Every CPG manufacturer follows a basic set of guidelines during the production process. For U.S. food, beverage, and dietary supplements manufacturers, the rules they follow are Good Manufacturing Practices (GMPs) – or current Good Manufacturing Practices (cGMPs). They’re the U.S. Food and Drug Administration’s (FDA) formal regulations that govern the design, monitoring, and control of manufacturing processes and facilities.
The addition of “current” reminds manufacturers they must employ the latest technologies and systems to comply with these regulations. cGMPs are comprehensive to guard against catastrophic risks, such as cross-contamination, adulteration, and mislabeling. Implementing cGMPs can help cut waste and protect the company and consumers.
Complying with GMPs requires manufacturers to establish quality management systems, obtain high-quality raw materials, implement standard operating procedures, maintain detailed records and documentation, and find potential product quality problems.
FDA Regulation 21 CFR Part 111 for Supplement Makers
cGMPs are part of Title 21 CFR, which uses the phrase “current good manufacturing practices” to describe these guidelines. Since June 2007, a different set of cGMPs has applied to dietary supplement manufacturers, with additional supporting guidance issued in 2010.
This regulation stipulates that anyone who produces, packages, labels, or holds a dietary supplement must create and implement cGMPs to ensure the supplement’s quality. This ensures the identity, purity, quality, strength, and composition of dietary supplements, which is a major step in assuring consumers they’re buying the type and amount of ingredients declared on the label.
Regulations also mandate cGMPs before companies can implement Hazard Analysis Critical Control Point (HACCP) programs and include detailed systems and procedures that act as guidelines to educate employees about best practices to prevent, eliminate, or reduce food safety hazards.
Why are cGMPs so important?
They serve as the foundation of any food safety program and must be part of every step of the process, or the entire system is vulnerable. The Global Food Safety Initiative (GFSI) incorporates several food safety management schemes, such as the Foundation Food Safety System Certification 22000 (FSSC 22000), the British Retail Consortium (BRC), Industry and Financial Systems (IFS), and Safe Quality Food (SQF). These food safety schemes vary in scope, structure, standards, and popularity, but they all include the same comprehensive cGMP and HACCP plans.
cGMPs prepare employees to respond to equipment failures or product contamination. Since different categories and facilities are subject to different cGMPs, companies should adopt policies and procedures tailored to their operations and the host country’s production guidelines.
Implementing cGMPs in five step
- Research: Take the time to learn about the latest cGMP regulations in the country of each manufacturing facility and, if you’re exporting, be aware of the regulations in the export countries.
- Development: Write down what you do, including various elements and tools such as policies, standard operating procedures (SOPs), schedules, records, and logistics. Conduct a risk assessment and gauge the risk levels for possible hazards. Ensuring the program can reduce and eliminate significant hazards is crucial at this stage.
- Implementation: When rolling out cGMPs, companies should inform employees about policies and train them on procedures, corrective actions, and proper recordkeeping. Companies need to provide the necessary resources and tools for employees to carry out their assigned duties at this stage.
- Validation: It’s essential to validate the programs and procedures to confirm they meet the necessary guidelines and applicable standards. Companies need to verify the program is serving its intended purpose. CGMP validation should occur at initial and annual stages and whenever changes occur.
- Verification: When verifying cGMPs, companies must check procedures regularly to confirm they remain effective
cGMPs are daily activities to control hazards introduced by personnel, operations, and the environment. Employees can present hazards in various ways, including sneezing, illness, cuts, infections, dirty hands, clothes, etc. Following cGMP procedures will help prevent these hazards, such as, for example, following the hand washing and uniform-changing procedures before returning to the production area.
Environmental hazards can include a leaking roof, dirty or corroded equipment, non-potable water, pests, and poor ventilation.
Common Prerequisite Programs (PRPs)
Documentation and recordkeeping. cGMPs require documentation of all practices and activities. Proper documentation and recordkeeping are necessary for effective cGMP implementation. Companies should control and list records in a register to track document numbers, version history, issue date, approver, and locations.
Develop procedures with enough detail, so anyone unfamiliar with the operation could perform the job by reading them. Additionally, regulators consider records and completed forms legal documents. Therefore they need to be verified and retained based on the amount of time outlined in the applicable standards, customer standards, and shelf life.
Personnel practices. To consistently produce safe food and comply with food regulations, each employee, visitor, and contractor should abide by all company personnel practices. Companies should train employees on these practices when hired, annually as a refresher, and when guidelines change. Training alone is insufficient. There also must be regularly conducted checks, observations, and inspections.
Because contractors and other facility visitors can be a common source of biological, chemical, and physical contamination, companies need to set traffic patterns for employees and visitors to ensure movements don’t cause contamination. For example, you must indicate on a site map where employees should wash hands, change, and remove uniforms.
Sanitation. To effectively remove residues from detergents or allergens – facilities need a comprehensive system that focuses on every aspect of sanitation. A program should outline all policies for the most effective cleaning and sanitizing of rooms, utensils, equipment, and anything else associated with producing food products to avoid cross-contamination.
Furthermore, establish a master sanitation schedule, which includes everything that needs cleaning. These sanitation programs should be validated at the design stage, annually, or when any element has changed. It’s essential to check them before production begins.
Water potability. Use adequate potable water supplies drawn from clean sources as a processing aid, cleaning solution, ingredient, or to make ice. An adequate water potability control should test the water annually and every time a source or delivery system is changed. When tested, water should be examined for heavy metals, bacteria, pH levels, and turbidity, when applicable.
Programs should also include a water map to indicate distribution flows, holding tanks, treatment locations, recycling, and sampling points with treatment validation and color-coding.
Pest control. Design and implement a pest control program to ensure the safety and suitability of food throughout the plant. There should also be methods in place to verify and validate pest control programs. The less pest activity there is, the better the program.
Facility and building design. Control the facility’s construction, location, and plant surroundings to prevent contamination. Build facilities at locations isolated from neighboring buildings, farms, or factories that could threaten food safety and quality. The materials used in facilities in contact and non-contact food surfaces should follow local regulations. Inspect the walls, ceilings, drop ceilings, doors, and other building elements regularly to eliminate possible contamination.
Additionally, companies should have a drain map identifying the drains and detailing wastewater flow through the facility.
Equipment and preventive maintenance (PM). All equipment should be assembled and installed according to sanitary design principles, coupled with PM and calibration schedules. A well-designed PM program will reduce the frequency of regular maintenance and cut emergency repairs by prolonging equipment lifespan. Rather than waiting for emergency repairs, design the PM program to anticipate issues, thus reducing downtime and saving money.
Receiving, storing, and shipping. Monitor everything that comes into a facility from the moment it hits the receiving dock to the moment it leaves. Employees should store all materials and products under sanitary and proper environmental conditions and in designated areas within the facility. However, requirements for storage vary depending on the type, nature, and temperature of the commodity.
For transportation, companies should have a mandatory freight questionnaire filled out before any contract is signed. This helps ensure the truck used is for food only.
Allergen identification, management, and communication are critical and must comply with regulations where the products are made and sold. This means companies need to be aware of the export market’s regulations.
Recalls. All raw materials and products should be lot-coded with recall systems in place. A fast and efficient recall procedure is essential to secure unsafe products quickly. Conduct mock recalls as needed to ensure the plan is sufficient.
Training and other document management
Employees should receive cGMP and role-specific training and set general and technical education requirements in the register. Organizations that meet cGMPs and commit to a program will substantially increase the product quality.
TraceGains has a robust suite of solutions to help manufacturers maintain cGMP compliance while streamlining and automating business processes. For more information, download our eBook “Ten Components of a Strong Good Manufacturing Program.”