Stent Coating Machine (Spray/Dip) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities conducted for the Stent Coating Machine (Spray/Dip) utilized in the R&D and Production of NDDS – Drug-Eluting Stents / Coated Devices. The report encompasses Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities, ensuring compliance with URS Annex 11 and Annex 15 acceptance criteria.

Scope and Boundaries

The scope of this validation encompasses the Stent Coating Machine used in the coating process of drug-eluting stents. The boundaries of this validation include all parameters affecting coating thickness uniformity, spray parameters, and drying time records. This validation does not extend to other equipment or processes outside of the specified machine and its direct operational environment.

Executed Protocol List

  • Design Qualification Protocol (DQP)
  • Installation Qualification Protocol (IQP)
  • Operational Qualification Protocol (OQP)
  • Performance Qualification Protocol (PQP)

Deviations Summary

During the validation process, no significant deviations were encountered. All protocols were executed as planned, adhering to the established acceptance criteria.

CPP Verification Summary

The key critical parameters (CPPs) verified during the validation include:

  • Coating thickness uniformity
  • Spray parameters
  • Drying time records

All CPPs were assessed and found to be within the specified limits, confirming the machine’s capability to produce compliant drug-eluting stents.

Conclusion

Based on the executed protocols and verification of critical parameters, the Stent Coating Machine (Spray/Dip) has been successfully validated for its intended use in the R&D and Production of NDDS – Drug-Eluting Stents / Coated Devices. Requalification is scheduled for every 12 months to ensure continued compliance and performance.

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Attachments Index

  • Attachment A: Design Qualification Protocol
  • Attachment B: Installation Qualification Protocol
  • Attachment C: Operational Qualification Protocol
  • Attachment D: Performance Qualification Protocol
  • Attachment E: Summary of CPP Verification Data

Approvals

Validated by: [Name, Title, Date]

Reviewed by: [Name, Title, Date]

Approved by: [Name, Title, Date]

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