Basic Principles of the Validation for Good Laboratory Practice Institutes
Toxicological Research 2009;25:1−8
Published online March 31, 2009
© 2009 The Korean Society Of Toxicology.


1Division of Inhalation Toxicology, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology, Jeollabuk-do 580-185, 2Department of Non-clinical Studies, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology, DeaJeon 305-343, 3Korea GMP Academy Co., Ltd., Chungcheongbuk-do 363-794, Korea
Chang-Woo Song, Division of Inhalation Toxicology, Korea Institute of Toxicology, Korea Research Institute of Chemical Technology, 1051 ShinJeong-dong, JeongEup-si, Jeollabuk-do 580-185, Korea E-mail: cwsong@kitox.re.kr
Received: October 2, 2008; Accepted: February 10, 2009
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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 : Good laboratory practice, Validation, Qualification, Calibration

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