Deviation Impact Assessment

Equipment: Jet Mill / Micronizer

Area: Production/Milling

Criticality: Critical

Product Impact: Direct

Deviation Details

[Provide a detailed description of the deviation here]

Classification

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

Product/Patient Impact

[Describe the potential impact on the product and patient safety]

Data Integrity Impact

[Assess the impact on data integrity due to the deviation]

Affected Batches/Studies

[List all affected batches or studies related to the deviation]

Investigation

[Outline the investigation process undertaken to assess the deviation]

CAPA (Corrective and Preventive Action)

[Detail the CAPA plan to address the deviation]

Re-test/Requalification Decision

[State the decision regarding re-testing or re-qualification of the equipment]

QA Disposition

[Provide the Quality Assurance disposition regarding the deviation]