Validation Summary Report (VSR)

Equipment

Cooling Tunnel / Cooling Conveyor

Subcategory

Suppositories & Implants

Area

Production

DQ/IQ/OQ/PQ Flags

Design Qualification: Yes

Installation Qualification: Yes

Operational Qualification: Yes

Performance Qualification: Yes

Acceptance Criteria Reference

URS Annex11

Key Critical Parameters

Cooling Temperature
Airflow
Time
PLC Logs
Audit Trail

Requalification Frequency

12 Months

Summary

This Validation Summary Report outlines the validation activities performed for the Cooling Tunnel / Cooling Conveyor used in the production of suppositories and implants. The report includes details on the executed protocols and the verification of critical parameters.

Scope/Boundaries

The scope of this validation encompasses the installation, operation, and performance qualifications of the Cooling Tunnel / Cooling Conveyor. It includes all relevant documentation and validation activities performed within the production area.

Executed Protocol List

DQ Protocol
IQ Protocol
OQ Protocol
PQ Protocol

Deviations Summary

No deviations were noted during the validation activities. All protocols were executed as per the established guidelines.

CPP Verification Summary

All Key Critical Parameters were verified and met the acceptance criteria outlined in the URS Annex11. The cooling temperature, airflow, time, PLC logs, and audit trail were all confirmed to be within specified limits.

Conclusion

The Cooling Tunnel / Cooling Conveyor has been successfully validated for use in the production of suppositories and implants. All qualification activities were completed in accordance with regulatory requirements, and the equipment is deemed suitable for its intended use.

Attachments Index

DQ Protocol Document
IQ Protocol Document
OQ Protocol Document
PQ Protocol Document
Validation Plan
Validation Report

Approvals

Prepared by: _________________________

Date: _________________________

Approved by: _________________________