Deviation Impact Assessment

Equipment: Glass Lined Reactor (GLR)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

1. Deviation Details

Deviation ID: ____________________

Date of Deviation: ____________________

Description of Deviation: _______________________________________________

2. Classification

Classification Type: ____________________

3. Product/Patient Impact

Potential Impact on Product: ___________________________________________

Potential Impact on Patient: ____________________________________________

4. Data Integrity Impact

Impact on Data Integrity: _______________________________________________

5. Affected Batches/Studies

List of Affected Batches/Studies: _____________________________________

6. Investigation

Investigation Summary: _________________________________________________

Root Cause Analysis: _________________________________________________

7. CAPA (Corrective and Preventive Actions)

Actions Taken: ______________________________________________________

Responsible Person: _________________________________________________

Due Date: ____________________

8. Re-test/Requalification Decision

Re-test/Requalification Required: Yes / No

If Yes, Details: _________________________________________________

9. QA Disposition

Disposition Decision: ________________________________________________

Comments: _______________________________________________________