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Comprehensive Deviation Report for Pharmaceutical Processes
This report captures and documents deviations that occur during pharmaceutical manufacturing, testing, or any operational process.
Deviations refer to any departure from approved procedures or processes, which may impact product quality or regulatory compliance.
The report helps to document, analyze, and address such deviations through
corrective and preventive action.
Parameter | Details |
---|---|
Deviation Report Title | Deviation Report for [Process or Equipment Name] |
Deviation Description | [Describe the deviation in detail] |
Root Cause | [Provide the identified root | cause of the deviation]
Impact Assessment | [Assess the impact of the deviation on product quality or compliance] |
Corrective Action | [Describe the corrective actions taken to address the deviation] |
Preventive Action | [List the preventive measures to avoid recurrence] |
Signatories | QA, QC, Department Manager |
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