Deviation Impact Assessment
Equipment Details
Equipment: Flake Crusher (Post-Roller Compaction)
Area: Production/Dry Granulation
Criticality: Major
Product Impact: Direct
Deviation Details
Description: [Insert detailed description of the deviation]
Date of Deviation: [Insert date]
Reported By: [Insert name]
Classification
Classification: [Insert classification]
Product/Patient Impact
Impact Assessment: [Insert assessment of the impact on product and patient]
Data Integrity Impact
Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Batches/Studies Affected: [Insert affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation findings]
Corrective and Preventive Actions (CAPA)
Actions Taken: [Insert details of CAPA]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
QA Disposition
Disposition: [Insert QA disposition]