Extruder (Single Screw) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Summary

This Validation Summary Report outlines the validation activities conducted for the Single Screw Extruder used in the Production of Solid Dosage Forms (OSD) within the Pellets area. The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). All qualifications have been executed in accordance with the acceptance criteria outlined in URS Annex11.

Scope and Boundaries

The scope of this validation includes the assessment of the Extruder’s performance and compliance with regulatory requirements. The boundaries of this validation encompass the entire lifecycle of the equipment from installation through to performance qualification, focusing specifically on the critical parameters of screw speed, feed rate, and torque.

Executed Protocol List

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

Deviations Summary

No deviations were noted during the execution of the DQ, IQ, OQ, and PQ protocols. All activities were performed as per the established procedures and protocols.

CPP Verification Summary

The critical process parameters (CPP) of screw speed, feed rate, and torque were verified during the OQ and PQ phases. All parameters were found to be within the acceptable limits as defined in the URS Annex11.

Conclusion

The validation activities for the Single Screw Extruder have been successfully completed, demonstrating that the equipment operates within the specified parameters and meets the required acceptance criteria. The equipment is validated for use in the production of solid dosage forms, with a requalification frequency set at every 24 months.

See also  Suppository Molding Machine – DQ Protocol

Attachments Index

  • Attachment 1: DQ Protocol and Report
  • Attachment 2: IQ Protocol and Report
  • Attachment 3: OQ Protocol and Report
  • Attachment 4: PQ Protocol and Report
  • Attachment 5: Calibration Certificates

Approvals

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

  • Quality Assurance Manager: ______________________
  • Validation Manager: ____________________________
  • Production Manager: ___________________________

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