Validation Summary Report (VSR)
Summary
This Validation Summary Report outlines the qualification activities for the Sampling Booth (Downflow/RLAF) used in the Production/Sampling area for Solid Dosage Forms (OSD). The report covers the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, confirming compliance with URS ISO14644 Annex 15 standards.
Scope and Boundaries
The scope of this validation encompasses the evaluation of the Sampling Booth’s design, installation, operational performance, and ongoing performance in the Production/Sampling area, focusing on air velocity, HEPA integrity, and differential pressure (DP) alarms.
Executed Protocol List
- DQ Protocol: Sampling Booth Design Qualification
- IQ Protocol: Sampling Booth Installation Qualification
- OQ Protocol: Sampling Booth Operational Qualification
- PQ Protocol: Sampling Booth Performance Qualification
Deviations Summary
No deviations were recorded during the qualification process. All tests were executed as per the approved protocols, meeting the acceptance criteria.
CPP Verification Summary
The following Key Critical Parameters (CPP) were verified during the qualification process:
- Air Velocity: Confirmed within acceptable limits
- HEPA Integrity: Passed all integrity tests
- DP Alarms: Functionality verified and alarms tested
Conclusion
The Sampling Booth (Downflow/RLAF) has successfully completed all qualification phases (DQ, IQ, OQ, PQ) as per the defined acceptance criteria in URS ISO14644 Annex 15. The equipment is deemed qualified for use in the Production/Sampling area for Solid Dosage Forms (OSD), with a requalification frequency of 12 months.
Approvals
Prepared by: ____________________ Date: ___________
Reviewed by: ____________________ Date: ___________
Approved by: ____________________ Date: ___________