Deviation Impact Assessment
Equipment Details
Equipment: Fluid Bed Processor (FBP) – Granulation
Area: Production/Granulation
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation ID: ____________________________
Date of Deviation: ____________________________
Description of Deviation: ____________________________
Classification
Classification: ____________________________
Product/Patient Impact
Impact Assessment: ____________________________
Data Integrity Impact
Data Integrity Assessment: ____________________________
Affected Batches/Studies
Affected Batches/Studies: ____________________________
Investigation
Investigation Summary: ____________________________
Corrective and Preventive Actions (CAPA)
CAPA Summary: ____________________________
Re-test/Requalification Decision
Decision: ____________________________
Rationale: ____________________________
QA Disposition
Disposition: ____________________________
Comments: ____________________________