Validation Summary Report (VSR)
Equipment:
Manual Inspection Booth (Controlled Lux)
Subcategory:
Ophthalmics (Sterile Eye Drops/Eye Ointments)
Area:
Production
DQ/IQ/OQ/PQ Flags:
Yes/Yes/Yes/Yes
Acceptance Criteria Reference:
URS
Key Critical Parameters:
- Illuminance range background contrast
Requalification Frequency:
12 Months
Summary:
This Validation Summary Report outlines the validation activities performed for the Manual Inspection Booth utilized in the production of ophthalmic products. The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring compliance with the established User Requirements Specification (URS).
Scope/Boundaries:
The scope of this validation encompasses the Manual Inspection Booth’s performance and its impact on the quality of sterile eye drops and eye ointments produced in the production area. The boundaries include the operational parameters defined in the URS and the testing protocols executed during validation.
Executed Protocol List:
- DQ Protocol
- IQ Protocol
- OQ Protocol
- PQ Protocol
Deviations Summary:
No significant deviations were encountered during the validation process. All protocols were executed as per the predefined acceptance criteria.
CPP Verification Summary:
The critical parameters were verified against the acceptance criteria outlined in the URS. The illuminance range and background contrast were tested and met the specified requirements.
Conclusion:
The validation of the Manual Inspection Booth has been successfully completed, demonstrating that the equipment operates within the defined specifications and meets the necessary regulatory requirements for the production of ophthalmic products.
Attachments Index:
- Executed Protocols
- Test Results
- Calibration Certificates
- Maintenance Records
Approvals:
Prepared by: ______________________
Date: ______________________
Reviewed by: ______________________
Date: ______________________
Approved by: ______________________
Date: ______________________