Deviation Impact Assessment Template

Equipment Information

Equipment: Fluid Bed Coater (Wurster/Bottom Spray)

Area: Production/Coating

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert deviation description here]

Date of Deviation: [Insert date here]

Reported By: [Insert name here]

Classification

Deviation Classification: [Insert classification here]

Product/Patient Impact

Impact Assessment: [Insert impact assessment here]

Data Integrity Impact

Data Integrity Assessment: [Insert assessment here]

Affected Batches/Studies

Affected Batches/Studies: [Insert affected batches/studies here]

Investigation

Investigation Summary: [Insert investigation summary here]

Root Cause: [Insert root cause here]

CAPA

Corrective Actions: [Insert corrective actions here]

Preventive Actions: [Insert preventive actions here]

Re-Test/Requalification Decision

Decision: [Insert decision here]

Rationale: [Insert rationale here]

QA Disposition

QA Disposition: [Insert QA disposition here]

Reviewed By: [Insert reviewer name here]

Date of Review: [Insert date here]