Dispensing Booth (Downflow) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment Information

Equipment: Dispensing Booth (Downflow)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Dispensing

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes

Acceptance Criteria Reference: URS ISO14644 Annex15

Key Critical Parameters: Air velocity, HEPA integrity, DP alarms

Requalification Frequency: 12M

Summary

This Validation Summary Report provides an overview of the validation activities performed for the Dispensing Booth (Downflow) utilized in the production of solid dosage forms. It includes details on the execution of the validation protocols, deviations encountered, and the verification of critical process parameters.

Scope and Boundaries

The scope of this validation encompasses the qualification of the Dispensing Booth (Downflow) within the Production/Dispensing area. It includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

Executed Protocol List

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

Deviations Summary

No significant deviations were encountered during the validation process. All protocols were executed as per the approved plans.

CPP Verification Summary

Critical Process Parameters (CPPs) were verified as follows:

  • Air Velocity: Verified within acceptable limits as per URS ISO14644 Annex15.
  • HEPA Integrity: Passed integrity tests with no breaches detected.
  • DP Alarms: Functionality tested and confirmed operational.

Conclusion

The validation activities for the Dispensing Booth (Downflow) have been successfully completed. All acceptance criteria have been met, and the equipment is deemed qualified for use in the production of solid dosage forms.

Attachments Index

  • Attachment 1: Design Qualification Protocol (DQP)
  • Attachment 2: Installation Qualification Protocol (IQP)
  • Attachment 3: Operational Qualification Protocol (OQP)
  • Attachment 4: Performance Qualification Protocol (PQP)
  • Attachment 5: Validation Summary Report (VSR)
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Approvals

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

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

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

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