Sakata Shinoi
Environmental Health Science Laboratory, Sumitomo Chemical Co, Ltd, 3-1-98, Kasugadenaka, Konohana-ku, Osaka, Japan.
Ann Ist Super Sanita. 2008;44(4):374-8.
For the implementation of the Organisation for Economic Co-operation and Development (OEC D) principles of good laboratory practice (GLP) and performance of studies according to worldwide regulatory requirements, test facilities (TFs) in Japan have been making constant effort to promote better understanding of this matter and improve communication with monitoring authorities (MAs). Their activities to ensure the international acceptance of data in accordance with the OEC D principles of GLP under the programme of mutual acceptance of data (MAD) are discussed with particular reference to the scope of Japan Society of Quality Assurance (JSQA), which comprises most of TFs in Japan, including international activities with EU, USA and Asian countries to establish global quality network.
为了实施经济合作与发展组织(OECD)的良好实验室规范(GLP)原则,并根据全球监管要求开展研究,日本的测试机构(TFs)一直在不断努力,以促进对这一问题的更好理解,并改善与监管当局(MAs)的沟通。特别提及日本质量保证协会(JSQA)的范围,讨论了它们在数据互认(MAD)计划下确保按照OECD的GLP原则使数据获得国际认可的活动。JSQA涵盖了日本的大多数测试机构,包括与欧盟、美国和亚洲国家建立全球质量网络的国际活动。