美国良好操作规范(GMP―21CFR Part 111)

[联邦法规]

[Title 21, V olume 2] [标题21，第2卷]

[Revised as of April 1, 2008] [日期为2008年4月1日] [CITE: 21CFR111] [引用：21CFR111]

TITLE 21--FOOD AND DRUGS 标题21 -食品和药物CHAPTER I--FOOD AND DRUG ADMINISTRATION 第一章-食品和药物管理局

DEPARTMENT OF HEALTH AND HUMAN SERVICES 部卫生与公众服务

SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION 子章节B组-人类食用的食物

PART 111 第111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS 现行良好操作规范在制造，包装，标签，或对食品补充剂控股作业

Subpart A--General Provisions 子部分-一般规定

Sec. 秒。111.1 Who is subject to this part? 111.1谁是受这部分？

(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: （一）除提供段（二本节），你必须遵守，如果你这部分的制造，包装，标签，或持有饮食的补充，其中包括：

(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and （1）膳食补充剂，但你制造的包装物或由他人标记;及

(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. （2）膳食补充剂进口或在任何国家或美国境内的进口提供，哥伦比亚特区，或波多黎各联邦。

(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. （二）的要求举行有关膳食补充剂并不适用于你是否保持在一个直接零售个人消费者零售的唯一目的建立的膳食补充剂。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. 阿零售的建立，并不包括为零售商或仓库或其他存储设施，销售直接向个人消费者仓库或其他存储设施。Sec. 秒。111.3 What definitions apply to this part? 111.3什么定义适用于本部分？

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: 的定义和节联邦食品，药品和化妆品法（该法）201条款的解释适用于本部分时，使用的条款就本部分。为此，下列定义也适用于：

Actual yield means the quantity that is actually produced at any appropriate step of manufacture or packaging of a particular dietary supplement. 实际收益率是指实际上是在任何制造或包装特殊膳食补充剂生产数量适当的步骤。

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. 批次指饮食补充剂是一致的，便是为了满足身份，纯度，强度规格，和组成，具体数量，即在规定的时限内根据一个单一的生产过程中产生的记录的生产同一周期。

Batch number, lot number, or control number means any distinctive group of letters, numbers, 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. 批号，批号，或控制数是指任何字母，数字或符号，或任何组合，独特的一群，从其中的制造，包装标签，完整的历史，和/或批处理或很多持有膳食补充剂可确定。

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. 组件是指任何人，包括那些可能不会出现在膳食补充剂完成一批物质在膳食补充剂的生产用途。组成部分包括膳食成分（如第201（后）的行为）和其他说明材料。

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 normal course of operations. 接触面指任何表面接触组件或营养补充剂，以及那些从表面上的排水组件或营养补充剂，或接触到的表面，组件或营养补充剂，在正常操作期间发生。Examples of contact surfaces include containers, utensils, tables, contact surfaces of equipment, and packaging. 表面接触的例子包括容器，用具，表，接触的设备表面和包装。

Ingredient means any substance that is used in the manufacture of a dietary supplement and that is intended to