Ultrafiltration/Diafiltration (UF/DF) Skid – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment: Ultrafiltration/Diafiltration (UF/DF) Skid

Area: R&D/Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Enter detailed description of the deviation here]

Date of Deviation: [Enter date]

Reported By: [Enter name]

Classification

Deviation Classification: [Enter classification e.g., Major, Minor]

Product/Patient Impact

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

Data Integrity Impact

Data Integrity Assessment: [Describe impact on data integrity]

Affected Batches/Studies

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

Investigation

Investigation Summary: [Provide summary of investigation conducted]

Root Cause Analysis: [Describe root cause]

CAPA (Corrective and Preventive Actions)

CAPA Summary: [Outline corrective and preventive actions taken]

Re-test/Requalification Decision

Decision: [State decision regarding re-test/requalification]

QA Disposition

Disposition: [Enter QA disposition]

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