Deviation Impact Assessment

Equipment: Fitz Mill / Comminuting Mill

Area: Production/Milling

Criticality: Major

Product Impact: Direct

Deviation Details

[Insert detailed description of the deviation here]

Classification

[Insert classification of the deviation here]

Product/Patient Impact

[Insert assessment of product/patient impact here]

Data Integrity Impact

[Insert assessment of data integrity impact here]

Affected Batches/Studies

[List affected batches or studies here]

Investigation

[Insert summary of the investigation conducted here]

Corrective and Preventive Actions (CAPA)

[Insert details of CAPA here]

Re-Test/Requalification Decision

[Insert decision regarding re-test/requalification here]

QA Disposition

[Insert QA disposition here]