SOP – Reduce Testing Procedure (API & Drug Product)

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Reduced Testing: The reduction of performance frequency of specified tests or testing intervals (in case of stability) on pre-selected batches and/or at pre-determined intervals of on-going stability based on trends, scientific rationale and risk assessment, rather than on a batch-by-batch or interval by interval basis, with the understanding that those batches/intervals not being tested still meet all acceptance criteria established for that product/material. This risk based activity represents a less than full schedule of testing and should therefore be justified, presented to and approved by the regulatory agency (if needed) prior to implementation.

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