Pharmaceutical starting materials: Safe trade

被引:0
|
作者
Vree, PH [1 ]
机构
[1] Inspectorate Hlth Care, NL-2500 BC The Hague, Netherlands
来源
DRUG INFORMATION JOURNAL | 2001年 / 35卷 / 02期
关键词
starting materials; glycerin; pharmaceutical ingredients; medicinal products; World Health Organization; Good Manufacturing Practice; Good Control Laboratory Practice;
D O I
暂无
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
High-quality starting materials for medicinal products are essential to the high quality of finished products. In 1995 and 1996 adulterated glycerin caused acute renal failure and subsequently death of about 88 children in Haiti. This case is discussed with respect to risk detection and analysis in the manufacture, distribution, and trade of active as well as nonactive starting materials. Parties involved are not sufficiently aware of the risks. Overall, there is lack of transparency. There is strong need for a Good Trading Practice. Recommendations to health authorities conclude this brief overview.
引用
收藏
页码:611 / 616
页数:6
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