Drying Oven / Drying Tunnel – Deviation Impact Assessment

Deviation Impact Assessment

Equipment Details

Equipment: Drying Oven / Drying Tunnel

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 Findings:

Corrective and Preventive Actions (CAPA)

Proposed CAPA:

Re-test/Requalification Decision

Re-test/Requalification Decision:

Quality Assurance Disposition

QA Disposition:

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