Details

Autor(en) / Beteiligte

• Organisation for Economic Co-operation and Development

Titel

OECD Principles on Good Laboratory Practice [electronic resource]

Link zum Volltext

• OECD iLibrary

Beschreibungen/Notizen

• Bibliographic Level Mode of Issuance: Monograph
• 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
• 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.
• English