Deviation Impact Assessment

Equipment: Microneedle Mold Filling / Casting System

Area: R&D/Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Please provide a detailed description of the deviation:

Classification

Select the classification of the deviation:

Major
Minor
Critical

Product/Patient Impact

Describe the potential impact on the product and/or patient:

Data Integrity Impact

Assess the impact on data integrity:

Affected Batches/Studies

Please list affected batches or studies:

Investigation

Outline the investigation conducted:

CAPA (Corrective and Preventive Actions)

Detail the CAPA plan:

Re-test/Requalification Decision

State the decision regarding re-testing or re-qualification:

QA Disposition

Provide the QA disposition:

Approval

Signature of responsible individual:

Date: