Deviation Impact Assessment Template

Equipment Details

Equipment: Ointment Tube Filling Machine (Sterile/Controlled)

Area: Production/Packaging

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert deviation description here]

Date of Deviation: [Insert date]

Deviation Number: [Insert deviation number]

Classification

Classification: [Insert classification here]

Product/Patient Impact

Impact Assessment: [Insert assessment of product/patient impact here]

Data Integrity Impact

Data Integrity Assessment: [Insert assessment of data integrity impact here]

Affected Batches/Studies

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

Investigation

Investigation Summary: [Insert investigation summary here]

CAPA (Corrective and Preventive Actions)

CAPA Actions: [Insert CAPA actions here]

Re-test/Requalification Decision

Decision: [Insert re-test/requalification decision here]

QA Disposition

Disposition: [Insert QA disposition here]