Good Laboratory Practice and Quality Control

Good Laboratory Practices and Quality Control at the UC San Diego Pediatric Pharmacology Laboratory

Our laboratory operates according to Good Laboratory Practices (GLP), in addition to being a licensed CLIA-compliant facility. These regulations were established by the FDA to ensure the quality of laboratory testing procedures, documentation, laboratory spaces, equipment and reagents. All procedures are codified by validated SOPs which are reviewed regularly. An independent external Quality Assurance/Quality Control entity (Atheln Inc.) routinely monitors compliance for all aspects of the laboratory. Additionally, the laboratory participates in:

• Biennial audits by the State of California Department of Health Services (CLIA licensure).
• Semi-annual blinded external quality control testing to ensure accurate testing in comparison with laboratories nationwide (Proficiency Testing - as a participant within the DAIDS Clinical Pharmacology QA Program).

Laboratory safety is further ensured through annual inspections of laboratory spaces, equipment and procedures conducted by UC San Diego Environmental Health and Safety (EH&S), http://www-ehs.ucsd.edu , laboratory staff and Atheln Inc.

The laboratory follows an established Safety Program and approved procedures for handling Blood Borne Pathogens which comply with all State and Federal regulations. All staff are trained by UC San Diego EH&S in emergency safety procedures and in the use of Personal Safety Equipment.