Out of Specification (OOS) results, identified when test outcomes or product characteristics do not align with the established acceptance criteria and these deviations could affect product quality. These findings necessitate immediate investigation and corrective measures, including root cause analysis and documentation, to uphold quality standards, regulatory compliance, and customer trust. This process ensures that any variance from quality benchmarks is promptly and effectively addressed, maintaining the integrity and reliability of pharmaceutical products.
Out of Specification (OOS)
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