Pin Mill – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment Information

Equipment: Pin Mill

Subcategory: Solid Dosage Form (OSD)

Area: Production/Milling

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

Acceptance Criteria Reference: URS

Key Critical Parameters: Disc speed, output PSD, temperature

Requalification Frequency: 24 Months

Summary

This Validation Summary Report outlines the validation activities conducted for the Pin Mill used in the Solid Dosage Form production area. The report includes details on the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases.

Scope and Boundaries

The scope of this validation encompasses all aspects of the Pin Mill’s operation within the production area, focusing on its ability to meet predefined specifications and regulatory requirements. The boundaries include the equipment itself, associated software, and relevant operational procedures.

Executed Protocol List

  • DQ Protocol
  • IQ Protocol
  • OQ Protocol
  • PQ Protocol

Deviations Summary

No deviations were noted during the validation process. All tests were conducted as per the approved protocols, and all results met the acceptance criteria defined in the URS.

CPP Verification Summary

The critical process parameters (CPPs) were verified as follows:

  • Disc Speed: Verified against specifications and found to be within acceptable limits.
  • Output PSD: Confirmed to meet the required particle size distribution.
  • Temperature: Monitored and maintained within specified ranges throughout the validation process.

Conclusion

The validation activities for the Pin Mill have been successfully completed, demonstrating that the equipment operates within the specified parameters and meets the acceptance criteria as outlined in the URS. The equipment is deemed suitable for its intended use in the Solid Dosage Form production area.

See also  De-lumper / Lump Breaker – DQ Protocol

Attachments Index

  • Attachment 1: DQ Protocol Document
  • Attachment 2: IQ Protocol Document
  • Attachment 3: OQ Protocol Document
  • Attachment 4: PQ Protocol Document
  • Attachment 5: Raw Data and Results

Approvals

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

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

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

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