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;
