Capper (Screw Cap) – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment: Capper (Screw Cap)

Subcategory: Solid Dosage Form (OSD)

Area: Packaging/Primary

DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes
Acceptance Criteria Reference: URS Annex11
Key Critical Parameters: Torque range, speed, reject sensors, audit trail
Requalification Frequency: 12M

Summary

This Validation Summary Report outlines the validation activities performed for the Capper (Screw Cap) used in the Solid Dosage Form packaging area. It includes details on the design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) phases.

Scope/Boundaries

The scope of this validation encompasses the Capper (Screw Cap) equipment and its associated systems within the packaging area for solid dosage forms. This report covers all relevant validation activities conducted from initial design through to performance qualification.

Executed Protocol List

  • DQ Protocol – Capper (Screw Cap)
  • IQ Protocol – Capper (Screw Cap)
  • OQ Protocol – Capper (Screw Cap)
  • PQ Protocol – Capper (Screw Cap)

Deviations Summary

No significant deviations were noted during the validation process. All tests were executed as per the approved protocols, and any minor discrepancies were documented and resolved in accordance with standard operating procedures.

CPP Verification Summary

The critical process parameters (CPP) for the Capper (Screw Cap) were verified as follows:

  • Torque Range: Verified within specified limits.
  • Speed: Confirmed to meet operational requirements.
  • Reject Sensors: Functionality tested and confirmed operational.
  • Audit Trail: Complete and compliant with regulatory requirements.

Conclusion

The validation of the Capper (Screw Cap) has been successfully completed. All qualification activities met the acceptance criteria outlined in the URS Annex11. The equipment is deemed qualified for use in the packaging of solid dosage forms.

See also  Parts Washer (GMP) – Deviation Impact Assessment

Attachments Index

  • Attachment 1: DQ Protocol
  • Attachment 2: IQ Protocol
  • Attachment 3: OQ Protocol
  • Attachment 4: PQ Protocol
  • Attachment 5: Validation Deviations Log

Approvals

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

  • Validation Manager: [Name, Signature, Date]
  • Quality Assurance: [Name, Signature, Date]
  • Operations Manager: [Name, Signature, Date]

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