Sterile Filtration Skid – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment: Sterile Filtration Skid

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

[Enter detailed description of the deviation here]

Classification

[Enter classification of the deviation (e.g., Major, Minor, etc.)]

Product/Patient Impact

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

Data Integrity Impact

[Assess the impact on data integrity, if applicable]

Affected Batches/Studies

[List affected batches or studies]

Investigation

[Summarize the investigation process and findings]

CAPA (Corrective and Preventive Actions)

[Outline the CAPA plan to address the deviation]

Re-test/Requalification Decision

[Document the decision regarding re-testing or re-qualification]

QA Disposition

[State the Quality Assurance disposition of the affected product]

See also  V Blender – Deviation Impact Assessment

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