Current state of the implementation of the OECD GLP principles in the OECD member countries and non-member economies in light of the outcome of the 1998-2002 pilot project of mutual joint visits
good laboratory practice;
test facilities;
mutual acceptance of data;
inspections;
D O I:
暂无
中图分类号:
R1 [预防医学、卫生学];
学科分类号:
1004 ;
120402 ;
摘要:
This paper describes the current situation as regards implementation of the Organisation for Economic Co-operation and Development (OECD) Council Decisions related to the mutual acceptance of data (MAD) in the assessment of chemicals in the 30 OECD member countries as well as in several non-member countries which adhere to the Council Acts. The cornerstone of MAD is the knowledge of and ensuing confidence in national good laboratory practice (GLP) compliance monitoring programmes which guarantees the acceptability for regulatory purposes of non-clinical environment and health safety data on chemicals and chemical products tested in these countries. The pilot project of mutual joint visits (MJV) undertaken by the OECD working group on GLP between 1998 and 2002 to observe and understand the way compliance monitoring is carried out in member countries was the successful basis for evaluation of the readiness of non-members to become full members of the OECD system on MAD and for a continuing on-site evaluation programme which began in 2008. The MJV project, its results and follow up by the Chemicals Committee and the continuing programme on on-site evaluations are described. Details are given on the work with non-member economies in the area of MAD and the status of their GLP compliance monitoring programmes.