Good laboratory practice. Part 3. Implementing good laboratory practice in the analytical lab

摘要

Laboratories submitting experimental results to the Food and Drug Administration (FDA) or the Environmental Protection Agency (EPA) in support of Good Laboratory Practice (GLP) nonclinical laboratory studies must conduct such work in compliance with the GLP regulations. To consistently meet these requirements, lab managers employ a "divide and conquer" strategy: they break up the laboratory operation into key unit functions. Next they consider the regulatory requirements that must be met by each key unit function. This is called the quality system approach for implementing GLP in the analytical laboratory and it is embraced by nearly every laboratory endeavoring to perform this kind of work.