Martin Matt
Professional Compounding Centers of America, Houston, Texas.
Int J Pharm Compd. 2018 Nov-Dec;22(6):475-478.
Compounders engaged in making sterile preparations need to employ a quality-assurance system of documented policies and procedures to attempt to reduce the possibility of contamination. The quality-assurance program will be monitored through the facility's quality-control system. Compounders should be aware of the requirements of each state they are licensed in as well as the inspection observations commonly noted in 483s issued by the U.S. Food and Drug Administration. Part 1 of this 2-part article discussed the currently evolving regulatory environment and why sterile compounding requires planning and monitoring to deliver quality compounds to patients. Part 2 examines the United States Pharmacopeia's discussion on the principles of quality assurance and quality control in sterile compounding.
从事无菌制剂配制的配药人员需要采用一套有文件记录的政策和程序的质量保证体系，以试图降低污染的可能性。质量保证计划将通过机构的质量控制系统进行监测。配药人员应了解其获得许可的每个州的要求，以及美国食品药品监督管理局发布的483表格中常见的检查结果。这篇分两部分的文章的第一部分讨论了当前不断演变的监管环境，以及为什么无菌配制需要规划和监测，以便为患者提供高质量的制剂。第二部分探讨了美国药典关于无菌配制中质量保证和质量控制原则的讨论。
