CFR Subpart C

CFR Subpart C
in effect

21 C.F.R. § 111.15 What sanitation requirements apply to your physical plant and grounds?

(a) Grounds. You must keep the grounds of your physical plant in a condition that protects against the contamination of components, dietary supplements, or contact surfaces. The methods for adequate ground maintenance include: (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; (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; (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; (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 (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. (b) Physical plant facilities. (1) You must maintain your physical plant in a clean and sanitary condition; and (2) You must maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated. (c) Cleaning compounds, sanitizing agents, pesticides, and other toxic materials. (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. (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: (i) To maintain clean and sanitary conditions; (ii) For use in laboratory testing procedures; (iii) For maintaining or operating the physical plant or equipment; or (iv) For use in the plant's operations. (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. (d) Pest control. (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; (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 (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. (e) Water supply. (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. (2) Water that is used in a manner such that the water may become a component of the dietary supplement, e.g., 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. (f) Plumbing. The plumbing in your physical plant must be of an adequate size and design and be adequately installed and maintained to: (1) Carry sufficient amounts of water to required locations throughout the physical plant; (2) Properly convey sewage and liquid disposable waste from your physical plant; (3) Avoid being a source of contamination to components, dietary supplements, water supplies, or any contact surface, or creating an unsanitary condition; (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 (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. (g) Sewage disposal. You must dispose of sewage into an adequate sewage system or through other adequate means. (h) Bathrooms. 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. (i) Hand-washing facilities. 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. (j) Trash disposal. You must convey, store, and dispose of trash to: (1) Minimize the development of odors; (2) Minimize the potential for the trash to attract, harbor, or become a breeding place for pests; (3) Protect against contamination of components, dietary supplements, any contact surface, water supplies, and grounds surrounding your physical plant; and (4) Control hazardous waste to prevent contamination of components, dietary supplements, and contact surfaces. (k) Sanitation supervisors. 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.

21 C.F.R. § 111.16 What are the requirements under this subpart C for written procedures?

You must establish and follow written procedures for cleaning the physical plant and for pest control.

21 C.F.R. § 111.20 What design and construction requirements apply to your physical plant?

Any physical plant you use in the manufacture, packaging, labeling, or holding of dietary supplements must: (a) Be suitable in size, construction, and design to facilitate maintenance, cleaning, and sanitizing operations; (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; (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. 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: (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; (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; (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; (4) Performing laboratory analyses and holding laboratory supplies and samples; (5) Cleaning and sanitizing contact surfaces; (6) Packaging and label operations; and (7) Holding components or dietary supplements. (d) Be designed and constructed in a manner that prevents contamination of components, dietary supplements, or contact surfaces. (1) The design and construction must include: (i) Floors, walls, and ceilings that can be adequately cleaned and kept clean and in good repair; (ii) Fixtures, ducts, and pipes that do not contaminate components, dietary supplements, or contact surfaces by dripping or other leakage, or condensate; (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; (iv) Equipment that controls temperature and humidity, when such equipment is necessary to ensure the quality of the dietary supplement; and (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. (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; (e) Provide adequate light in: (1) All areas where components or dietary supplements are examined, processed, or held; (2) All areas where contact surfaces are cleaned; and (3) Hand-washing areas, dressing and locker rooms, and bathrooms. (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. (g) Provide effective protection against contamination of components and dietary supplements in bulk fermentation vessels, by, for example: (1) Use of protective coverings; (2) Placement in areas where you can eliminate harborages for pests over and around the vessels; (3) Placement in areas where you can check regularly for pests, pest infestation, filth or any other extraneous materials; and (4) Use of skimming equipment. (h) Use adequate screening or other protection against pests, where necessary.

21 C.F.R. § 111.23 Under this subpart C, what records must you make and keep?

(a) You must make and keep records required under this subpart C in accordance with subpart P of this part. (b) You must make and keep records of the written procedures for cleaning the physical plant and for pest control. (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).

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