Ophthalmic Filling Machine (Dropper Bottles) – Deviation Impact Assessment

Deviation Impact Assessment

Equipment Details

Equipment: Ophthalmic Filling Machine (Dropper Bottles)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details


Classification

Major
Minor
Critical

Product/Patient Impact


Data Integrity Impact


Affected Batches/Studies


Investigation


Corrective and Preventive Actions (CAPA)


Re-test/Requalification Decision


Quality Assurance (QA) Disposition


Approval

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