Deviation Impact Assessment Template
Equipment Information
Equipment: Spray Dryer (Nano/Micro particles)
Area: R&D/Production
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification, e.g., Major, Minor]
Product/Patient Impact
Potential Impact on Product: [Describe potential impact]
Potential Impact on Patient: [Describe potential impact]
Data Integrity Impact
Data Integrity Concerns: [Describe any concerns related to data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Provide summary of investigation findings]
Corrective and Preventive Actions (CAPA)
CAPA Plan: [Detail the CAPA plan]
Re-test/Requalification Decision
Re-test/Requalification Required: [Yes/No]
Details: [Provide details of re-test/requalification decision]
Quality Assurance Disposition
QA Disposition: [Enter QA disposition, e.g., Accept, Reject]
Comments: [Any additional comments from QA]