Deviation Impact Assessment

Equipment Details

Equipment: Aseptic Filling Machine (Vials/PFS/Cartridges)

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

Classification: [Insert classification here]

Product/Patient Impact

Impact Assessment: [Insert assessment here]

Data Integrity Impact

Impact Assessment: [Insert assessment here]

Affected Batches/Studies

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

Investigation

Investigation Summary: [Insert summary of investigation here]

Investigation Lead: [Insert name]

CAPA (Corrective and Preventive Actions)

CAPA Summary: [Insert CAPA summary here]

Responsible Person: [Insert name]

Due Date: [Insert due date]

Re-test/Requalification Decision

Decision: [Insert decision here]

Rationale: [Insert rationale here]

QA Disposition

Disposition: [Insert disposition here]

QA Reviewer: [Insert name]

Review Date: [Insert date]