标准物质生产质量管理体系

IF 0.8 4区医学 Q4 CHEMISTRY, MEDICINAL

Pharmaceutical Chemistry Journal Pub Date : 2024-06-21 DOI:10.1007/s11094-024-03150-w

V. S. Pyzhov, V. I. Gegechkori, V. A. Darina, E. A. Pogrebinskaya

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引用次数: 0

摘要

文章论述了质量管理体系（QMS）在创建和补充通用标准物质（RM）库以及协调国际标准方面的作用。文章展示了质量管理体系在该领域的应用如何通过控制技术流程各阶段的质量来确保高质量的标准物质生产。该出版物重点介绍了质量管理体系在最大限度地减少与标准物质生产相关的错误和风险方面的潜力，从而提高标准物质在科研和生产领域使用时的可靠性和准确性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Quality Management System in Production of Reference Materials

The article touches the most relevant aspects of the role of quality management systems (QMSs) in the creation and replenishment of universal bases of reference materials (RMs) and harmonization of international standards. The article demonstrates how application of a QMS in this area ensures high-quality RM production by controlling the quality at each stage of the technological process. The publication focuses on the potential of a QMS to minimize errors and risks associated with the production of RMs, which increases their reliability and accuracy when used in scientific and production areas.

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来源期刊

Pharmaceutical Chemistry Journal CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

1.30

自引率

22.20%

发文量

226

审稿时长

3-8 weeks

期刊介绍： Pharmaceutical Chemistry Journal is a monthly publication devoted to scientific and technical research on the creation of new drugs and the improvement of manufacturing technology of drugs and intermediates. International contributors cover the entire spectrum of new drug research, including: methods of synthesis; results of pharmacological, toxicological, and biochemical studies; investigation of structure - activity relationships in prediction of new compounds; methods and technical facilities used; and problems associated with the development of ecologically safe and economically feasible methods of industrial production. In addition, analytical reviews of the international literature in the field provide coverage of the most recent developments around the world. Pharmaceutical Chemistry Journal is a translation of the Russian journal Khimiko-Farmatsevticheskii Zhurnal. The Russian Volume Year is published in English from April. All articles are peer-reviewed.