Having a good food safety program is key to food business success. Yet, it’s hard to know where to start with creating your plans and documents. The FDA’s Good Manufacturing Practices (GMPs) are a set of standards that regulate food safety. They serve as a model for creating a successful food safety plan.
The GMPs are not comprehensive, but they identify key risks that may exist in your process and show how you and your team can control them.
Beyond their value in shaping food safety plans, GMPs are regulated and inspected by the FDA. Even if you are a small producer, the FDA can inspect you on your GMPs. Therefore, it’s extra important that your food safety processes are in compliance.
The GMPs contain five main areas of focus. In this blog post, we will discuss those areas and their importance, and share the value of GMPs for your food safety plan overall.
Good Manufacturing Practices 5 Areas of Focus
The FDA has organized the Good Manufacturing Practices into five areas of focus. These areas each address a part of the food production and storage process. The overall goal of the GMPs is to keep hazards out of the finished product.
Designing a food safety plan that addresses each of these areas of focus will ensure you are adhering to the GMPs. It will also guarantee that you are keeping your product as food safe as possible.
These are the five areas of focus covered in the FDA GMPs:
1. General Provisions
This section outlines the expectations for people who produce the food. It outlines the responsibilities of the business owners and management regarding when people can be allowed to work after illness. It also details personal hygiene requirements and the expectations around food safety training.
Example from the GMP regulations: Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food
2. Buildings and Facilities
This section contains requirements for the physical space where the food is produced. It includes expectations around the layout, facilities, and cleaning practices necessary to ensure a safe environment.
Example from the GMP regulations: The plant and facilities shall: Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact.
3. Equipment
This section explains the expectations around keeping equipment safe and sanitary. In particular, it covers controls for regulating temperatures and notifying employees if they fluctuate too much.
Example from the GMP regulations: Seams on food-contact surfaces shall be smoothly bonded or maintained to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms.
4. Production and Process Controls
This section discusses the sanitation processes that need to be in place to keep food safe. It also covers how to prevent contamination during post-production storage and distribution.
Example from the GMP regulations: Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed 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.
5. Defect Action Levels
This section acknowledges that sometimes foods that are produced safely still contain low levels of natural or unavoidable defects that are not hazardous to health. It defines the maximum allowed levels of defects such as insects, rodent filth, and mold. The FDA still expects these levels to be as low as possible and provides guidance on how to manage them.
Example from the GMP regulations: 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.
Together, these focus areas show how to safely operate a food safe production facility. For more information about the specifics contained within each of the focus areas, refer to this FDA resource.
Why the Good Manufacturing Practices are Valuable
The Good Manufacturing Practices are an invaluable tool for food safety, both for new processors and existing food facilities.
If you are just starting to produce at scale, the GMPs are a great template for creating a food safety plan. Make sure you cover all the areas discussed above to give you a strong, comprehensive food safety plan. If you have an SOP that documents how you will carry out each process, you will be in compliance with the regulations.
In particular, the GMPs are valuable because they cover personnel requirements and detail what to do in the case of bacteria cross contamination and allergen cross contact.
Most bacterial and viral food contamination is caused by the people making the food. The GMP guidance on personal health and hygiene, and instructions on behavior help you control that risk.
Cross contact is a big issue for allergens. Nearly a third of food recalls are because an allergen was not listed on the label. The GMPs clearly outline how to prevent cross contact between allergens and what to do if an allergen gets into a food. If you can catch this before the allergen ends up in the final product, you save on the cost of having a recall due to misbranding and you protect your consumer.
It’s important to show buyers and auditors you are continually improving your food safety program. Thus, even established businesses with great food safety plans benefit from reviewing the GMPs regularly. Often looking at the guidelines will help you identify and eliminate inefficiencies in your own procedures.
The GMPs are one of the best food safety tools the FDA provides. Whether you are just getting into business or have been producing food for years, reviewing the GMPs and using them to inform your SOPs and food safety plan will ensure you are adhering to FDA regulations, producing safe food, and protecting your consumers.