Microencapsulation Reactor / Vessel – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment Details

Equipment: Microencapsulation Reactor / Vessel

Area: R&D/Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description:

Classification

Classification of Deviation:

Major
Minor
Critical

Product/Patient Impact

Impact Assessment:

Data Integrity Impact

Data Integrity Assessment:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

Corrective and Preventive Actions (CAPA)

CAPA Plan:

Re-test/Requalification Decision

Decision:

QA Disposition

QA Disposition:

Signature

Prepared By:

Date:

See also  Ribbon Blender – PQ Protocol

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