Validation Summary Report (VSR)

Equipment Information

Equipment: Cap Tightening / Capping Machine

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes

Acceptance Criteria Reference: URS Annex11

Key Critical Parameters: Torque range reject logic audit trail

Requalification Frequency: 12M

Summary

This Validation Summary Report outlines the validation activities conducted for the Cap Tightening / Capping Machine in the production area for ophthalmic products. The report summarizes the execution of the DQ, IQ, OQ, and PQ protocols, along with key findings and conclusions.

Scope/Boundaries

The scope of the validation encompasses the Cap Tightening / Capping Machine used for the capping of sterile eye drops and ointments. The boundaries include all operational parameters, maintenance, and compliance with relevant regulatory requirements.

Executed Protocol List

DQ Protocol – Document Number: DQ-001
IQ Protocol – Document Number: IQ-001
OQ Protocol – Document Number: OQ-001
PQ Protocol – Document Number: PQ-001

Deviations Summary

No significant deviations were noted during the execution of the validation protocols. All critical parameters were within specified limits, and any minor observations were addressed promptly.

CPP Verification Summary

The critical process parameters (CPPs) related to torque settings were verified against the acceptance criteria. The torque range reject logic audit trail was successfully validated, ensuring compliance with the URS Annex11 requirements.

Conclusion

The validation activities for the Cap Tightening / Capping Machine have been successfully completed. The equipment meets all specified requirements, and the validation is deemed successful. The machine is approved for use in the production of sterile ophthalmic products.

Attachments Index

Attachment 1: DQ Protocol Report
Attachment 2: IQ Protocol Report
Attachment 3: OQ Protocol Report
Attachment 4: PQ Protocol Report
Attachment 5: Audit Trail Documentation

Approvals

Validated by: ______________________

Date: ______________________________

Approved by: ______________________