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质量控制分析方法:复方药房质量保证的过程验证模型

Quality-control analytical methods: a process verification model for quality assurance in a compounding pharmacy.

作者信息

Zolner William J

机构信息

Eagle Analytical Services, Ltd., Houston, Texas.

出版信息

Int J Pharm Compd. 2008 May-Jun;12(3):247-51.

PMID:23969715
Abstract

There are virtually thousands of examples of uses of the "process" model of quality assurance in modern industrial applications, so the precedent for this type of quality-assurance in modern industrial applications, so the precedent for this type of quality-assurance and quality-control program is well estabilished and thoroughly accepted. The initiation of a process verification model for quality assurance and control, and the documentation involved in the process, constitute appropriate proof that a compounding pharmacy is developing quality preparations, which in turn can be used to improve a pharmacy's operation.

摘要

在现代工业应用中,实际上有成千上万使用质量保证“流程”模型的例子,所以这种质量保证和质量控制程序在现代工业应用中的先例已经确立并被广泛接受。启动质量保证和控制的流程验证模型以及该流程中涉及的文档,构成了一家复方制药企业正在研发高质量制剂的适当证据,这反过来又可用于改善制药企业的运营。

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