Deviation Impact Assessment

Equipment Details

Equipment: Suppository Cutting Machine

Area: Production

Criticality: Major

Product Impact: Direct

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification of Deviation: Major

Product/Patient Impact

Impact on Product: [Insert details of product impact]

Impact on Patient: [Insert details of patient impact]

Data Integrity Impact

Impact on Data Integrity: [Insert details of data integrity impact]

Affected Batches/Studies

Affected Batches/Studies: [Insert affected batches or studies]

Investigation

Investigation Summary: [Insert summary of investigation]

Investigation Findings: [Insert findings]

Corrective and Preventive Actions (CAPA)

CAPA Summary: [Insert summary of CAPA]

Responsible Person: [Insert name]

Due Date: [Insert due date]

Re-test/Requalification Decision

Re-test/Requalification Required: [Yes/No]

Details: [Insert details if applicable]

Quality Assurance (QA) Disposition

QA Disposition: [Insert QA disposition]

Comments: [Insert any additional comments]