Deviation Impact Assessment

Equipment Details

Equipment: Solvent Addition / Metering Pump

Area: R&D/Production

Criticality: Major

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Deviation Classification:

Major
Minor
Critical

Product/Patient Impact

Impact on Product/Patient:

Data Integrity Impact

Impact on Data Integrity:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

CAPA

Corrective and Preventive Actions (CAPA):

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition:

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