Oecd principles of good laboratory practice pdf

This clarification was considered necessary, since it was recognised that some test facilities have test sites located under the jurisdiction of another country. Series on principles of good laboratory practice and compliance monitoring. Implementation of the oecd principles of good laboratory. Oecd principles on good laboratory practice read online. Comparison chart of fda and epa good laboratory practice glp regulations and the oecd principles of glp document issued on. Pdf the oecd principles of good laboratory practice and. These principles are not supplied by nata but must be obtained by the facility from the oecd environment directorate, environmental health. Oecd principles of good laboratory practice title oecd principles of good laboratory practice legislative basis directive 8718eec, directive 88320eec previous titles other references notes this annex is an extract from a decision of the council concerning mutual acceptance of data in the assessment of chemicals. Oecd series on principles of good laboratory practice and compliance monitoring no. General accreditation criteria organisation for economic. Good documentation and quality management principles vimal sachdeva technical officer inspector, who prequalification of. The principles of good laboratory practice glp have been developed to promote the quality and validity of test data used for determining the safety of chemicals and chemicals products. Pdf the oecd principles of good laboratory practice and the.

General questions and answers concerning oecd principles of. Pdf good laboratory practice glp guidelines for the. Oecd principles of good laboratory practice accreditation criteria publications checklist. However, the scope and application of 21 cfr part 11 is under discussion 5. The handbook sets forth the oecd principles in their original text, supplemented by sections on training and the implementation of glp. Oecd ilibrary oecd principles on good laboratory practice. National association of testing authorities, australia. The principles of good laboratory practice glp are a managerial quality control system covering the organisational process and the conditions under which nonclinical health and environmental studies are planned, performed, monitored, recorded. Oecd principles of good laboratory practice as revised in 1997 the oecd principles of good laboratory practice are contained in annex ii of the decision of the council concerning the mutual acceptance of data in the assessment of chemicals c8final see part two of this document for the text of that council decision. Oecd series on principles of good laboratory practice glp. Good laboratory practice glp requirements, based on these fundamental scientific principles and practices, are indispensable for providing scientific confidence in studies conducted for chemical safety determinations. The principles of good laboratory practice of the organisation for economic cooperation and development oecd form the basis of this series of guidance documents. Comparison chart of fda and epa good laboratory practice glp regulations and the oecd.

This is the complete set of the series on oecd principles of good laboratory practice glp which set the quality standards for the organisation and. For decisions of safety, there must be rigorous and thorough application of fundamental scientific practices, irrespective of the purpose of the study and where it is conductedacademic, industry, or a contract laboratory. What are the main requirements of glp good laboratory. The purpose of these principles of good laboratory practice is to promote the development of quality test data. Oecd ilibrary the oecd principles of good laboratory. Envjmmono201647 4 also published in the series on principles of good laboratory practice and compliance monitoring no. A revised version was published in 1998 taking scientific and technical. Oecd principles of good laboratory practice glp and glp compliance monitoring. The preclinical safety data generated in an oecd member country in accordance with the principles of glp are indeed accepted in other member countries for purposes of assessment.

Oecd series on principles of good laboratory practice and compliance monitoring. Comparable quality of test data forms the basis for the mutual acceptance of test data among countries. Oecd principles on good laboratory practice oecd ilibrary. Comparison chart of fda and epa good laboratory practice glp regulations and the oecd principles of glp. This document cancels and replaces the environment monograph no. The good laboratory practice guidelines glp have been in existence for nonclinical safety studies since 1976. The principles have been created in the context of harmonising testing procedures for the mutual acceptance of data mad. Good laboratory practice or glp is a set of principles intended to assure the quality and integrity of nonclinical laboratory studies that are intended to support research or marketing permits. Oecd principles of good laboratory practice course will explain how to manage and conduct nonclinical environnmental health and safety studies in order to comply with the oecd principles of good laboratory practice. Oecd principles of good laboratory practice pdf 95. Oecd countries and full adherents have agreed that a safety test carried out in accordance with the oecd test guidelines and principles of good laboratory. Having confidence in scientific procedures and data is the sine qua non for determining the safety of chemicals and chemical products. Oecd principles of good laboratory practice recognition application document section 1. Oecd series on principles of good laboratory practice and.

The periodic inspection of test facilities andor auditing of studies for the purpose of verifying adherence to glp principles. These principles should be followed to collect data for the registration of. The application of the principles of glp to computerised systems. The training is designed to be conducted over a threeday period. These principles cover the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. Principles of good laboratory practice and compliance monitoring, contains the principles of glp as revised in 1997 and, in part two, the three oecd council acts related to the mutual acceptance of data. Oecd organization for the economic cooperation and development first decision in 1981. This white paper at hand summarizes the sections of the oecd series on principles of good laboratory practice glp and compliance monitoring regulations which are relevant to electronic systems like labfolder, also pointing out the labfolder implementation to meet these technical requirements. The oecd principles of good laboratory practice and the current bioethics chapter pdf available january 2012 with 122 reads how we measure reads.

The oecd guidance documents for governments on monitoring compliance with the good laboratory practice principles are also included. This content applies to human and veterinary medicines. Good laboratory practice glp compliance monitoring. This document provides the full text of the oecd principles of good laboratory practice as revised in 1997. About oecd01mar20download purpose of the oecd principles of glp general information on the australian glp compliance monitoring program oecd public website on glp the oecd website on glp provides information on glp compliance monitoring, the. Pdf on jan 1, 2012, miroslav radenkovic and others published the oecd principles of good laboratory practice and the current bioethics find, read and cite. Reach regulation of 18 december 2006 and directive 2006121ec of 18 december 2006. Oecd series on principles of good laboratory practice and compliance monitoring the general criteria for the conduct of nonclinical health and environmental safety studies are described in the oecd principles of good laboratory practice. Good laboratory practice glp regulations became part of the regulatory landscape. Government and industry are concerned ab out the quality of nonclinical health and environmental safety studies upon which hazard assessments are based. This is the second version of the who handbook on glp.

Oecd position paper regarding the relationship between the. Oecd council acts on mutual acceptance of data mad. This publication thus presents the state of the art on good laboratory practice and compliance monitoring. This is the complete set of the series on oecd principles of good laboratory practice glp which set the quality standards for. Correct, complete, current, and consistent information. Glp is a formal regulation that was created by the fda united states food and drug administration in.

There are also product oriented directives referring to glp obligations. Oecd principles of good laboratory practice glp select all. The working group on good laboratory practices proposed clarification of this decision based on the revised oecd principles of glp and recommended the procedures set out below. The principles of good laboratory practice glp are a managerial quality control system covering the organisational process and the conditions under which nonclinical health and environmental studies are planned, performed, monitored, recorded, reported and retained or archived. The principles of good laboratory practice glp define a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived. Good documentation practice is an expected practice. With such considerations in mind the swg recommended that whotdr adopt the revised oecd principles of good laboratory practice as its official guidance for nonclinical safety testing. The oecd principles of good laboratory practice oecd series on principles of good laboratory practice and compliance monitoring, number 1, envmcchem9817, or subsequent revisions are adopted as the glp standard by the pest management regulatory agency pmra. These were formally recommended for use in oecd member countries and were widely accepted as the international standard for good laboratory practice. Good laboratory practice oecd principles and guidance for compliance monitoring this publication unites all of the oecd documents related to good laboratory practice and compliance monitoring, and, in the annex, reproduces the three oecd council decisions related to the mutual acceptance of data in the assessment of chemicals. It is a quality system which intends to ensure through careful and accurate documentation, covering all aspects of study and of its environment, the quality, integrity and. Good laboratory practice compliance european medicines.

Comparison chart of fda and epa good laboratory practice. Oecd principles of good laboratory practice glp and glp. The oecd principles were published in 1982 as environmental monograph 45 the oecd principles of good laboratory practice. The organisation for economic cooperation and development oecd principles of good laboratory practice glp are intended to assure data quality and integrity.

The training is based on the organization for economic cooperation and development oecd glp principles which are recognized as the international standard for glp. Data and research on test guidelines including chemical testing and assessment, chemical safety, animal welfare, endocrine disrupters, good laboratory practice glp, mutual acceptance of data mad. Oecd series on principles of good laboratory practice. This is the complete set of the series on oecd principles of good laboratory practice glp which set the quality standards for the organisation and management of test facilities and for performing and reporting studies related to the safety of chemical substances and preparations. Principles of good laboratory practice that is consistent with the oecd principles of good laboratory practice glp compliance monitoring.