eBook

Nine Components of a Strong Good Manufacturing Program

The U.S. Food and Drug Administration (FDA) created Good Manufacturing Practices (GMPs) to ensure various products intended for human consumption and use are safe and effective. The FDA enforces GMPs through its Current Good Manufacturing Practices (cGMP) provisions and covers a broad range of industries, including cosmetics, food, medical devices, and prescription drugs. These regulations contain minimum requirements for methods, facilities, and controls used in the manufacturing, processing, testing, and packaging of products.

Failure to comply with GMPs can lead to a product recall or seizure, regulatory fines, and serious legal consequences. GMPs are designed as detailed programs and procedures to instruct employees on proper practices to prevent, eliminate, or reduce safety hazards. They clearly define manufacturing processes and controls to ensure manufacturers produce goods to specifications. If any alterations or circumstances affect production, the product must be analyzed and checked for quality. If product quality suffers, employees should discard it.

Good Manufacturing Practices (GMPs) are considered the foundation of any food safety program since they provide the necessary environmental and operating conditions to produce high quality and safe foods.

It’s essential to any food safety plan that companies have strong GMP programs in place. With adequately implemented GMP programs, plant employees can handle situations such as equipment breakdowns, damage, or production line contaminations. Since different categories require different GMP regulations, each company should adopt policies and procedures specific to its operations and where companies sell their products.

The nine components of a robust GMP program include:

1. Building and Facility Design and Management

2. Equipment and Preventive Maintenance

3. Personnel Practices

4. Sanitation Programs

5. Receiving, Storage, and Shipping

6. Implementation, Validation, and Verification Processes

7. Allergen Control Program

8. Recall and Traceability Systems

9. Documentation and Recordkeeping

So, how do you get started? We’ve outlined how companies can guarantee their business builds and maintains a reliable GMP program.