Deviation Impact Assessment

Equipment: Nanoparticle Reactor (Batch)

Area: R&D/Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

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 investigation findings here]

Corrective and Preventive Actions (CAPA)

[Insert details of CAPA here]

Re-test/Requalification Decision

[Insert decision regarding re-testing/requalification here]

QA Disposition

[Insert QA disposition here]