The Role of GMP in The Food Industry
Eric Hansen
Good Manufacturing Practices (GMP) are more than just industry regulations – they are the cornerstone of success for food and beverage companies. Their role in food industry success is critical—they help food and beverage companies maintain food safety and quality while increasing their productivity. All relevant food legislation, including the FDA’s Food Safety Modernization Act (FSMA), emphasizes these practices, including customer certification requirements.
Good Manufacturing Practices Contextualized
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.
GMP Benefits
GMPs can provide a number of benefits for food manufacturers, including:
Preventing foodborne illness: GMPs can help to 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 high-quality.
Increased profits: GMPs can help to increase profits by reducing the risk of lawsuits and fines.
Because consumers can’t always tell whether food products are safe just by looking at them, manufacturers have a tremendous responsibility to provide safe, quality goods to the public. 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 which 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.
GMP Development: A Timeline
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 were 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 that 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.
Good Manufacturing Practices Guidelines
While every food safety plan should be robust enough to include detailed steps for minimizing risks, there are a few basic GMP principles under which many of these tactics can be categorized. Here is a loose outline of operational conditions and procedures included in the FDA’s recommendations for current GMPs:
Proper maintenance, layout, and operation of food processing facilities
Proper maintenance of equipment and utensils
Sanitation processes and controls necessary to ensure food is suitable for human consumption, which includes:
Protection against physical, chemical, and microbial contaminants
Monitoring of critical control points like humidity, pH, flow rate, time, and temperature
Protection against natural defects, including a pest control program
Avoidance of foreign materials such as glass, metal, and plastic in finished products
In addition to these overarching guidelines, GMPs can also be broken down further, as outlined below.
What Are the Five Main Components of Good Manufacturing Practices?
GMPs in food industry establishments should focus on the five main categories below.
People
The foundation of any strong GMP program is people. If the individuals on the plant floor (and those in managerial roles) aren’t properly trained, they can’t be expected to implement processes and procedures effectively. Therefore, food companies must invest in training, so employees know GMP quality control standards and how to carry them out. It cannot be a “one and done” activity. However, training methods should be assessed and reassessed regularly.
Premises
Having a clean, safe environment is essential in food manufacturing, where products routinely come into contact with surfaces. The premises should be designed in a way that allows for effective cleaning and a reduced risk of cross-contamination.
In the food industry, “premises” also refers to equipment. All machines should be validated and calibrated, and there should be procedures, schedules, and records in place for cleaning and maintenance.
Processes/Paperwork
GMP processes refer to the documentation that proves that procedures are followed. Auditors will use this documentation to check facilities and ensure GMP procedures are being carried out effectively. Therefore, thorough documentation can benefit food manufacturers, though it certainly doesn’t have to mean keeping binders, notebooks, or other handwritten paperwork. In fact, digitizing your GMPs with plant management software can simplify your approach by ensuring all employees have access to pre-op and sanitation programs at their fingertips, record sign-offs can be completed easily in one convenient platform, and food safety checks can be carried out and reviewed for thorough recordkeeping.
Products & Primary Materials
Among the most important aspects of food manufacturing are products and primary materials. Products refer to the end goods sold to customers, such as retailers and restaurants, which will ultimately reach the consumer. Primary materials, on the other hand, are raw or semi-processed ingredients. If primary materials aren’t properly inspected prior to entering production, dangerous products could wind up on the market. GMPs must therefore incorporate quality tactics to monitor for and address deviations in incoming materials.
Procedures
Procedures themselves must be closely analyzed, updated routinely, and implemented effectively. They must also be well-documented so that if a problem occurs, it can be quickly and easily traced to the course through measures such as root cause analysis.
What Are the 10 Principles of GMP?
Principles of GMP in food industry establishments can be broken down into ten key components:
1. Write detailed, step-by-step procedures
The first step of GMPs is to establish detailed, step-by-step standard operating procedures (SOPs) in writing. These will act as a roadmap for consistent performance. Written procedures also allow workplace standards to be established and ensure that tasks are performed the same way each time.
2. Follow established procedures
Written SOPs are only as effective as the people who perform them. To that end, it’s important that employees know not to take any shortcuts, make modifications, or deviate from written instructions in any way. Again, the goal is to achieve a consistent, high-quality product.
3. Document everything
Timely and accurate documentation promotes regulatory compliance and also ensures any issues can be traced to the source. Accurate recordkeeping also provides a way to evaluate issues to prevent them from happening again. Moreover, records are required for audits, so having an effective documentation system ensures that all of your necessary records will be easily accessible.
4. Validate the SOPs and specs
To make sure SOPs work as they should, you must validate your processes. This is also achieved through routine documentation and precise following of written procedures. When performed consistently, these activities ensure a quality and consistent output is achieved.
5. Integrate quality and safety into equipment and facilities
Productivity, quality, and safety should be incorporated into the design and construction of food manufacturing facilities and equipment. This prioritizes quality and consistency at every processing step.
6. Maintain equipment and facilities
A number of maintenance activities must be performed on equipment and facilities consistently. Records should be kept to back up the work performed. This reduces safety concerns and mitigates quality control issues.
7. Establish, develop, and demonstrate job competence
Job competency should be demonstrated by every team member. GMP requires employees to be thoroughly competent in their roles, but note that competency may mean different things to different people. For this reason, competency should be defined for every role so employees know exactly what’s expected of them.
8. Ensure cleanliness
Protect products against contamination by making sanitization efforts routine tasks. Different products will call for specific degrees of cleanliness, so outline necessary steps and implement checks for each zone in the facility.
9. Build quality into the product
Systematic quality control of components and processes should be implemented in every step of production, from packaging and labeling to any cooking or handling processes. Set clearly defined controls and keep clear records to ensure quality is consistent. You can even automate some aspects of your quality control program with tactics such as real-time statistical process control (SPC) that can help you identify and correct non-conformances quickly with real-time data capture and specification verification.
10. Conduct audits.
While you can perform checks in your own facility to verify that GMPs are working effectively, having a fresh set of eyes can uncover inefficiencies or other areas of opportunities internal parties may have overlooked. Audits are therefore an essential aspect of both GMP success and regulatory compliance.
What Are Examples of Good Manufacturing Practices?
Implementing GMPs may look different for every company and perhaps for even different plant locations. With that in mind, here are some examples of GMPs in food industry facilities you might consider implementing in your own plant.
A robust hygiene program that identifies and eliminates potential sources of contamination
A thorough maintenance schedule for equipment and facilities, including preventive activities
Detailed job descriptions that clearly define employees’ roles
A system for investigating and addressing complaints and following through to resolution
A clear documentation strategy which might include best practices such as:
Documents should not be handwritten
Documents must be routinely reviewed and updated
Documents must be approved, signed, and dated by the appropriate party
Any modifications or corrections to documents must be signed and dated
Whenever possible, photographs should accompany documents indicating an observed issue
Inspections that are performed routinely to monitor GMP effectiveness
Audit checklists that can outline GMP guidelines
In Conclusion
Establishing, implementing, and routinely performing GMPs is an extensive undertaking. Yet, it’s among the most important things any food and beverage facility can do to ensure safe, consistent products and compliance. By adhering to the five components and ten principles of GMPs outlined above, you can ensure every aspect of your manufacturing process is designed to mitigate food safety events.
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