Deviation Impact Assessment

Equipment Information

Equipment: Binder Solution Preparation Tank

Area: Production/Granulation

Criticality: Major

Product Impact: Direct

CSV Required: No

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Deviation Date: [Insert date]

Reported By: [Insert name]

Classification

Classification of Deviation: Major

Product/Patient Impact

Impact on Product: [Insert details on how the product is impacted]

Impact on Patient: [Insert details on patient safety or efficacy concerns]

Data Integrity Impact

Impact on Data Integrity: [Insert details on data integrity concerns]

Affected Batches/Studies

Affected Batches/Studies: [Insert batch or study numbers impacted]

Investigation

Investigation Summary: [Insert summary of the investigation conducted]

Root Cause Analysis: [Insert findings related to the root cause]

Corrective and Preventive Actions (CAPA)

CAPA Summary: [Insert details of corrective and preventive actions taken]

Re-test/Requalification Decision

Re-test/Requalification Required: [Yes/No]

Details: [Insert details on re-test or requalification requirements]

QA Disposition

QA Disposition: [Insert QA’s final disposition on the deviation]