Extrusion System (Liposome Extruder) – Deviation Impact Assessment

Deviation Impact Assessment

Equipment Information

Equipment: Extrusion System (Liposome Extruder)

Area: R&D/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

CAPA (Corrective and Preventive Action)

Re-test/Requalification Decision

QA Disposition

See also  Pass Box (Dynamic with HEPA) – PQ Protocol

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