Deviation Impact Assessment

Equipment: Nitrogen Purging System

Specify the nature of the deviation, including the date it was identified and any relevant observations.

Classify the deviation (e.g., Major, Minor, Critical) based on the impact on the production process.

Detail the potential impact on the product quality and patient safety, including any risks associated with the deviation.

Assess whether the deviation has affected the integrity of any data collected during the qualification activities.

List all affected batches or studies that may have been impacted by the deviation.

Outline the steps taken to investigate the deviation, including root cause analysis and any findings.

Describe the actions taken to correct the deviation and prevent recurrence, including timelines for implementation.

Document the decision regarding re-testing or re-qualification of the equipment affected by the deviation.

Provide the Quality Assurance disposition regarding the deviation and the overall impact on product release.