Deviation Impact Assessment

Equipment Details

Equipment: Drum Tippler/Drum Tumbler

Area: Production/Dispensing

Criticality: Major

Product Impact: Direct

CSV Required: No

Deviation Details

Description of Deviation: [Insert description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification of Deviation: [Insert classification]

Product/Patient Impact

Impact on Product: [Insert product impact assessment]

Impact on Patient: [Insert patient impact assessment]

Data Integrity Impact

Data Integrity Assessment: [Insert data integrity impact]

Affected Batches/Studies

Affected Batches/Studies: [Insert affected batches or studies]

Investigation

Investigation Summary: [Insert summary of the investigation]

Root Cause: [Insert root cause]

Corrective and Preventive Actions (CAPA)

Actions Taken: [Insert actions taken]

Preventive Measures: [Insert preventive measures]

Re-test/Requalification Decision

Re-test Required: [Yes/No]

Requalification Required: [Yes/No]

Quality Assurance Disposition

Disposition: [Insert QA disposition]

Comments: [Insert additional comments]