《兽医临床试验金标准》的质量要点。

N J Dent
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引用次数: 2

摘要

质量保证(QA)自1976年《良好实验室规范》(GLP)成立以来,一直在其中发挥着关键作用。GLP现在被公认为质量标准,从最近发布的OECD GLP原则(1997年修订)的介绍性声明中可以看出,明确指出“GLP是一个质量体系,涉及组织过程和条件,在这些条件下,非临床健康和环境安全研究是计划、执行、监测、记录、存档和报告的”。因此,我们可以看到GLP合规性与ISO/EN认证体系之间的密切比较,ISO/EN认证体系已被全球其他机构采用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Essentials of quality in "the gold standard veterinary clinical trial".

Quality Assurance (QA) has played a pivotal role within Good Laboratory Practice (GLP) since its inception in 1976. GLP is now recognized as a quality standard, as can be seen from the introductory statement of the recently issued OECD Principles of GLP (revised in 1997) that clearly state "GLP is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported". We can, therefore, see a close comparison between GLP compliance and the ISO/EN accreditation systems that have been adopted by other institutes on a worldwide basis.

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