Colloid Mill (if used) – Deviation Impact Assessment

Deviation Impact Assessment

Equipment: Colloid Mill

Area: Production

Criticality: Major

Product Impact: Direct

CSV Required: No

Deviation Details

[Insert detailed description of the deviation here]

Classification

[Insert classification of the deviation here]

Product/Patient Impact

[Insert assessment of product/patient impact here]

Data Integrity Impact

[Insert assessment of data integrity impact here]

Affected Batches/Studies

[Insert list of affected batches/studies here]

Investigation

[Insert summary of the investigation here]

Corrective and Preventive Actions (CAPA)

[Insert CAPA details here]

Re-test/Requalification Decision

[Insert re-test/requalification decision here]

Quality Assurance (QA) Disposition

[Insert QA disposition here]

See also  Tablet Metal Detector (Inline) – DQ Protocol

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