[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2015]
[CITE: 21CFR111]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
PART 111    CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
第111部分 饮食添加剂生产、包装、标签和储藏操作的CGMP规范
Subpart A--General Provisions 一般规定
Sec. 111.1 Who is subject to this part?
这部分的主要内容是什么？
(a) Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including:
除了b节中规定的以外，生产、包装、贴标或保存膳食补充剂都受到这个规范的支配，包括：
(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and一个生产商生产的膳食补充剂，却由另一个进行包装或贴标；
(2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
出口到任何国家或美国地区，哥伦比亚特区，或波多黎各自由邦的膳食补充剂
(b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.
若这些膳食补充剂在零售店唯一的目的是零售给个人消费者，则控制膳食补充剂的有关需求不适用。零售店不包括零售商的仓库或其他存储设施，或直接销售给个人消费者的仓库或其他存储设施。record是什么意思中文
Sec. 111.3 What definitions apply to this part?
如何定义这部分？
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when used in this part. For the purpose of this part, the following definitions also apply:
联邦食品、药品和化妆品法案（该法案）第201节中的定义和术语解释适用于此部分所用到的术语。基于此部分的目的，下面的定义同样适用：
Actual yield means the quantity that is actually produced at any appropriate step of manufacture or packaging of a particular dietary supplement.
实际产量是指在一个独有的膳食补充剂生产、加工、包装的任何适当步骤所产生的实际数量。
Batch means a specific quantity of a dietary supplement that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified time period according to a single manufacturing record during the same cycle of manufacture.
批是指在规定限度内具有同一性质和质量,并在同一连续生产周期中生产出来的一定数量的膳食补充剂。
Batch number, lot number, or control number means any distinctive group of letters, numb
ers, or symbols, or any combination of them, from which the complete history of the manufacturing, packaging, labeling, and/or holding of a batch or lot of dietary supplements can be determined.
用于识别“批”的一组数字或字母加数字。用以追溯和审查该批药品的生产历史。
Component means any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement. Component includes dietary ingredients (as described in section 201(ff) of the act) and other ingredients.
组分是指用于膳食补充剂生产的相关成分，包括在最终成品中不出现的物质。组分包括膳食成分（如法案201节中所述的营养成分和另外的成分）。
Contact surface means any surface that contacts a component or dietary supplement, and those surfaces from which drainage onto the component or dietary supplement, or onto surfaces that contact the component or dietary supplement, occurs during the norma
l course of operations. Examples of contact surfaces include containers, utensils, tables, contact surfaces of equipment, and packaging.
接触组分或膳食补充剂的那些表面以及经常在正常加工过程中会将污水滴溅在组分或膳食补充剂上或溅在接触组分或膳食补充剂的那些表面上的表面。包括容器、器皿。桌子，设备接触面和包装。
Ingredient means any substance that is used in the manufacture of a dietary supplement and that is intended to be present in the finished batch of the dietary supplement. An ingredient includes, but is not necessarily limited to, a dietary ingredient as defined in section 201(ff) of the act.
成分是指用于膳食补充剂生产的任何物质，以及在成品中出现的相关成分。包括一种成分，但不一定限于法案第201节中定义的膳食成分。
In-process material means any material that is fabricated, compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any other way for use in the manufacture of a dietary supplement.
中间产品是指制造、混合、基础、提取、筛选、消毒、源于化学反应的任何物料或以其他方式用于膳食补充剂的生产的物料。
Lot means a batch, or a specific identified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and composition; or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

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