Vacuum Degassing System – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment: Vacuum Degassing System

Subcategory: Suppositories & Implants

Area: Production

Summary

This Validation Summary Report outlines the validation activities conducted for the Vacuum Degassing System used in the production of suppositories and implants. The validation process adheres to the requirements set forth in the User Requirements Specification (URS) Annex 11.

Scope/Boundaries

The scope of this validation includes the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Vacuum Degassing System. The system is utilized within the production area specifically for the formulation of suppositories and implants.

Executed Protocol List

  • DQ Protocol: Vacuum Degassing System DQ – [Date]
  • IQ Protocol: Vacuum Degassing System IQ – [Date]
  • OQ Protocol: Vacuum Degassing System OQ – [Date]
  • PQ Protocol: Vacuum Degassing System PQ – [Date]

Deviations Summary

No significant deviations were encountered during the validation process. All activities were performed in compliance with the established protocols and acceptance criteria.

CPP Verification Summary

The following key critical parameters were verified during the validation process:

  • Vacuum pressure: Confirmed to be within acceptable limits as per URS Annex 11.
  • Degassing time: Verified against established benchmarks.
  • Audit trail logs: Reviewed and found to be complete and accurate.

Conclusion

The validation activities for the Vacuum Degassing System have been successfully completed. The system meets all specified requirements and is deemed suitable for use in the production of suppositories and implants. Requalification is scheduled to occur every 12 months.

See also  Sampling Booth (Downflow/RLAF) – Deviation Impact Assessment

Attachments Index

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

Approvals

Prepared by: [Name], [Title], [Date]

Reviewed by: [Name], [Title], [Date]

Approved by: [Name], [Title], [Date]

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