Part 1: Introduction to Good Manufacturing Practices (GMPs) and Their Importance

One misstep in a food production facility can lead to costly recalls, damaged brand trust, and even consumer harm. That’s why Good Manufacturing Practices (GMPs) are more than regulatory checkboxes, they’re the foundation of food safety and operational success.

GMPs help food and beverage companies maintain consistency, prevent contamination, and comply with both regulatory and customer-driven standards like FSMA and GFSI. Whether you're managing raw ingredients, sanitation protocols, or documentation, GMPs keep everything aligned.

What Are Good Manufacturing Practices

Establishing, implementing, and maintaining GMP in food industry plants is an ongoing process that requires an in-depth and comprehensive approach. Here’s a closer look at how principles of GMP in food industry establishments can help plant management in the food industry thrive.

GMPs help manufacturers improve the production of their goods. When followed precisely, they promote consistency in procedures and products within a safe environment to reduce the risk of recalls, contamination, and profit loss.

While GMPs are primarily used in the food industry, they also apply in the production of: 

• Beverages

• Cosmetic products

• Pharmaceuticals

• Dietary supplements

• Medical devices

GMPs are all-encompassing in manufacturing; they cover every aspect of each process to prevent risks that could develop anywhere in the supply chain or manufacturing environment. Their goal is to maintain the integrity of products with sound operating procedures, ensuring the highest standards are met through every step from testing and development to storage. By following GMPs, food industry professionals can expect to mitigate contamination, testing failures, problems caused by environmental factors, and potentially harmful deviations.

The History of GMPs

To fully understand the importance of GMPs, it’s helpful to look at why they were developed. Prior to their existence, several noteworthy safety incidents in the U.S. were caused by food and medicine issues. The history of GMPs dates back to 1906, with many key milestones that have led to the practices we know today.

The Pure Food & Drug Act of 1906

According to The Mastery Institute, there were no federal regulations in place to protect consumers from dangerous products prior to the start of the 20th century. As industrialism accelerated, however, people were increasingly getting their food from remote sources instead of relying on local farmers. There was no control over preservatives or other toxic additives, and ice was the main method for the preservation of foods such as unpasteurized milk.

To measure the amounts of preservatives in the food and determine whether they had an impact on health, Dr. Harvey W. Wiley of the Department of Agriculture established the Poison Squad in 1903. It quickly raised awareness of the need for consumer safety measures.

Then, in 1906, Upton Sinclair’s The Jungle revealed a secret side of the meatpacking industry. The public’s response prompted Congress to establish the first Pure Food and Drug Act of 1906, which prevented interstate transport of unlawful food and drugs, implemented labeling requirements, and prohibited additives that would pose health hazards. While it was an important step for consumer safety, it also left room for risks.

The Elixir Sulfanilamide Toxin

In the 1930s, sulfanilamide was widely used to treat strep throat. While the drug was originally tested by manufacturer S.E. Massengill Company for flavor and appearance, it was shortly linked to death by kidney failure in more than 100 people, including many children. By 1938, the Federal Food, Drug, and Cosmetic Act was passed to require drug manufacturers to prove that a drug was safe before it could go to market. The FDA was given authority to inspect factories, and federal court injunctions became permissible when needed.

The Thalidomide Incident

Although thalidomide had been approved in Canada and Europe to treat morning sickness, DFA pharmacologist Frances Oldham Kelsey held off on approving an application from Richardson Merrill for the drug in the United States. After discovering that certain drugs could pass to babies through a mother’s placenta. She kept thalidomide off the market in the U.S., but many babies were born with deformities worldwide. In response to the incident, Congress passed the Drug Amendments of 1962 to tighten control over new drugs. While GMPs had been loosely in place since the FDA’s establishment, these amendments formalized them.

Many more laws have been introduced since 1962. For instance, in 1983, anti-tampering regulations were established after several Chicago residents died from taking Tylenol, which had been laced with cyanide. For this reason, it’s critical that food industry professionals stay up-to-date with new and developing GMPs to ensure public safety.

GMP Benefits

GMPs can provide several benefits for food manufacturers, including:

• Preventing foodborne illness: GMPs can help prevent foodborne illness by reducing the risk of contamination.

• Reducing product recalls: GMPs can help to reduce product recalls by identifying and addressing potential hazards before they cause problems.

• Improving customer satisfaction: GMPs can help to improve customer satisfaction by ensuring that food products are safe and of high quality.

• Increased profits: GMPs can help to increase profits by reducing the risk of lawsuits and fines.

Consumers often can't visually detect unsafe food products. Therefore, manufacturers bear the responsibility to ensure that products are safe and of high quality. Following GMPs helps to promote quality, ensuring safe products for mass distribution. This increases the likelihood of products being free of dangerous substances or contaminants that could cause harm to consumers.

GMPs can also help for compliance purposes, as regulatory bodies such as the FDA require the implementation of GMPs. For instance, GMPs are part of the FDA’s Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule, an aspect of FSMA that became final in 2015 and applies to nearly all food companies. 

There are many binding requirements of current GMPs (CGMPs), including:

• Qualification of employees who manufacture, process, pack, or hold food to perform their assigned duties

• Education, training, and/or necessary experience for employees to ensure the food they manufacture, process, pack, or hold is clean and safe, including training in the principles of food hygiene and food safety

• GMPs to address allergen cross-contact

• GMPs for holding and distributing human food by-products used for animal food

GMPs are also a key component in Global Food Safety Initiative (GFSI) schemes, a program with credentials that can help food companies attract or maintain customers and ensure the quality of their products.

Conclusion: What’s Next in GMP Mastery?

Understanding the "what" and "why" of GMPs is only the beginning. In Part 2: Practical Steps to Implement and Maintain GMPs, we’ll dive into actionable strategies to bring these practices to life in your facility. Learn how to integrate GMPs seamlessly into your operations, optimize compliance efforts, and unlock their full potential to safeguard your business and customers.

Stay tuned, your GMP journey is just getting started!