Good Manufacturing Practices
Good Manufacturing Practices (GMPs) describe the methods, equipment, facilities, and controls for producing processed food. As the minimum sanitary and processing requirements for producing safe and wholesome food, they are an important part of regulatory control over the safety of the nation's food supply. The GMP regulation (Part 117 of Title 21 of the Code of Federal Regulations) has been in effect for over 30 years and is periodically revised.
GMPs describe the general conditions or practices in a food processing facility, more specific sanitation procedures and standard operating procedures that are site specific should be developed for each plant. GMPs also apply to all parts of a food operation including: receiving, storage, processing, handling, and shipping of the finished product. Each processing facility is required to have a customized, written GMP program.
The Importance of GMPs
- GMPs extend the shelf and storage life of products
- GMPs reduce the risk of a product or process suspension
- Proper GMPs reduce the risk of foodborne illnesses
- Reduced product reprocessing
- Compliance with federal and commercial product specifications
- Reduced number of product rejections, returns, and/or complaints
Buildings and Facilities
- All walls should be constructed of a smooth, non-toxic, easily cleanable surface that is impervious to water, sanitizers, etc.
- Walls should be free of cracks and holes which may harbor pests and reduce cleaning efficiencies.
- Walls should be free of dust, dirt, product accumulation and flaking paint.
- Walls should be sealed at the wall/floor juncture.
- All walls shall be sealed around the openings through which equipment, pipes or other items pass.
- All walls shall be free of dust, dirt and food accumulation.
- All windows shall be in good repair with no broken panes of glass.
- All windows shall clean, free from dust, dirt, and mold.
- All electrical boxes mounted to walls should be in good repair, free of rust, flaking paint and should be mounted flush and caulked.
- Electrical boxes shall be free of dust, dirt and food accumulation inside and out.
- Boxes should be in good repair with not rust or flaking paint, and should be tightly sealed to preclude insects.
- All ceilings shall be constructed of a smooth, non-absorbent and easily cleanable material.
- All ceiling surfaces, as well as overhead installations or structures including ventilation units, light fixtures, electrical raceways, piping, etc., shall be clean, free of product buildup, dust, mold, webbing, rust, peeling or flaking paint.
- There will be no evidence of or active water leaks on ceilings.
- Insulation material used on overhead lines shall be in good repair, smooth, non-absorbent and easily cleanable.
- Nails, staples or screws shall not be used to secure ceiling material in processing, ingredient or packaging areas.
- No strings, ropes, wires or tapes are to be used as pipe or line supports.
- Floors shall be well drained, smooth and clean, with no open cracks, holes or broken areas.
- All perimeters should have an uncluttered 18-inch wide strip to assure cleanliness, allow proper inspections and comply with fire regulations.
- Floors shall be maintained in a clean condition with no excessive accumulations or static buildup of product.
- Concrete floors will not be cracked or eroded, which causes absorption and unclean surfaces.
- There should be no holes, missing concrete or low spots causing standing water.
- Drains will have traps, drain covers and will be maintained in clean condition, with care taken to keep water in the trap and prevent objectionable odors.
- All cracks at the floor-wall junctures must be sealed to prevent product buildup and possible insect harborage.
- All doors shall be tight fitting, clean and in good repair.
- They shall be self-closing if open to the outside.
- If the door is open, it shall be equipped with an effective air curtain or strip door.
- Doors shall be tight fitting at the bottom to preclude the entrance of insects and rodents.
- All holes in hollow wood or metal doors must be sealed to prevent harborage inside.
- Adequate ventilation in the processing area shall be provided to maintain proper environmental and sanitary conditions for equipment, ingredients, finished goods and packaging materials.
- All systems shall be cleanable, function properly and be designed in a manner to prevent product contamination from condensation, mold, bacteria, insects, dust and odors.
- Objectionable odors, fumes or vapors shall not be present.
- All fans, fan guards, duct work, louvers and heat/air conditioning units will be clean and in good repair.
- All ceiling mounted fans or vents will have properly functioning, self-closing louvers and will be screened to prevent insect entry.
- All critical processing areas shall be maintained under positive air pressure to prevent dust, flying insect entry and cross contamination.
- All filters and screens used in ventilation systems shall be routinely inspected and replaced or cleaned as necessary.
- All toilet and locker room facilities shall be vented mechanically to the outer air.
- Condensation shall not be present on walls or ceilings.
- The growth of weeds and tall grass along the building perimeter shall be arrested.
- The surrounding premises shall be free of standing water or other drainage problems. All storm sewers and catch basins shall be kept clear and operative.
- The area shall be free of drippings, tunneling or any other signs of rodent activity. Rodent traps are to be maintained in an orderly fashion.
- There shall be no apparent signs of pest activity immediately surrounding the building.
- All roads, lots and yards shall be adequately paved and maintained.
- Roads and parking lots should be graded so that water drains away from the building.
- All scrap, pallet, equipment, etc., are to be stored off the ground and away from building walls.
- Excessive amounts of scrap or idle equipment shall be disposed of to reduce pest activity.
- Any outside waste compactor/disposal area shall be clean and properly maintained.
- Suitable covers shall be provided for outside waste containers. The surrounding area shall be free of paper, trash and litter.
- The areas under and around loading docks are to be kept clean and uncluttered.
- The building roof shall be free of standing water, product dust, accumulated filth and unessential materials.
- There shall be no signs of pest or rodent activity on the building roof.
- Operate systems for waste management and disposal in an adequate manner so they do not constitute a source of contamination.
- Evaluate your system for handling, storing, and discarding food waste and other garbage to minimize the potential for contamination.
- Clean and sanitize waste receptacles and dumpsters to minimize odor and reduce attraction of pests.
Sanitary Facilities and Controls
- The water supply shall be sufficient for the operations intended and shall be derived from an adequate source.
- Any water that contacts food or food contact surfaces shall be safe and of adequate sanitary quality.
- Running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food packaging materials, and/or for employee sanitary facilities.
- FDA guidelines for water temperature indicate that hot water for hand washing in toilet facilities and hand washing sinks should be at least 100⁰F/38⁰C. Hot water used as part of a sanitizing procedure should be at least 170⁰F/77⁰C.
- Plumbing shall be of adequate size and design to carry sufficient quantities of water to required locations.
- Plumbing shall properly convey sewage and liquid disposable waste from the plant.
- Plumbing shall avoid being a source of contamination to food, water supplies, equipment, and utensils.
- Adequate floor drainage shall be provided 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.
- Plumbing must provide that the is no backflow from, or cross connection between, piping systems that discharge waste-water or sewage and piping systems that carry water for food for food processing.
- Backflow is the flow of water or other liquids, mixtures, or substances into a potable water system other than the intended source.
- A cross connection exists when a direct arrangement of a piping line that allows the potable water supply to be connected to a line that contains a contaminant.
- An adequate number of hand washing stations shall be provided within the processing area.
- All hand washing stations will be maintained in a clean condition.
- Single service towels, tempered water, dispenser soap, and proper disposal will be provided at each hand washing station.
- A sign at each hand washing station will be conspicuously posted which instructs employees to wash their hands prior to returning to work. Hand sanitizing stations will be provided where deemed necessary.
- Employees will be provided with a clean, sanitary and properly functioning toilet and hand washing facility.
- All toilets, urinals and hand washing facilities will be clean and properly functioning.
- Hand washing stations shall have sufficient pressures of both hot and cold water.
- Hand washing soap, in a suitable dispenser, must be provided at each basin.
- An adequate supply of toilet tissue and single service towels shall be provided.
- Doors to toilet facilities shall be self-closing and will not open directly into processing, ingredient or packaging areas.
- There shall be no clogged drains or overflowing toilets.
- Legible signs shall be posted conspicuously in all toilet facilities directing employees to wash their hands before returning to work.
- All walls, ceilings and floors shall be clean and in good repair.
- Waste containers shall be provided for used towels or other wastes and will have self-closing covers.
- All toilet facilities shall be mechanically ventilated to outer air.
- All equipment shall be designed in such a manner to effectively and efficiently fulfill its use while protecting the product from contamination.
- All equipment shall be of food-grade, smooth, impervious, non-toxic, non-absorbent and corrosion-resistant material where it has direct product contact.
- All non-food grade materials such as wire, tape, string, wood and cardboard shall not be used as a temporary design or repair.
- All equipment shall be free of rough surfaces and cracked walls where product may become static and make cleaning difficult.
- All equipment shall be free of oil leaks and excessive grease buildup or bearings and motor housing where it may contaminate product.
- Equipment shall be constructed in such a manner to preclude metal to metal contact.
- Appropriate lids/covers shall be provided to protect the product from contamination.
- All food equipment shall be installed in such a manner to provide easy access for cleaning and inspections.
- Equipment shall be free of flaking paint and rust.
- Conveyor belts shall be free of loose string, metal clips and loose pieces of rubber.
- All processing equipment shall be free of leaks at valves, gaskets, fittings, etc.
- Thermometers, recording charts and pressure gauges shall be provided where applicable. They must be in good working order and easily accessible.
- Equipment shall be designed to preclude or divert condensations away from product and product contact surfaces.
Unessential items are items which when not stored in their proper place contribute to poor housekeeping and pest control problems. These shall be properly managed and stored.
- Brooms, squeegees and mops should have hangers and should be kept off the floor.
- Small articles such as pencils, knives, fused, tools, etc. should not be left in or on electrical panels, switchboards, processing equipment etc.
- Idle equipment should be removed from processing areas and stored in a clean fashion.
- Obsolete equipment shall not be allowed to accumulate to the point of causing housekeeping or pest control problems.
- All processing equipment shall be maintained in a clean and sanitary manner.
- Each piece of equipment shall have written procedures for complete breakdown and cleaning.
- All equipment/utensils shall be stored in a sanitary manner when not in use.
- All equipment shall be cleaned and sanitized on a regular schedule that insures that wholesomeness of the product by reducing bacterial loads.
- All cleaning procedures shall be followed as outlined in the cleaning manual.
- Valves, gaskets and pumps shall be maintained in a clean and sanitary manner.
- All reusable ingredient containers should be thoroughly cleaned before re-use.
- No steel wool or metal sponges should be used in the cleaning of equipment.
Cleaning & Sanitizing Procedures
Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against the contamination of food, food contact surfaces, or food packaging materials.
- Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to be food from becoming adulterated.
- All food contact surfaces, including and food contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against the contamination of food.
- Food contact surfaces used for manufacturing or holding low moisture food shall be in a dry sanitary condition at the time of use.
- When surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried prior to subsequent use.
- In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food contact surfaces shall be cleaned and sanitized prior to use and after any interruption during which the food contact surfaces may have become contaminated.
- Where equipment and utensils are used in a continuous production operation, the utensils and food contact surfaces of the equipment shall be cleaned and sanitized as necessary.
- Cleaned and sanitized portable equipment and utensils should be stored in a location and manner that protects food contact surfaces from contamination.
- Single service articles should be stored in appropriate containers and hall be handles, dispensed, used, and disposed of in a manner that protect against contamination of food and food contact surfaces.
- Sanitizing agents shall be adequate and safe under conditions of use.
- Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment.
- Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe and adequate under the conditions of use.
“Any person who, by medical examination or supervisory observation, is shown to have, or appears to have an illness, open lesion (including boils, sores, or infected wounds, and/or any other abnormal source of microbial contamination by which there is a reasonable possibility of contamination of food, food-contact surfaces, packaging materials shall be excluded from operations which may result in such contamination until the condition is corrected.
Personnel shall be instructed to report such health conditions to their supervisors.
- No persons with any disease capable of being transmitted to others through the contamination of food shall work in any capacity which brings them into direct contact with milk products, product-contact surfaces or packaging.
- Illness or Injury without Diagnosis: Milk plant employees shall be instructed to report:
- Symptoms of acute gastrointestinal illness such as:
- abdominal cramps or discomfort; vomiting
- diarrhea, fever, loss of appetite for 3 + days,
- Pustular lesion (boil or infected wound) that is on:
- hands, wrists or exposed portions of arm
- other body parts if lesion is open/draining ** lesion may be covered by a durable, moisture proof, tight-fitting barrier.
- Symptoms of acute gastrointestinal illness such as:
- Plant operators who have received reports of illness under Section 13 from employees who have handled pasteurized milk products or associated product-contact surfaces, shall immediately notify the Milk Regulatory Agency.
- The immediate restricting of that person from duties requiring handling milk products, product-contact surfaces.
- Immediate exclusion of affected milk products from distribution/use when medically appropriate
i.e., a medical evaluation of the sequence of events indicates that contamination of milk product may have occurred.
- The immediate requesting of medical and bacteriological examination of the person at risk.
- Wearing suitable, clean outer garments including boots or shoe covers
- Maintaining adequate personal cleanliness
- Washing hands1 thoroughly (for at least 20 seconds), sanitizing when necessary
- On entering the food handling areas
- After each and every visit to the toilet
- After using handkerchief or tissue
- After smoking, chewing, eating, drinking
- After handling wash down hoses, dropped product
or any unsanitary or contaminated material
- Removing all unsecured jewelry and other objects
- Maintaining gloves if used; replacing if soiled
- Glove should be of an impermeable material. Impermeable materials do not allow water, oils, or other materials in the food to be absorbed by or pass through the glove. Both vinyl and latex are acceptable materials.
- Wearing, where appropriate hair nets, beard covers, etc.
- Storing clothing/personal items away from process area
- Confining food, gum, smoking, etc. away from process area
- Taking any other precautions needed to protect food, food contact surfaces, packaging materials, etc. from contamination with microorganism or foreign materials
- Be convenient to all toilets and to all rooms in which milk plant operations are conducted (e.g., entrance).
- Provide hot & cold and/or warm running water, soap & individual sanitary towels (hand free preferred) or other approved drying devices.
- Be kept in clean condition and good repair.
- Steam-water mixing valves and vats for washing bottles, cans & similar equipment are not used for hand-washing
Pasteurized Milk Ordinance Section 7, Item 16r
- Liquid soap dispenser
- Hand wash sink that delivers running water at a temperature of at least 100 degrees F (38 degrees C). Note: In this example, foot pedals are used to turn the water on and off so that employees do not touch dirty faucets after they have washed their hands.
- Disposable paper towels in a dispenser
- Waste container. Note: The container that shall be designated so employees do not open it with their clean hands.
Education & Training
- Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or combination thereof, to provide a level of competency necessary for production of clean and safe food.
- Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices.
- Responsibility for assuring compliance by all personnel with all requirements cGMPs shall be clearly assigned to competent supervisory personnel.
- Written employee GMPs developed for the plant
- Employees required to review written GMPs
- Employees given formal training
- Employees sign-off that they understand GMPs
- Supervisory monitoring to ensure that employees understand & follow GMPS
- Regulators/Auditors monitor supervisors and employees to ensure that they understand and follow GMPs
No pests shall be allowed in any area of a food plant and effective measures shall be taken to exclude pests from the processing areas to protect against contamination of food on the premises by pests. A pest is defined as any objectionable animals or insects including, but not limited to: birds, rodents, and insects. Pest may carry a number of different types of organisms that can cause illness and disease.
Pets and other domesticated animals should also never be allowed into any area were food is received, processed, or stored.
Process control is a statistical and engineering discipline that deals with the design and mechanisms for maintaining the output of a specific process within a desired range. These activities are involved in ensuring a process is predictable, stable, and consistently operating at the target level of performance with only normal variation. Process control enables mass production of continuous process as well a level of automation by which a small staff may operate a complex process from a central control room.
All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. All food that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected, or if permissible, treated or processed to eliminate the contamination.
Processes and Controls
- Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food shall be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.
- Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act. Compliance with this requirement may be verified by any effective means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.
- Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with current Food and Drug Administration regulations and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Compliance with this requirement may be accomplished by purchasing raw materials and other ingredients under a supplier's guarantee or certification, or may be verified by analyzing these materials and ingredients for aflatoxins and other natural toxins.
- Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall comply with applicable Food and Drug Administration regulations and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective means, including purchasing the materials under a supplier's guarantee or certification, or examination of these materials for contamination.
- Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the act. Material scheduled for rework shall be identified as such.
- Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the act.
- Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.
- Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.
- All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. One way to comply with this requirement is careful monitoring of physical factors such as time, temperature, humidity, aw, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food.
- Food that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, shall be held in a manner that prevents the food from becoming adulterated within the meaning of the act. Compliance with this requirement may be accomplished by any effective means, including:
- (i) Maintaining refrigerated foods at 45 °F (7.2 °C) or below as appropriate for the particular food involved.
- (ii) Maintaining frozen foods in a frozen state
- (iii) Maintaining hot foods at 140 °F (60 °C) or above
- (iv) Heat treating acid or acidified foods to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.
- Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the act.
- Work-in-process shall be handled in a manner that protects against contamination.
- Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food. Food transported by conveyor shall be protected against contamination as necessary.
- Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.
- Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.
- Food, raw materials, and other ingredients that are adulterated within the meaning of the act shall be disposed of in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it shall be reconditioned using a method that has been proven to be effective or it shall be reexamined and found not to be adulterated within the meaning of the act before being incorporated into other food.
- Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step.
- Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water used shall be safe and of adequate sanitary quality.
- Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. Compliance with this requirement may be accomplished by any effective means, including one or more of the following:
- (i) Using ingredients free of contamination.
- (ii) Employing adequate heat processes where applicable.
- (iii) Using adequate time and temperature controls
- (iv) Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them.
- (v) Cooling to an adequate temperature during manufacturing.
- (vi) Disposing of batters at appropriate intervals to protect against the growth of microorganisms.
- Filling, assembling, packaging, and other operations shall be performed in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any effective means, including:
- (i) Use of a quality control operation in which the critical control points are identified and controlled during manufacturing.
- (ii) Adequate cleaning and sanitizing of all food-contact surfaces and food containers
- (iii) Using materials for food containers and food- packaging materials that are safe and suitable
- (iv) Providing physical protection from contamination, particularly airborne contamination.
- (v) Using sanitary handling procedures.
- Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:
- (i) Monitoring the aw (water activity) of food.
- (ii) Controlling the soluble solids-water ratio in finished food.
- (iii) Protecting finished food from moisture pickup, by use of a moisture barrier or by other means, so that the aw of the food does not increase to an unsafe level.
- Food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:
- (i) Monitoring the pH of raw materials, food in process, and finished food.
- (ii) Controlling the amount of acid or acidified food added to low-acid food.
- When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.
- Food-manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.
21 CFR 110.80 e [51 FR 22475, June 19, 1986, as amended at 65 FR 56479, Sept. 19, 2000]
Warehousing and Distribution
- All stock shall be stored 18 inches from the wall and 5 inches off the floor.
- All stock shall be stored in a clean and dry environment.
- Finished goods, raw materials and quarantined damaged goods shall be stored separately.
- All stock shall be stored in an orderly manner and properly stacked to prevent damage.
- All partially used ingredient or packaging containers shall be properly resealed or covered to preclude contamination.
- All pallets, racks and shelving shall be clean and in good repair.
- All damaged finished product shall be disposed of in a timely manner.
- All stock shall be rotated on a first-in, first-out (FIFO) basis.
- Finished product, packaging material, equipment or ingredients will not be stored in close proximity to any chemicals, cleaning compounds, pesticides or odorous materials.
- All ingredients, packaging material and finished products shall be handled, stored or processed in such a manner as to assure a safe, wholesome and unadulterated product.
- All pesticides shall be stored in a locked area and separated from all ingredients, cleaning material, equipment/utensils and sanitizers.
- All sanitizers, cleaning compounds, and chemicals shall be stored separately from all ingredients, packaging material and finished product in such a manner as to prevent any contamination.
- There will be no flaking or peeling paint, static product, soil buildup, or rust on or above product zones.
- All product or product containers shall be adequately protected to preclude contamination.
- There will be no condensation above product zones.
- All conveyor belts in direct product contact shall be constructed of a non-toxic and non-absorbent material and shall be clean and in good repair.
- Lights shall be provided with adequate shielding to protect from breakage.
- Wood, cardboard or other absorbent materials shall not be used for product contact surfaces.
- Air used for conveying product or packaged materials shall be filtered, clean and oil-free.
- Glass will not be used in, above or near processing or ingredient areas.
- All gasket material will be non-toxic, non-absorbent and will be in good condition (not torn, frayed or deteriorated).
- Pressure cleaning/sanitizing shall not be conducted near, on or above product zones during processing or packaging.
- All tanks, vats and blenders shall be covered.
- No objectionable odors or abnormal odors shall be present.
- Rotten or spoiled food should be removed from all areas as they often result in objectionable odors and other food safety hazards.
- All strong chemical odors which could contaminate food shall be prevented.
- All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles.
- All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source.
- Chemical, microbial, or extraneous material testing procedures shall be used where necessary to identify failures or possible food contamination.
- All food that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected, or if permissible, treated or processed to eliminate contamination.
- Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food packaging materials are safe and suitable.
- Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function.
- Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, or refuse.
- When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food.
- Food transported by conveyor shall be protected against contamination as necessary.
- Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing and/or storage in a manner that protects against contamination.
- Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting, inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect against food contamination.
- Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food.
- Protection may be provided by adequate cleaning and sanitizing of food contact surfaces, and by using time and temperature controls at and between each manufacturing step.
- Filling, assembling, packaging, and other operations shall be performed in a way that food is protected from contamination.
- Food manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for contamination of the human food.
Defect Action Levels
Natural or unavoidable defects in food for human use that present no health hazard:
- Some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. The Food and Drug Administration establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action.
- Defect action levels are established for foods whenever it is necessary and feasible to do so. These levels are subject to change upon the development of new technology or the availability of new information.
- Compliance with defect action levels does not excuse violation of the requirement in section 402(a)(4) of the act that food not be prepared, packed, or held under unsanitary conditions or the requirements in this part that food manufacturers, distributors, and holders shall observe current good manufacturing practice. Evidence indicating that such a violation exists causes the food to be adulterated within the meaning of the act, even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, distributor, and holder of food shall at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.
- The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated within the meaning of the act, regardless of the defect level of the final food.
- A compilation of the current defect action levels for natural or unavoidable defects in food for human use that present no health hazard may be obtained upon request from the Center for Food Safety and Applied Nutrition (HFS-565), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
21 CFR 110.110 g [51 FR 22475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
GMP vs. SOP
GMPs are usually refer to practices and procedures performed by a food processor which can affect the safety of the food product. GMPs may refer to the people, equipment, process and the environment in the production process.
A Standard Operating Procedure is “established or prescribed methods to be followed routinely for the performance of designated operations or in designated situations.” SOPs may be thought of as one task that is performed in the production process.