Good Laboratory Practices regulatory authorities

Analytical chemistry is a critical component of worker safety, re-entry, and other related studies intended to assess the risk to humans during and subsequent to pesticide applications. The analytical aspect takes on added significance when such studies are intended for submission to the U.S. Environmental Protection Agency and/or other regulatory authorities and are thus required to be conducted according to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Good Laboratory Practice (GLP) Standards, or their equivalent. This presentation will address test, control, and reference substance characterization, use-dilution (tank mix) verification, and specimen (exposure matrix sample) analyses from the perspective of GLP Standards requirements. 

Regulatory authorities perform the watchdog role to ensure that animal studies comply with Good Laboratory Practice (GLP), clinical trials are... 

Like any document, the toxicology report must be fit-for-purpose. Its content and format must be tailored to meet the requirements of the reader (not just the convenience of the author). The main difficulties arise because the report has to serve scientific, administrative, and regulatory functions, which often have contradictory constraints. Furthermore, the document must comply with Good Laboratory Practice (GLP) regulations, which are inconsistent between regions or even within the same region for different types of test substance (see Note 1). Once the report has been issued (in draft or final form), it will be consulted by many different experts, each with their own agenda ... 

These examples have been provided here to illustrate the point that the application of Good Laboratory Practice is not rigidly universal, in that one would be able to draw up a list of studies which are mandatorily subjected to the rules of GLP. Rather, the necessity to follow the strict regulations of GLP will be determined by the two basic principles of the scope of GLP - the safety-relatedness of the investigation and the foreseeable submission to an Regulatory Authority - the interpretation of which may, however, under different circumstances lead to different answers and conclusions. 

The definition of a non-clinical health and environmental safety study takes up again the scope of Good Laboratory Practice in reiterating that it means an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data on its properties and/or its safety, intended for submission to appropriate regulatory authorities . While it should be clear in general, what a study is, there may be some need for additional clarifications regarding what may constitute a study under GLP . 

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