FDA guidelines-for out of specifications (OOS) in industries

Testing lies at the heart of drug manufacturer's successful operation. Laboratory testing, which is required by the CGMP regulations is obligatory to confirm that components, containers and closures, in-process materials, and finished products conform to specifications, including stability specifications. Testing also supports analytical and process validation efforts. CGMP regulations specifies that finished drug products that fail to convene established standards, specifications, or other relevant quality control criteria will be rejected. Any unexplained inconsistency of the failure of a batch or any of its contents to meet any of its specifications and that tests result that fall out of specifications (OOS) shall be thoroughly investigated, whether or not the batch has already been distributed. For the release of test batch OOS investigation is mandatory. If the OOS is confirmed the batch is rejected and if the OOS is found inconclusive then QA may be able to justify and release the batch.