GLP and other quality assurance systems - A comparison

被引：3

作者：

Hembeck, HW ^{[1
]}

机构：

[1] Bundesinst Gesundheitlichen Verbraucherschutz & V, GLP Bundesstelle, D-14195 Berlin, Germany

来源：

ACCREDITATION AND QUALITY ASSURANCE | 2002年 / 7卷 / 07期

关键词：

Quality Assurance; Assurance System; Quality Assurance System;

D O I：

10.1007/s00769-002-0491-x

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

World wide, there are a good number of systems for assuring quality, effectiveness, and harmlessness of substances and/or products. For "laboratory investigations" in the broadest sense in the area regulated by law (i.e., by laws or other mandatory regulations) the following should be mentioned: GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice). In the areas not regulated by law, the QA/QM systems ISO 9000:2000 If and DIN EN ISO/IEC 17025 (former DIN EN 45000 ff) are used voluntarily (with the exception of the official control of foodstuffs). In the following, we will attempt to address the problematic issues in the comparison of GLP with other QA/QM systems.

引用

页码：266 / 268

页数：3