Case Packer – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities performed for the Case Packer used in the packaging of IV Infusions (LVP/SVP – Bags/Bottles) within the Packaging/Secondary area. The report includes the validation phases of DQ, IQ, OQ, and PQ, confirming compliance with the acceptance criteria as per URS Annex 11.

Scope/Boundaries

The scope of this validation encompasses the Case Packer’s performance and operational qualifications, ensuring that it meets the specified requirements for the packaging of IV Infusions. The boundaries include all operational and control aspects of the equipment within the Packaging/Secondary area.

Executed Protocol List

  • DQ Protocol – Case Packer
  • IQ Protocol – Case Packer
  • OQ Protocol – Case Packer
  • PQ Protocol – Case Packer

Deviations Summary

No deviations were noted during the execution of the validation protocols. All tests were conducted as per the approved protocols, and the equipment met all acceptance criteria.

CPP Verification Summary

The key critical parameter verified during the validation was the pack integrity audit trail. The results confirmed that the Case Packer consistently maintains pack integrity throughout the packaging process, ensuring compliance with regulatory standards.

Conclusion

Based on the executed validation protocols, the Case Packer is deemed qualified for use in the packaging of IV Infusions (LVP/SVP – Bags/Bottles) within the Packaging/Secondary area. The equipment meets all specified acceptance criteria and is approved for routine use. Requalification is scheduled at a frequency of 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: Pack Integrity Audit Trail Report
See also  Air Classifier Mill – IQ Protocol

Approvals

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

  • Validation Manager: ____________________ Date: ___________
  • Quality Assurance: ____________________ Date: ___________
  • Operations Manager: ____________________ Date: ___________

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