Investigation in the pharmaceutical manufacturing context is a systematic examination and analysis aimed at uncovering the root causes and contributing factors of deviations, nonconformities, quality issues, or complaints. This process involves gathering, analysing, and evaluating evidence or information to not only determine the underlying reasons for these incidents but also to identify and implement corrective and preventive actions to prevent their recurrence. Investigations, often initiated in response to quality incidents, product failures, or regulatory findings, require thorough documentation, data analysis, and effective collaboration and communication to ensure timely resolution and drive continuous improvement in quality management processes.
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