SOP – Reduce Testing Procedure (API & Drug Product)


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.


There are no reviews yet.

Be the first to review “SOP – Reduce Testing Procedure (API & Drug Product)”