Tablet Metal Detector (Inline) – Validation Summary Report (VSR) Template

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
See also  Spheronizer / Marumerizer – PQ Protocol

Approvals

Approved by: ______________________

Date: ______________________

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