The Application of the GLP Principles to Field Studies [electronic resource] / Organisation for Economic Co-operation and Development

Format:

Book

Government document

Author/Creator:

Organisation for Economic Co-operation and Development.

Contributor:

Organisation for Economic Co-operation and Development, Contributor.

Series:

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, 2077785X ; no.6.

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, 2077785X ; no.6

Language:

English

Subjects (All):

Laboratories--Management.

Laboratories.

Physical Description:

1 online resource (16 pages)

Place of Publication:

Paris : OECD Publishing, 1999.

Language Note:

English

Summary:

This document specifies the application of the Good Laboratory Practice principles to field studies, interpreting such concepts as study, test site, study director, management responsibilities, quality assurance, etc. for application in this specific context.

Contents:

Background 8 Interpretations Relateed to Definitions of Terms 9 Interpretations Related to Test Facility Organisation and Personnel 10 -Test Facility Management’s Responsibilities 10 -Study Director’s Responsibilities 11 -Principal Investigator‘s Responsibilities 11 Interpretations Related to the Quality Assurance Programme 12 Interpretations Related to Facilities 13 -General 13 -Facilities for Handling Test and Reference Items  13 -Waste Disposal 13 Interpretations Related to Apparatus, Material and Reagents 14 Interpretations Related to Test Systems 14 Interpretations Related to Rest and Reference Items 14 -Receipt, Handling, Sampling and Storage 14 -Characterisation 15 Interpretations Related to Standard Operating Procedures 15 Interpretations Related to Performance of the Study 16 -Study Plan 16 -Conduct of the Study 16 Interpretations Related to Reporting of Study Results 16 Interpretations Related to Storage and Retention of Records and Materials 16

Notes:

Bibliographic Level Mode of Issuance: Monograph

ISBN:

9789264078635 (PDF)