A Framework for Technology Transfer to Satisfy the Requirements of the New ...

(Article)

A risk-based model allows the manufacturer to fully consider process and product design at the outset of tech transfer.

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