Deviation Impact Assessment

Equipment Details

Equipment: High Pressure Reactor / Hydrogenator

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

Potential Impact on Data Integrity:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

Corrective and Preventive Actions (CAPA)

CAPA Summary:

Re-Test/Requalification Decision

Re-Test/Requalification Decision:

QA Disposition

QA Disposition: