Deviation Impact Assessment
Equipment Details
Equipment: Suppository Stripping Machine
Area: Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Impact on Product: [Insert product impact]
Impact on Patient: [Insert patient impact]
Data Integrity Impact
Impact on Data Integrity: [Insert data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [Insert affected batches or studies]
Investigation
Investigation Summary: [Insert summary of the investigation]
Investigation Findings: [Insert findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of CAPA]
Responsible Person: [Insert name]
Due Date: [Insert due date]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Insert details]
QA Disposition
QA Disposition: [Insert QA disposition]
Disposition Date: [Insert date]