Unclassified
ENV/JM/MONO(99)21Organisation de Coopération et de Développement Economiques
OLIS :27-Sep-2000Organisation for Economic Co-operation and Development Dist. :28-Sep-2000__________________________________________________________________________________________
Or. Eng.
ENVIRONMENT DIRECTORATE
JOINT MEETING OF THE CHEMICALS COMMITTEE AND
THE WORKING PARTY ON CHEMICALS, PESTICIDES AND BIOTECHNOLOGY OECD Series on Principles of GLP and Compliance Monitoring Number 5(Revid)Connsus Document
COMPLIANCE OF LABORATORY SUPPLIERS WITH GLP PRINCIPLES Unclassified如何炒方便面
ENV/JM/MONO(99)21
Or. Eng.95824
ENV/JM/MONO(99)21
员工安全培训总结
ENV/JM/MONO(99)21 REVISED CONSENSUS DOCUMENT
OECD SERIES
至相寺
ON
甲骨文的故事PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING
Number 5(revid)
怪诞不经的意思
GLP Connsus Document
COMPLIANCE OF LABORATORY SUPPLIERS WITH GLP PRINCIPLES
农民入党志愿书Environment Directorate
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
五次中东战争
Paris 1999
ENV/JM/MONO(99)21
FOREWORD
In the framework of the OECD Connsus Workshop on Good Laboratory Practice, held 16th-18th October 1990 in Bad Dürkheim, Germany, a Working Group met to discuss and arrive at connsus on the compliance of laboratory suppliers with Principles of GLP. The Working Group was chaired by Dr. David Moore (Head, GLP Compliance Monitoring Authority, United Kingdom). Participants in the Working Group reprented GLP compliance monitoring units and test facilities in Austria, Finland, France, Germany, Japan, Sweden and the United Kingdom.
The Working Group established the context of this connsus document, and made recommendations related to the role of suppliers vis-à-vis GLP Principles including the role of accreditation as a complementary tool to GLP compliance. It reached connsus and provided guidance on issues related to veral specific categories of supplies. The issues are t out in the document.
The draft connsus document developed by the Working Group was circulated to Member countries and revid, bad on the comments received. It was subquently endord by the OECD Panel on GLP and the Chemicals Group and Management Committee of the Special Programme on the Control of Chemicals. The Environment Committee then recommended that this document be derestricted under the authority of the Secretary-General.
In light of the adoption of the Revid OECD Principles of GLP in 1997, this Connsus Document was reviewed by the Working Group on GLP and revid to make it consistent with modifications made to the Principles. It was endord by the Working Group in April 1999 and, subquently by the Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology in August 1999. It too is declassified under the authority of the Secretary-General.
ENV/JM/MONO(99)21
GLP CONSENSUS DOCUMENT
COMPLIANCE OF LABORATORY SUPPLIERS WITH GLP PRINCIPLES
五笔口诀顺口溜Background
The responsibilities of the management of test facilities are defined in the OECD Principles of Good Laboratory Practice1 under the heading of Test Facility Organisation and Personnel (Section II.1). Test facility management should ensure that the GLP Principles are complied with at the test facility and that a sufficient number of qualified personnel, appropriate facilities, equipment and materials are available for the timely and proper conduct of the study. They also should ensure that test facility suppliers meet requirements appropriate to their u in a study. On the basis of the requirements, suppliers of materials ud in studies submitted to regulatory authorities need not be included in national GLP compliance programmes but they do play a definite role relating to the responsibilities of the management of test facilities.
As by definition in the GLP Principles, the responsibility for the quality and fitness for u of equipment and materials rests entirely with the management of the test facility. The acceptability of equipment and materials in GLP-compliant laboratories should therefore be guaranteed to any regul
atory authority to whom studies are submitted. The main purpo of this document is to offer advice to both test facility management and suppliers as to how they might meet GLP requirements through national accreditation schemes and/or working to formal national or international standards, or by adopting other measures which may be appropriate to a particular product. National or international standards, which may be t by an accreditation organisation, may be applied whenever they are acceptable to the test facility’s management. The management of facilities, individually or in co-operation with each other, should thus maintain clo contacts with suppliers and with their accreditation organisations.
Standards and accreditation schemes
Laboratories u various supplied materials in studies conducted in compliance with the GLP Principles. Suppliers have attempted to produce products which satisfy urs’ obligations as t out in the GLP Principles. Many suppliers have adopted manufacturing practices which comply with formal national or international standards, or have become accredited within various national schemes. The initiatives have been taken in the anticipation that supplied products will therefore be acceptable to regulatory authorities who require studies to be conducted in compliance with GLP Principles.
Suppliers are recommended to implement International Standard ISO 9001, and particularly Part 1 -Specification for Design/Development, Production, Installation and Servicing. This International Standard can be supported with European Standard EN 45001; the importance of Paragraph 5.4.7 of the latter, which refers to subcontracting, is emphasized.
Where appropriate, accreditation can be especially uful to suppliers. Accreditation schemes frequently monitor members’ implementation of national and international standards; thus a supplier or 1 See The OECD Principles of Good Laboratory Practice (as revid in 1997), No. 1 in this OECD ries on
Principles of GLP and Compliance Monitoring.
