Coding Machine (Inkjet / Laser) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

1. Summary

This Validation Summary Report outlines the validation activities performed for the Coding Machine (Inkjet / Laser) used in the packaging of suppositories and implants. The report encompasses the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, ensuring compliance with regulatory standards and internal quality requirements.

2. Scope and Boundaries

The scope of this validation covers the Coding Machine utilized in the packaging area for printing on suppositories and implants. This includes all relevant processes, equipment, and personnel involved in the operation of the coding machine. The boundaries of this validation are defined by the operational limits of the equipment as per the User Requirement Specification (URS) Annex 11.

3. Executed Protocol List

  • DQ Protocol – Coding Machine
  • IQ Protocol – Coding Machine
  • OQ Protocol – Coding Machine
  • PQ Protocol – Coding Machine

4. Deviations Summary

During the validation process, no significant deviations were noted that would impact the integrity of the validation. Minor observations were documented and addressed in accordance with standard operating procedures.

5. CPP Verification Summary

Key critical parameters were verified during the OQ and PQ phases, focusing on print quality audit trail logs. All parameters met the acceptance criteria outlined in the URS Annex 11. The verification confirmed that the coding machine operates within defined specifications.

6. Conclusion

The validation of the Coding Machine (Inkjet / Laser) for the packaging of suppositories and implants has been successfully completed. All DQ, IQ, OQ, and PQ activities were executed as planned, with acceptance criteria met. The equipment is deemed qualified for use in the specified application.

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7. Attachments Index

  • Attachment 1: DQ Protocol Report
  • Attachment 2: IQ Protocol Report
  • Attachment 3: OQ Protocol Report
  • Attachment 4: PQ Protocol Report
  • Attachment 5: Audit Trail Logs

8. Approvals

This Validation Summary Report has been reviewed and approved by the following personnel:

  • Quality Assurance: [Name, Title, Date]
  • Validation Manager: [Name, Title, Date]
  • Production Manager: [Name, Title, Date]

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