Validation Summary Report
Equipment: Tablet Metal Detector (Inline)
Subcategory: Solid Dosage Form (OSD)
Area: Production/Compression
Summary
This Validation Summary Report (VSR) outlines the validation activities conducted for the Tablet Metal Detector (Inline) utilized in the Production/Compression area. The equipment has undergone Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with URS Annex11 acceptance criteria.
Scope/Boundaries
The scope of this validation includes the assessment of the Tablet Metal Detector’s performance in detecting metal contaminants in solid dosage forms. The boundaries of this validation encompass the operational parameters, calibration, and maintenance procedures applicable to the equipment.
Executed Protocol List
- Design Qualification (DQ) Protocol
- Installation Qualification (IQ) Protocol
- Operational Qualification (OQ) Protocol
- Performance Qualification (PQ) Protocol
Deviations Summary
No deviations were reported during the validation activities. All protocols were executed as per the established procedures and acceptance criteria.
CPP Verification Summary
The key critical parameter verified during the validation was the sensitivity reject verification audit trail. The equipment demonstrated compliance with the specified sensitivity thresholds, ensuring effective detection of metal contaminants.
Conclusion
The validation of the Tablet Metal Detector (Inline) has been successfully completed. All acceptance criteria have been met, and the equipment is deemed qualified for use in the Production/Compression area. Requalification is scheduled to occur every 12 months.
Attachments Index
- Attachment 1: DQ Protocol Report
- Attachment 2: IQ Protocol Report
- Attachment 3: OQ Protocol Report
- Attachment 4: PQ Protocol Report
- Attachment 5: Sensitivity Audit Trail
Approvals
Approved by: ______________________
Date: ______________________