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: ____________________________