Validation Summary Report

Equipment: Checkweigher (Inline)

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Packaging/Primary

Summary

This Validation Summary Report (VSR) outlines the validation activities conducted for the Checkweigher (Inline) used in the packaging of sterile eye drops and eye ointments. The report details the execution of DQ, IQ, OQ, and PQ protocols in accordance with the acceptance criteria referenced in the URS Annex 11.

Scope/Boundaries

The scope of this validation encompasses the installation, operational qualification, and performance qualification of the inline checkweigher in the packaging process for sterile ophthalmic products. The boundaries of this validation include all relevant equipment, software, and processes related to the checkweigher.

Executed Protocol List

DQ Protocol – Checkweigher (Inline)
IQ Protocol – Checkweigher (Inline)
OQ Protocol – Checkweigher (Inline)
PQ Protocol – Checkweigher (Inline)

Deviations Summary

No deviations were noted during the validation activities. All protocols were executed as per the established procedures and acceptance criteria.

CPP Verification Summary

The following key critical parameters were verified:

Accuracy
Reject Logic
Audit Trail

All parameters met the acceptance criteria defined in the URS Annex 11.

Conclusion

The validation of the Checkweigher (Inline) has been successfully completed. The equipment has demonstrated compliance with the specified acceptance criteria and is fit for its intended use in the packaging of sterile ophthalmic products. Requalification is scheduled for 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

Approvals

This report has been reviewed and approved by the following personnel:

Quality Assurance Manager: [Name]
Validation Lead: [Name]
Production Manager: [Name]