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EMA:制药用水质量指南 20200720

20 July 2020EMA/CHMP/CVMP/QWP/496873/2018Committee for Medicinal Products for Human Use (CHMP)
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20 July 2020
EMA/CHMP/CVMP/QWP/496873/2018
Committee for Medicinal Products for Human Use (CHMP)
Committee for Medicinal Products for Veterinary Use (CVMP)
Guideline on the quality of water for pharmaceutical use
制药用水质量指南
Executive summary执行摘要
This guideline replaces the Note for Guidance on quality of water for pharmaceutical use (CPMP/QWP/158/01,EMEA/CVMP/115/01) originally adopted in May 2002, and the CPMP Position Statement on the Quality of Water used in the production of Vaccines for parenteral use (EMEA/CPMP/BWP/1571/02 rev.1).
本指南取代2002年5月生效的《制药用水质量指南说明》(CPMP/QWP/158/01, EMEA/CVMP/115/01),和CPMP《注射疫苗生产用水质量立场声明》(EMEA/CPMP/BWP/1571/02rev.1)。
The note for guidance has been updated to reflect the following changes in the European Pharmacopoeia:
此次对指南说明进行了更新,反映出欧洲药典中的以下变化:
• revised monograph for Water for Injections (0169) allowing the possibility to use methods other than distillation for producing water of injectable quality;
•注射用水(0619)专论修订内容,修订后允许使用非蒸馏方法制备注射用水;
• new monograph for Water for preparation of extracts (2249);
•新订提取用水专论(2249);
• suppression of the monograph for Water, highly purified (1927).
•废除高纯水专论(1927)
The guideline has also been updated to reflect current expectations for the minimum acceptable quality of water used in the manufacture of active substances and medicinal products for human and veterinary use.
本指南亦进行了更新,以反映目前对人用与兽用API和制剂生产用水的最低可接受质量标准要求。
1. Introduction (background)概述(背景)
Water is one of the major utilities used by the pharmaceutical industry. It may be present as anexcipient or used for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent for rinsing vessels, equipment, primary packaging materials, etc.
水是制药行业所用的主要公用系统之一。它可以作为辅料使用,亦可用于药品调配;可用于合成,亦可用于制剂生产,或作为清洁剂用于淋洗贮罐、设备、内包材等。
Different grades of water quality are required depending on the different pharmaceutical uses. Control ofthe quality of water, in particular the microbiological quality, is a major concern and the pharmaceutical industry devotes considerable resource to the development and maintenance of water purification systems.
不同级别的水质量由药品的不同用途决定。水质检测,尤其是微生物质量,是重要的关注点,制药企业都会投入相当大的资源建设和维护制水系统。
The European Pharmacopoeia (Ph. Eur.) provides quality standards for grades of water for pharmaceutical use including Water for Injections (WFI), Purified Water and Water for preparation of extracts.
欧洲药典提供了不同级别制药用水的质量标准,包括注射水(WFI)、纯化水和提取用水。
Until April 2017, the production of Water for Injections (WFI) had been limited to production by distillation only. Following extensive consultation with stakeholders, the Ph.Eur. monograph for Water for Injections (0169) was revised in order to allow the production of WFI by a purification process equivalent to distillation, such as reverse osmosis, which may be single-pass or double-pass, coupled with other appropriate techniques such as electro-deionisation, ultra filtration ornanofiltration. The revised monograph was published in the Ph. Eur. Supplement 9.1 and became effective on 1 April 2017.
2017年4月前,注射水的制备仅限于使用蒸馏方法。在广泛征求利益相关人意见之后,EP修订了注射用水专论(0169),允许采用等同于蒸馏的纯化工艺制备WFI,例如反渗透方法,可以是单通道,亦可以是双通道,配以其它适当的技术如电除盐、超滤或纳滤。修订后的专论已在EP9.1中发布,于2017年4月1日生效。
This change brings the Ph.Eur. more closely in line with the US Pharmacopeia and the Japanese Pharmacopoeia, allowing production of WFI by distillation or by a purification process proven “equivalent or superior to distillation”, and “by distillationor by reverse osmosis and/or ultrafiltration”, respectively.
该变化使用EP与USP和JP更为接近,后2者分别允许使用蒸馏和其它被证明“等同或优于蒸馏的”纯化工艺,“通过蒸馏或反渗透和/或超滤”制备WFI。
In addition, the Ph. Eur.Commission has adopted a new policy for the test for bacterial endotoxins, reflected in the revision of general chapter 5.1.10 Guidelines for using the test for bacterial endotoxins and the general monograph for Substances for pharmaceutical use (2034). As a consequence, new monographs for substances for pharmaceutical use will no longer include the test for bacterial endotoxins (with possible exceptions). This aspect is now covered by the general monograph, which includes recommendations for establishing limits and information on how to evaluate the pyrogenicity of substances and where,according to the monographs on Parenteral preparations (0520) and Preparations for irrigation (1116), the requirements apply to the finished product.
此外,EP委员会已通过了新的细菌内毒素检查方针,反映在通则5.1.10“细菌内毒素检测使用指南”和“药用物质(2034)”通论的修订版本中。这样,新的药用物质通论将不再包括细菌内毒素检测(可能有例外)。目前该内容由通论覆盖,其中包括了建立限度的建议和如何评估药用物质热原性的信息。根据注射剂(0520)专论和灌注剂(1116)专论,上述这些要求均适用于制剂。
The opportunity has alsobeen taken to update terminology and requirements to reflect currentexpectations.
同时我们还借此机会更新了术语和要求,以反映出目前的期望。
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发布于 2020-07-22 10:41:00 © 著作权归作者所有
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