Deviation Impact Assessment
Equipment Details
Equipment: Suppository Blister Packing Machine
Area: Packaging
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
Description of Deviation: [Enter details of the deviation here]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Deviation Classification: [Enter classification]
Product/Patient Impact
Impact Assessment: [Enter assessment of impact on product and patient]
Data Integrity Impact
Impact Assessment: [Enter assessment of data integrity impact]
Affected Batches/Studies
List of Affected Batches/Studies:
- [Batch/Study 1]
- [Batch/Study 2]
- [Batch/Study 3]
Investigation
Investigation Summary: [Enter summary of investigation findings]
CAPA (Corrective and Preventive Actions)
Actions Taken: [Enter details of CAPA]
Responsible Person: [Enter name]
Due Date: [Enter due date]
Re-test/Requalification Decision
Decision: [Enter decision regarding re-test/requalification]
QA Disposition
Disposition Summary: [Enter QA disposition details]