By Charity Ogunsanya

Published in: CfPA Webinar

Published on: November 4, 2023

This 90-minute accredited training will benefit manufacturers of cGMP products in designing an effective, robust and compliant OOS investigation process.

Some FDA (form 483’s) and other regulatory bodies’ inspectional findings, FDA warning letters, product recalls and plant shut down (voluntary or involuntary) sometimes relate to incomplete, ineffective and non-compliant OOS investigations that impacts a manufactured product. Per the regulations, all Failures.

Deviation or OOS results investigations regardless of its product impact should be appropriately documented, investigated, analyzed for root cause(s), with a justifiable retest plan and an effective corrective action plan. Understanding how to identify a true OOS from other types of Laboratory investigations (i.e. Invalid Assays, Known Lab Error, Atypical Events or a Lab Calibration out of Tolerance) as well as when to perform a retest based on the findings of the OOS investigation is critical to achieving compliance. It is also critical to know when and how to apply “averaging” versus an “outlier” to an original test and re-test data generated during an OOS result. This will allow a product manufacturer to achieve compliance relating to an OOS investigational process.

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