Lyophilizer (Freeze Dryer) – NDDS – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment Details

Equipment: Lyophilizer (Freeze Dryer) – NDDS

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Major
Minor
Critical

Product/Patient Impact

Potential 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

Decision on Re-Test/Requalification:

QA Disposition

QA Disposition:

Approved
Rejected
Pending

Additional Comments

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