RMG (Rapid Mixer Granulator) – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment: RMG (Rapid Mixer Granulator)

Area: Production/Granulation

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation ID: [Enter Deviation ID]
Date of Deviation: [Enter Date]
Description: [Enter Description of Deviation]

Classification

Classification Type: [Enter Classification Type, e.g., Major/Minor]

Product/Patient Impact

Impact Assessment: [Describe the potential impact on product and patient safety]

Data Integrity Impact

Data Integrity Assessment: [Assess the impact on data integrity]

Affected Batches/Studies

Affected Batches: [List affected batches]
Affected Studies: [List affected studies]

Investigation

Investigation Summary: [Provide a summary of the investigation conducted]

CAPA (Corrective and Preventive Action)

CAPA Plan: [Describe the CAPA plan to address the deviation]

Re-test/Requalification Decision

Decision: [State the decision regarding re-testing or re-qualification]

QA Disposition

Disposition: [Enter QA disposition regarding the deviation]

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