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ISPE Talks Process Validation: Managing CMOs, Figuring PPQ Batches

 
• By Joanne S. Eglovitch

The pharmaceutical industry is proposing new approaches for managing validation activities of contract manufacturing organizations and for estimating the number of batches to run during process validation.

A pharmaceutical industry group is recommending some new ideas for overseeing the process validation activities of contract manufacturers and for calculating the number of batches to run to ensure that a process is in a state of control.

These were the topics of two recent discussion papers issued by the International Society for Pharmaceutical Engineering.

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