Nonclinical Laboratories (GLP)

During a GLP audit, we evaluate:

• Personnel and training
• Quality assurance unit
• Facilities
• Equipment calibration and maintenance
• SOPs
• Animal care
• Histology/pathology
• Test and control articles
• Validation of computerized systems
• Protocol
• Final study report
• Record retention

Benefits:

• Audits conducted during the live phase of the study can identify potential issues before completion of the study.
• Sponsors can be assured that contracted services are sufficient to support the requirements of the protocol.

Common Discoveries:

• An audit during the live phase found lesions on animals that were not captured as an adverse event during the daily animal observations.
• Comparison of the study data with the final study report found unreported events that were not included in final, approved study report.