Validation Summary Report (VSR)
Equipment: Dose Metering Test System (Spray Pattern / Shot Weight)
Summary
This Validation Summary Report outlines the validation activities conducted for the Dose Metering Test System utilized in the QC/Production area for Nasal & Otic Products. The report includes the execution of DQ, IQ, OQ, and PQ protocols as per URS Annex11 acceptance criteria.
Scope and Boundaries
The scope of this validation encompasses the Dose Metering Test System, focusing on its application in the testing of both sterile and non-sterile nasal and otic products. The boundaries include all operational aspects of the system within the QC/Production area.
Executed Protocol List
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Deviations Summary
No deviations were noted during the execution of the validation protocols. All activities were conducted in compliance with the defined acceptance criteria.
CPP Verification Summary
The key critical parameters verified include:
- Dose uniformity
- Spray geometry
- Audit trail integrity
All parameters met the acceptance criteria as specified in URS Annex11.
Conclusion
The Dose Metering Test System has been successfully validated for use in the testing of nasal and otic products. The system operates within defined parameters, and its performance is compliant with regulatory requirements. Requalification is scheduled every 12 months.
Attachments Index
- Executed Protocols
- Raw Data and Results
- Calibration Certificates
- Audit Trail Records
Approvals
This report has been reviewed and approved by the following personnel:
- Quality Assurance Manager: [Name]
- Validation Lead: [Name]
- Production Manager: [Name]