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[研究检查程序的协调标准。意大利研究质量保证小组]

[Harmonization criteria for inspection procedures. Italian Group for Quality Assurance in Research].

作者信息

Di Prospero Paola

机构信息

Laboratorio di Tossicologia Applicata, Istituto Superiore di Sanità, V.le Regina Elena 299, 00161 Roma.

出版信息

Ann Ist Super Sanita. 2002;38(1):35-9.

Abstract

In order to achieve higher levels of harmonisation for the application of the principles of good laboratory practice (GLP), the monitoring Authority has set up for the inspectors some guidelines to conduct inspections, as approved by the National co-ordination committee. The extension of these guidelines should allow for an improved application of the GLP principles taking into account actual situations detected during inspections carried out over the past years. In this respect a great number of observations formulated by the inspectors after inspecting several test facilities have been examined without revealing laboratories' and inspectors' identities. In addition to this, the observations made by the inspectors during the annual training course at the Istituto Superiore di Sanità in 2000 have been carefully considered.

摘要

为了在良好实验室规范(GLP)原则的应用方面实现更高水平的协调统一,监管机构已为检查员制定了一些经国家协调委员会批准的检查指南。考虑到过去几年检查中发现的实际情况,这些指南的扩展应有助于更好地应用GLP原则。在这方面,已对检查员在检查多个测试设施后提出的大量意见进行了审查,同时未透露实验室和检查员的身份。此外,还仔细考虑了检查员在2000年于高等卫生研究院举办的年度培训课程期间所提出的意见。

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