Toxicological Research

Korean Society of Toxicology & Korea Environmental Mutagen Society (한국독성학회)
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Basic Principles of the Validation for Good Laboratory Practice Institutes

  • Cho, Kyu-Hyuk (Division of Inhalation Toxicology, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology) ;
  • Kim, Jin-Sung (Department of Non-clinical Studies, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology) ;
  • Jeon, Man-Soo (Korea GMP Academy Co., Ltd.) ;
  • Lee, Kyu-Hong (Division of Inhalation Toxicology, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology) ;
  • Chung, Moon-Koo (Department of Non-clinical Studies, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology) ;
  • Song, Chang-Woo (Division of Inhalation Toxicology, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology)
  • Published : 2009.03.01
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Abstract

Validation specifies and coordinates all relevant activities to ensure compliance with good laboratory practices (GLP) according to suitable international standards. This includes validation activities of past, present and future for the best possible actions to ensure the integrity of non-clinical laboratory data. Recently, validation has become increasingly important, not only in good manufacturing practice (GMP) institutions but also in GLP facilities. In accordance with the guideline for GLP regulations, all equipments used to generate, measure, or assess data should undergo validation to ensure that this equipment is of appropriate design and capacity and that it will consistently function as intended. Therefore, the implantation of validation processes is considered to be an essential step in a global institution. This review describes the procedures and documentations required for validation of GLP. It introduces basic elements such as the validation master plan, risk assessment, gap analysis, design qualification, installation qualification, operational qualification, performance qualification, calibration, traceability, and revalidation.

Keywords

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