Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities performed for the Weighing Balance (Analytical) used in the Production/Dispensing area. The equipment has been validated in accordance with the established protocols and acceptance criteria.

Scope/Boundaries

The scope of this validation includes the installation, operational, and performance qualification of the Analytical Weighing Balance. The boundaries are limited to the production and dispensing processes associated with solid dosage forms (OSD).

Executed Protocol List

• DQ Protocol – Design Qualification
• IQ Protocol – Installation Qualification
• OQ Protocol – Operational Qualification
• PQ Protocol – Performance Qualification

Deviations Summary

No deviations were reported during the execution of the validation protocols. All activities were completed as per the approved protocols.

CPP Verification Summary

The key critical parameters verified during the validation process include:

• Accuracy
• Repeatability
• Linearity

All parameters met the acceptance criteria as outlined in the URS SOP Calibration.

Conclusion

The Weighing Balance (Analytical) has successfully passed all validation phases (DQ, IQ, OQ, PQ) and is deemed suitable for use in the Production/Dispensing area for solid dosage forms (OSD). The requalification frequency is established at 12 months.

Attachments Index

• Attachment 1: DQ Protocol Document
• Attachment 2: IQ Protocol Document
• Attachment 3: OQ Protocol Document
• Attachment 4: PQ Protocol Document
• Attachment 5: Calibration SOP

Approvals

Prepared by: [Name], [Title]

Approved by: [Name], [Title]