A Corrective Action Plan (CAP) in pharmaceutical manufacturing is a structured document that specifies the steps, responsibilities, timelines, and resources required to effectively address and correct identified deviations, nonconformities, or quality issues within manufacturing processes, systems, or products. The CAP process includes conducting a thorough root cause analysis, implementing corrective actions, verifying the effectiveness of these actions, and maintaining comprehensive documentation. This systematic approach ensures the prevention of issue recurrence, enhances process improvements, and guarantees adherence to Good Manufacturing Practice (GMP) standards and regulatory compliance, thereby upholding the integrity and quality of pharmaceutical products.
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