title: The establishment of good laboratory practices at the Naval Medical Research Institute Toxicology Detachment.
abstract: A quality-management program (QMP) has been launched at the Naval Medical Research Institute Toxicology Detachment to support the planning, assessment, interpreting, and reporting of toxicology study data. The QMP conforms to the intent of the Good Laboratory Practice established by the Food and Drug Administration and the Environmental Protection Agency for regulatory compliance. The biomedical data necessary to characterize the toxicity of materials of interest to the Navy are used to formulate occupational and environmental health-hazard evaluations and risk assessments, including appropriate exposure limits for personnel for Navy-specific circumstances of exposure. The goal of the QMP is to help management and investigators ensure the quality and integrity of the data collected in laboratory animal toxicology studies. These data are used to reduce or eliminate potential health risks from exposure to toxicants during Navy operations. The primary purpose of the risk-reduction program is to help ensure readiness to accomplish the military mission. This article briefly reviews the need for the QMP and the military relevance of the quality-assurance requirements. The pros and cons of establishing the QMP are discussed, and examples of specific research projects and programs that support the need for a quality management program are presented. Aspects of integrating the QMP program to ensure compliance with Good Laboratory Practice are reviewed, and the value of the improvements in the quality of data from the Naval Medical Research Institute/Toxicology Detachment is summarized.
authors.affiliation: Naval Medical Research Institute Toxicology Detachment (NMRI/TD), WPAFB, OH 45433-7903, USA.
authors.forename: K R
authors.initials: KR
authors.lastname: Still
authors.forename: G B
authors.initials: GB
authors.lastname: Briggs
authors.forename: G
authors.initials: G
authors.lastname: Dickson
authors.forename: W W
authors.initials: WW
authors.lastname: Jederberg
mesh_terms: D000047:Academies and Institutes / Q000592:standards*; D019985:Benchmarking / Q000379:methods*; D003625:Data Collection / Q000592:standards; D003627:Data Interpretation, Statistical; D006801:Humans; D007753:Laboratories / Q000592:standards*; D009326:Naval Medicine; D016730:Program Development; D018570:Risk Assessment; D017749:Total Quality Management / Q000458:organization & administration*; D014116:Toxicology; D014481:United States; D014484:United States Environmental Protection Agency; D014486:United States Food and Drug Administration