欧洲药典在线27.2内容（征求意见截止日期2015-6-30）
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| Capillary viscometer method | |
| Determination of bactericidal, fungicidal or yeasticidal activity | |
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| Deletion of the test for heavy metals | |
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| Hydroxychloroquine sulfate | |
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| Infectious chicken anaemia vaccine live | |
| Introduction or modification of the deree of hydration in monograph titles | |
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| Propylene glycol dilaurate | |
| Propylene glycol monolaurate | |
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| Substances for pharmaceutical use | |
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| Triamcinolone hexacetonide | |
| Triglycerides, medium-chain | |
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NOTE ON THE MONOGRAPH 修订说明
Related substances. The current reference to the EMA guideline on the limits of genotoxic impurities has been replaced by a reference to the new ICH M7 guideline Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk that will be applicable as of 1 January 2016.
有关物质：目前关于基因毒性杂质引用EMA指南，该指南已被新的ICH M7取代。自2016年1月1日起，对药品中DNA活性（致突变）杂质需进行评估和控制，以限制潜在的致突变风险。
Bacterial endotoxins. The requirements associated with the test have been clarified and aligned with the new policyapproved by the European Pharmacopoeia Commission at its 149th session (June 2014) for the application of the test for bacterial endotoxins to substances for pharmaceutical use (see Useful information section on Pharmeuropa online). This revision goes hand-in-hand with the revision of chapter 5.1.10 Guidelines for using the test for bacterial endotoxins, published in Pharmeuropa 26.4, which includes recommendations for establishing limits and information on how to evaluate the pyrogenicity of substances. 细菌内毒素：药典在线26.4期中公布了5.1.10指南修订，对细菌内毒素进行了修改，本章节中进行相应修订，包括了如何评估物质热源性的信息，以及建立限度的建议。
In accordance with the newly adopted policy, new monographs on substances for pharmaceutical use will no longer include the test for bacterial endotoxins (with possible exceptions); this aspect will now be covered by this general monograph. In other words, it is the manufacturer’s responsibility to decide whether or not the requirements for bacterial endotoxins have to be applied and, if so, to calculate the corresponding limits. Moreover, as specified in the monographs on Parenteral preparations (0520) and Preparations for irrigation (1116), these requirements apply to the finished product. To ensure that a preparation complies with requirements, the manufacturer may therefore use substances that comply with the test for bacterial endotoxins and/or demonstrate that the process includes an appropriate procedure for the removal of bacterial endotoxins. This decision is part of an overall control strategy that the manufacturer establishes for a preparation, as is the decision on whether or not to perform the test for bacterial endotoxins at the level of the substance, in accordance with the General Notices - Demonstration of compliance with the Pharmacopoeia: “An article is not of Pharmacopoeia quality unless it complies with all the requirements stated in the monograph. This does not imply that performance of all the tests in a monograph is necessarily a prerequisite for a manufacturer in assessing compliance with the Pharmacopoeia before release of a product. The manufacturer may obtain assurance that a product is of Pharmacopoeia quality on the basis of its design, together with its control strategy and data derived, for example, from validation studies of the manufacturing process.”
根据新采用的方针，新的药用物质各论将不再包括细菌内毒素（可能有例外），这方面将由本通论覆盖。换句话说，生产商有责任来决定是否适用细菌内毒素的要求，如果适用，应计算相应的限度。并且，正如注射制剂（0520）和灌洗剂（1116）通论中所说，这些要求适用于制剂产品。为保证制剂符合要求，生产商可能会使用符合细菌内毒素测试要求的物质，和/或证明工艺包括了适当的程序来去除细菌内毒素。该决定是生产商建立全面制剂质量控制策略的一部分，该策略保证制剂符合通论---药典符合性证明，生产商可以决定是否在原料药中检测细菌内毒素。“药品的一个成分如果不符合各论中说明的所有要求则不是药典品质。这并不是说生产商在评估药典符合性时必须测试各论中的所有检测项目才可以放行一个药品。生产商可以通过设计，联合其控制策略和产生的数据，例如，生产工艺的验证研究，来保证产品具有药典品质。
2034修订内容
For active substances in a new application for a medicinal product for human use, the requirements of the ICH M7 guidelineon the limits of genotoxic impurities and the corresponding questions and answers documents published on the website of the European Medicines Agency (or similar evaluation principles for non-European Union member states) Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk must be followed.
Bacterial endotoxins (2.6.14). If offered as bacterial endotoxin-free grade, the substance for pharmaceutical use complies with the test for bacterial endotoxins. The limit and test method (if not gelation method A) are stated in the individual monograph. The limit is calculated in accordance with the recommendations in general chapter 5.1.10. Guidelines for using the test for bacterial endotoxins, unless a lower limit is justified from results from production batches or is required by the competent authority. Where a test for bacterial endotoxins is prescribed, a test for pyrogens is not required.84
Bacterial endotoxins (2.6.14). If offered as a bacterial endotoxin-free grade or if intended for use in the manufacture of parenteral preparations or preparations for irrigation without a further appropriate procedure for the removal of bacterial endotoxins, the substance for pharmaceutical use complies with the test for bacterial endotoxins. The limit, when not indicated in the individual monograph, is determined in accordance with the recommendations of general chapter 5.1.10. Guidelines for using the test for bacterial endotoxins.
注射用水修订说明
NOTE ON THE MONOGRAPH
There have been ongoing discussions for many years as to whether there is a need to include non-distillation technologies as a method for production of water for injections (WFI). The main concerns had been linked to the microbiological safety of the water produced by membrane techniques. Following the survey issued by the EDQM in March 2010 to gather data on the use of non-distillation technologies for producing WFI, as well as the expert workshop organised by the EDQM in March 2011 (Water for Injections – Potential Use of Membrane Systems for the Production), it was considered that sufficient evidence had been provided for the Ph. Eur. Commission to recommend initiating discussions with stakeholders regarding the potential use of membrane systems for the production of WFI. 业内持续讨论了很多年是否需要将非蒸馏技术作为注射用水的生产方法。主要关注是膜技术产生的水的微生物安全。EDMQ在2010年3月公布了关于收集使用非蒸馏技术生产WFI数据的调查结果之后，EDQM在2011年3月组织了专家工作组（注射用水---膜系统用于生产的可能性），可以认为欧洲药典委员会已收到了充分的证据，可以建议开始与干系人讨论关于膜系统用于WFI生产的可能性。
A revision of the monograph is proposed to take into account current manufacturing practices using methods other than distillation for producing water of injectable quality. The monograph revision is supported by the evidence provided in the document Reverse osmosis in Ph. Eur. monograph Water for injections (0169), published in Pharmeuropa (Useful information). 考虑到目前使用非蒸馏技术生产注射质量用水的生产实践，提出了对各论的修订。各论修订由“欧洲药典各论注射用水中的反渗透”文件提供的证据来支持，该文件公布在欧洲药典在线（有用信息）。
Production: the monograph has been revised to include, in addition to distillation, reverse osmosis coupled with suitable techniques, for the production of WFI; a requirement for regular total organic carbon monitoring has been added to emphasise further the specific test controls required in the Production section.
生产：各论进行了修订，以包括除蒸馏以外的反渗透联合适当技术来生产WFI，强调要求进行常规TOC监控，来对生产部分进行进一步指定测试控制。
As a result of introducing non-distillation technologies into this monograph, the monograph Water, highly purified (1927) will be made redundant and will be deleted from the Ph. Eur.
作为引入非蒸馏技术至本各论的结果，各论高纯水（1927）将成为多余，将从药典中删除。
修订后征求意见正文
PRODUCTION15
Water for injections in bulk is obtained from water that complies with the regulations on water intended for human consumption laid down by the competent authority or from purified water. It is produced either:16
– by distillation in an apparatus of which the parts in contact with the water are of neutral glass, quartz or a suitable metal and which is fitted with an effective device to prevent the entrainment of droplets; The correct maintenance of the apparatus is essential. the first portion of the distillate obtained when the apparatus begins to function is discarded and the distillate is collected; or17
– by reverse osmosis, which may be single-pass or double-pass, coupled with other suitable techniques such as deionisation and/or ultrafiltration.18
Correct operation monitoring and maintenance of the system are essential.19
In order to ensure the appropriate quality of the water, validated procedures, in-process monitoring of the electrical conductivity, and regular total organic carbon and microbial monitoring are applied.20
Water for injections in bulk is stored and distributed in conditions designed to prevent growth of micro-organisms and to avoid any other contamination.21
来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201522794713331/
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