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KMID : 0379520090250010001
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한국독성학회지
2009 Volume.25 No. 1 p.1 ~ p.8
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Basic Principles of the Validation for Good Laboratory Practice Institutes
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Cho Kyu-Hyuk
Kim Jin-Sung
Song Chang-Woo
Chung Moon-Koo
Lee Kyu-Hong
Jeon Man-Soo
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Abstract
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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.
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KEYWORD
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Good laboratory practice, Validation, Qualification, Calibration
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