Blister Packing Machine (Thermoform) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Summary

This Validation Summary Report (VSR) outlines the validation activities performed for the Blister Packing Machine (Thermoform) utilized in the Packaging/Primary area for Solid Dosage Forms (OSD). The report covers the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, ensuring compliance with regulatory requirements and the acceptance criteria specified in the URS Annex 11.

Scope and Boundaries

The scope of this validation includes the installation and operational performance of the Blister Packing Machine (Thermoform) within the Packaging area. The boundaries of this validation extend to the critical parameters including forming temperature, sealing temperature, dwell time, pressure, reject PLC, and their respective monitoring and control systems.

Executed Protocol List

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

Deviations Summary

During the validation process, no critical deviations were identified. All parameters were within the acceptable limits as defined in the URS Annex 11. Any minor observations were documented and addressed promptly.

CPP Verification Summary

The critical process parameters (CPPs) including forming temperature, sealing temperature, dwell pressure, and reject PLC were validated and verified against the acceptance criteria. All measurements were recorded and confirmed to be within the specified limits.

Conclusion

Based on the executed validation protocols and the successful verification of critical parameters, the Blister Packing Machine (Thermoform) is deemed qualified for use in the production of Solid Dosage Forms (OSD) within the Packaging area. Requalification is scheduled to occur every 12 months.

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Attachments Index

  • Attachment 1: DQ Protocol
  • Attachment 2: IQ Protocol
  • Attachment 3: OQ Protocol
  • Attachment 4: PQ Protocol
  • Attachment 5: Deviations Log
  • Attachment 6: CPP Verification Data

Approvals

The undersigned approve this Validation Summary Report:

__________________________
Validation Manager

__________________________
Quality Assurance Representative

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