Assuring quality of a manufactured product requires certain procedures and standards. In many industries, these procedures and standards are often referred to as Good Manufacturing Practices, or GMPs. The Food and Drug Administration (FDA) outlines Current food Good Manufacturing Practices, or CGMPs, in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110).
The FDA provides CGMPs to assure that food processors maintain sanitary conditions that minimize the risk of contamination by “hazardous” materials. We’ll cover what the FDA considers hazards in a future blog entry. But for now, we’ll focus on CGMPs.
So what aspects of a food processing operation should be controlled and monitored to assure they conform to CGMPs? Through working with food processors, we’ve found that just about every aspect of a food processing operation might come under scrutiny during an inspection — from the personal hygiene of the workers in the plant, to the equipment used to make the food products, to the processing facility itself.
The FDA outlines CGMPs in five subparts:
1. General Provisions
— Do you know the terminology that should be used in describing CGMPs? This first section provides guidelines. It also explains when to use “shall” versus “should” in differentiating between when compliance is necessary (“shall”) and when procedures and practices are directly related to unsanitary conditions as specified in Section 402(4)(a) (“should”). It also delineates plant and employee responsibilities with regard to personal hygiene. Food safety education is addressed as well as the need for supervisory personnel to ensure compliance.
2. Building and Facilities
— How should a facility be designed and maintained to help assure food safety? In this section, CGMPs are outlined for the maintenance of the grounds, including litter control, waste removal and treatment, and grounds maintenance and drainage. Plants should be designed and built to reduce the potential for contamination. Sanitary operations, facilities, and controls are also outlined.
— This section provides requirements and expectations for the design, construction, and maintenance of equipment and utensils to ensure sanitary conditions. But did you know it also includes an automatic control for regulating temperature or an alarm system to alert employees to significant change in temperature? Other requirements are general and intended to prevent contamination from any source.
4. Process and Controls
— How should a food processing facility keep sanitary conditions in check? This section of CGMPs addresses general sanitation and controls necessary to ensure that food is suitable for human consumption. It addresses the monitoring of physical factors (critical control points or CCPs), such as time, temperature, humidity, pH, flow rate, and acidification. Warehouse and distribution requirements are also included, requiring finished foods to be stored and distributed under conditions that protect against physical, chemical and microbial contamination. The container must also be protected from deterioration. This section also outlines very general requirements for warehousing and distribution.
5. Defect Action Levels
— There may be unsanitary circumstances that are simply inescapable. So how does the FDA address this? This last part allows the FDA to define maximum defect action levels (DALs) for a defect that is natural or unavoidable even when foods are produced under CGMPs (as covered in the sections above). These defects are not hazardous to health at low levels and include rodent filth, insects or mold. Those exceeding maximum DALs will be considered in violation.
We continue to appreciate the diligence our food processing customers demonstrate in following CGMPs to assure high-quality food products. What are your facility’s CGMPs, and how do you verify that your operation is in compliance? As you have gained experience in the industry, are there any types of required controls that surprised you? What other aspects of food processing do you think should be controlled that aren’t currently covered in regulations? We’d love to hear more about the policies and procedures that have been successful for you. And to learn more about food safety practices and CGMPs for food processing, check out our white paper, Understanding GMPs in Food Processing.