Deviation Impact Assessment

Equipment Details

Equipment: Vent Filter (Sterile Gas Filter Assembly)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: No

Deviation Details

Provide a detailed description of the deviation.

Classification

Classify the deviation (e.g., Major, Minor, Critical).

Product/Patient Impact

Assess the potential impact on the product and patient safety.

Data Integrity Impact

Evaluate any impact on data integrity resulting from the deviation.

Affected Batches/Studies

List all affected batches or studies related to the deviation.

Investigation

Document the investigation process, findings, and any conclusions drawn.

CAPA (Corrective and Preventive Actions)

Outline the corrective and preventive actions taken in response to the deviation.

Re-test/Requalification Decision

State the decision regarding re-testing or re-qualification of the equipment.

QA Disposition

Provide the final disposition from Quality Assurance regarding the deviation.