Five Types of GMPs for Food Processing

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

The FDA establishes CGMPs to guarantee that food processors maintain hygienic conditions, minimizing the risk of contamination by harmful substances. In a future post, we'll discuss what the FDA considers hazardous. For now, let's focus on CGMPs.

What aspects of a food processing operation should be regulated and monitored to ensure compliance with CGMPs? From the personal hygiene of plant workers to the equipment used in food production, nearly every detail can come under scrutiny during inspections. Our work with food processors has shown that almost every element of food processing could be examined.

The FDA details CGMPs across five main areas:

1. General Provisions

This section clarifies terminology and explains the difference between "shall" and "should," indicating when compliance is mandatory versus when practices relate to unsanitary conditions as outlined in Section 402(4)(a). It also covers employee and plant responsibilities regarding cleanliness, food safety education, and supervision to ensure adherence to standards.

2. Building and Facilities

How should a facility be structured and kept clean to support food safety? This section outlines expectations for maintaining grounds, including litter control, waste management, and drainage. It also discusses proper facility design to reduce contamination risks, along with sanitary operational guidelines.

3. Equipment

This section specifies requirements for designing, constructing, and maintaining equipment and utensils to uphold sanitary conditions. Did you know it also includes automatic temperature controls or alarms to notify staff of significant changes? Other requirements aim to prevent contamination from various sources.

4. Process and Controls

How can a food processing facility maintain sanitary conditions? This section covers general sanitation and necessary controls to ensure food is safe for consumption. It addresses monitoring critical control points like time, temperature, humidity, pH, flow rates, and acidification. It also includes warehouse and distribution rules, requiring finished food storage and transportation under protective conditions. Containers must remain undamaged. This section also sets broad requirements for warehousing and distribution.

5. Defect Action Levels

There may be unavoidable unsanitary situations. To handle this, the FDA defines maximum defect action levels (DALs) for non-hazardous defects that occur even under CGMP compliance. Examples include rodent droppings, insects, or mold. Exceeding these limits would result in violations.

We greatly admire the dedication of our food processing clients in adhering to CGMPs to produce high-quality food. What are your facility's CGMPs, and how do you confirm compliance? Have you encountered any unexpected controls while gaining experience? Are there other food processing elements you believe should be regulated but aren't yet? We'd love to hear about successful policies and procedures. For further insights into food safety practices and CGMPs, check out our white paper, Understanding GMPs in Food Processing.