美国良好操作规范

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 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 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, ground, 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 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. 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 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 supplement 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, 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 that 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 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, pesticide, 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 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 outside 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 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 previously 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 without 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 supplement, 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 quotient 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 dietary supplements. 除了这部分，你必须遵守其他适用的法律规定和有关膳食补充剂的行为规则。 Subpart B-Personnel 部分B -人事 Sec. 秒。 111.8 What are the requirements under this subpart B for written procedures? 111.8什么是根据本书面程序 ， 部分B的要求？ You must establish and follow written procedures for fulfilling the requirements of this subpart. 你必须建立和遵循履行本附书面程序的规定。 Sec. 秒。 111.10 What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices? 111.10什么要求防止生病或受感染人员的微生物污染和卫生习惯申请？ (a) Preventing microbial contamination . （1） 防止微生物污染 。 You must take measures to exclude from any operations any person who might be a source of microbial contamination, due to a health condition, where such contamination may occur, of any material, including components, dietary supplements, and contact surfaces used in the manufacture, packaging, labeling, or holding of a dietary supplement. 你必须采取措施 ， 排除任何行动 ， 任何人可能是谁微生物污染的来源，由于卫生条件下，这种污染可能发生的任何材料，包括组件，膳食补充剂，并在接触面用于制造包装，标签，或膳食补充剂举行。 Such measures include the following: 这些措施包括以下内容： (1) Excluding from working in any operations that may result in contamination any person who, by medical examination, the persons acknowledgement, or supervisory observation, is shown to have, or appears to have, an illness, infection, open lesion, or any other abnormal source of microbial contamination, that could result in microbial contamination of components, dietary supplements, or contact surfaces, until the health condition no longer exists; and （1）由任何行动的工作 ， 可能导致在任何谁污染，医生检查，该人的确认，或监督观察，结果表明有，或看来，疾病，感染，开放病变，或任何人排除其他不正常的微生物污染的来源，这可能对部分微生物污染的结果，膳食补充剂，或接触面，直到健康状况不再存在;及 (2) Instructing your employees to notify their supervisor(s) if they have or if there is a reasonable possibility that they have a health condition described in paragraph (a)(1) of this section that could result in microbial contamination of any components, dietary supplements, or any contact surface. （2）指导你的员工通知其主管（拧），如果他们有或有合理的可能性 ， 他们有一个健康状况 ， 在本节段可能导致微生物污染的任何组成部分（1）（1）所描述，膳食补充剂，或任何接触面。 (b) Hygienic practices . If you work in an operation during which adulteration of the component, dietary supplement, or contact surface could occur, you must use hygienic practices to the extent necessary to protect against such contamination of components, dietary supplements, or contact surfaces. （二） 卫生习惯 。如果你在行动期间 ， 该组件掺假，膳食补充剂，或接触面可能发生的工作，您必须使用卫生做法在必要情况下 ， 以防止这种污染成分，膳食补充剂，或联系表面。 These hygienic practices include the following: 这些卫生习惯包括以下内容： (1) Wearing outer garments in a manner that protects against the contamination of components, dietary supplements, or any contact surface; （1）穿着的方式 ， 对部分污染的保护外衣，膳食补充剂，或任何接触面; (2) Maintaining adequate personal cleanliness; （2）保持适当的个人清洁; (3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with microorganisms) in an adequate hand-washing facility: （3）彻底洗手（如有必要的消毒 ， 以防止微生物污染与适当的手）洗手设施： (i) Before starting work; and （i）在开始工作; (ii) At any time when the hands may have become soiled or contaminated; （二在任何时候手中可能已经成为时间）弄脏或污染; (4) Removing all unsecured jewelry and other objects that might fall into components, dietary supplements, equipment, or packaging, and removing hand jewelry that cannot be adequately sanitized during periods in which components or dietary supplements are manipulated by hand. （4）删除所有无担保珠宝和其他物品可能落入组件，膳食补充剂，设备或包装，并消除手工首饰 ， 不能在其中得到充分的组件或膳食补充剂是由手工操作时期消毒。 If hand jewelry cannot be removed, it must be covered by material that is maintained in an intact, clean, and sanitary condition and that effectively protects against contamination of components, dietary supplements, or contact surfaces; 如果手首饰不能被删除，它必须涵盖材料 ， 保持一个完整的，清洁和卫生情况 ， 并有效地保护了对组件的污染，膳食补充剂，或接触面; (5) Maintaining gloves used in handling components or dietary supplements in an intact, clean, and sanitary condition. （5）保持手套用在处理一个完整的，清洁和卫生情况组件或膳食补充剂。 The gloves must be of an impermeable material; 该手套必须是一个防渗材料; (6) Wearing, where appropriate, in an effective manner, hair nets, caps, beard covers, or other effective hair restraints; （6）服装，在适当情况下，有效地，头发网，帽子，胡须套，或其他有效头发限制; (7) Not storing clothing or other personal belongings in areas where components, dietary supplements, or any contact surfaces are exposed or where contact surfaces are washed; （七）不储存在那里组成部分，膳食补充剂，或任何接触面接触或接触面的清洗领域的衣物或其他个人财物; (8) Not eating food, chewing gum, drinking beverages, or using tobacco products in areas where components, dietary supplements, or any contact surfaces are exposed, or where contact surfaces are washed; and 地区（8）不进食，嚼口香糖，喝饮料，或在使用烟草制品成分，膳食补充剂，或任何接触面接触，或接触面的清洗;及 (9) Taking any other precautions necessary to protect against the contamination of components, dietary supplements, or contact surfaces with microorganisms, filth, or any other extraneous materials, including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin. （9）采取任何必要对零部件的污染，保护，膳食补充剂，或与其他预防措施表面微生物，污物，或任何其他无关的材料，包括出汗，头发，化妆品，烟草，化学品，并应用于皮肤药品。 Sec. 秒。 111.12 What personnel qualification requirements apply? 111.12什么资格要求的人员申请？ (a) You must have qualified employees who manufacture, package, label, or hold dietary supplements. （1）您必须拥有合格的员工谁制造，包装，标签，或持有膳食补充剂。 (b) You must identify who is responsible for your quality control operations. （b）你必须确定谁是你的质量控制操作负责。 Each person who is identified to perform quality control operations must be qualified to do so and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations. 每个确定谁是执行质量控制操作者必须具备这样做 ， 并且有独特和不同的有关履行这些职责的人 ， 否则也当不执行这些行动的这种行动的责任。 (c) Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the persons assigned functions. （三）每个人从事制造，包装，标签，或控股，或进行任何质量控制操作，必须有教育，培训或经验的人来执行的分配职能。 Sec. 秒。 111.13 What supervisor requirements apply? 111.13上级的规定适用于什么？ (a) You must assign qualified personnel to supervise the manufacturing, packaging, labeling, or holding of dietary supplements. （1）您必须指定合格的人员来监督制造，包装，标签，或膳食补充剂举行。 (b) Each supervisor whom you use must be qualified by education, training, or experience to supervise. （二）每个主管人必须为您使用合格的教育，培训，监督或经验。 Sec. 秒。 111.14 Under this subpart B, what records must you make and keep? 在这个子部分B 111.14，什么记录必须保持你的？ (a) You must make and keep records required under this subpart B in accordance with subpart P of this part. （1）您必须制作并保存在此按照本部分附P附乙所需的记录。 (b) You must make and keep the following records: （b）你必须制作并保存以下记录： (1) Written procedures for fulfilling the requirements of this subpart B; and （1）书面程序履行本附B的要求; (2) Documentation of training, including the date of the training, the type of training, and the person(s) trained. （2）文档的培训，包括培训日期，培训类型，而该人（拧）培训。 Subpart C-Physical Plant and Grounds C小节-物理设备和场地 Sec. 秒。 111.15 What sanitation requirements apply to your physical plant and grounds? 111.15什么卫生要求适用于您的身体工厂和理由？ (a) Grounds . （一） 理由 。 You must keep the grounds of your physical plant in a condition that protects against the contamination of components, dietary supplements, or contact surfaces. 你必须保持一个条件 ， 对组件的污染保护，膳食补充剂，或联络您的身体植物表面的理由。 The methods for adequate ground maintenance include: 提供足够的地面维修的方法包括： (1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the physical plant so that it does not attract pests, harbor pests, or provide pests a place for breeding; （一）妥善贮存设备，清除垃圾和废物，减少内物质设备附近杂草或草 ， 以便它不会引起害虫，港口害虫，或提供害虫滋生的地方; (2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where components, dietary supplements, or contact surfaces are exposed; （2）保持道路，庭院，停车场 ， 使他们不构成面源污染情况组件，膳食补充剂，或接触面接触; (3) Adequately draining areas that may contribute to the contamination of