Mar 9, 2020 · From phase-I laboratory investigation, when laboratory error remains unidentified, issue Out of Specification (OOS) investigation form (Phase-II) (Annexure-3) and intimate to QA for cross-functional investigation as per SOP on “Event reporting and investigation” / Incident.

Please document the purpose of additional testing as detailed above. Document result of Retesting in this section. Please attach hardcopy of raw data.

Investigation of the Production Process (Part D of OOS form) assists the analyst to explain the OOS result and is part of the decision-making process to accept or reject a result.

Dec 1, 2023 · A: An out-of-specification (OOS) result in the pharmaceutical industry refers to a test result that falls outside the established acceptance criteria or specifications for a particular product.

Apr 17, 2024 · This SOP is applicable to the results, which is out of specification obtained in Quality Control Laboratory for Raw/ packaging materials, finished products for releasing parameters.

Oct 8, 2023 · To describe the procedure for handling of Out Of Specification (OOS) laboratory test results to ensure that the OOS test results are properly investigated and corrective actions are taken to avoid recurrence.

Dec 12, 2024 · This SOP is applicable to all Quality Control (QC) laboratory personnel and relevant stakeholders involved in the testing and release of raw materials, in-process materials, finished products, and stability samples.

This 3-page document is a form used to report microbiology out-of-specification (OOS) test results. It includes sections to document the product and test details, evaluate the initial test and laboratory testing process, determine if the initial result is …

Jun 5, 2021 · The scope includes Out of Specification (OOS) results for in-house testing of incoming material, manufactured raw materials and finished products, and laboratory work performed by the contract laboratory.

Jan 2, 2023 · OOS results observed during the following samples (method validation, method transfer, product development, vendor qualification, swab, organoleptic tests (like odor and taste), and samples analyzed during analyst qualification on the previously approved sample.