Abbott Laboratories High-quality laboratory practices have long been the standard in most academic core facilities. Both promote product safety and efficacy, but GLPs focus more on research and drug development and cGMPs on production and testing of clinical materials and products for sale. Both the FDA and the EPA have GLP regulations that govern the entire preclinical trial process.
Analytical testing is one part of that process and is frequently contracted to outside laboratories.
For these reasons, academic facilities can be involved in GLP testing but are less likely to perform cGMP testing, and so this presentation focused on GLPs in academic facilities. A client must tell you when samples are to be handled under GLP conditions, but upon accepting these samples, you become responsible for complying with GLP regulations. For example, there may be a calibrated, monitored freezer for GLP sample storage and a separate logbook specifically for GLP samples. Only certain personnel may be designated to handle and test GLP samples on specific, calibrated instruments following SOPs. There may be special data analysis, archiving, and retrieval systems just for these samples.