Deviation Impact Assessment

Equipment: Blow-Fill-Seal (BFS) Machine

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

[Insert detailed description of the deviation]

Classification

[Insert classification of the deviation]

Product/Patient Impact

[Insert assessment of product and patient impact]

Data Integrity Impact

[Insert assessment of data integrity impact]

Affected Batches/Studies

[Insert details of affected batches or studies]

Investigation

[Insert summary of the investigation conducted]

Corrective and Preventive Actions (CAPA)

[Insert details of CAPA taken]

Re-test/Requalification Decision

[Insert decision on re-testing or re-qualification]

Quality Assurance (QA) Disposition

[Insert QA disposition related to the deviation]