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;