Validation Summary Report (VSR)

Equipment Information

Equipment: Dispensing Booth

Subcategory: API Manufacturing (Chemical Synthesis)

Area: Production/Dispensing

Validation Flags

DQ: Yes

IQ: Yes

OQ: Yes

PQ: Yes

Acceptance Criteria Reference

URS ISO14644 Annex15

Key Critical Parameters

Air velocity
HEPA integrity
DP alarms

Requalification Frequency

12 Months

Summary

This Validation Summary Report outlines the validation activities conducted for the Dispensing Booth used in API Manufacturing. The report includes details of the executed protocols, deviations, critical parameter verification, and final conclusions.

Scope and Boundaries

The scope of this validation includes the Dispensing Booth’s operational parameters, environmental controls, and compliance with relevant standards. The boundaries are defined by the equipment’s operational limits and the requirements set forth in the URS.

Executed Protocol List

DQ Protocol
IQ Protocol
OQ Protocol
PQ Protocol

Deviations Summary

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

CPP Verification Summary

All critical parameters, including air velocity, HEPA integrity, and DP alarms, were verified and found to be within acceptable limits as per the acceptance criteria.

Conclusion

The Dispensing Booth has been successfully validated, meeting all the specified requirements and acceptance criteria. It is deemed suitable for use in API Manufacturing.

Attachments Index

Executed Protocols
Calibration Certificates
Test Results
Deviation Reports

Approvals

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Validation Manager

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Quality Assurance