Deviation Impact Assessment
Equipment Information
Equipment: High Shear Granulator (HSG)
Area: Production/Granulation
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Type: [Insert classification type]
Severity: [Insert severity level]
Product/Patient Impact
Impact Assessment: [Insert assessment of impact on product/patient]
Data Integrity Impact
Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation]
Findings: [Insert key findings]
Corrective and Preventive Actions (CAPA)
Actions Taken: [Insert details of CAPA]
Responsible Person: [Insert name]
Due Date: [Insert due date]
Re-test/Requalification Decision
Decision: [Insert re-test/requalification decision]
Rationale: [Insert rationale for decision]
Quality Assurance Disposition
Disposition: [Insert QA disposition]
Reviewed By: [Insert name]
Date of Review: [Insert date]