No Other Way
CGMPs in CFR 21 Part 117 In 21 CFR Part 117, FDA established a CGMP regulation as part of the “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food” rule.
Part 117 establishes requirements for CGMPs and for hazard analysis and risk-based preventive controls for human food (PCHF) and related requirements.
Generally, domestic and foreign food facilities that are required to register with FDA by Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must comply with the requirements for risk-based preventive controls in Part 117 (unless an exemption applies). The modernized CGMPs generally apply to establishments that manufacture, process, pack, or hold food and apply to some activities that are exempt from the preventive controls requirements, such as juice and seafood processing.
HACCP: What is it? HACCP stands for Hazard Analysis and Critical Control Point system. The FDA defines it as “a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.” From growing food on farms to manufacturing it to eating food in a restaurant, HACCP is meant to provide guidance all along the food chain.
As of 4/23/13 Federal legislations require all schools and residential facilities participating in the National School Lunch Program and National School Breakfast Program to implement a HACCP food safety program. In addition, each school/residential facility must have at least two food safety inspections per year.
What is the ISO? The International Organization for Standardization is an independent, non-governmental organization, whose membership consists of different national standards bodies.[9] As of 2022, there are 167 members representing ISO in their country, with each country having only one member.[8] The organization develops and publishes international standards in all technical and nontechnical fields other than electrical and electronic engineering, which are the responsibility of the International Electrotechnical Commission.[7] As of 2023, the ISO has developed over 24,676 standards, covering everything from manufactured products and technology to food safety, agriculture, and healthcare.[8][10] ISO has 804 technical committees and subcommittees concerned with standards development.[
21CFRPart 117, sub paragraph B 117.80
Raw materials, other ingredients, and rework must be held in bulk, or in containers designed and constructed so as to protect against allergen cross-contact and against contamination and must be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework must be identified as such.
117.80 Processes and controls.
(a) General.
(1) All operations in the manufacturing, processing, packing, and holding of food (including operations directed to receiving, inspecting, transporting, and segregating) must be conducted in accordance with adequate sanitation principles.
(2) Appropriate quality control operations must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable.
(3) Overall sanitation of the plant must be under the supervision of one or more competent individuals assigned responsibility for this function.
(4) Adequate precautions must be taken to ensure that production procedures do not contribute to allergen cross-contact and to contamination from any source.
(5) Chemical, microbial, or extraneous-material testing procedures must be used where necessary to identify sanitation failures or possible allergen cross-contact and food contamination.
(6) All food that has become contaminated to the extent that it is adulterated must be rejected, or if appropriate, treated or processed to eliminate the contamination.
(b) Raw materials and other ingredients.
(1) Raw materials and other ingredients must be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and must be stored under conditions that will protect against allergen cross-contact and against contamination and minimize deterioration. Raw materials must be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food must be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not cause allergen cross-contact or increase the level of contamination of the food.
(2) Raw materials and other ingredients must either not contain levels of microorganisms that may render the food injurious to the health of humans, or they must be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated.
(3) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins must comply with FDA regulations for poisonous or deleterious substances before these raw materials or other ingredients are incorporated into finished food.
(4) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material must comply with applicable FDA regulations for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food.
(5) Raw materials, other ingredients, and rework must be held in bulk, or in containers designed and constructed so as to protect against allergen cross-contact and against contamination and must be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework must be identified as such.
(6) Frozen raw materials and other ingredients must be kept frozen. If thawing is required prior to use, it must be done in a manner that prevents the raw materials and other ingredients from becoming adulterated.
(7) Liquid or dry raw materials and other ingredients received and stored in bulk form must be held in a manner that protects against allergen cross-contact and against contamination.
(8) Raw materials and other ingredients that are food allergens, and rework that contains food allergens, must be identified and held in a manner that prevents allergen cross-contact.
(c) Manufacturing operations.
(1) Equipment and utensils and food containers must be maintained in an adequate condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment must be taken apart for thorough cleaning.
(2) All food manufacturing, processing, packing, and holding must be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food.
(3) Food that can support the rapid growth of undesirable microorganisms must be held at temperatures that will prevent the food from becoming adulterated during manufacturing, processing, packing, and holding.
(4) Measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms must be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated.
(5) Work-in-process and rework must be handled in a manner that protects against allergen cross-contact, contamination, and growth of undesirable microorganisms.
(6) Effective measures must be taken to protect finished food from allergen cross-contact and from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they must not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in allergen cross-contact or contaminated food. Food transported by conveyor must be protected against allergen cross-contact and against contamination as necessary.
(7) Equipment, containers, and utensils used to convey, hold, or store raw materials and other ingredients, work-in-process, rework, or other food must be constructed, handled, and maintained during manufacturing, processing, packing, and holding in a manner that protects against allergen cross-contact and against contamination.
(8) Adequate measures must be taken to protect against the inclusion of metal or other extraneous material in food.
(9) Food, raw materials, and other ingredients that are adulterated:
(i) Must be disposed of in a manner that protects against the contamination of other food; or
(ii) If the adulterated food is capable of being reconditioned, it must be:
(A) Reconditioned (if appropriate) using a method that has been proven to be effective; or
(B) Reconditioned (if appropriate) and reexamined and subsequently found not to be adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act before being incorporated into other food.
(10) Steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming must be performed so as to protect food against allergen cross-contact and against contamination. Food must be protected from contaminants that may drip, drain, or be drawn into the food.
(11) Heat blanching, when required in the preparation of food capable of supporting microbial growth, must 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. Growth and contamination by thermophilic microorganisms in blanchers must be minimized by the use of adequate operating temperatures and by periodic cleaning and sanitizing as necessary.
(12) Batters, breading, sauces, gravies, dressings, dipping solutions, and other similar preparations that are held and used repeatedly over time must be treated or maintained in such a manner that they are protected against allergen cross-contact and against contamination, and minimizing the potential for the growth of undesirable microorganisms.
(13) Filling, assembling, packaging, and other operations must be performed in such a way that the food is protected against allergen cross-contact, contamination and growth of undesirable microorganisms.
(14) Food, such as dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies principally on the control of aw for preventing the growth of undesirable microorganisms must be processed to and maintained at a safe moisture level.
(15) Food, such as acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms must be monitored and maintained at a pH of 4.6 or below.
(16) When ice is used in contact with food, it must be made from water that is safe and of adequate sanitary quality in accordance with § 117.37(a), and must be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.
Preventive Controls
117.135 Preventive controls.
(a)
(1) You must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act. (2) Preventive controls required by paragraph (a)(1) of this section include:
(i) Controls at critical control points (CCPs), if there are any CCPs; and
(ii) Controls, other than those at CCPs, that are also appropriate for food safety.
(b) Preventive controls must be written.
(c) Preventive controls include, as appropriate to the facility and the food:
(1) Process controls. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing, acidifying, irradiating, and refrigerating foods. Process controls must include, as appropriate to the nature of the applicable control and its role in the facility's food safety system:
(i) Parameters associated with the control of the hazard; and
(ii) The maximum or minimum value, or combination of values, to which any biological, chemical, or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process control.
(2) Food allergen controls. Food allergen controls include procedures, practices, and processes to control food allergens. Food allergen controls must include those procedures, practices, and processes employed for:
(i) Ensuring protection of food from allergen cross-contact, including during storage, handling, and use; and
(ii) Labeling the finished food, including ensuring that the finished food is not misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
(3) Sanitation controls. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards. Sanitation controls must include, as appropriate to the facility and the food, procedures, practices, and processes for the:
(i) Cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment;
(ii) Prevention of allergen cross-contact and cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product.
(4) Supply-chain controls. Supply-chain controls include the supply-chain program as required by subpart G of this part. (5) Recall plan. Recall plan as required by § 117.139.
(6) Other controls. Preventive controls include any other procedures, practices, and processes necessary to satisfy the requirements of paragraph (a) of this section. Examples of other controls include hygiene training and other current good manufacturing practices.
What is a Critical Control point:
Critical Control Point (CCP) is the point where the failure of a Standard Operation Procedure (SOP) could cause harm to customers and to the business, or even loss of the business itself. It is a point, step, or procedure at which controls can be applied and a food safety hazard can be prevented, eliminated, or reduced to acceptable (critical) levels.
Our “Food Fence” is the only known contrivance devised specifically to impede “cross contact” at that vital final point of service (CCP) in a cafeteria, buffet, or food court, when the server or self-service clientele unintentionally(often unknowingly, spills an allergen bearing a particle into a neighboring menu item.
Cross-contact happens when one food comes into contact with another food, and their proteins mix. As a result, each food then contains small amounts of the other food. These amounts are so small that they usually can’t be seen. Even this tiny amount of food protein has caused reactions in people with food allergies! The term “cross-contact” is fairly new. Mistakenly, some people may call this “cross-contamination.”
Due to the likelihood of cross-contact, buffets are a high-risk choice for a guest who has a food allergy.
Our “Food Fence” is the only known tool engineered to impede “cross contact” at that vital final point of service in a cafeteria, buffet, or food court, when the server or self-service clientele unintentionally(often unknowingly, spills an allergen bearing a particle into a neighboring menu item.