Abstract:

The GLP (Good Laboratory Practice) regulations, first promulgated by the US FDA (Food and Drug Administration) in 1976, have had a major impact on the way that those laboratories engaged in studies on the safety and efficacy testing of pharmaceuticals were managed and controlled. Since then, the concept has extended to environmental testing, particularly in the USA (Environmental Protection Agency; EPA), and to other areas.

GLP covers the organizational process and the conditions under which non-clinical laboratory and field studies are planned, conducted, monitored, recorded and reported. They intend to promote the quality and validity of test data and to improve the international acceptance of data generated in adherence to GLP principles.

GLP requirements are a component of the Agency’s harmonization initiative which aims to improve our ability to share the burden of the registration process with other Organization for Economic Cooperation and Development (OECD) member countries through the exchange of reviews based on mutually acceptable studies.

Students should learn and follow the GLP rules to achieve quality laboratory work. A complete guideline about the GLP rules will be provided by the lecturer on the first teaching day. The need to follow these rules, which ensure and improve the quality of results, will be explained. GLP intend to facilitate the learning of laboratory matters, and could help students to find work more easily once they finish their degree. The guideline comprises several sections: equipment and utensils, materials and products, and chemical products related to disinfection and cleanliness, energy and storage, among others. Since the complete rules cannot be applied in a teaching laboratory, this project focuses on 15 essential rules whose fulfilment is surveyed by the lecturer.

This study describes the results obtained in several analytical laboratories employed in the Chemistry Degree at the Universitat Jaume I regarding laboratory work following the GLP rules in the academic period 2007-2010.

This work has been supported by projects from the USE (Unitat de Suport Educatiu, Universitat Jaume I) and from the Spanish Ministry of Education and Science (MEC) CTQ 200764473/BQU