Validation Summary Report for Shaking Incubator

Summary

This Validation Summary Report (VSR) outlines the validation activities performed for the Shaking Incubator utilized in the Production/Cell Culture area for Biologics Upstream Processing. The equipment has undergone Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with the acceptance criteria outlined in URS Annex 11.

Scope/Boundaries

The scope of this validation includes the Shaking Incubator used for cell culture processes. It encompasses the evaluation of critical parameters such as temperature, RPM, and uniformity, as well as the review of PLC logs. The boundaries of this validation extend to the operational limits defined in the URS.

Executed Protocol List

• DQ Protocol – Shaking Incubator
• IQ Protocol – Shaking Incubator
• OQ Protocol – Shaking Incubator
• PQ Protocol – Shaking Incubator

Deviations Summary

No deviations were noted during the execution of the validation protocols. All tests were completed as per the protocol requirements.

CPP Verification Summary

The key critical parameters (CPPs) of temperature, RPM, and uniformity were verified against the acceptance criteria. All parameters were found to be within acceptable limits as per the specifications detailed in URS Annex 11.

Conclusion

The Shaking Incubator has been successfully validated for use in Production/Cell Culture for Biologics Upstream Processing. The equipment meets all acceptance criteria and is deemed suitable for its intended use. Requalification is scheduled to occur every 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: Raw Data Logs

Approvals

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

• Validation Manager: [Name]
• Quality Assurance Representative: [Name]
• Production Supervisor: [Name]