Deviation Impact Assessment

Equipment Details

Equipment: De-lumper / Lump Breaker

Area: Production/Sieving

Criticality: Major

Product Impact: Direct

CSV Required: No

Deviation Details

[Insert detailed description of the deviation here]

Classification

[Insert classification of the deviation here]

Product/Patient Impact

[Insert assessment of potential product/patient impact here]

Data Integrity Impact

[Insert assessment of data integrity impact here]

Affected Batches/Studies

[Insert list of affected batches/studies here]

Investigation

[Insert details of the investigation conducted here]

CAPA (Corrective and Preventive Action)

[Insert details of the CAPA plan here]

Re-test/Requalification Decision

[Insert decision regarding re-testing/requalification here]

QA Disposition

[Insert QA disposition here]