Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities conducted for the SIP System used in the production of prefilled syringes and cartridges. The report includes a summary of the executed protocols, deviations, and critical parameter verification.

Scope & Boundaries

The scope of this validation encompasses the SIP System utilized in the production area for prefilled syringes and cartridges. The boundaries include all equipment and processes associated with the SIP System within the production environment.

Executed Protocol List

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)

Deviations Summary

No significant deviations were noted during the validation process. All protocols were executed as per the established criteria.

CPP Verification Summary

The following critical parameters were verified during the validation:

Temperature
Pressure
Hold
Audit Trail Logs

All critical parameters met the acceptance criteria as specified in the URS Annex 15.

Conclusion

The validation of the SIP System for the production of prefilled syringes and cartridges has been successfully completed. All acceptance criteria have been met, and the system is deemed qualified for use. Requalification will be conducted every 12 months.

Attachments Index

Attachment 1: DQ Report
Attachment 2: IQ Report
Attachment 3: OQ Report
Attachment 4: PQ Report

Approvals

Validated by: ______________________

Date: ______________________

Approved by: ______________________