Validation Summary Report (VSR)

Equipment Information

Equipment: Tablet Checkweigher (Inline)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Compression

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

Acceptance Criteria Reference: URS Annex11

Key Critical Parameters: Accuracy reject mechanism audit trail

Requalification Frequency: 12M

Summary

This Validation Summary Report outlines the validation activities conducted for the Tablet Checkweigher used in the Solid Dosage Form production area. The objective is to ensure that the equipment operates within established parameters and meets regulatory requirements.

Scope/Boundaries

The scope of this validation includes the installation, operational, and performance qualification of the Tablet Checkweigher. It covers all relevant aspects of the equipment’s functionality within the production/compression area.

Executed Protocol List

DQ Protocol
IQ Protocol
OQ Protocol
PQ Protocol

Deviations Summary

During the validation process, no significant deviations were noted that would impact the validity of the qualification results. All tests were performed in accordance with the approved protocols.

CPP Verification Summary

Critical Process Parameters (CPP) were verified through a series of tests that confirmed the accuracy of the reject mechanism and the integrity of the audit trail. All parameters met the acceptance criteria as defined in the URS.

Conclusion

The validation activities for the Tablet Checkweigher have been successfully completed. The equipment has been demonstrated to operate within the required specifications and is suitable for use in the Solid Dosage Form production process.

Attachments Index

Attachment 1: DQ Protocol Report
Attachment 2: IQ Protocol Report
Attachment 3: OQ Protocol Report
Attachment 4: PQ Protocol Report
Attachment 5: Calibration Certificates

Approvals

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

Name: [Approver Name 1] – [Title]
Name: [Approver Name 2] – [Title]
Name: [Approver Name 3] – [Title]