Validation Summary Report (VSR)

Equipment: Tablet/Capsule Counter Filler

Subcategory: Solid Dosage Form (OSD)

Area: Packaging/Primary

Summary

This Validation Summary Report outlines the validation activities conducted for the Tablet/Capsule Counter Filler, ensuring compliance with regulatory requirements and internal quality standards.

Scope and Boundaries

The scope of this validation includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Tablet/Capsule Counter Filler. The boundaries are limited to the equipment’s operation within the Packaging/Primary area.

Executed Protocol List

• DQ Protocol: DQ-001
• IQ Protocol: IQ-002
• OQ Protocol: OQ-003
• PQ Protocol: PQ-004

Deviations Summary

No deviations were noted during the validation process. All protocols were executed as per the established procedures.

CPP Verification Summary

The key critical parameters verified during the validation include:

• Counting Accuracy: Pass
• Speed: Within specified limits
• Rejects: Within acceptable range
• Audit Trail: Fully functional

Conclusion

The Tablet/Capsule Counter Filler has successfully met all validation requirements as per URS Annex 11. It is deemed suitable for use in the Packaging/Primary area with a requalification frequency of 12 months.

Attachments Index

• Attachment 1: DQ Protocol Report
• Attachment 2: IQ Protocol Report
• Attachment 3: OQ Protocol Report
• Attachment 4: PQ Protocol Report

Approvals

Prepared by: [Name, Title]

Reviewed by: [Name, Title]

Approved by: [Name, Title]