Deviation Impact Assessment
Equipment Details
Equipment: Planetary Mixer (Wet Mass)
Area: Production/Granulation
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Description: [Insert detailed description of the deviation]
Date of Occurrence: [Insert date]
Reported By: [Insert name]
Classification
Deviation Classification: Major
Product/Patient Impact
Impact Assessment: [Insert assessment of product and patient impact]
Data Integrity Impact
Data Integrity Assessment: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of CAPA]
Re-test/Requalification Decision
Decision: [Insert decision on re-test/requalification]
Quality Assurance (QA) Disposition
Disposition: [Insert QA disposition]