Ribbon Blender – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment Details

Equipment: Ribbon Blender

Area: Production/Blending

Criticality: Major

Product Impact: Direct

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification: [Insert classification of the deviation]

Product/Patient Impact

Impact Analysis: [Insert analysis of potential product/patient impact]

Data Integrity Impact

Data Integrity Analysis: [Insert analysis of data integrity impact]

Affected Batches/Studies

Affected Batches/Studies: [Insert affected batches or studies]

Investigation

Investigation Summary: [Insert summary of investigation conducted]

Findings: [Insert findings from the investigation]

Corrective and Preventive Actions (CAPA)

CAPA Plan: [Insert details of the CAPA plan]

Re-test/Requalification Decision

Re-test/Requalification Decision: [Insert decision regarding re-testing or re-qualification]

Quality Assurance (QA) Disposition

QA Disposition: [Insert QA disposition details]

Signatures

Prepared By: _________________________

Date: _________________________

Reviewed By: _________________________

Date: _________________________

See also  Pin Mill – DQ Protocol

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