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QA Head shall critique & approved process validation protocol, approve validation report for its completeness and correctness with regard to all info and report, and to make certain implementation of SOP.Sampling system is suitable to assess the capability on the process to continuously generate product meeting expected specs.A overall performance
This program is not going to cover formulation advancement, the regulatory submission processes or detailed engineering patterns and related qualification.Concurrent validation need to only be applied below Outstanding problems exactly where the urgency of product availability is vital. The choice have to be very carefully evaluated, with a radical
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