Deviation Impact Assessment
Equipment Details
Equipment: Capsule Polisher
Area: Production/Capsules
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Classification
Classification of Deviation: [Insert classification]
Product/Patient Impact
Potential Impact on Product: [Describe potential product impact]
Potential Impact on Patients: [Describe potential patient impact]
Data Integrity Impact
Impact on Data Integrity: [Describe impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide summary of investigation]
Corrective and Preventive Actions (CAPA)
CAPA Actions: [List CAPA actions taken]
Re-test/Requalification Decision
Decision on Re-test/Requalification: [Insert decision]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]
Signatures
Prepared By: [Name and Title]
Date: [Insert date]
Reviewed By: [Name and Title]
Date: [Insert date]