Phase 1 investigation refers to accessing laboratory data, an analyst, and the supervisor verifies initial preparation. Phase 2 Investigation is conducted when the initial investigation clears laboratory error cause for the OOS result.
The Current Good Manufacturing Practice for Finished Pharmaceuticals (211.192 production record reviews) requires the quality control team to review and approve the production of drug products and control records, including packaging and labelling. This is to ensure compliance with pre-established procedures before the release of a batch.