<659>你最喜欢谁 PACKAGING AND STORAGE REQUIREMENTS
<659>包装和储存要求
(Chapter to become official May 1, 2016)
（本章节2016年5月1号正式生效）
Delete the following：
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Every monograph in the USP and NF shall have packaging and storage requirements. For the packaging portion of the statement, the choice of containers is given in this chapter. For drug product packaging requirements, definitions are provided to guide lection and adaptation. For active pharmaceutical ingredients (APIs), the choice would be tight, well-clod or, where needed, a light-resistant container. For excipients, given their typical prentation as large-volume commodity items (containers ranging from drums to tank cars), a well-clod container is an appropriate default.
在USP和NF的每个专论中应要有包装和储存的要求。对于包装的声明部分，本章节提供了容器的选择。对于药品包装的要求，定义进行导向筛选和改编。对于API，要选择密封的、密闭性好的或者根据需要选择耐光的容器。对于赋形剂，和大容量商品一样，鉴于他们的典型性质，（容器从圆桶到罐车），默认是一个密闭性好的容器。
Where no specific directions or limitations are provided in the article’s labeling, articles shall be protected from moisture, freezing, and excessive heat and, where necessary, from light during shipping and distribution. Drug substances are exempt from this standard. USP38.
在物品的标签上没有提供特定的方向或局限性。物品在运输和配送过程中应该防潮、防冻、防过热，必要时要避光。药物不受这个标准限制。
PACKAGING
包装
会计职业生涯规划书Packaging must not interact physically or chemically with official articles in any way that c
aus their safety, identity, strength, quality, or purity to fail to conform to requirements.
荣格自传包装不能以任何方式使物品化学和物理方面产生相互影响，从而导致他们的安全性、特性、强度、质量或纯度不符合要求。
Packaging container choices are given in this chapter. For drug products and active pharmaceutical ingredients (APIs), the container choices are tight, well-clod, or, where needed, light-resistant. For excipients, given their typical prentation as large-volume commodity items (containers ranging from drums to tank cars), a well-clod container is an appropriate default. For articles other than drug substances and drug products, where no specific directions or limitations are provided, articles shall be protected from moisture, freezing, and excessive heat, and, where necessary, from light during shipping and distribution.
本章节提供了包装容器的选择。对于药品和揣读音API降火的食物包装的要求，要选择密封的、密闭性好的或者根据需要选着耐光的容器。对于赋形剂，和大容量商品一样，鉴于他们的典型性质，（容器从圆桶到罐车），默认是一个密闭好的容器。没有提供特定的方向或局限性时，对于除了药物和药品外的其他物品，在运输和配送过程中应该防潮、防冻、防过热，必要时要避光。
The compendial requirements for the u of specified containers apply also to articles as packaged by the pharmacist or other dispenr, unless otherwi indicated in the individual monograph. USP38
使用指定容器的药典要求对药剂师或其他分配者包装物品时同样适用，除非在专论中另有说明。
GENERAL DEFINITIONS
一般概念
英语小故事
Packaging system (also referred to as a container–closure system): The sum of packagin
g components that together contain and protect the article. This includes primary packaging components and condary packaging components, if the latter is intended to provide additional protection.
节水包装系统（也称为容器密封系统）：指共同盛装和保护物品的所有包装组件的总和。如果次级包装组件具有为物品提供额外保护的功能，则容器密封系统包括初级包装组件和次级包装组件。
草原生态系统Container: A receptacle that holds an intermediate compound, active pharmaceutical ingredient, excipient, or dosage form and is or may be USP38 in direct contact with the articles. The immediate container is that which is in direct contact with the article at all times. The closure is a part of the container. Before being filled, the container should be clean. Special precautions and cleaning procedures may be necessary to ensure that each container is clean and that extraneous matter is not introduced into or onto the article. USP38
容器：能够保存中间体、原料药、辅料或剂型的容器，是 或可能是 和物品直接接触。直接包装的容器会一直直接接触药品。密封也是容器的一部分。在填装之前，容器应该干净。特殊的预防措施和清洁程序可能是必要的，可以保证每个容器的干净，异物不会引入或粘到药品上。
Packaging component: Any single part of the package or container–closure system including the container (e.g., ampuls, prefilled syringes, vials, bottles); container liners (e.g., tube cartridge liners); closures (e.g., screw caps, stoppers); ferrules and overals; closure liners; inner als; administration ports; overwraps; administration accessories; and labels.
包装组件：容器密封系统或包装的任何一个部分，包括容器（如：安瓿、预灌封注射器、西林瓶、瓶子）；容器衬垫（例如管衬）；瓶塞（螺旋盖、胶塞）；套管和胶塞顶封；瓶塞衬垫；内封；输液口；外包装；给药配件和标签。
Primary packaging component: Packaging components that are in direct contact or may become in direct contact with the article.
初级包装组件指的是与物品直接接触或可能变成直接接触的包装组件。
