Deviation Impact Assessment

Equipment Details

Equipment: Dust Extraction Unit (LEV for dispensing)

Area: Production/Containment

Criticality: Major

Product Impact: Indirect

CSV Required: No

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification: Major

Product/Patient Impact

Impact Assessment: [Insert assessment of product/patient impact]

Data Integrity Impact

Assessment: [Insert assessment of data integrity impact]

Affected Batches/Studies

Affected Batches: [Insert list of affected batches/studies]

Investigation

Investigation Summary: [Insert summary of the investigation]

Root Cause Analysis: [Insert root cause analysis]

Corrective and Preventive Actions (CAPA)

Actions Taken: [Insert details of CAPA]

Responsible Individual: [Insert name]

Target Completion Date: [Insert date]

Re-test/Requalification Decision

Decision: [Insert re-test/requalification decision]

Quality Assurance Disposition

Disposition: [Insert QA disposition]

Reviewed By: [Insert name]

Date of Review: [Insert date]