Introduction to Good Manufacturing Practices (GMPs): What You Need to Know

Posted by Denis Storey on March 17, 2020 at 2:32 PM

Introduction to Good Manufacturing Practices (GMPs)- What You Need to Know v2Every manufacturer in consumer-packaged goods follows a basic set of rules when making their products. For food, beverage, and dietary supplement manufacturers in the United States, those rules are known as 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. Every aspect of the manufacturing process is examined and covered by CGMPs to guard against catastrophic risks, such as cross-contamination, adulteration, and mislabeling. Implementing CGMPs can help reduce waste and protects both the company and consumer from negative food, beverage, or supplement safety events.

Complying with CGMPs requires manufacturers to establish quality management systems, obtain high-quality raw materials, implement standard operating procedures, maintain detailed records and documentation, and find potential problems with product quality.

CGMPs are enforced under Title 21 CFR, which uses the phrase “current good manufacturing practices” to describe these guidelines. Since June 2007, a different set of CGMPs have applied to dietary supplement manufacturers, with additional supporting guidance issued in 2010.

FDA regulation 21 CFR part 111 for supplement manufacturers:

  • Requires certain activities in manufacturing, packaging, labeling, and holding of dietary supplements to ensure that a dietary supplement contains what it is labeled to contain and is not contaminated with harmful or undesirable substances such as pesticides, heavy metals, or other impurities.

  • Requires certain activities that will ensure the identity, purity, quality, strength, and composition of dietary supplements, which is a significant step in assuring consumers they’re purchasing the type and amount of ingredients declared on the label.

CGMPs are required before companies can implement Hazard Analysis Critical Control Point (HACCP) programs. They’re designed as detailed systems and procedures that include guidelines to educate employees about best practices to prevent, eliminate, or reduce food safety hazards. So why are CGMPs so important? Form 483s

They serve as the foundation of any food safety program and if they’re not engrained into every step of the process, the whole system is vulnerable. More recently, the Global Food Safety Initiative (GFSI) has recognized several food safety management schemes that meet internationally recognized food safety requirements, 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.

With CGMPs in place, employees are better prepared to handle situations such as equipment breakdowns, damages, or product contamination. Since different categories and facilities are subject to different CGMPs, companies should adopt policies and procedures tailored to their operations, as well as to the host country’s production guidelines.

So how do companies successfully implement CGMPs?

Successfully Implementing CGMPs

The launch and maintenance of CGMPs are broken down into five stages.

  1. Research: Take the time to learn about the latest CGMP rules and laws in the country of each manufacturing facility and, if you’re exporting, be aware of the rules in the export countries.

  2. 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 find the risk levels for possible hazards. Ensuring the program can reduce and eliminate significant hazards is crucial at this stage.

  3. Implementation: When rolling out your CGMPs, employees should be informed of the policies and trained on procedures, corrective actions, and proper recordkeeping. In this stage, companies need to provide the necessary resources and tools for employees to carry out their assigned duties.

  4. Validation: It’s important 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. All CGMPs should be validated at the initial and annual stages, as well as whenever changes occur.

  5. Verification: When verifying CGMPs, companies must regularly verify procedures to confirm continued effectiveness.

CGMPs are daily activities set in place to control hazards introduced by personnel, operations, and the environment. Employees can introduce hazards in a variety of ways that include sneezing, illnesses, cuts, infections, dirty hands and 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, among others.

Common Prerequisite Programs (PRPs)

Documentation and Recordkeeping

CGMPs require all practices be documented and activities recorded. Proper documentation and recordkeeping are necessary for effective CGMP implementation. Documents and records should be controlled and listed in a register to track document numbers, version history, issue date, approver, and locations, among other elements.

Procedures should be developed with enough detail so anyone unfamiliar with the operation could perform the job by reading the procedures. Additionally, records, completed forms, or information produced from following a procedure are considered legal documents, therefore they need to be verified and retained based on the amount of time outlined in the applicable standards, customer standards, or shelf life, plus an additional year.

Personnel Practices

To consistently produce safe food and comply with food regulations, each employee, visitor, and contractor should abide by all company personnel practices. Employees should be trained on these practices when they’re hired, annually as a refresher, and when guidelines change. Training alone is insufficient. There must also 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, it must be indicated on a site map where employees should wash hands and change and remove uniforms.

Sanitation

To effectively remove residues – whether 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 products to avoid cross-contamination.

Furthermore, a master sanitation schedule should be established which includes everything that needs to be cleaned.

These sanitation programs should be validated at the design stage, annually, when any element has changed and should always be checked before production.

Water Potability

Adequate potable water supplies drawn from a known clean source should be used as a processing aid, cleaning solution, ingredient, or to make ice.

An effective water potability control should test the water at least annually as well as 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 (if applicable), and sampling points with treatment validation and color-coding for non-potable pipes.

Pest Control

A pest control program should be designed and implemented 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

The facility construction, location, and plant surroundings should all be controlled to prevent contamination. Facilities should be built at locations isolated from neighboring buildings, farms, or factories that could negatively affect the safety and quality of the food produced.

The materials used in facilities in contact and non-contact food surfaces should follow local regulations. The condition of the walls, ceilings, drop ceilings, doors, and other building elements should be inspected 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 significantly reduce the frequency of regular maintenance and reduce emergency repairs by prolonging the lifespan of all equipment. Rather than waiting for emergency repairs, the PM program should be designed to anticipate issues, thus reducing downtime and saving money.

Receiving, Storing, and Shipping

Everything that comes into a facility needs to be monitored from the moment it hits the receiving dock to the moment it leaves.

All materials and products should be stored under both sanitary and proper environmental conditions (temperature, humidity) and in designated areas within the facility, which should also be listed on the site map. However, conditions 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, and that no metals, chemicals, or other materials, such as glass, are carried in the same truck.

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 so that traces and recalls can be completed rapidly should product retrieval be necessary. A fast and efficient recall procedure is essential to quickly secure unsafe products. Conduct mock recalls as needed to ensure the plan is sufficient.

Employees should receive CGMP training as well as role-specific training. General and technical training requirements should be set in the training register.

Organizations that meet CGMPs will not only comply with the legislation, but also commit to a program that will substantially increase the quality of their products as well as revenues and customer satisfaction.

TraceGains has a robust suite of solutions to help food, beverage, and dietary supplement manufacturers maintain compliance with CGMPs while streamlining and automating business processes throughout operations. For more information about building a strong CGMP program, download our complimentary eBook today.

Tags: GFSI, GMP, FSSC 22000, IFS 22000