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复方药房质量控制中使用的分析方法。

Analytic Methods Used in Quality Control in a Compounding Pharmacy.

作者信息

Allen Loyd V

机构信息

International Journal of Pharmaceutical Compounding.

出版信息

Int J Pharm Compd. 2017 Jan-Feb;21(1):31-37.

Abstract

Analytical testing will no doubt become a more important part of pharmaceutical compounding as the public and regulatory agencies demand increasing documentation of the quality of compounded preparations. Compounding pharmacists must decide what types of testing and what amount of testing to include in their quality-control programs, and whether testing should be done in-house or outsourced. Like pharmaceutical compounding, analytical testing should be performed only by those who are appropriately trained and qualified. This article discusses the analytical methods that are used in quality control in a compounding pharmacy.

摘要

随着公众和监管机构对复方制剂质量文件的要求越来越高,分析检测无疑将成为药物配制中更重要的一部分。配制药师必须决定在其质量控制程序中应包括哪些类型的检测以及检测的数量,以及检测是应在内部进行还是外包。与药物配制一样,分析检测应由经过适当培训和具备资质的人员进行。本文讨论了配制药房质量控制中使用的分析方法。

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