Deviation Impact Assessment Template

Equipment: Depyrogenation Tunnel / Dry Heat Sterilizer (Glass Bottles)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Enter the specific details of the deviation here.

Classification

Classify the deviation (e.g., Major, Minor, Critical).

Product/Patient Impact

Describe the potential impact on product quality and patient safety.

Data Integrity Impact

Assess any impact on data integrity related to the deviation.

Affected Batches/Studies

List the affected batches or studies.

Investigation

Summarize the investigation findings related to the deviation.

CAPA (Corrective and Preventive Action)

Detail the CAPA plan to address the deviation.

Re-test/Requalification Decision

Decide on the need for re-testing or re-qualification.

QA Disposition

Provide the Quality Assurance disposition regarding the deviation.