Deviation Impact Assessment

Equipment: Depyrogenation Tunnel

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

[Insert details of the deviation here]

Classification

[Insert classification of the deviation here]

Product/Patient Impact

[Insert potential impact on product/patient here]

Data Integrity Impact

[Insert assessment of data integrity impact here]

Affected Batches/Studies

[List affected batches or studies here]

Investigation

[Insert investigation findings here]

CAPA (Corrective and Preventive Actions)

[Insert CAPA details here]

Re-test/Requalification Decision

[Insert decision regarding re-test/requalification here]

QA Disposition

[Insert QA disposition here]