Five Types of GMPs for Food Processing

Ensuring the quality of manufactured goods involves specific procedures and standards. In numerous industries, these standards are commonly referred to as Good Manufacturing Practices, or GMPs. The Food and Drug Administration (FDA) outlines Current Good Manufacturing Practices, or CGMPs, in Title 21 of the Code of Federal Regulations, specifically in Part 110 (21 CFR 110).

The FDA establishes CGMPs to guarantee that food processors maintain hygienic conditions that reduce the risk of contamination from harmful substances. We'll explore what the FDA considers hazardous materials in a future post. For now, let's focus on CGMPs.

Which elements of a food processing operation should be regulated and monitored to ensure compliance with CGMPs? From the personal hygiene of workers to the machinery used in production and the facility itself, nearly every aspect can be scrutinized during inspections. Our experience working with food processors shows that maintaining these standards requires attention to detail across the entire operation.

The FDA breaks down CGMPs into five key areas:

1. General Provisions

This section introduces the terminology used to describe CGMPs and clarifies when to use "shall" versus "should." While "shall" indicates mandatory compliance, "should" highlights practices linked to unsanitary conditions as defined in Section 402(4)(a). It also covers employee responsibilities regarding cleanliness and emphasizes the importance of supervisory oversight to ensure adherence to these standards.

2. Building and Facilities

How should a processing facility be constructed and maintained to support food safety? This section specifies guidelines for maintaining the premises, including waste management and drainage systems. It also outlines the design principles for reducing contamination risks, along with expectations for sanitary operations and facilities.

3. Equipment

This section details the requirements for designing, building, and maintaining equipment to meet sanitary standards. Interestingly, it also includes provisions for automatic temperature controls and alarm systems to alert staff of critical changes. General requirements are in place to prevent contamination from various sources.

4. Process and Controls

How does a food processing facility maintain sanitary conditions? This section focuses on general sanitation measures and necessary controls to ensure food safety. It discusses monitoring critical factors like time, temperature, humidity, pH levels, and flow rates. Additionally, it covers warehouse and distribution protocols, emphasizing the protection of finished products from contamination. The packaging must also remain intact during storage and transport.

5. Defect Action Levels

Not all contaminants can be entirely eliminated, even under ideal conditions. To address this, the FDA sets maximum defect action levels (DALs) for unavoidable defects that pose no health risks at low concentrations. Examples include insect fragments or mold spores. Exceeding these levels could result in regulatory violations.

We continue to admire the dedication shown by our food processing clients in adhering to CGMPs. What steps does your facility take to comply with these regulations, and how do you verify ongoing compliance? Over time, some companies discover unexpected requirements that catch them off guard. Are there other aspects of food processing you believe deserve more attention in current regulations? Let us know what strategies have worked best for your business. To dive deeper into food safety practices, check out our white paper, Understanding GMPs in Food Processing.