Checkweigher – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment Information

Equipment: Checkweigher

Subcategory: Suppositories & Implants

Area: Packaging

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

Acceptance Criteria Reference: URS Annex11

Key Critical Parameters: Weight accuracy reject logic audit trail logs

Requalification Frequency: 12M

Summary

This Validation Summary Report outlines the validation activities performed for the Checkweigher used in the Packaging area for Suppositories & Implants. The validation process includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Scope and Boundaries

The scope of this validation encompasses the Checkweigher’s operational parameters, including its weight accuracy, reject logic, and audit trail logs. The boundaries of this validation are limited to the Checkweigher’s performance in the Packaging area for Suppositories & Implants.

Executed Protocol List

  • DQ Protocol – Checkweigher
  • IQ Protocol – Checkweigher
  • OQ Protocol – Checkweigher
  • PQ Protocol – Checkweigher

Deviations Summary

No deviations were noted during the execution of the validation protocols. All acceptance criteria were met as per the URS Annex11.

CPP Verification Summary

Critical Process Parameters (CPP) were verified during the OQ and PQ stages. The weight accuracy reject logic and audit trail logs were confirmed to function within the defined acceptance criteria.

Conclusion

Based on the executed protocols and verification activities, the Checkweigher is deemed qualified for use in the Packaging area for Suppositories & Implants. It meets all specified acceptance criteria and is ready for routine operation.

Attachments Index

  • Attachment 1: DQ Protocol Document
  • Attachment 2: IQ Protocol Document
  • Attachment 3: OQ Protocol Document
  • Attachment 4: PQ Protocol Document
  • Attachment 5: Validation Summary Report Document
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Approvals

Prepared By: [Name, Title]

Approved By: [Name, Title]

Date: [Date]

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