Navigating Deviations through OOSL and OOTC in Pharmaceutical Manufacturing Maintaining the highest quality and safety standards is paramount within the pharmaceutical industry. This necessitates meticulous testing throughout the manufacturing process, from raw materials to finished products. Two crucial concepts in this realm are Out-of-Specification Limits (OOSL) and Out-of-Trend Criteria (OOTC). While both signify deviations from the ideal, a clear understanding of the distinction is essential for guaranteeing patient safety and product efficacy. Differentiating OOSL and OOTC for Effective Quality Control Out-of-Specification Limits (OOSL): Established compendia, Drug Master Files (DMFs), or drug applications define acceptable ranges for a drug's properties (chemical composition, physical characteristics, storage performance) – these constitute the specifications. An OOSL event occurs when a test result falls completely outside these pre-defined limits. This signifi
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