EPA's GLP compliance review of chemistry laboratories.
The Good Laboratory Practice (GLP) Standards regulations do not provide specific requirements for the operation of a specimen analysis laboratory, such as a testing facility that performs pesticide residue analysis in support of a tolerance study. Thus, some judgment must be applied by a regulated analytical laboratory to assure compliance with GLP Standards regulations that were designed primarily for testing facilities that apply test substances to test systems. This presentation will provide some insight as to EPA's compliance approach, as well as identifying problem areas encountered in past inspections of analytical laboratories.
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U.S. EPA National Enforcement Investigations Center, Denver, Colorado 80225.
D002623:Chemistry Techniques, Analytical; D005161:Facility Regulation and Control / Q000458:organization & administration*; D017408:Guidelines as Topic; D007753:Laboratories / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D014481:United States; D014484:United States Environmental Protection Agency