Zolner William J
Eagle Analytical Services, Ltd., Houston, Texas.
Int J Pharm Compd. 2009 Sep-Oct;13(5):412-8.
Undeniably, one of the most important considerations in a compounding pharmacy's procedures is quality. Developing a comprehensive quality-control potency program must begin with the most basic activities performed at a compounding pharmacy to the most crucial activities. If the basics are not met, the crucial activities of compounding sterile and nonsterile preparations and the quality of the end product are in jeopardy. Basic definitions are provided in thisg article as well as a discussion on a three-step method on setting up a quality-control potency testing program, to include (1) process design and how to reduce the potential of variations and mistakes in compounded preparations, (2) process verification, and (3) how to set up a sampling plan to monitor ongoing quality. Also included are suggestions on how to get started on the development of a quality-control potency testing program.
不可否认，在配制药房的程序中，最重要的考虑因素之一就是质量。制定一个全面的质量控制效力计划，必须从配制药房执行的最基本活动开始，直至最关键的活动。如果连基本要求都达不到，那么配制无菌和非无菌制剂的关键活动以及最终产品的质量都将受到威胁。本文提供了基本定义，并讨论了建立质量控制效力测试计划的三步方法，包括：（1）流程设计以及如何降低配制制剂中出现变异和错误的可能性；（2）流程验证；（3）如何建立一个抽样计划以监测持续的质量。此外，还包括关于如何着手制定质量控制效力测试计划的建议。
