Quality assurance in toxicology studies in developing countries.
As developing countries become more involved in the international chemical trade, they must adhere to certain requirements for importation of their chemicals into foreign countries. These developing countries will be required to provide basic safety information on their chemical products, including data developed from chemical and toxicologic testing. These data must be developed in accordance with the national requirements of the importing country. Many importing countries have adopted the OECD Test Guidelines and the OECD Principles of Good Laboratory Practice (GLP) as primary guidance to assure the quality of laboratory data. These procedures provide a basis for internationally acceptable data. Several countries have incorporated many of these provisions into their national laws or administrative procedures. These procedures describe the process of documenting the conduct of laboratory studies, including recording of data, reporting of study results, and storage of data gathered. This process is intended to assure the quality and integrity of the data so that, if required, the study can be reconstructed by an auditor or an inspector. Details of these procedures and their applicability to the international chemical trade are discussed.
Morris
C R
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International Chemical Consultants, Alexandria, Virginia 22312.
D003906:Developing Countries; D004282:Documentation / Q000592:standards; D007753:Laboratories / Q000592:standards*; D011786:Quality Control; D013048:Specimen Handling / Q000592:standards; D014116:Toxicology / Q000379:methods / Q000592:standards*