In the context of pharmaceutical manufacturing quality management, a deviation is recognised as any unplanned event that strays from set standards, procedures, specifications, or expected results. This encompasses a wide array of causes, including equipment failures, human error, environmental changes, or unforeseen events. Critical for maintaining GMP standards, documenting, investigating, and understanding deviations are steps to pinpoint root causes, evaluate their impact on product quality, safety, and efficacy, and to devise corrective and preventive actions. These measures are crucial for ensuring continuous compliance and enhancing the integrity of the manufacturing process.
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