Deviation Impact Assessment Template
Equipment Details
Equipment: DPI
Area: MDI Bulk Compounding Vessel (Jacketed SS)
Criticality: Prepare suspension/solution for MDI
Product Impact: Production
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification, e.g., Major, Minor]
Product/Patient Impact
Potential Impact on Product: [Insert details]
Potential Impact on Patient: [Insert details]
Data Integrity Impact
Impact on Data Integrity: [Insert details]
Affected Batches/Studies
Affected Batches/Studies: [Insert batch/study numbers]
Investigation
Investigation Summary: [Insert summary of the investigation]
Investigation Findings: [Insert findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert CAPA details]
Re-Test/Requalification Decision
Re-Test/Requalification Required: [Yes/No]
Details of Re-Test/Requalification: [Insert details]
QA Disposition
QA Disposition: [Insert QA decision]