OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring

ISSN :
2077-785X (online)
DOI :
10.1787/2077785x
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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. The GLP Principles cover all aspects of a laboratory’s daily activity, such as the layout of testing and storage areas to prevent contamination, cleaning and calibration of equipment, handling of test animals, and recording and archiving of test results. The GLP Principles thereby help ensure that studies submitted to regulatory authorities, to notify or register chemicals, are of sufficient quality and rigour and are verifiable.

Also available in: French
 
OECD Principles on Good Laboratory Practice

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Author(s):
OECD
Publication Date :
26 Jan 1998
Pages :
41
ISBN :
9789264078536 (PDF)
DOI :
10.1787/9789264078536-en

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This document provides the full text of the OECD Principles of Good Laboratory Practice as revised in 1997. 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. It is a managerial concept covering the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. Its principles are required to be followed by test facilities carrying out studies to be submitted to national authorities for the purposes of assessment of chemicals and other uses relating to the protection of man and the environment.

Also available in: French

 

PART ONE: THE OECD PRINCIPLES OF GLP
Section I. Introduction 13
-Preface 13
-1. Scope 13
-2. Definitions of Terms 14
Section II. Good Laboratory Practice Principles ECTION II GOOD LABORATORY PRACTICE PRINCIPLES 17
-1. Test Facility Organisation and Personnel 17
-2. Quality Assurance Programme 20
-3. Facilities 21
-4. Apparatus, Material, and Reagents 22
-5. Test Systems 22
-6. Test and Reference Items 23
-7. Standard Operating Procedures 24
-8. Performance of the Study 25
-9. Reporting of Study Results 28
-10. Storage and Retention of Records and Materials 29
PART TWO: OECD COUNCIL ACTS RELATED TO GLP PRINCIPLES AND COMPLIANCE MONITORING
-Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals [C(81)30(Final]  33
-Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice [C(89)87(Final)] 35
-Council Decision on Adherence of Non-Member Countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals [C(81)30(Final) and C(89)87(Final)] [C(97)114/Final 39