质量保证:复合记录审核以防止错误。

Q4 Medicine

International journal of pharmaceutical compounding Pub Date : 2023-05-01

Jessica Hawkins

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引用次数: 0

摘要

本文着眼于采取一种积极主动的方法，在设施水平上发现药物复合中的不一致。回顾了美国药典章节药物配制-非无菌制剂和美国药典章节药物配制-无菌制剂的2022年出版物中规定的非无菌和无菌配制中主配方和配制记录的详细要求。在此总结之后，介绍了如何通过定期审计和报告来利用记录保存要求，以及如何将这些审计或报告纳入设施的质量保证计划，以满足错误检测和预防要求。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

本刊更多论文

Quality Assurance: Compounding Record Audits for Error Prevention.

This article looks at taking a proactive approach in discovering inconsistencies in pharmaceutical compounding at a facility level. Details on the requirements for master formulation and compounding records in nonsterile and sterile compounding as laid out in the 2022 publications of United States Pharmacopeia Chapter <795> Pharmaceutical Compounding- Nonsterile Preparations and United States Pharmacopeia Chapter <797> Pharmaceutical Compounding-Sterile Preparations are reviewed. Following this summary, information is then presented on how to utilize the record-keeping requirements to a facility's advantage through regular auditing and reporting and how to incorporate these audits or reports into a facility's quality-assurance program to fulfill error detection and prevention requirements.

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来源期刊

International journal of pharmaceutical compounding Medicine-Medicine (all)

CiteScore

0.40

自引率

0.00%

发文量

期刊介绍： The International Journal of Pharmaceutical Compounding (IJPC) is a bi-monthly, scientific and professional journal emphasizing quality pharmaceutical compounding. IJPC is the only publication that covers pharmaceutical compounding topics relevant and necessary to empower pharmacists to meet the needs of today"s patients. No other publication features hands-on, how-to compounding techniques or the information that contemporary pharmacists need to provide individualized care.