Deviation Impact Assessment Template
Equipment Details
Equipment: Aseptic Filling (PFS/Vials) for LAI
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Insert deviation description here]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: [Insert classification]
Product/Patient Impact
Potential Impact on Product: [Insert impact details]
Potential Impact on Patient: [Insert impact details]
Data Integrity Impact
Impact on Data Integrity: [Insert details]
Affected Batches/Studies
Affected Batches: [Insert batch numbers]
Affected Studies: [Insert study details]
Investigation
Investigation Summary: [Insert investigation summary]
Corrective and Preventive Actions (CAPA)
CAPA Details: [Insert CAPA details]
Re-test/Requalification Decision
Decision: [Insert decision]
Rationale: [Insert rationale]
Quality Assurance (QA) Disposition
QA Disposition: [Insert disposition]