Okeke Claudia C, Allen Loyd V
Claumek Pharma Science, Rockville, Maryland.
Int J Pharm Compd. 2010 Jan-Feb;14(1):60-4.
To ensure the quality of compounded preparations, an efficient quality-assurance program is necessary. This article clearly defines the elements necessary to establish a quality-assurance program that meets the standards set forth in the United States Pharmacopeia in the area of personnel training. It is essential that compounders have knowledge of the substances used in compounding and the devices used in the compounding facility. Specific and continuous training is essential to provide the compounder with the necessary knowledge to get the job completed. Knowledge of basic science principles is necessary to enable the compounder to understand and interpret scientific data and reports provided by the suppliers. In addition, handling and manipulating the equipment requires specific training to ensure that the results generated by the equipment are correct and accurate.
为确保复方制剂的质量，高效的质量保证计划必不可少。本文明确界定了建立符合美国药典在人员培训领域所规定标准的质量保证计划所需的要素。配制人员必须了解用于配制的物质以及配制设施中使用的设备。特定且持续的培训对于为配制人员提供完成工作所需的知识至关重要。具备基础科学原理知识对于使配制人员能够理解和解读供应商提供的科学数据及报告很有必要。此外，操作和使用设备需要特定培训，以确保设备产生的结果正确且准确。
