Deviation Impact Assessment
Equipment Details
Equipment: Roller Compactor
Area: Production/Dry Granulation
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Classification of Deviation: [Enter classification, e.g., Minor, Major, Critical]
Product/Patient Impact
Potential Impact on Product: [Describe potential impact on product quality or safety]
Potential Impact on Patients: [Describe potential impact on patients]
Data Integrity Impact
Data Integrity Assessment: [Describe any impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
Investigation Findings: [List findings from the investigation]
CAPA (Corrective and Preventive Action)
CAPA Plan: [Describe the CAPA plan developed to address the deviation]
Implementation Date: [Enter date of implementation]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details of Re-test/Requalification: [Provide details if applicable]
QA Disposition
QA Disposition: [Enter QA disposition regarding the deviation]