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配制基础:实施《美国药典》第797章“药物配制 - 无菌制剂”的注意事项,第18部分:肠外营养配制自动配制设备的验证以及成品制剂放行检查和测试

Basics of compounding: considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparations, part 18: verification of automated compounding devices for parenteral nutrition compounding and finished preparation release checks and tests.

作者信息

Allen Loyd V, Okeke Claudia C

机构信息

International Journal of Pharmaceutical Compounding, Edmond, Oklahoma.

出版信息

Int J Pharm Compd. 2010 Mar-Apr;14(2):142-9.

Abstract

A sound quality-assurance program, which should include standard operating procedures, documentation, verification, and analytical and microbiological testing, is necessary to ensure the quality of compounded preparations. This article discusses in a practical matter verification of automated compounding devices for parenteral nutrition compounding and finished preparation release checks and tests, and provides practice clarification to the standards set forth by the United States Pharmacopeial Convention, Inc.

摘要

一个完善的质量保证计划对于确保配制制剂的质量是必要的,该计划应包括标准操作规程、文件记录、验证以及分析和微生物检测。本文从实际操作的角度讨论了用于肠外营养配制的自动配药设备的验证以及成品制剂放行检查和测试,并对美国药典委员会制定的标准进行了实践说明。

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