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	Good Laboratory Practice OECD Principles and Guidance for Compliance Monitoring
	OECD. Published by : OECD Publishing

	Version: Print (Paperback) + Free PDF
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Availability: Available Publication date: 18 Jan 2006 Language: English Pages: 140 ISBN: 9789264012820 OECD Code: 972005101P1

Other Versions & Languages | Table of contents

This publication units 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 includes the international standards for quality of non-clinical environmental, health and safety data on chemicals and chemical products in a regulatory context—the OECD Principles of Good Laboratory Practice—and supporting Consensus and Advisory Documents on their interpretation and application. The OECD guidance documents for governments on monitoring compliance with the Good Laboratory Practice Principles are also included. This publication thus presents the state of the art on Good Laboratory Practice and compliance monitoring.

Other languages: French (Available)

Other Versions: E-book - PDF Format

Table of contents:

Part I. The OECD Principles of Good Laboratory Practice
-Section I. Introduction
-Section II. Good Laboratoy Practice Principles
Part II. Consensus and Advisory Documents on the Application of the Principles of Good Laboratory Practice
-Chapter 1. Consensus Documents
--1. Quality Assurance and Good Laboratory Practice
--2. Compliance of Laboratory Suppliers with Good Laboratory Practice Principles
--3. The Application of Good Laboratory Practice Principles to Field Studies
--4. The Application of Good Laboratory Practice Principles to Short-Term Studies
--5. The Role and Responsiblities of the Study Director in Good Laboratory Practice Studies
--6. The Application of the Principles of GLP to Computerised Systems
--7. The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies
-Chapter 2. Advisory Documents of the Working Group on GLP
--8. The Role and Responsiblities of the Sponsor in the Application of the Principles of Good Laboratory Practice
--9. The Application of the OECD Principles of GLP to in vitro Studies.
Part III. Guidance and Advisory Documents for Good Laboratory Practice Compliance Monitoring Authorities
-Chapter 3. Guidance for GLP Monitoring Authorities
--1. Guides for Compliance Monitoring Procedures for Good Laboratory Practice
--2. Guidance for the Conduct of Test Facilities Inspections and Study Audits
--3. Guidance for the Preparation of GLP Inspection Reports
-Chapter 4. Adivsory Document of the Working Group on GLP
--1. Requesting and Carrying Out Inspections and Study Audits in Another Country
Annex. OECD Council Acts Relatd to the Mutual Acceptance of Data
-Introduction
-1. Decision of the Council concerning the mutual acceptanceof data in the assessment of chemicals [C(81)30(Final)]
-2. Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice [C(89)87(Final)]
-3. Council Decision concerning the 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]

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