Nasal/Otic Compounding Vessel (Jacketed SS) – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment Information

Equipment: Nasal/Otic Compounding Vessel (Jacketed SS)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Minor
Major
Critical

Product/Patient Impact

Potential Impact on Product/Patient:

Data Integrity Impact

Impact on Data Integrity:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Details:

Corrective and Preventive Action (CAPA)

CAPA Plan:

Re-test/Requalification Decision

Decision on Re-test/Requalification:

Quality Assurance (QA) Disposition

QA Disposition:

See also  Nasal/Otic Compounding Vessel (Jacketed SS) – Equipment Validation SOP

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