Deviation Impact Assessment Template
Equipment: RMG (Rapid Mixer Granulator)
Area: Production/Granulation
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation ID: [Enter Deviation ID]
Date of Deviation: [Enter Date]
Description: [Enter Description of Deviation]
Classification
Classification Type: [Enter Classification Type, e.g., Major/Minor]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product and patient safety]
Data Integrity Impact
Data Integrity Assessment: [Assess the impact on data integrity]
Affected Batches/Studies
Affected Batches: [List affected batches]
Affected Studies: [List affected studies]
Investigation
Investigation Summary: [Provide a summary of the investigation conducted]
CAPA (Corrective and Preventive Action)
CAPA Plan: [Describe the CAPA plan to address the deviation]
Re-test/Requalification Decision
Decision: [State the decision regarding re-testing or re-qualification]
QA Disposition
Disposition: [Enter QA disposition regarding the deviation]