通过熟练度测试方案分析纯化药用水的概述

Caterina Mazzoni, Anne Tirard, A. Boubetra
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引用次数: 0

摘要

水是制药业使用的主要成分之一。它可以作为赋形剂或用于产品的重组,在合成过程中,在成品生产过程中或作为清洗剂。根据不同的医药用途,需要不同等级的水质。化学、物理和微生物质量控制对于验证采出水是否符合现行法规至关重要。医药用水质量控制必须采用的方法详见国际药典。然而,实验室几乎没有手段来检查获得的结果,并向药品监管机构和客户协会证明他们的能力。作为认证标准物质(CRM),能力测试计划(PTS)是客观检查实验室性能的一个很好的工具。此外,PTS中收集的数据代表了测试分析方法的最新状态的快照。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Overview of Analyses of Purified Pharmaceutical water through Proficiency-testing Schemes Results
Water is one of the major components used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent. Different grades of water quality are required depending on the different pharmaceutical uses. Chemical, physical and microbiological quality controls are essential to verify that the produced water meets the regulations in force. The methods that must be applied for quality control of water for pharmaceutical purpose are described in the international Pharmacopeia. However, laboratories have few means at their disposal to check obtained results and to prove their competence to drug regulatory agencies and customers associations. As Certified Reference Materials (CRM), Proficiency Testing Schemes (PTS) is an excellent tool to objectively check laboratories performances. Moreover, data collected in PTS represent a snapshot of the state of the art of tested analytical methods.
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