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质量控制分析方法:最大限度降低不符合规格制剂的概率:那些让你不禁思考……嗯!的结果

Quality-Control Analytical Methods: Minimizing the Probability of Out-of-Specification Preparations: Results That Make You Say...Hmmm!

作者信息

Odegard Russell D

机构信息

Dynalabs, LLC, St. Louis, Missouri.

出版信息

Int J Pharm Compd. 2008 Mar-Apr;12(2):130-5.

Abstract

To prevent compounding of an out-of-specification preparation, the possible causes of such an error must be identified and eliminated. Implementation of simple practices can decrease the probability of errors, resulting in a safer situation for both the patient and the pharmacy. The United States Pharmacopeia-National Formulary is the standard-setting reference for compounding procedures; all compounding pharmacists should read and adhere to those standards. This article discusses these standards as they relate to drug potency, sterility, endotoxin, and particulate matter results.

摘要

为防止不合规格制剂的重复出现,必须找出并消除此类错误的可能原因。实施简单的操作规范可降低出错概率,从而为患者和药房营造更安全的环境。《美国药典-国家处方集》是配制程序的标准制定参考文件;所有从事配制工作的药剂师都应阅读并遵守这些标准。本文将讨论这些与药品效力、无菌性、内毒素和颗粒物结果相关的标准。

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