Blister Packing Machine (Thermoform) – Deviation Impact Assessment

Deviation Impact Assessment

Equipment Details

Equipment: Blister Packing Machine (Thermoform)

Area: Packaging/Primary

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Classification

Minor
Major
Critical

Product/Patient Impact

Data Integrity Impact

Affected Batches/Studies

Investigation

Corrective and Preventive Actions (CAPA)

Re-test/Requalification Decision

QA Disposition

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