Bottle Unscrambler – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment: Bottle Unscrambler

Subcategory: Solid Dosage Form (OSD)

Area: Packaging/Primary

Summary

This Validation Summary Report (VSR) outlines the validation activities conducted for the Bottle Unscrambler used in the packaging of solid dosage forms. The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, all of which have been completed successfully.

Scope/Boundaries

The scope of this validation encompasses the Bottle Unscrambler within the packaging area for solid dosage forms. The validation activities are limited to the equipment’s operation, performance, and integration into the existing packaging line.

Executed Protocol List

  • DQ Protocol: Bottle Unscrambler Design Qualification
  • IQ Protocol: Bottle Unscrambler Installation Qualification
  • OQ Protocol: Bottle Unscrambler Operational Qualification
  • PQ Protocol: Bottle Unscrambler Performance Qualification

Deviations Summary

No deviations were noted during the validation process. All protocols were executed as per the approved plans and specifications.

CPP Verification Summary

The key critical parameters verified during the validation include:

  • Speed: Confirmed to be within specified limits.
  • Jam Sensors: Functionality tested and confirmed operational.
  • Interlocks: Verified to ensure safety and compliance.

Conclusion

Based on the executed validation protocols, the Bottle Unscrambler is deemed qualified for use in the packaging of solid dosage forms. The equipment meets the acceptance criteria as outlined in the User Requirement Specification (URS).

Requalification Frequency

The Bottle Unscrambler will be subject to requalification every 24 months to ensure continued compliance and performance.

Attachments Index

  • Attachment 1: DQ Protocol Document
  • Attachment 2: IQ Protocol Document
  • Attachment 3: OQ Protocol Document
  • Attachment 4: PQ Protocol Document
  • Attachment 5: User Requirement Specification (URS)
See also  Lyophilizer (if lyophilized syringe/cartridge) – IQ Protocol

Approvals

This report has been reviewed and approved by the following individuals:

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

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