回奶的食物有哪些
于国民
凡例
1.1总体概述
共享纸巾机The General Notices apply to all monographs and other texts of the European Pharmacopoeia.
总体概述适用于所有的专论和湿气很重怎么调理欧洲药典中的其它内容。
The official texts of the European Pharmacopoeia are published in English and French. Translations in other languages may be prepared by the signatory States of the European Pharmacopoeia Convention. In ca of doubt or dispute, the English and French versions are alone authoritative.
欧洲药典的官方内容以法语和英语出版。欧洲药典公约的签署国可以将其翻译成另外的语言。如有疑问或争议,英语和法语版本为独有的权威性。
In the texts of the European Pharmacopoeia, the word ‘Pharmacopoeia’ without qualification means the European Pharmacopoeia. The official abbreviation Ph. Eur. may be ud to indicate the European Pharmacopoeia.
在欧洲药典的内容中,如无特殊规定,‘药典’一词指欧洲药典。官方缩写Ph.Eur.也指欧洲药典。
The u of the title or the subtitle of a monograph implies that the article complies with the requirements of the relevant monograph. Such references to monographs in the texts of the Pharmacopoeia are shown using the monograph title and reference number in italics.
专论标题和副标题的使用意味着产品符合相关专论的要求。在药典正文中,对专论的参引以专论标题和斜体的参考号表示。
在我的心里A preparation must comply throughout its period of validity; a distinct period of validity and/or specifications for opened or broached containers may be decided by the competent authority. The subject of any other monograph must comply throughout its peri
od of u. The period of validity that is assigned to any given article and the time from which that period is to be calculated are decided by the competent authority in light of experimental results of stability studies.
药品在有效期内必须性质稳定,对于打开或开盖容器的明确的有效期和/或说明应由主管当局批准。任何另外的专论的内容必须遵守其使用周期。任何给出药品的有效期和有效期的起始时间由权力机构经稳定性研究的试验结果决定。
Unless otherwi indicated in the General Notices or in the monographs, statements in monographs constitute mandatory requirements. General chapters become mandatory when referred to in a monograph, unless such reference is made in a way that indicates that it is not the intention to make the text referred to mandatory but rather to cite it for information.
除非在凡例和专论中另有指定,专论中的说明为强制性要求。当在专论中涉及通用章节时,通用章节变成法定要求。除非这种提及的方式表明,它不打算使提到的文字作为强制性要求,而只是引用它的信息。
从优The active substances, excipients, pharmaceutical preparations and other articles described in the monographs are intended for human and veterinary u (unless explicitly restricted to one of the us). 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 asssing compliance with the Pharmacopoeia before relea of a product. The manufacturer may obtain assurance that a product is of Pharmacopoeia quality from data derived, for example, from validation studies of the manufacturing process and from in-process controls. Parametric relea in circumstances deemed appropriate by the competent authority is thus not precluded by the need to comply with the Pharmacopoeia.
各论中描述的活性成分(药用物质),赋形剂,(辅助药物),药物制剂,和另外意欲为人和兽所用的产品(除非明确限制其中一个的使用)。除非产品符合专论中的所有要求,否则它就不符合药典的质量要求。但这并不表示厂商在放行产品前评估产品是否符合药典要求的先决条件是进行专论中的所有测试。生产厂商可以从导出的数据来来保证产品具有
药典规定的质量,例如,生产过程和进程内控制的验证。在特定情况下,参数释放被主管当局视为适合的,但并没有排除符合药典要求的需要。
The tests and assays described are the official methods upon which the standards of the Pharmacopoeia are bad. With the agreement of the competent authority, alternative methods of analysis may be ud for control purpos, provided that the methods ud enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were ud. In the event of doubt or dispute, the methods of analysis of the Pharmacopoeia are alone authoritative.
描述的试验和分析方法都是基于药典标准的官方方法,经主管当局允许可采用其它的分析方法以达到控制目的。如果官方方法被使用,可以对是否符合专论标准作出明确的判断。若出现争论或异 议,应以药典方法为准。
Certain materials that are the subject of a pharmacopoeial monograph may exist in different grades suitable for different purpos. Unless otherwi indicated in the monograph, the requirements apply to all grades of the material. In some monographs, p
articularly tho on excipients, a list of functionality-related characteristics that are relevant to the u of the substance may be appended to the monograph for information. Test methods for determination of one or more of the characteristics may be given, also for information.
药典各论中的某些物质有多个等级,可满足各种需要。除各论中另有说明,这些要求适用于所有等级的物料。在一些各论中,特别是赋形剂,一系列相关的功能特性都有介绍,其中给出了一些特性的检测方法情感心理学。
Quality systems. The quality standards reprented by monographs are valid only where the articles in question are produced within the framework of a suitable quality system.
质量系统. 专论中给出的质量标准只有对适当的质量体系生产框架内产出的产品存在质疑时才被验证。
General monographs. Substances and preparations that are the subject of an individual
monograph are also required to comply with relevant, applicable general monographs. Cross-references to applicable general monographs are not normally given in individual monographs.
孕前准备最佳方案一般专论. 各论中介绍的药物和制剂也应符合总论中相关又适用的要求。相互参照可适用的总论通常没有在各论中指出。
General monographs apply to all substances and preparations within the scope of the Definition ction of the general monograph, except where a preamble limits the application, for example to substances and preparations that are the subject of a monograph of the Pharmacopoeia.
除了有在引言限制其应用,如规定适用于药典各论中的物质,总论的内容适用于各论定义范围内的所有药物和制剂。