Quality assurance in manufacturing is essential to ensure that products meet the required standards. In many industries, these standards are referred to 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). These guidelines help food processors maintain clean and safe conditions throughout the production process.
The FDA’s CGMPs are designed to minimize the risk of contamination by harmful substances. While we will explore what the FDA considers hazardous in a future post, our focus here is on understanding the key areas that need to be controlled and monitored to comply with CGMPs. From employee hygiene to equipment maintenance and facility design, nearly every aspect of a food processing operation can be inspected during an audit.
CGMPs are divided into five main sections:
**1. General Provisions**
This section defines key terms and clarifies when to use "shall" versus "should." It also outlines responsibilities for both the plant and employees, including personal hygiene, food safety training, and supervision to ensure compliance.
**2. Building and Facilities**
It provides guidance on how facilities should be constructed and maintained to prevent contamination. This includes proper grounds management, waste control, drainage, and sanitation practices.
**3. Equipment**
This part sets requirements for the design, construction, and upkeep of equipment to maintain hygienic conditions. It also includes specifications for temperature controls and alarm systems to monitor critical changes.
**4. Process and Controls**
Here, the FDA outlines general sanitation practices and controls necessary to ensure food is safe for consumption. It covers monitoring of critical control points like time, temperature, and pH, as well as storage and distribution conditions.
**5. Defect Action Levels**
Even under strict CGMPs, some defects may still occur. This section allows the FDA to set maximum allowable levels for unavoidable defects such as insect fragments or mold, which are not harmful at low levels.
At Vikan, we admire the commitment of our food processing clients in following these practices. How does your facility ensure compliance with CGMPs? Have you encountered any unexpected requirements during your operations? Are there other areas of food processing that should be regulated but aren’t currently covered? We’d love to hear about your experiences and best practices. For more information on food safety and CGMPs, check out our white paper: *Understanding GMPs in Food Processing.*
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