新版美国良好操作规范GMP21CFRPart111课件doc.docx

1、新版美国良好操作规范GMP21CFRPart111课件doc联邦法规 Title 21, Volume 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 CONS

2、UMPTION 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 provi

3、ded 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

4、 ， 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 a

5、pply 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

6、 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 Cosmet

7、ic 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

8、 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

9、 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

10、 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, includ

11、ing 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

12、 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

13、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 be present in the finished batch of th

14、e dietary supplement. An ingredient includes, but is not necessarily limited to, a dietary ingredient as defined in section 201(ff) of the act. 成分是指在一个膳食补充剂生产中使用的物质 ， 并拟在膳食补充剂完成一批存在。一种成分，包括但不一定限于，作为第201定义的膳食成分（法郎的行为）。 In-process material means any material that is fabricated, compounded, blended, gr

15、ound, extracted, sifted, sterilized, derived by chemical reaction, or processed in any other way for use in the manufacture of a dietary supplement. 在进程的任何物质手段是捏造的，复杂，混合，地面，提取，筛选，消毒，通过化学反应，或以任何其他方式处理在膳食补充剂的生产使用得来的材料。 Lot means a batch, or a specific identified portion of a batch, that is uniform and

16、 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 spe

17、cifications for identity, purity, strength, and composition. 地段指一批，或特定确定了一个批处理部分，即是一致的 ， 就是为了满足身份，纯度，强度规格，并组成;或者，在连续过程中产生的饮食的补充，具体案件确定数额的方式生产在时间和数量的指定单位 ， 是一致的 ， 目的是要满足的身份，纯度，强度规格，和组成。 Microorganisms means yeasts, molds, bacteria, viruses, and other similar microscopic organisms having public health

18、 or sanitary concern. 微生物是指酵母菌，霉菌，细菌，病毒和其他类似的具有公共健康或卫生关注的微生物。 This definition includes species that: 这个定义包括物种： (1) May have public health significance; （1）5月对公众卫生的重要性; (2) May cause a component or dietary supplement to decompose; （2）可能会导致部分或膳食补充剂分解; (3) Indicate that the component or dietary supplem

19、ent is contaminated with filth; or （3）表明 ， 组件或膳食补充剂与污物污染;或 (4) Otherwise may cause the component or dietary supplement to be adulterated. （4），否则可能会导致部分或营养补充剂是掺假。 Must is used to state a requirement. 必须用于国家规定。 Pest means any objectionable insect or other animal including birds, rodents, flies, mites,

20、 and larvae. 害虫是指任何不良昆虫或其他动物包括鸟类，老鼠，苍蝇，螨虫和幼虫。 Physical plant means all or any part of a building or facility used for or in connection with manufacturing, packaging, labeling, or holding a dietary supplement. 物理植物是指所有或任何建筑物或或与制造，包装，标签，或举办膳食补充剂连接使用设施的一部分。 Product complaint means any communication tha

21、t contains any allegation, written, electronic, or oral, expressing concern, for any reason, with the quality of a dietary supplement, that could be related to current good manufacturing practice. Examples of product complaints are: Foul odor, off taste, illness or injury, disintegration time, color

22、 variation, tablet size or size variation, under-filled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are superpotent, subpotent, or contain the wrong ingredient, or contain a drug or other contaminant (eg, bacteria, pesti

23、cide, mycotoxin, glass, lead). 产品投诉的任何通信手段包含任何指控，书面，电子或口头表示关注因任何原因，与一名膳食补充剂的质量，这可能与目前的良好生产规范。产品投诉的例子有：难闻的气味，关闭口味，生病或受伤，解体时，颜色的变化，平板尺寸或大小的变化，在充满容器，异物在膳食补充剂容器，包装不当，起假，或者是superpotent，subpotent，或控制饮食补充剂错误的成分，或含有药物或其他污染物（如细菌，农药，霉菌毒素，玻璃，铅）。 Quality means that the dietary supplement consistently meets the

24、established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act. 质量是指膳食补充剂始终符合身份，纯度，强度既定的规范，和组成，以及污染物

25、的限制，并已生产，包装，标签和条件下进行 ， 以防止根据第402（1）（1掺假），（1）（2），（1）（3），和（a）（4）行为。 Quality control means a planned and systematic operation or procedure for ensuring the quality of a dietary supplement. 质量控制手段 ， 有计划和有系统的运作 ， 确保膳食补充剂的质量或程序。 Quality control personnel means any person, persons, or group, within or outs

26、ide of your organization, who you designate to be responsible for your quality control operations. 质量控制人员 ， 是指任何人，人，或在境内或境外的组织，谁您指定组，对您的质量控制操作负责。 Representative sample means a sample that consists of an adequate number of units that are drawn based on rational criteria, such as random sampling, and

27、that are intended to ensure that the sample accurately portrays the material being sampled. 代表性的样本是指样本的足够数量的单位所组成的基础上制定合理的标准 ， 如随机抽样，并说是为了确保样本准确地描绘了被采样的材料。 Reprocessing means using, in the manufacture of a dietary supplement, clean, uncontaminated components or dietary supplements that have been pre

28、viously removed from manufacturing and that have been made suitable for use in the manufacture of a dietary supplement. 使用后处理方法的膳食补充剂生产，清洁无污染组件或膳食补充剂，先前已删除从制造业和已作出在膳食补充剂的生产使用。 Reserve sample means a representative sample of product that is held for a designated period of time. 储备样本指产品 ， 在一段时间指定期间举行的

29、代表性。 Sanitize means to adequately treat cleaned equipment, containers, utensils, or any other cleaned contact surface by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other microorganisms, but with

30、out adversely affecting the product or its safety for the consumer. 消毒方法适当处理的一个过程 ， 是在破坏公共健康的微生物的生长细胞 ， 有效的清洗设备，容器，用具，或任何其他清洁接触面，并能显着减少其他微生物的数字，但不影响该产品或其对消费者的安全。 Theoretical yield means the quantity that would be produced at any appropriate step of manufacture or packaging of a particular dietary su

31、pplement, based upon the quantity of components or packaging to be used, in the absence of any loss or error in actual production. 理论产量是指在没有任何损失或错误的情况下实际生产数量将在任何制造或包装特殊膳食补充剂的适当步骤后组件或包装数量为基础，制作使用。 Water activity (aw) is a measure of the free moisture in a component or dietary supplement and is the qu

32、otient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. 水分活度 （Aw）为是一个组件或膳食补充剂自由水分的措施 ， 是由单纯的水在相同温度下的蒸气压力分为物质的水蒸汽压力商。 We means the US Food and Drug Administration (FDA). 我们指美国食品及药物管理局（FDA）。 You means a person who manufactures, packages, labels, or holds dietary supplements. 你是指一个人谁制造，包装，标签，或持有膳食补充剂。 Sec. 秒。 111.5 Do other statutory provisions and regulations apply? 111.5做其他法定规定和条例适用？ In addition to this part, you must comply with other applicable statutory provisions and regulations under the act related to dietar