Lyophilizer (Freeze Dryer) – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment Details

Equipment: Lyophilizer (Freeze Dryer)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Deviation Classification:

Minor
Major
Critical

Product/Patient Impact

Describe Product/Patient Impact:

Data Integrity Impact

Describe Data Integrity Impact:

Affected Batches/Studies

List Affected Batches/Studies:

Investigation

Investigation Summary:

Corrective and Preventive Actions (CAPA)

Describe CAPA:

Re-test/Requalification Decision

Re-test/Requalification Decision:

Quality Assurance Disposition

QA Disposition:

Submit Assessment