[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
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 person's 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 person's 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 components, dietary supplements, or contact surfaces by seepage, filth or any other extraneous materials, or by providing a breeding place for pests; （3）有适当的排水领域，可能有助于组件的污染，膳食补充剂，或接触面的渗漏，污物或任何其他无关的材料，或通过提供滋生的地方;
(4) Adequately operating systems for waste treatment and disposal so that they do not constitute a source of contamination in areas where components, dietary
supplements, or contact surfaces are exposed; and （4）有适当经营废物处理和排放系统，使它们不构成面源污染情况组件，膳食补充剂，或接触面接触;及
(5) If your plant grounds are bordered by grounds not under your control, and if those other grounds are not maintained in the manner described in this section, you must exercise care in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth or any other extraneous materials that may be a source of contamination. （5如果您的工厂理由的理由不接壤，在你的控制，如果这些其他原因不能在本节中描述的方式保存），你必须行使的检查，消灭，或其他手段植物护理排除害虫，灰尘和脏物或任何其他无关的材料，可能是一个污染源。
(b) Physical plant facilities . （二）体育工厂设施。(1) You must maintain your physical plant in a clean and sanitary condition; and （1）您必须保持您在清洁和卫生情况的绿化植物;和
(2) You must maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated. （2）你必须保持自己的身体厂修理足以防止元件，膳食补充剂，或接触面成为污染。
(c) Cleaning compounds, sanitizing agents, pesticides, and other toxic materials . （三）清洁剂，消毒剂，杀虫剂和其他有毒物质。(1) You must use cleaning compounds and sanitizing agents that are free from microorganisms of public health significance and that are safe and adequate under the conditions of use. （1）您必须使用清洁剂和消毒剂均与公众健康的微生物自由和安全，并根据使用的条件足够。
(2) You must not use or hold toxic materials in a physical plant in which components, dietary supplements, or contact surfaces are manufactured or exposed, unless those materials are necessary as follows: （2）不得使用或持有物理工厂的组件，膳食补充剂，或接触面制造或暴露，有毒物质，除非这些材料是必要的，因为如下：
(i) To maintain clean and sanitary conditions; （一）保持清洁和卫生条件;
(ii) For use in laboratory testing procedures; （二）对于在实验室的测试程序的使用;
(iii) For maintaining or operating the physical plant or equipment; or （三），以维持或经营实体工厂或设备;或(iv) For use in the plant's operations. （四）对于在工厂的操作使用。
(3) You must identify and hold cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, and other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces. （3）您必须确定并保持清洁剂，消毒剂，杀虫剂，农药化学品和方式，对污染保护的元件，膳食补充剂，或与其他有毒物质的表面。
(d) Pest control . （四）害虫控制。(1) You must not allow animals or pests in any area of your physical plant. Guard or guide dogs are allowed in some areas of your physical plant if the presence of the dogs will not result in contamination of components, dietary supplements, or contact surfaces; （1）您绝不允许任何动物或对您的身体厂房面积虫害。民警卫队或导盲犬在允许对您的身体种植一些地区如果狗的存在将不会导致污染的部件，膳食补充剂，或联系表面;
(2) You must take effective measures to exclude pests from the physical plant and to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests; and （2）你必须采取有效措施，排除身体植物害虫，并防止污染，保护元件，膳食补充剂，和接触面由害虫的处所;和
(3) You must not use insecticides, fumigants, fungicides, or rodenticides, unless you take precautions to protect against the contamination of components, dietary supplements, or contact surfaces. （三）不得使用杀虫剂，熏蒸剂，杀菌剂，或杀鼠剂，除非你采取预防措施，对零部件的污染，保护，膳食补充剂，或接触的表面。
(e) Water supply . （五）供水。(1) You must provide water that is safe and sanitary, at suitable temperatures, and under pressure as needed, for all uses where water does not become a component of the dietary supplement. （1）你必须提供的水是安全和卫生，在适当温度和压力下，根据需要，为所有使用在水不会成为膳食补充剂的成分。
(2) Water that is used in a manner such that the water may become a component of the dietary supplement, eg, when such water contacts components, dietary supplements, or any contact surface, must, at a minimum, comply with applicable Federal, State, and local requirements and not contaminate the dietary supplement. （2）水是采用的方式，这样的水可能成为膳食补充剂成分，例如，当这种水接触部件，膳食补充剂，或任何接触面，必须在最低限度，遵守适用的联邦，州和地方的要求，而不是污染的饮食补充。
(f) Plumbing . （六）管道。The plumbing in your physical plant must be of an adequate size and design and be adequately installed and maintained to: 在您的物理设备水管必须是一个适当的规模和设计，并有足够的安装和维护：
(1) Carry sufficient amounts of water to required locations throughout the physical plant; （1）携带足够的水相当于所需地点的物理设备;
(2) Properly convey sewage and liquid disposable waste from your physical plant; （2）正确转达你的物理设备一次性污水和液体废物的;
(3) Avoid being a source of contamination to components, dietary supplements, water supplies, or any contact surface, or creating an unsanitary condition; （3）避免成为污染来源的组件，膳食补充剂，供水，或任何接触面，或创建不卫生的条件;
(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and （4）在所有领域提供足够的地面排水层时受水浸式清洁或正常操作释放或排放水或其他液体废物的地板上;及
(5) Not allow backflow from, or cross connection between, piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities. （5）不允许倒流的，或交叉连接之间，管道系统，排放废水或污水管道清洗接触面，或在浴室或使用手洗手设施系统，进行营养补充品生产用水。
(g) Sewage disposal . （七）污水处理。You must dispose of sewage into an adequate sewage system or through other adequate means. 你必须处理的污水适当的排污系统或通过其他适当手段。
(h) Bathrooms . （八）浴室。You must provide your employees with adequate, readily accessible bathrooms. The bathrooms must be kept clean and must not be a potential source of contamination to components, dietary supplements, or contact surfaces. 你必须提供足够的，易于使用的浴室，你的员工。浴室必须保持干净，不能有污染的可能来源的组件，膳食补充剂，或接触的表面。(i) Hand-washing facilities . （一）洗手设施。You must provide hand-washing facilities that are designed to ensure that an employee's hands are not a source of contamination of components, dietary supplements, or any contact surface, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature. 您必须提供洗手的目的是确保雇员的手是不是对部分污染水源工程，膳食补充剂，或任何接触面，通过提供足够的设施，方便，运行提供适当温度的水。
(j) Trash disposal . （十）垃圾的处理方法。You must convey, store, and dispose of trash to: 你必须传达，贮存和处置垃圾的：
(1) Minimize the development of odors; （1）尽量减少产生异味;
(2) Minimize the potential for the trash to attract, harbor, or become a breeding place for pests; （2）最大限度地降低垃圾吸引，港口，或成为滋生蚊虫的地方的潜力;
(3) Protect against contamination of components, dietary supplements, any contact surface, water supplies, and grounds surrounding your physical plant; and （3）对部分污染保护，膳食补充剂，任何接触面，水的供应和自己的身体周围的场地设备;及
(4) Control hazardous waste to prevent contamination of components, dietary supplements, and contact surfaces. （4）控制危险废物，以防止污染成分，膳食补充剂，和接触面。
(k) Sanitation supervisors . （十一）卫生监督员。You must assign one or more employees to supervise overall sanitation. Each of these supervisors must be qualified by education, training, or experience to develop and supervise sanitation procedures. 您必须指定一个或多个员工的整体卫生监督。这些监督员都必须通过教育，培训或经验的合格的卫生发展和监督程序。
Sec. 秒。111.16 What are the requirements under this subpart C for written procedures? 111.16哪些书面程序，根据本C小节要求？
You must establish and follow written procedures for
cleaning the physical plant and for pest control. 你必须建立和遵循清洁物质设备和控制虫害的书面程序。
Sec. 秒。111.20 What design and construction requirements apply to your physical plant? 111.20什么样的设计和施工要求适用于你的身体电厂？
Any physical plant you use in the manufacture, packaging, labeling, or holding of dietary supplements must: 您的任何物质设备的制造，包装，标志，或膳食补充剂控股必须使用：
(a) Be suitable in size, construction, and design to facilitate maintenance, cleaning, and sanitizing operations; （一）在规模，适合建设和设计，方便维修，清洁和消毒工作;
(b) Have adequate space for the orderly placement of equipment and holding of materials as is necessary for maintenance, cleaning, and sanitizing operations and to prevent contamination and mixups of components and dietary supplements during manufacturing, packaging, labeling, or holding; （二）有秩序的设备放置足够的空间和材料持有的是必要的维修，清洁和消毒行动，并在生产过程中防止污染和零部件与膳食补充剂mixups，包装，标签，或持有;
(c) Permit the use of proper precautions to reduce the potential for mixups or contamination of components, dietary supplements, or contact surfaces, with microorganisms, chemicals, filth, or other extraneous material. （三）允许适当的预防措施来减少对mixups或潜在污染的部件，膳食补充剂，或接触面的微生物，化学品，脏物，或其他附加材料。Your physical plant must have, and you must use, separate or defined areas of adequate size or other control systems, such as computerized inventory controls or automated systems of separation, to prevent contamination and mixups of components and dietary supplements during the following operations: 你的身体厂必须要有，你必须使用单独的或定义，例如电脑化库存管理或分离自动化系统足够的规模或其他控制系统，地区，以防止在以下操作污染和零部件与膳食补充剂mixups：
(1) Receiving, identifying, holding, and withholding from use, components, dietary supplements, packaging, and labels that will be used in or during the manufacturing, packaging, labeling, or holding of dietary supplements; （1）接收，识别，持有，使用和截留，组件，膳食补充剂，包装和标签将用于或在制造，包装，标签，或膳食补充剂的举行;
(2) Separating, as necessary, components, dietary supplements, packaging, and labels that are to be used in manufacturing from components, dietary supplements, packaging, or labels that are awaiting material review and disposition decision, reprocessing, or are awaiting disposal after rejection; （2）必要时分离，元件，膳食补充剂，包装和标签，将在制造中使用的组件，膳食补充剂，包装或标签，正在等待材料进行审查和处理决定，再加工，或等待处理后排斥反应;
(3) Separating the manufacturing, packaging, labeling, and holding of different product types including different types of dietary supplements and other foods, cosmetics, and pharmaceutical products; （3）分离的制造，包装，标签，和不同的产品类型，包括膳食补充剂和其他食品，化妆品不同类型的控股，和医药产品;
(4) Performing laboratory analyses and holding laboratory supplies and samples; （4）表演的实验室分析，举办实验室用品和样品;
(5) Cleaning and sanitizing contact surfaces; （5）清洗和消毒，接触面;
(6) Packaging and label operations; and （6）包装和标签的行动;
(7) Holding components or dietary supplements. （7）控股组件或膳食补充剂。
(d) Be designed and constructed in a manner that prevents contamination of components, dietary supplements, or contact surfaces. （d）设计和方式，防止污染的部件，膳食补充剂，或与曲面构成。
(1) The design and construction must include: （1）设计和建造必须包括：
(i) Floors, walls, and ceilings that can be adequately cleaned and kept clean and in good repair; （一）地板，墙壁和天花板，可以充分清洗，保持清洁和维修良好;
(ii) Fixtures, ducts, and pipes that do not contaminate components, dietary supplements, or contact surfaces by dripping or other leakage, or condensate; （二）照明灯，管道，水管，不污染成分，膳食补充剂，或接触面的滴水或其他渗漏，或冷凝物;
(iii) Adequate ventilation or environmental control equipment such as airflow systems, including filters, fans, and other air-blowing equipment, that minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate components, dietary supplements, or contact surfaces; （三）足够的通风或环境控制设备，如气流系统，包括过滤器，风扇和其他空气吹设备，尽量减少气味（包括蒸汽和有毒气体的地区），他们可能污染气体成分，膳食补充剂，或接触面;
(iv) Equipment that controls temperature and humidity, when such equipment is necessary to ensure the quality of the dietary supplement; and （四）设备，控制温度和湿度，当这些设备是必要的，以确保膳食补充剂的质量;和
(v) Aisles or working spaces between equipment and walls that are adequately unobstructed and of adequate width to permit all persons to perform their duties and to protect against contamination of components, dietary supplements, or contact surfaces with clothing or personal contact. （五）之间的过道或设备和有足够的畅通和足够的宽度，允许所有的人履行其职责，并针对部分污染保护，膳食补充剂，或与工作空间的墙壁表面衣物或个人联系。
(2) When fans and other air-blowing equipment are used, such fans and equipment must be located and operated in a manner that minimizes the potential for microorganisms and particulate matter to contaminate components, dietary supplements, or contact surfaces; （2）当风扇和其他空中吹设备的使用，这些球迷和设备必须位于的方式，最大限度地降低对微生物的潜力和可吸入颗粒物的污染成分，膳食补充剂，或与经营的表面;
(e) Provide adequate light in: （五）提供适当的光在：
(1) All areas where components or dietary supplements are examined, processed, or held; （1）所有地区的组件或膳食补充剂的研究，加工或举行;
(2) All areas where contact surfaces are cleaned; and （2）所有地区，接触面的清洁;和
(3) Hand-washing areas, dressing and locker rooms, and bathrooms. （3）洗手区，更衣室和更衣室和浴室。
(f) Use safety-type light bulbs, fixtures, skylights, or other glass or glass-like materials when the light bulbs, fixtures, skylights or other glass or glass-like materials are suspended over exposed components or dietary supplements in any step of preparation, unless your physical plant is otherwise constructed in a manner that will protect against contamination of components or dietary supplements in case of breakage of glass or glass-like materials. （六）使用安全型灯泡，灯具，天窗，或其他玻璃或玻璃般的灯泡时，装置，天窗或其他玻璃或玻璃等材料，超过部件或暴露在任何步骤的膳食补充剂悬浮物准备，除非你的身体，否则工厂的方式建造，将防范的组成部分或在玻璃或玻璃破碎膳食补充剂的污染情况等材料。
(g) Provide effective protection against contamination of components and dietary supplements in bulk fermentation vessels, by, for example: （g）提供对组件和发酵的散装船膳食补充剂，污染的有效保护，例如：
(1) Use of protective coverings; （1）保护层的使用;
(2) Placement in areas where you can eliminate harborages for pests over and around the vessels; （2）在地区安置在这里您可以消除对周围船只害虫harborages;
(3) Placement in areas where you can check regularly for pests, pest infestation, filth or any other extraneous materials; and （3）安置在某些地区可以定期检查虫害，虫灾，污物或任何其他无关的材料;及
(4) Use of skimming equipment. （4）略读设备的使用。
(h) Use adequate screening or other protection against pests, where necessary. （八）使用适当的检查或对害虫，必要时其他保护。
Sec. 秒。111.23 Under this subpart C, what records must you make and keep? 根据这项C小节111.23，什么记录必须保持你的？
(a) You must make and keep records required under this subpart C in accordance with subpart P of this part. （1）你必须保持必要的按照本C小节与本A部分P记录。(b) You must make and keep records of the written procedures for cleaning the physical plant and for pest control. （b）你必须制作并保存的清洁物质设备和控制虫害的书面程序的记录。
(c) You must make and keep records that show that water, when used in a manner such that the water may become a
component of the dietary supplement, meets the requirements of 111.15(e)(2). （三）您必须制作并保存记录，以证明水时使用的方式，这样的水可能成为膳食补充剂的组成部分，符合111.15（五）（2）的要求。
Subpart D--Equipment and Utensils 子部分? -设备及用具Sec. 秒。111.25 What are the requirements under this subpart D for written procedures? 111.25哪些书面程序，根据本附研发需求？
You must establish and follow written procedures for fulfilling the requirements of this subpart D, including written procedures for: 你必须建立和遵循履行本合伙开发，包括书面的程序要求书面程序：
(a) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement; （1）校准仪器和控制您在生产或测试组件或膳食补充剂的使用;
(b) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and （二）校准，检测，检查和自动化，机械和电子设备;
(c) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements. （三）维护，清洁和消毒，必要时，所有的设备，用具，以及其他任何接触面，用于制造，包装，标签，或持有部件或膳食补充剂。
Sec. 秒。111.27 What requirements apply to the equipment and utensils that you use? 111.27适用于什么要求的设备和用具的使用？
(a) You must use equipment and utensils that are of appropriate design, construction, and workmanship to enable them to be suitable for their intended use and to be adequately cleaned and properly maintained. （一）必须使用的设备和器具，是适当的设计，施工和工艺，使他们能够对自己的适合用途得到充分的清洁及妥善保养。(1) Equipment and utensils include the following: （1）设备和用具包括以下内容：
(i) Equipment used to hold or convey; （一）设备用于存放或运送;
(ii) Equipment used to measure; （二）用于测量设备;
(iii) Equipment using compressed air or gas; （三）设备使用压缩空气或气体;
(iv) Equipment used to carry out processes in closed pipes and vessels; and （四）设备用来进行封闭管道和船只程序;
(v) Equipment used in automated, mechanical, or electronic systems. （五）在自动化设备，机械或电子系统中。
(2) You must use equipment and utensils of appropriate design and construction so that use will not result in the contamination of components or dietary supplements with: （2）您必须使用适当的设备和用具的设计和建设，使利用不会在组件或膳食补充剂与污染的结果：
(i) Lubricants; （一）润滑油;
(ii) Fuel; （二）燃料;
(iii) Coolants; （三）冷却液;
(iv) Metal or glass fragments; （四）金属或玻璃碎片;
(v) Filth or any other extraneous material; （五）污物或任何其他外来物质;
(vi) Contaminated water; or （六）被污染的水;或
(vii) Any other contaminants. （七）任何其他污染物。
(3) All equipment and utensils you use must be: （3）所有设备和器具使用，必须：
(i) Installed and maintained to facilitate cleaning the equipment, utensils, and all adjacent spaces; （一）安装和维护，以方便清洁的设备，用具，以及所有相邻的空间;
(ii) Corrosion-resistant if the equipment or utensils contact components or dietary supplements; （二）耐腐蚀，如果设备或用具接触部件或膳食补充剂;
(iii) Made of nontoxic materials; （三）无毒材料制造;
(iv) Designed and constructed to withstand the environment in which they are used, the action of components or dietary supplements, and, if applicable, cleaning compounds and sanitizing agents; and （四）设计及建造，经受住它们使用的组件或膳食补充剂的行动，如果适用，清洁剂和消毒剂环境;
(v) Maintained to protect components and dietary supplements from being contaminated by any source. （五）维护，保护元件和膳食补充剂被污染的任何源。
(4) Equipment and utensils you use must have seams that are smoothly bonded or maintained to minimize accumulation of dirt, filth, organic material, particles of components or dietary supplements, or any other extraneous materials or contaminants. （4）设备和器具必须为您使用的是顺利保税或维护以尽量减少灰尘，污物，有机物质积累接缝，粒子的组成部分或膳食补充剂，或任何其他无关的材料或污染物。
(5) Each freezer, refrigerator, and other cold storage compartment you use to hold components or dietary supplements: （5）每个冰柜，冰箱，冷藏及其他车厢使用持有组件或膳食补充剂：
(i) Must be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device that indicates and records, or allows for recording by hand, the temperature accurately within the compartment; and （一）必须装有一个指示温度计，温度测量装置，或温度记录装置，指示和记录，或记录允许的手，在车厢内精确的温度;及
(ii) Must have an automated device for regulating temperature or an automated alarm system to indicate a significant temperature change in a manual operation. （二）必须有调节温度或自动报警系统显示在一个手动操作温度变化显着的自动化设备。
(6) Instruments or controls used in the manufacturing, packaging, labeling, or holding of a dietary supplement, and instruments or controls that you use to measure, regulate, or record temperatures, hydrogen-ion concentration (pH), water activity, or other conditions, to control or prevent the growth of microorganisms or other contamination must be: （6）文书或控制的制造，包装，标志，或膳食补充剂持有使用，文书或控制，用于测量，调节，或记录温度，氢离子浓度（pH值），水的活动，或，其他条件以控制或防止微生物或其他污染物的增长必须是：(i) Accurate and precise; （一）准确和精确;
(ii) Adequately maintained; and （二）充分维护;及
(iii) Adequate in number for their designated uses. （三）适当在其指定的使用次数。
(7) Compressed air or other gases you introduce mechanically into or onto a component, dietary supplement, or contact surface or that you use to clean any contact surface must be treated in such a way that the component, dietary supplement, or contact surface is not contaminated. （7）压缩空气或其他气体你介绍机械进入或到一个组成部分，膳食补充剂，或接触面，或者使用清洁任何接触表面必须处理的方式，组件，膳食补充剂，或接触面不受污染。
(b) You must calibrate instruments and controls you use in manufacturing or testing a component or dietary supplement. （b）你必须校准设备和控制您在生产或测试组件或膳食补充剂的使用。You must calibrate: 你必须调整：
(1) Before first use; and （1）在首次使用;及
(2) At the frequency specified in writing by the manufacturer of the instrument and control; or （2在频率）指定由该文书的书写和控制制造商;或
(3) At routine intervals or as otherwise necessary to ensure the accuracy and precision of the instrument and control. （3）在例行的间隔或其他必要措施，确保准确性和文书和控制精度。
(c) You must repair or replace instruments or controls that cannot be adjusted to agree with the reference standard. （三）您必须维修或更换工具或无法进行调整，以同意参考标准控制。
(d) You must maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other contact surfaces used to manufacture, package, label, or hold components or dietary supplements. （d）您必须保持，清洁和消毒，必要时，所有设备，用具，以及任何其他接触面用于制造，包装，标签，或持有部件或膳食补充剂。
(1) Equipment and utensils must be taken apart as necessary for thorough maintenance, cleaning, and sanitizing. （1）设备和用具外，必须采取必要进行彻底的维修，清洁和消毒。
(2) You must ensure that all contact surfaces, used for manufacturing or holding low-moisture components or dietary supplements, are in a dry and sanitary condition when in use. （2）你必须确保所有接触的表面，制造或持有低水分组件或膳食补充剂使用的，是在干燥，卫生情况时使用。When the surfaces are wet-cleaned, they must be sanitized, when necessary, and thoroughly dried before subsequent use. 当表面的湿清洗，他们必须消毒，必要时，再彻底干燥后使用。
(3) If you use wet processing during manufacturing, you must clean and sanitize all contact surfaces, as necessary, to protect against the introduction of microorganisms into components or dietary supplements. （3）如果您在生产过程中使用的湿处理，你必须清洁和消毒一切必要接触的表面，防止微生物的成组件或膳食补充剂介绍。When cleaning and sanitizing is necessary, you must clean and sanitize all contact surfaces before use and after any interruption during which the contact surface may have become contaminated. If you use contact surfaces in a continuous production operation or in consecutive operations involving different batches of the same dietary supplement, you must adequately clean and sanitize the contact surfaces, as necessary. 当清洁和消毒是必要的，你必须清洁和消毒，接触面都在使用之前和之后，在此期间，接触面可能已被污染的中断。如果您使用的接触面在一个连续的生产经营，或在涉及不同批次的连续行动同样的营养补充剂，你必须充分清洁和消毒的接触面，必要的。
(4) You must clean surfaces that do not come into direct contact with components or dietary supplements as frequently as necessary to protect against contaminating components or dietary supplements. （4）您必须清洁的表面不与组件或按必要的频率，以防止污染成分或膳食补充剂膳食补充剂的直接接触。
(5) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) must be: （5）单服务的物品（如一次性使用，纸杯，纸毛巾）必须准备用具：
(i) Stored in appropriate containers; and （i）在适当的容器内;及
(ii) Handled, dispensed, used, and disposed of in a manner that protects against contamination of components, dietary supplements, or any contact surface. （二）处理，在配发，使用和处置的方式，对部分污染保护的，膳食补充剂，或任何接触面。(6) Cleaning compounds and sanitizing agents must be adequate for their intended use and safe under their conditions of use; （6）清洁剂和消毒剂必须有足够其用途，并根据使用条件的安全;
(7) You must store cleaned and sanitized portable equipment and utensils that have contact surfaces in a location and manner that protects them from contamination. （7）你必须存储清洗和消毒便携式设备和器具表面接触的地点和方式，保护他们免受污染。
[72 FR 34942, June 25, 2007, as amended at 73 FR 13124, Mar. 12, 2008] [72阻燃34942，2007年6月25日，截至73阻燃13124，2008年3月12日修订]
Sec. 秒。111.30 What requirements apply to automated, mechanical, or electronic equipment? 111.30什么要求适用于自动化，机械或电子设备？
For any automated, mechanical, or electronic equipment that you use to manufacture, package, label, or hold a dietary supplement, you must: 对于任何自动化，机械或电子设备，用于制造，包装，标签，或持有饮食的补充，你必须：
(a) Design or select equipment to ensure that dietary supplement specifications are consistently met; （一）设计或选择装备，以确保膳食补充剂规格始终满足;
(b) Determine the suitability of the equipment by ensuring that your equipment is capable of operating satisfactorily within the operating limits required by the process; （二）确定，确保你的设备是内运作的经营能力的限制令人满意的过程所需的设备是否合适;
(c) Routinely calibrate, inspect, or check the equipment to ensure proper performance. （三）经常校准，检查，或检查设备，以确保适当的表现。Your quality control personnel must periodically review these calibrations, inspections, or checks; 您的质量控制人员必须定期检讨这些校准，检查，或检查;
(d) Establish and use appropriate controls for automated, mechanical, and electronic equipment (including software for a computer controlled process) to ensure that any changes to the manufacturing, packaging, labeling, holding, or other
operations are approved by quality control personnel and instituted only by authorized personnel; and （四）建立和使用自动化，机械和电子设备（包括计算机控制的过程适当的控制软件），以确保任何制造，包装的变化，贴标，控股或其他操作人员的质量控制和批准提起只有经授权的人员;
(e) Establish and use appropriate controls to ensure that the equipment functions in accordance with its intended use. （五）建立和使用适当的管制，以确保按照其用途设备的功能。These controls must be approved by quality control personnel. 这些控制必须经质量管理人员。
Sec. 秒。111.35 Under this subpart D, what records must you make and keep? 在这个子部分?111.35，什么记录必须保持你的？
(a) You must make and keep records required under this subpart D in accordance with subpart P of this part. （1）你必须保持必要的按照本附D与本部分附P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, including written procedures for: （1）书面程序履行本子部分，包括书面的程序要求：
(i) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement; （一）校准仪器和控制您在生产或测试组件或膳食补充剂的使用;
(ii) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and （二）校准，检测，检查和自动化，机械和电子设备;
(iii) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements; （三）维护，清洁和消毒，必要时，所有的设备，用具，以及其他任何接触面，用于制造，包装，标签，或持有部件或膳食补充剂;
(2) Documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment, unless such documentation is kept with the batch record; （2）文档，个别设备的日志，对使用，维护清洁，日期和消毒设备，除非这些文件是与批记录在案;
(3) Documentation of any calibration, each time the calibration is performed, for instruments and controls that you use in manufacturing or testing a component or dietary supplement. In your documentation, you must: （3）任何校准文件，每次进行校准仪器和控制您在生产或测试组件或膳食补充剂的使用。在你的文档，你必须：
(i) Identify the instrument or control calibrated; （一）确定或控制仪器校准;
(ii) Provide the date of calibration; （二）提供的校准日期;
(iii) Identify the reference standard used including the certification of accuracy of the known reference standard and a history of recertification of accuracy; （三）确定的参考标准，用于包括已知的参考标准，认证和准确的重新认证历史的准确性;
(iv) Identify the calibration method used, including appropriate limits for accuracy and precision of instruments and controls when calibrating; （四）确定校准使用的方法，包括准确性和校准仪器和控制精度时，适当限制;
(v) Provide the calibration reading or readings found; （五）提供阅读或校准读数找到;
(vi) Identify the recalibration method used, and reading or readings found, if accuracy or precision or both accuracy and precision limits for instruments and controls were not met; and （六）确定校准方法中使用，并阅读或读数发现，如果准确性或精度或两者准确性和文书和控制精度的限制没有得到满足;及
(vii) Include the initials of the person who performed the calibration and any recalibration. （七）包括人谁执行的校准和任何校准的缩写。
(4) Written records of calibrations, inspections, and checks of automated, mechanical, and electronic equipment; （4）有书面记录的校准，检查和自动化，机械和电子设备的检查;
(5) Backup file(s) of current software programs (and of outdated software that is necessary to retrieve records that you are required to keep in accordance with subpart P of this part, when current software is not able to retrieve such records) and of data entered into computer systems that you
use to manufacture, package, label, or hold dietary supplements. （5）备份文件（章目前的软件程序）（和过时的软件，是必要的检索，您必须按照跟上这一部分，
目前的软件时，不能检索这些记录附P记录）数据输入到计算机系统，用于制造，包装，标签，或持有膳食补充剂。
(i) Your backup file (eg, a hard copy of data you have entered, diskettes, tapes, microfilm, or compact disks) must be an exact and complete record of the data you entered. （一）您的备份文件（例如，你已经进入，软盘，磁带，缩微胶片，光盘数据或硬拷贝）必须是输入的数据准确，完整记录。
(ii) You must keep your backup software programs and data secure from alterations, inadvertent erasures, or loss; and （ii）您必须让您的备份软件程序和数据安全的改建，无心创作意图，或损失;及
(6) Documentation of the controls that you use to ensure that equipment functions in accordance with its intended use. （6）控制，您使用，以确保文件，根据设备的功能与用途。
Subpart E--Requirement to Establish a Production and Process Control System 子部分专-要求建立一个生产和过程控制系统
Sec. 秒。111.55 What are the requirements to implement a production and process control system? 111.55有什么要求实施生产过程控制系统？
You must implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. 你必须实施生产过程控制，涵盖了制造，包装，标签的所有阶段的系统，以及饮食补充剂举行，以确保膳食补充剂的质量，而且膳食补充剂的包装和作为主制造指定标记记录。
Sec. 秒。111.60 What are the design requirements for the production and process control system? 111.60什么是为生产和过程控制系统的设计要求是什么？(a) Your production and in-process control system must be designed to ensure that the dietary supplement is manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and （1）您的生产和过程控制系统的设计必须确保膳食补充剂的生产，包装，标签，和方式，以确保膳食补充剂的质量，而且膳食补充剂的包装和标签举行所规定的主生产记录;和
(b) The production and in-process control system must include all requirements of subparts E through L of this part and must be reviewed and approved by quality control personnel. （二）生产和过程控制系统必须包括通过这个L部分的子部分的所有位置的要求，必须审查和质量控制人员批准。
Sec. 秒。111.65 What are the requirements for quality control operations? 111.65什么是质量控制操作要求？
You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. 你必须落实到制造，包装标识，质量控制操作，并持有生产的食品补充，以确保膳食补充剂的质量经营，而且膳食补充剂的包装和在主生产记录中指定的标记。
Sec. 秒。111.70 What specifications must you establish? 111.70什么你必须建立规范？
(a) You must establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. （a）你必须建立一个对任何点，步骤，或在生产过程中的阶段规范，控
制是必要的，以确保膳食补充剂的质量，而且膳食补充剂的包装和在主生产记录中指定的标记。
(b) For each component that you use in the manufacture of a dietary supplement, you must establish component specifications as follows: （二）对于每个组件，您在一个膳食补充剂生产使用，您必须建立组件的规格如下：
(1) You must establish an identity specification; （1）你必须建立一个标识规范;
(2) You must establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met; and （2）你必须建立规范的组件是必要的，以确保纯度，强度和膳食补充剂成分规格制造采用的是组合得到满足;及
(3) You must establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement. （3）你必须建立对污染的可能掺假或可能导致对膳食补充剂完成一批掺假，以确保膳食补充剂的质量这些类型的限制。
(c) For the in-process production: （三）对于在进程内生产的：
(1) You must establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; （1）你必须建立任何点，步骤，或在主生产记录阶段控制是必要的，以帮助确保符合规格要求的身份，纯度，强度和膳食补充剂的成分，并在过程规范必要时，提供有关污染的可能掺假或可能导致对膳食补充剂完成一批掺假这些类型的限制;
(2) You must provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; and （2）你必须提供满足为什么在进程规格的基础上适当的文件，会议内容与规范相结合，将有助于确保符合规格要求的身份，纯度，强度，以及膳食补充剂成分和污染就可能掺假或可能导致对膳食补充剂完成一批掺假这些类型的限制;和
(3) Quality control personnel must review and approve the documentation that you provide under paragraph (c)(2) of this section. （3）质量控制人员必须审查和批准的文件，你根据第（三）（2提供）本条。
(d) You must establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement. （四）必须建立膳食补充剂标签（标签规范）和包装可能会在（包装规格）膳食补充剂接触的规格。包装，可能与膳食补充剂接触必须是安全和合适的用途和不能反应或吸收或其他影响安全或膳食补充剂的质量。
(e) For each dietary supplement that you manufacture you must establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement. （五）对于每个膳食补充，你生产，必须建立身份，纯度，强度产品规格，以及对膳食补充剂完成一批组成，并就污染可能掺假，或可能导致这些类型的限制以掺假的，对膳食补充剂完成一批确保膳食补充剂的质量。
(f) If you receive a product from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order. （f）如果您收到一个包装供应商的产品或作为膳食补充剂标签（和分配，而不是返回到供应商），你必须建立规范，提供足够的保证，您收到的产品有足够的识别，是符合您的订单。
(g) You must establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you used the specified packaging and that you applied the specified label. （七）必须建立的包装规格和成品包装和标记膳食补充剂，包括规格，确保您使用指定的包装，标签和应用，你指定标签。
Sec. 秒。111.73 What is your responsibility for determining whether established specifications are met? 111.73什么是你的决定是否符合既定规范的责任？
You must determine whether the specifications you establish under 111.70 are met. 您必须确定您是否规范建立在111.70得到满足。
Sec. 秒。111.75 What must you do to determine whether specifications are met? 111.75你做什么，必须确定是否符合规格要求？
(a) Before you use a component, you must: （一）在您使用的组件，您必须：
(1)(i) Conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition the agency under paragraph (a)(1)(ii) of this section and the agency exempts you from such testing; （1）（一）进行至少有一个适当的测验或考试，以验证任何组件，是膳食成分标识，除非你呈请根据本条第（一）（1）（ii）该机构和该机构豁免你从这些测试;
(ii) You may submit a petition, under 21 CFR 10.30, to request an exemption from the testing requirements in paragraph (a)(1)(i) of this section. （ii）您可以提交一份请愿书，21岁以下的病死率10.30，要求从本款第（一）（1）（i）该测试要求豁免。The petition must set forth the scientific rationale, and must be accompanied by the supporting data and information, for proposed alternative testing that will demonstrate that there is no material diminution of assurance, compared to the assurance provided by 100 percent identity testing, of the identity of the dietary ingredient before use when the dietary ingredient is obtained from one or more suppliers identified in the petition. 请愿书必须阐明科学原理，并必须由支持数据和资料的陪同下，对拟议其他测试，以证明有没有保证材料的减少，而由百分之百的身份测试提供了保证的身份，膳食成分的使用前当膳食成分是从在请愿书中的一个或多个供应商。If FDA grants the petition, you must conduct the tests and examinations for the dietary ingredient, otherwise required under 111.75(a)(1)(i), under the terms specified by FDA when the petition is granted; and 如果FDA授予的请愿书，你必须进行测试和膳食成分的考试，否则要求下111.75（1）（1）（i）根据美国FDA规定的条件，当请愿案获准;及
(2) Confirm the identity of other components and determine whether other applicable component specifications established in accordance with 111.70(b) are met. （2）确认身份的其他组成部分，并确定是否其他适用的组件的规格建立了111.70按照（b）得到满足。To do so, you must either: 为此，你必须：
(i) Conduct appropriate tests or examinations; or （一）进行适当的测试或考试;或
(ii) Rely on a certificate of analysis from the supplier of the component that you receive, provided that: （二）关于证书的分析依靠的元件供应商，您会收到，但条件是：
(A) You first qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations; （a）你先资格，通过建立对供应商的测试或检验结果确认，供应商的证书的可靠性分析的供应商;
(B) The certificate of analysis includes a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; （乙）的分析证书，包括对测试或检验方法的说明（仛）使用，测试或考试的限制，以及测试或考试的实际效果;
(C) You maintain documentation of how you qualified the supplier; （c）你是如何保持你的文档合格的供应商;
(D) You periodically re-confirm the supplier's certificate of analysis; and （d）你定期重新确认供应商的分析证书;
(E) Your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier. （e）你的质量管理人员审查和批准文件，阐述了合格的基础上（和重新获得资格的任何供应商）。
(b) You must monitor the in-process points, steps, or stages where control is necessary to ensure the quality of the finished batch of dietary supplement to: （b）您必须监测过程点，步骤或阶段，在管制是必要的，以确保饮食中补充一批成品质量：
(1) Determine whether the in-process specifications are met; and （1）确定是否在进程符合规格要求;及
(2) Detect any deviation or unanticipated occurrence that may result in a failure to meet specifications. （2）发现任何偏离或意料之外的事件，可能导致不符合规范。
(c) For a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), you must verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement. （三）完成的一个子集饮食补充批，你通过一个健全的统计抽样计划确定（或每一批成品），您必须确认您的膳食补充剂完成一批符合身份，纯度，强度，结构产品规格，并就污染可能掺假或可能导致对膳食补充剂完成一批掺假这些类型的限制。To do so: 这样做：
(1) You must select one or more established specifications for identity, purity, strength, composition, and the limits on those types of contamination that may adulterate or that may lead to adulteration of the dietary supplement that, if tested or examined on the finished batches of the dietary supplement, would verify that the production and process control system is producing a dietary supplement that meets all product specifications (or only those product specifications not otherwise exempted from this provision by quality control personnel under paragraph (d) of this section); （1）您必须选择一个或多个身份，纯度，强度，建立规范的组成，以及对污染的可能掺假或可能导致对膳食补充剂掺假这些类型的限制，如果测试或成品检验膳食补充剂的批次，将核查的生产和过程控制系统，其产生的膳食补充剂，以满足所有的产品（或只有那些没有其他产品规格从这一质量管理人员提供豁免规格段（四本节））;
(2) You must conduct appropriate tests or examinations to determine compliance with the specifications selected in paragraph (c)(1) of this section; （2）您必须进行适当的检查或检验，以确定在第（c）（1选择了符合规格）本条;
(3) You must provide adequate documentation of your basis for determining that compliance with the specification(s) selected under paragraph (c)(1) of this section, through the use of appropriate tests or examinations conducted under paragraph (c)(2) of this section, will ensure that your finished batch of the dietary supplement meets all product specifications for identity, purity, strength, and composition, and the limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the dietary supplement; and （3）您必须为确定与规范（拧）根据第（三）（1中选择符合您的基础上适当的文件）本条，通过适当的检查或根据第（三）（2举行的考试使用本节），将确保您的饮食补充完成一批符合身份，纯度，强度所有产品规格，和组成，以及对污染的可能掺假，或可能导致掺假这些类型的限制，的膳食补助金
(4) Your quality control personnel must review and approve the documentation that you provide under paragraph (c)(3) of this section. （4）您的质量管理人员必须审查和批准的文件，你根据第（三）（第3条规定本节）。
(d)(1) You may exempt one or more product specifications from verification requirements in paragraph (c)(1) of this section if you determine and document that the specifications you select under paragraph (c)(1) of this section for determination of compliance with specifications are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage. （四）（1）您可豁免本节的一个或多个在第（c）（1核查要求的产品规格）如果您决定和文件的规格你根据第（三）（1选择本节）的对符合规格的决心是无法验证的生产和过程控制系统，其产生的膳食补充剂，以满足豁免的产品规格，也没有检验或检验批次的完成阶段免征产品规格等科学有效的方法。In such a case, you must document why, for example, any component and in-process testing, examination, or monitoring, and any other information, will ensure that such exempted product specification is met without verification through periodic testing of the finished batch; and 在这种情况下，你必须文件为何，例如，任何组件和过程，测试，检验，或监测，以及任何其他信息，以确保这些豁免产品规格不符合核查通过对一批成品定期测试;和
(2) Your quality control personnel must review and approve the documentation that you provide under paragraph (d)(1) of this section. （2）您的质量管理人员必须审查和批准的文件，你根据第（四）（1提供）本条。
(e) Before you package or label a product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must visually examine the product and have documentation to determine whether the specifications that you established under 111.70 (f) are met. （五）在你包装或标签的产品，
您将收到包装或作为膳食补充剂标签（和分配，而不是返回到供应商），您必须视觉检查产品，并在文档，以确定是否规范，你根据111.70条（f）得到满足。
(f)(1) Before you use packaging, you must, at a minimum, conduct a visual identification of the containers and closures and review the supplier's invoice, guarantee, or certification to determine whether the packaging specifications are met; and （六）（1）在您使用的包装，你必须至少进行一次封闭容器和视觉识别和审查供应商的发票，担保，或证明，以确定是否符合规格的包装;及
(2) Before you use labels, you must, at a minimum, conduct
a visual examination of the label and review the supplier's invoice, guarantee, or certification to determine whether label specifications are met. （2）在使用标签，您必须至少进行标签的视觉检查和审查供应商的发票，担保，或证明，以确定是否符合规格标签。
(g) You must, at a minimum, conduct a visual examination of the packaging and labeling of the finished packaged and labeled dietary supplements to determine whether you used the specified packaging and applied the specified label. （七）必须至少，进行包装的视觉检查和成品包装和标签膳食补充剂，以确定是否使用指定的包装和应用指定标签标识。
(h)(1) You must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods. （八）（1）你必须确保测验和考试，用于确定是否符合规格要求是恰当的，科学有效的方法。
(2) The tests and examinations that you use must include at least one of the following: （2）测验和考试，您的使用必须至少包括以下之一：
(i) Gross organoleptic analysis; （一）总感官分析;
(ii) Macroscopic analysis; （二）宏观分析;
(iii) Microscopic analysis; （三）微观分析;
(iv) Chemical analysis; or （四）化学分析;或
(v) Other scientifically valid methods. （五）其他科学有效的方法。
(i) You must establish corrective action plans for use when an established specification is not met. （i）您使用必须建立纠正行动计划成立时不符合规范。
[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007; 73 FR 27727, May 14, 2008] [72阻燃34942，2007年6月25日，截至72阻燃34968，2007年6月25日修订; 73阻燃27727，08年5月14日]
Sec. 秒。111.77 What must you do if established specifications are not met? 111.77你做什么，必须建立规范，如果不能满足？
(a) For specifications established under 111.70(a), (b)(2),
(b)(3), (c), (d), (e), and (g) that you do not meet, quality control personnel, in accordance with the requirements in subpart F of this part, must reject the component, dietary supplement, package or label unless such personnel approve a treatment, an in-process adjustment, or reprocessing that will ensure the quality of the finished dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. （一）为根据111.70（一），（二）（2建立规范），（二）（3），（三），（四），（五），和（g），您不符合质量控制人员，按照本部分合伙的要求，必须摒弃组件，膳食补充剂，包装或标签，除非这些人员通过一个进程的调整，或再加工，以确保成品的膳食补充剂的质量待遇，而且膳食补充剂的包装和在主生产记录中指定的标记。No finished batch of dietary supplements may be released for distribution unless it complies with 111.123(b). 没有完成的膳食补充剂可释放一批分发，除非它符合111.123（b）项。
(b) For specifications established under 111.70(b)(1) that you do not meet, quality control personnel must reject the component and the component must not be used in manufacturing the dietary supplement. （b）下111.70（二）（1建立规范），您不符合质量控制人员必须拒绝组件和组件不能生产的膳食补充剂使用。
(c) For specifications established under 111.70(f) that you do not meet, quality control personnel must reject the product and the product may not be packaged or labeled for distribution as a dietary supplement. （三）为根据111.70条（f），你不符合，质量控制人员必须拒绝的产品和产品不得用于包装或作为膳食补充剂销售标规格。
Sec. 秒。111.80 What representative samples must you collect? 111.80代表性的样本要什么你收集？
The representative samples that you must collect include: 代表性样品，你必须收集包括：
(a) Representative samples of each unique lot of components, packaging, and labels that you use to determine whether the components, packaging, and labels meet specifications established in accordance with 111.70(b) and (d), and as applicable, 111.70(a) (and, when you receive components, packaging, or labels from a supplier, representative samples of each unique shipment, and of each unique lot within each unique shipment); （一）的代表样本，每个组件，包装独特的很多，标签，用于确定是否组成部分，包装和标签符合确立的111.70规范（二）和（d），以及适用，111.70（1）（并且，当您收到从供应商组成部分，包装或标签，有代表性的样本每个独特的转运，并在每一个独特的装运每一个独特的地段）;
(b) Representative samples of in-process materials for each manufactured batch at points, steps, or stages, in the manufacturing process as specified in the master manufacturing record where control is necessary to ensure the identity, purity, strength, and composition of dietary supplements to determine whether the in-process materials meet specifications established in accordance with 111.70(c), and as applicable, 111.70(a); （b）代表样品在加工材料的每个点，步骤或阶段制造的一批，在如主生产记录中指定在管制是必要的，以确保自己的身份，纯度，强度制作过程和膳食组成补充，以决定是否在进程材料符合确立的111.70规范（三），以及适用，111.70（1）;
(c) Representative samples of a subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch), before releasing for distribution to verify that the finished batch of dietary supplement meets product specifications established in accordance with 111.70(e), and as applicable, 111.70(a); （三）对每一个膳食补充剂，你制造的，你通过一个完善的统计抽样计划，确定完成批次样品集代表（或每一批成品），然后分发给释放，以验证对膳食补充剂的完成一批符合产品规格建立了111.70（e）和适用，按照111.70（1）;
(d) Representative samples of each unique shipment, and of each unique lot within each unique shipment, of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) to determine whether the received product meets specifications established in accordance with 111.70(f), and as applicable, 111.70(a); and （d）代表每一个独特的样本装运，并在每一个独特的装运您收到的产品包装或作为膳食补充剂的标签，每个独特的地段（和分配，而不是返回到供应商），以确定是否收到产品符合确立的111.70规范（六），以及适用，111.70（a）和
(e) Representative samples of each lot of packaged and labeled dietary supplements to determine whether the packaging and labeling of the finished packaged and labeled dietary supplements meet specifications established in accordance with 111.70(g), and as applicable, 111.70(a). （五）各代表的大量样品包装和膳食补充剂标签，以确定是否包装和成品包装和膳食补充剂标签符合确立的111.70规格标签（g）和适用，111.70（a）条。
Sec. 秒。111.83 What are the requirements for reserve samples? 111.83哪些留样的要求？
(a) You must collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute. （1）您必须收集并保存每一个地段留样的包装和标签您分发膳食补充剂。
(b) The reserve samples must: （二）留样必须：
(1) Be held using the same container-closure system in which the packaged and labeled dietary supplement is distributed, or if distributing dietary supplements to be packaged and labeled, using a container-closure system that provides essentially the same characteristics to protect against contamination or deterioration as the one in which it is distributed for packaging and labeling elsewhere; （1）举行使用相同的容器封闭制度，包装和标签的膳食补充剂的分配，或者分配膳食补充剂的包装和标签，使用容器密闭系统，提供基本相同的特点，防止污染或恶化，在其所分配的包装和标签地方之一;
(2) Be identified with the batch, lot, or control number; （2）对同批次，批次，查出若干或控制;
(3) Be retained for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of
the last batch of dietary supplements associated with the reserve sample, for use in appropriate investigations; and （3）为保留过去的一年保质日期（如约会保质期使用），或2从与储备相关的膳食补充剂样本，最后一批分配之年，在适当调查的使用;和
(4) Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specifications. （4）包括至少两次的数量为所有测试或检验，以确定是否有必要的食品补充品符合产品规格。
Sec. 秒。111.87 Who conducts a material review and makes a disposition decision? 111.87谁的材料进行审查并作出处理决定？
Quality control personnel must conduct all required material reviews and make all required disposition decisions. 质量控制人员必须进行所有必要的材料审查和作出一切必要的处置决定。
Sec. 秒。111.90 What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with 111.70 is not met? 111.90什么要求适用于治疗，在进程的调整，和后处理当有偏差或意料之外的事件，或当一个规范确立的111.70不满足？
(a) You must not reprocess a rejected dietary supplement or treat or provide an in-process adjustment to a component, packaging, or label to make it suitable for use in the manufacture of a dietary supplement unless: （1）你不能重新处理一膳食补充剂或拒绝治疗或提供一个进程调整组件，包装或标签，使之适合于一个膳食补充剂的制造，除非：
(1) Quality control personnel conduct a material review and make a disposition decision to approve the reprocessing, treatment, or in-process adjustment; and （1）质量控制人员进行材料进行审查并作出处理决定批准后处理，治疗，或在进程调整;和(2) The reprocessing, treatment, or in-process adjustment is permitted by 111.77; （2）加工，处理，或者在进程调整允许111.77;
(b) You must not reprocess any dietary supplement or treat or provide an in-process adjustment to a component to make it suitable for use in the manufacture of a dietary supplement, unless: （b）您不能重新处理任何膳食补充剂或治疗，或提供一个进程内组件调整，使其适合于一个膳食补充剂生产使用，除非：
(1) Quality control personnel conduct a material review and make a disposition decision that is based on a scientifically valid reason and approves the reprocessing, treatment, or in-process adjustment; and （1）质量控制人员进行材料进行审查并作出处理决定是基于科学的正当理由，并批准后处理，治疗，或在进程调整;和
(2) The reprocessing, treatment or in-process adjustment is permitted by 111.77; （2）加工，处理或过程的调整是允许111.77;
(c) Any batch of dietary supplement that is reprocessed, that contains components that you have treated, or to which you have made in-process adjustments to make them suitable for use in the manufacture of the dietary supplement must be approved by quality control personnel and comply with 111.123(b) before releasing for distribution. （三）任何膳食补充剂一批再行处理，包含您已处理，或您已在进程的调整，使他们在对膳食补充剂的制造必须由适当的质量控制人员通过组件并遵守111.123（b）在分发释放。
Sec. 秒。111.95 Under this subpart E, what records must you make and keep? 在这个子部分的位置111.95，什么记录必须保持你的？
(a) You must make and keep records required under this subpart E 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附位置所需的记录。
(b) Under this subpart E, you must make and keep the following records: （二）根据本附的位置，你必须制作并保存以下记录：
(1) The specifications established; （1）规范建立;