1.1 本标准涵盖E55委员会使用的与制药和生物制药工业相关的术语，用于制药和生物医药产品的制造。除非对制药和生物制药制造有更明确的描述，否则不包括一般理解和通用的术语或在其他容易获得的参考文献中充分定义的术语。 1.2 因此，该术语旨在选择制药和生物制药产品制造中通常使用的术语，并在后续章节中列出的许多文件中发布。 该列表还旨在定义在其他相关ASTM国际标准中显著出现而在其他地方没有出现的术语。 1.3 这些定义与监管机构（如美国食品药品监督管理局、欧洲药品管理局、医药和医疗器械管理局（日本）、其他和国家主管当局（人类）以及其他权威机构（如ICH、ISO和国家标准组织）发布的定义基本相同。 1.4 本术语补充了当前有关药物和生物制药产品制造术语的文件。 1.5 越来越多的产品名称以及化学、物理、机械、分析和统计测试和标准的名称在与制药和生物制药产品制造相关的文献、监管环境和商业中被普遍使用。 1.6 单位- 以国际单位制表示的数值应视为标准。本标准不包括其他测量单位。 1.7 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。

1.1 This standard covers terminology used by the E55 Committee relating to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to pharmaceutical and biopharmaceutical manufacturing may be more clearly stated. 1.2 This terminology is, therefore, intended to be selective of terms used generally in the manufacture of pharmaceutical and biopharmaceutical products and published in a number of documents such as those listed in the succeeding section. The listing is also intended to define terms that appear prominently within other related ASTM International standards and do not appear elsewhere. 1.3 The definitions are substantially identical to those published by regulatory agencies such as the U.S. Food and Drug Administration, European Medicines Agency, Pharmaceutical and Medical Devices Agency (Japan), other and national competent authorities (human) as well as other authoritative bodies, such as ICH, ISO, and national standards organizations. 1.4 This terminology supplements current documents on terminology that concentrate on the manufacture of pharmaceutical and biopharmaceutical products. 1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with the manufacture of pharmaceutical and biopharmaceutical products. 1.6 Units— The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.