Deviation Impact Assessment
Equipment: Fluid Bed Granulator (FBG)
Area: Production/Granulation
Criticality: Critical
Product Impact: Direct
CSV Required: Yes
Deviation Details
[Enter detailed description of the deviation here]
Classification
[Enter classification of the deviation (e.g., Major, Minor, Critical)]
Product/Patient Impact
[Describe how the deviation may impact the product or patient safety]
Data Integrity Impact
[Assess the impact on data integrity due to the deviation]
Affected Batches/Studies
[List affected batches or studies here]
Investigation
[Outline the investigation process and findings]
CAPA (Corrective and Preventive Action)
[Detail the CAPA plan to address the deviation]
Re-test/Requalification Decision
[Determine if re-testing or requalification is necessary and describe the decision process]
QA Disposition
[Provide QA’s final disposition regarding the deviation]