Deviation Impact Assessment Template
Equipment Details
Equipment: Suppository Base Melting Vessel (Jacketed SS)
Area: Production
Criticality: High
Product Impact: Cocoa Butter
Deviation Details
Deviation Description: [Enter deviation description here]
Date of Deviation: [Enter date]
Deviation Classification
Classification: [Classify the deviation, e.g., Minor, Major, Critical]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product quality and patient safety]
Data Integrity Impact
Data Integrity Assessment: [Describe any impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Summarize the investigation process and findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Outline the CAPA measures implemented]
Re-test/Requalification Decision
Decision: [State the decision regarding re-testing or re-qualification]
Quality Assurance Disposition
QA Disposition: [State the final QA disposition regarding the deviation]
CSV Required
CSV Requirement: Yes