(329)TEACHING CHEMISTRY LABORATORIES WORKING WITH GOOD LABORATORY PRACTICES

摘要

The GLP (Good Laboratory Practice)regulations, first promulgated by the US FDA (Food and DrugAdministration)in 1976, have had a major impact on the way that those laboratories engaged instudies on the safety and efficacy testing of pharmaceuticals were managed and controlled. Sincethen, the concept has extended to environmental testing, particularly in the USA (EnvironmentalProtection Agency; EPA), and to other areas.GLP covers the organizational process and the conditions under which non-clinical laboratory and fieldstudies are planned, conducted, monitored, recorded and reported. They intend to promote the qualityand validity of test data and to improve the international acceptance of data generated in adherence toGLP principles.GLP requirements are a component of the Agency’s harmonization initiative which aims to improveour ability to share the burden of the registration process with other Organization for EconomicCooperation and Development (OECD)member countries through the exchange of reviews based onmutually acceptable studies.Students should learn and follow the GLP rules to achieve quality laboratory work. A completeguideline about the GLP rules will be provided by the lecturer on the first teaching day. The need tofollow these rules, which ensure and improve the quality of results, will be explained. GLP intend tofacilitate the learning of laboratory matters, and could help students to find work more easily once theyfinish their degree. The guideline comprises several sections: equipment and utensils, materials andproducts, and chemical products related to disinfection and cleanliness, energy and storage, amongothers. Since the complete rules cannot be applied in a teaching laboratory, this project focuses on 15essential rules whose fulfillment is surveyed by the lecturer.This study describes the results obtained in several analytical laboratories employed in the ChemistryDegree at the Universitat Jaume I (UJI)regarding laboratory work following the GLP rules in theacademic period 2007-2010.