Quality assurance in manufacturing is essential to ensure that products meet the required standards and are safe for consumers. In many industries, these standards are known as Good Manufacturing Practices (GMPs). Specifically, the U.S. Food and Drug Administration (FDA) has established Current Good Manufacturing Practices (CGMPs) for food production, outlined in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110).
The FDA developed CGMPs to help food processors maintain clean and sanitary conditions, reducing the risk of contamination from harmful substances. While we’ll explore what the FDA considers hazardous in a future post, this article will focus on the core requirements of CGMPs.
Every part of a food processing operation can be inspected during an audit — from employee hygiene and equipment maintenance to facility design and storage conditions. To ensure compliance, the FDA outlines five key subparts of CGMPs:
**1. General Provisions**
This section defines key terms and explains the use of "shall" versus "should" in regulatory language. It also sets expectations for personal hygiene, food safety training, and the role of supervisors in enforcing standards.
**2. Building and Facilities**
Facility design plays a critical role in food safety. This subpart covers grounds maintenance, waste management, drainage, and the overall structure of the plant to minimize contamination risks.
**3. Equipment**
Equipment must be designed, built, and maintained to prevent contamination. This includes temperature controls and alarm systems to monitor critical conditions. The goal is to ensure all tools and machinery support a hygienic environment.
**4. Process and Controls**
This section outlines the need for monitoring critical control points (CCPs), such as temperature, time, and humidity, to ensure food remains safe. It also addresses warehouse and distribution practices to protect products from contamination during storage and transport.
**5. Defect Action Levels**
Some defects are unavoidable even under strict CGMPs. The FDA allows for maximum defect action levels (DALs) for non-harmful contaminants like insect fragments or mold. Products exceeding these limits may be considered non-compliant.
At Vikan, we value the commitment our customers show in following these guidelines to deliver high-quality, safe food products. We’re always interested in hearing about your experiences with CGMPs — which controls have been most impactful? Are there areas you think should be addressed more closely? Share your insights and let us know how you ensure compliance in your operations. For more information on food safety and GMPs, check out our white paper, *Understanding GMPs in Food Processing*.
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