Deviation Impact Assessment
Equipment Details
Equipment: Aseptic Filling Machine (IV Bottles)
Area: 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
Impact Assessment: [Enter assessment of potential impact on product/patient]
Data Integrity Impact
Data Integrity Assessment: [Enter assessment of potential impact on data integrity]
Affected Batches/Studies
List of Affected Batches/Studies:
- [Batch/Study 1]
- [Batch/Study 2]
- [Batch/Study 3]
Investigation
Investigation Summary: [Enter summary of the investigation conducted]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter summary of CAPA actions taken]
Re-test/Requalification Decision
Decision: [Enter decision regarding re-test/requalification]
Justification: [Enter justification for decision]
QA Disposition
Disposition Summary: [Enter QA disposition regarding the deviation]