Validation Summary Report (VSR)
Equipment: Weighing Balance (Platform/Floor)
Subcategory: Solid Dosage Form (OSD)
Area: Production/Dispensing
Summary
This report summarizes the validation activities performed for the Weighing Balance used in the Production and Dispensing area for Solid Dosage Forms. The validation process included Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), all of which were executed according to the URS SOP Calibration.
Scope/Boundaries
The scope of this validation encompasses the Weighing Balance used for weighing solid dosage forms in the Production/Dispensing area. The boundaries include all relevant operational procedures and calibration processes as per established SOPs.
Executed Protocol List
- DQ Protocol
- IQ Protocol
- OQ Protocol
- PQ Protocol
Deviations Summary
No deviations were noted during the validation process. All protocols were executed as planned, adhering to the established acceptance criteria.
CPP Verification Summary
The key critical parameters verified during the validation included:
- Accuracy
- Linearity
- Corner Test
All parameters met the acceptance criteria as specified in the URS SOP Calibration.
Conclusion
Based on the validation activities performed, the Weighing Balance is deemed qualified for use in the Production/Dispensing area for Solid Dosage Forms. The equipment will require requalification every 12 months to ensure continued compliance and performance.
Attachments Index
- DQ Protocol Document
- IQ Protocol Document
- OQ Protocol Document
- PQ Protocol Document
- Calibration Certificates
Approvals
Validated by: [Name], [Title], [Date]
Approved by: [Name], [Title], [Date]