Deviation Impact Assessment

Equipment: Nitrogen Purging System

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

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

Classification

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

Product/Patient Impact

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

Data Integrity Impact

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

Affected Batches/Studies

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

Investigation

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

Corrective and Preventive Actions (CAPA)

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

Re-Test/Requalification Decision

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

QA Disposition

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