Management of Out of Specification (OOS) for Finished Product

Abstract

Background of the study: Difficult lies at the core of drug producer successful operation. Laboratory testing, which is compulsory by the CGMP regulations are required to check that components, containers and closures, in-process materials, and finished products conform to specifications, including stability specifications. Objective of the study: The objective of the investigation procedure should clearly state when the investigation is required, and define OOS, OOT, and aberrant results. OOS results are most often generated due to laboratory or manufacturing-related errors, the setting of inappropriate specifications, or poor method development. Materials and Methods: The current work is an effort to deliberate several aspects of finding the root cause for the OOS during the finished product analysis by using HPLC. Results and Discussion: Product’s individual unknown impurity was not in specification limit and, hence study carried out to find the root cause. Conclusion: After conducting detail investigation it was proved that an analyst conducted the analysis of the product after the due date to expiry.