Sterility Test Isolator / System (if NDDS sterile) – Deviation Impact Assessment

Deviation Impact Assessment

Equipment Details

Equipment: Sterility Test Isolator / System

Area: Microbiology

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Classification

Minor
Major
Critical

Product/Patient Impact

Data Integrity Impact

Affected Batches/Studies

Investigation

CAPA (Corrective and Preventive Actions)

Re-test/Requalification Decision

QA Disposition

See also  Sterile Holding Tank (Pressurized) – IQ Protocol

Also Check:

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VHP Generator / Decontamination Unit – Deviation Impact Assessment

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