"US FDA GMP (Good Manufacturing Practice) Regulations for Food Production Enterprises"
Shanghai Nena Environmental Technology Co., Ltd. 2008-10-27 23:49:38
A General Provisions
§110.3 Definitions
The definitions and interpretations of terms in Section 210 of the Federal Food, Drug, and Cosmetic Act (hereinafter referred to as "the Act") apply to the same terms in this regulation, and the following definitions also apply:
(a) Acidic foods or acidified foods (Acid foods or acidified foods): Foods with a pH value equal to or lower than 4.6.
(b) Adequate (Adequate): The requirements needed to achieve the predetermined goals of good public health practices.
(c) Batter (Batter): A semi-fluid substance, usually containing flour and other ingredients. It can be used to dip the main components of food, coat the exterior, or directly bake food.
(d) Blanching (Blanching): Thermal treatment of food (excluding tree nuts and peanuts) before packaging, partially or completely inactivating natural enzymes and causing physical or biochemical changes in the food.
(e) Critical control point (Critical control point): A point in the food processing process where improper control could likely cause, trigger, or lead to hazards, or result in contamination or decomposition of the finished product.
(f) Food (Food): As defined in section (f) of the 210 Act, including various raw materials and ingredients.
(g) Food contact surfaces (Food contact surfaces): Surfaces that come into contact with food, as well as surfaces that frequently splash wastewater onto food or surfaces that contact food during normal processing. "Food contact surfaces" include utensils and equipment surfaces that contact food.
(h) Lot (Lot): Food produced within a specific time period and marked with a specific number.
(i) Microorganisms (Microorganisms): Yeasts, molds, bacteria, and viruses, including but not limited to those microorganisms affecting public health. "Undesirable microorganisms" include those significantly impacting public health, causing food decomposition, contaminating food with impurities, or making food adulterated as defined by the Act. In some cases, the FDA uses the adjective "microbial" in these regulations instead of phrases containing "microorganism."
(j) Pest (Pest): Any annoying animal or insect, including but not limited to birds, rodents, flies, and larvae.
(k) Plant (Plant): Buildings or facilities used or related to food processing, packaging, labeling, or storage, or parts thereof.
(l) Quality control operation (Quality control operation): Planned and systematic procedures aimed at preventing food from becoming adulterated as defined by the Act through all necessary measures.
(m) Rework (Rework): Clean, non-adulterated food suitable for consumption that has been removed from the processing process for reasons other than sanitation or reprocessed and reconditioned.
(n) Safe moisture content (Safe-moisture level): The moisture content in food that is sufficient to prevent the growth of undesirable microorganisms under specified processing, storage, and distribution conditions. The highest safe moisture content of a food depends on its water activity (aw). If there are sufficient data indicating that the food under one or below that water activity will not favor the growth of undesirable microorganisms, then that water activity can be considered safe for that food.
(o) Sanitize (Sanitize): The process of appropriately treating food contact surfaces to effectively destroy cells of microorganisms hazardous to public health and substantially reduce the numbers of other undesirable microorganisms without adversely affecting the safety of the product or consumers.
(p) Shall (Shall): Used to express mandatory requirements.
(q) Should (Should): Used to express recommended or suggested procedures or to determine recommended equipment.
(r) Water activity (Water activity, aw): A measure of the amount of free water in food, equal to the vapor pressure of water in a substance divided by the vapor pressure of pure water at the same temperature.
§110.5 Current Good Manufacturing Practices (CGMP)
(a) The standards and definitions of this regulation are used to determine whether a food: (1) is an adulterated food as defined in section 402(a)(3) of the Act, meaning the food was processed under unsuitable conditions for producing food; or (2) is food as defined in section 402(a)(4) of the Act, meaning the food was manufactured, packed, or held under insanitary conditions, thereby possibly being contaminated or harmful to human health. The standards and definitions of this regulation also apply to determining whether a food violates section 361 of the "Public Health Service Act" (42 U.S.C. 264).
(b) Food subject to specific "Current Good Manufacturing Practices" must also comply with the requirements of those regulations.
§110.10 Personnel
The factory management organization should take all reasonable measures and preventive measures to ensure:
(a) Disease Control: Employees who are found to have or exhibit diseases, open wounds (including boils or infected wounds), or other potential abnormal sources of microbial contamination for food, food contact surfaces, or food packaging materials, based on medical examinations or supervisory observations, shall not participate in operations that may cause contamination until the above conditions are resolved. Employees should be advised to report such conditions to their superiors.
(b) Hygiene: Employees who directly contact food, food contact surfaces, and food packaging materials during work should follow hygiene standards while on duty to ensure food remains free from contamination. Methods to maintain cleanliness include, but are not limited to:
(1) Wearing appropriate outerwear to prevent contamination of food, food contact surfaces, or food packaging materials.
(2) Maintaining personal cleanliness.
(3) Thoroughly washing hands at proper handwashing facilities before starting work, after each departure from the workstation, and at any other time when hands may have become dirty or contaminated (disinfection may be required to prevent microbial contamination).
(4) Removing loose jewelry and other items that may fall into food, equipment, or containers; removing jewelry that cannot be thoroughly disinfected when manually handling food. If jewelry cannot be removed, it can be covered with a clean material to prevent contamination.
(5) If gloves are used in food processing, they must be intact, clean, made of non-porous materials, and sanitized.
(6) Properly wearing hairnets, headbands, hats, beard covers, or other effective hair restraints as needed.
(7) Not storing clothing or other personal items in areas where food is exposed or where equipment and utensils are washed.
(8) Restricting behaviors like eating, chewing gum, drinking beverages, or smoking to areas outside food exposure zones or equipment and utensil cleaning areas.
(9) Taking other necessary precautions to prevent contamination of food, food contact surfaces, or food packaging materials by microorganisms or foreign matter (including, but not limited to: sweat, hair, cosmetics, tobacco, chemicals, and skin medications).
(c) Education and Training: Personnel responsible for supervising hygiene or food contamination should have basic education or experience, or both, to ensure the production of sanitary and safe food. Food operators and supervisors should be adequately trained in food processing techniques and food protection principles and understand the dangers of poor personal hygiene and unsanitary operations.
(d) Supervision: Competent supervisory personnel should be clearly tasked with ensuring compliance by all employees with all provisions of this chapter.
§110.19 Exceptions
(a) The following operations are not within the scope of this chapter: enterprises that only engage in the harvesting, storage, or distribution of one or several "raw agricultural commodities" as defined in section 210(r) of federal law, which only undergo general washing, sorting, handling, or other forms of processing before being sold to consumers.
(b) However, if necessary, the FDA will issue special regulations to bring these exempted operations under regulation.
B Buildings and Facilities
§110.20 Plant and grounds
(a) Grounds: The surrounding grounds of the food plant within the control of the operator should be maintained to prevent food contamination. Appropriate maintenance methods include, but are not limited to:
(1) Reasonably placing equipment, clearing leaves and waste, and cutting weeds near buildings and structures that may become breeding grounds or habitats for pests.
(2) Keeping roads, yards, and parking lots so they do not become sources of contamination for food exposure areas.
(3) Appropriately draining water from areas that may become contaminated due to leaks, dirt on shoes, or providing pest breeding grounds.
(4) Managing waste disposal systems so they do not become sources of contamination for food exposure areas.
If the grounds connected to the plant are not within the operator's control and are not managed according to the methods described in paragraphs (a)(1)-(3) of this section, then inspections, pest control, or other measures should be taken inside the plant to eliminate pests, dirt, and filth that may become sources of food contamination.
(b) Plant construction and design: The buildings and structures of the plant should be of adequate size, construction, and design suitable for maintaining and operating for food production purposes. The plant and facilities must:
(1) Provide sufficient space for equipment placement and material storage to meet hygienic operations and safe food production.
(2) Take appropriate preventive measures to reduce potential contamination of food, food contact surfaces, or food packaging materials by microorganisms, chemicals, dirt, or other extraneous materials. Potential food contamination can be reduced through appropriate safety controls and operational standards or effective design, including separating potentially contaminating operations through location, timing, isolation, airflow, enclosed systems, or other effective methods.
(3) Take appropriate preventive measures to protect bulk food in outdoor fermentation containers through any effective means:
(i) Using protective covers;
(ii) Controlling the area above and around the container to eliminate pest hiding places;
(iii) Regularly inspecting for pests and their activities;
(iv) Skimming off floating debris from the surface of the fermentation container when necessary.
(4) Be constructed reasonably, with floors, walls, and ceilings that can be adequately cleaned, kept clean, and well maintained; ensure that drips or condensation from fixed equipment and pipelines do not contaminate food, food contact surfaces, or food packaging materials; provide walkways and working spaces between equipment and walls that are not obstructed, have appropriate widths for normal employee operations, and prevent food or food contact surfaces from being contaminated by clothing or employee contact.
(5) Provide appropriate lighting for handwashing areas, changing rooms, restrooms, and all areas for food inspection, processing, storage, and equipment or utensil cleaning; install safety-type light bulbs, fixed fixtures, skylights, or other suspended glass above exposed food at any stage of food manufacturing, or use other methods to prevent food contamination in case of broken glass.
(6) Provide adequate ventilation or control equipment in areas where harmful gases may contaminate food, minimizing odors and vapors (including water vapor and various harmful fumes); place fans and other air-blowing equipment appropriately and operate them in ways that minimize potential contamination of food, food packaging materials, or other food contact surfaces.
(7) Install screens or other pest-proofing devices where necessary.
§110.35 Sanitation Operations
(a) General Maintenance: The buildings, fixed equipment, and other tangible facilities of the factory must be kept sanitary and well maintained to prevent food from becoming adulterated as defined by the Act. Cleaning and sanitizing of utensils and equipment must prevent contamination of food, food contact surfaces, or food packaging materials.
(b) Storage of Items and Toxic Substances Used for Cleaning and Disinfecting: (1) Cleaning agents and sanitizers used for cleaning and disinfecting must not carry undesirable microorganisms and must be safe and suitable for use. This can be verified by any effective method, such as requiring guarantees or certificates from suppliers upon purchase or testing these substances for contamination. Only the following toxic substances may be used or stored in plants where food is processed or exposed:
(i) Items necessary for maintaining cleanliness and sanitation;
(ii) Items required for laboratory analysis;
(iii) Items necessary for the maintenance and operation of the plant and equipment;
(iv) Items required for plant operations.
(2) Toxic cleaning agents, sanitizers, and pesticides must be identified, controlled, and stored to prevent contamination of food, food contact surfaces, or food packaging materials. All relevant regulations issued by federal, state, and local government agencies regarding the application, use, and possession of these products must be followed.
(c) Pest Control: No pests may exist in food plants. Watchdogs or guide dogs may be allowed in certain areas of the plant if they will not cause contamination of food, food contact surfaces, or food packaging materials. Effective measures must be taken in processing areas to eliminate pests and prevent food contamination in these areas. Pesticides and rodenticides must be used cautiously and with restrictions to prevent contamination of food, food contact surfaces, and food packaging materials.
(d) Sanitation of Food Contact Surfaces: All food contact surfaces, including food contact surfaces of utensils and equipment, must be cleaned as necessary to prevent food contamination.
(1) Food contact surfaces used for processing or storing low-moisture-content food must be dry and sanitary when in use. These surfaces, if washed with water, must be sanitized and dried completely before the next use if necessary.
(2) In wet processing, all food contact surfaces must be cleaned and sanitized before use and after any interruption that may have caused contamination to prevent microbial contamination of food. When equipment and utensils are in continuous operation, they must be cleaned and sanitized as necessary.
(3) Non-food contact surfaces of equipment used in food production in food plants must also be cleaned as necessary to prevent food contamination.
(4) Single-use items (such as utensils used once, paper cups, napkins) must be stored in appropriate containers and handled, distributed, used, and disposed of in a manner that does not cause contamination of food or food contact surfaces.
(5) Sanitizers must be used in appropriate and safe amounts under usage conditions. Facilities, procedures, or equipment that can consistently keep equipment and utensils clean and provide appropriate cleaning and sanitizing treatments may be used for cleaning and sanitizing equipment and utensils.
(e) Storage and Handling of Clean, Portable Equipment and Utensils. Clean and sanitized portable equipment and utensils with food contact surfaces must be stored and handled in a way that prevents contamination of food contact surfaces.
§110.37 Sanitary Facilities and Controls
Each plant must provide appropriate sanitary facilities and equipment, including, but not limited to:
(a) Water Supply: The water supply must meet the set operational requirements and come from appropriate sources. Water that comes into contact with food or food contact surfaces must be safe and of appropriate sanitary quality; water of appropriate temperature and pressure must be provided wherever water is needed for food processing, cleaning of equipment, utensils, and food packaging materials, or employee sanitary facilities.
(b) Plumbing: The size and design of the plumbing must be appropriate and properly installed and maintained so that:
(1) An adequate supply of water is delivered to all locations in the plant where water is needed.
(2) Sewage and liquid wastes are properly drained from the plant.
(3) It does not become a source of contamination for food, water supply, equipment, or utensils or create unsanitary conditions.
(4) Proper floor drainage facilities must be provided for all areas where equipment is rinsed or water or other liquid wastes are discharged onto the floor during normal operations.
(5) Ensure that sewage or liquid waste discharge pipe systems do not backflow or cross-connect with pipes that convey food or water used in food processing.
(c) Sewage Disposal: Sewage must be discharged into an appropriate sewage system or otherwise treated appropriately.
(d) Toilet Facilities: Each plant must provide appropriate and convenient toilet facilities for its employees. This requirement can be met by:
(1) Keeping facilities sanitary.
(2) Ensuring facilities are always in good repair.
(3) Installing doors that close automatically.
(4) Installing doors that do not open toward areas where food is exposed to air pollution unless other measures are taken to prevent such pollution (e.g., double doors and positive-pressure airflow systems).
(e) Handwashing Facilities: Handwashing facilities must be appropriate and convenient and provide live water at an appropriate temperature. This requirement can be met by:
(1) Installing handwashing and hand sanitizing facilities at all locations where good sanitary practices require employees to wash and/or sanitize their hands.
(2) Providing effective hand cleaning and sanitizing preparations.
(3) Providing sanitary towels or appropriate hand drying facilities.
(4) Designing and constructing devices or fixtures, such as water supply valves, to prevent contamination of clean, sanitized hands.
(5) Using easily understandable signs to instruct employees who handle exposed food, food contact surfaces, or food packaging materials to wash their hands and, if appropriate, sanitize them before starting work, after each departure from the workstation, and whenever their hands may have become soiled or contaminated. These signs can be posted in processing areas and all areas where employees might come into contact with the aforementioned food, materials, or surfaces.
(6) Constructing and maintaining waste receptacles in a manner that prevents contamination of food.
(f) Garbage and Rubbish Disposal: The transportation, storage, and disposal of garbage and all refuse must be conducted in a manner that minimizes odor generation, attraction, and harborage of pests, and prevents contamination of food, food contact surfaces, water supply, and grounds.