[Criteria for evaluating deviations from good laboratory practice].
The assessment of compliance with the principles of good laboratory practice (GLP) requires that different observations be integrated in a comprehensive assessment of the adequacy of the test facility inspected. The major types of deviations are examined in detail, since they might jeopardize the scientific quality of data. These are: a) deviations, even though seemingly minor ones, which could signal an inadequate understanding of the GLP principles (e.g., insufficient attention to personnel training); b) inadequate application of the GLP principles to basic procedures and/or structures (e.g., clean-dirty interfaces in the laboratory animal unit); c) inadequacies concerning specific study types. The elaboration of new guidelines leads to the definition of new quality requirements and critical points. One such case is the development of tests to identify endocrine effects which in turn triggers the need of structures and personnel adequate to examine seminological or hormonal parameters.
Mantovani
Alberto
A
Laboratorio di Tossicologia Comparata ed Ecotossicologia, Istituto Superiore di Sanità, V.le Regina Elena 299, 00161 Roma. alberto@iss.it
D000014:Abnormalities, Drug-Induced / Q000209:etiology; D016573:Agrochemicals / Q000592:standards / Q000633:toxicity; D000818:Animals; D019411:Clinical Laboratory Techniques / Q000592:standards*; D004353:Drug Evaluation, Preclinical / Q000592:standards; D004703:Endocrine System / Q000187:drug effects; D005260:Female; D019983:Guideline Adherence / Q000331:legislation & jurisprudence / Q000592:standards*; D017408:Guidelines as Topic; D015386:Hazardous Substances / Q000592:standards / Q000633:toxicity; D006728:Hormones / Q000502:physiology; D007558:Italy; D007756:Laboratory Animal Science / Q000331:legislation & jurisprudence / Q000592:standards; D008297:Male; D011247:Pregnancy; D012106:Research / Q000331:legislation & jurisprudence / Q000592:standards*; D012107:Research Design; D014116:Toxicology / Q000331:legislation & jurisprudence / Q000592:standards*
D016573:Agrochemicals; D015386:Hazardous Substances; D006728:Hormones