Deviation Impact Assessment Template

Equipment: Sachets & Stick Packs (Non-Sterile)

Area: Equipment

Criticality: Direct

Product Impact: Prepare bulk powder blend or granulation for sachet filling

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

[Insert list of affected batches/studies here]

Investigation

[Insert details of the investigation conducted here]

CAPA (Corrective and Preventive Action)

[Insert details of CAPA here]

Re-test/Requalification Decision

[Insert decision on re-test/requalification here]

QA Disposition

[Insert QA disposition here]

CSV Required

Yes