Validation Summary Report (VSR)

Summary

The Validation Summary Report for the Dust Extraction Unit (LEV for dispensing) encompasses the validation activities conducted to ensure compliance with the User Requirement Specification (URS) and to confirm that the equipment meets its intended use in the production of Solid Dosage Forms (OSD).

Scope and Boundaries

This report covers the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of the Dust Extraction Unit within the Production/Containment area. The boundaries include all relevant operational parameters and critical quality attributes associated with the equipment.

Executed Protocol List

• DQ Protocol – Dust Extraction Unit
• IQ Protocol – Dust Extraction Unit
• OQ Protocol – Dust Extraction Unit
• PQ Protocol – Dust Extraction Unit

Deviations Summary

No deviations were noted during the validation process. All protocols were executed according to established procedures and acceptance criteria.

CPP Verification Summary

The key critical parameters verified during the validation process include:

• Airflow capture velocity
• Filter integrity

All critical parameters met the established acceptance criteria as outlined in the URS.

Conclusion

The Dust Extraction Unit has successfully passed all validation phases (DQ, IQ, OQ, PQ) and is deemed compliant with the URS. The equipment is fit for use in the production of Solid Dosage Forms (OSD) and will be requalified every 24 months as per the established frequency.

Attachments Index

• Attachment 1: DQ Protocol
• Attachment 2: IQ Protocol
• Attachment 3: OQ Protocol
• Attachment 4: PQ Protocol
• Attachment 5: URS Document

Approvals

Prepared by: [Name], [Title]

Approved by: [Name], [Title]

Date: [Date]