A Crash Course in Good Manufacturing Practices

Manufacturers are required to follow an abundance of rules and regulations that can become overwhelming. Good manufacturing practices, or GMP, are a set of regulations that may appear to add to that list, but these important safety measures protect your customers and encourage manufacturers to improve their product quality.

This handy guide will give you an overview of what GMPs are, why they’re important, what guidelines are included in GMPs, and how to best integrate GMPs into your daily processes.

What is GMP?

GMP stands for Good Manufacturing Practices. GMPs set regulations for consistent production and quality control. They’re most often thought of in relation to food safety, but these standards are also enforced in the manufacturing process for medical devices, healthcare, medicinal products, pharmaceutical products, food and drink, drug products, dietary supplements, and more. The specific regulations differ between industries, but the ultimate goal for GMPs remains the same: to keep consumers safe and ensure consistent product quality from manufacturers.

GMP is sometimes referred to as cGMP, or Current Good Manufacturing Practices, because utilizing up-to-date equipment and technology is imperative to achieving safety and quality standards set by GMP. In other words, what was considered safe 25 years ago may not be considered safe today.

In the United States, the U.S. Food and Drug Administration, or FDA, enforces Good Manufacturing Practices. The guidelines were established by the Federal Food, Drug, and Cosmetic Act and the regulations can be found under Title 21 of the US Code of Federal Regulations, Parts 210 and 211 (21 CFR Parts 210 and 211). Noncompliance can result in product recalls, seizure of goods and premises, fines, and jail time.

GMP is not exclusive to the United States. The European Union has its own set of regulations, for instance, and the World Health Organization (WHO) established an ongoing process of outlining GMPs in 1968. Since then, over 100 countries have since adopted these regulations.

What are GMP guidelines?

GMP guidelines give manufacturers a detailed picture of how to meet regulatory GMP requirements. These guidelines also outline practices that ensure that the manufacturer will produce high-quality goods for their customers safely and effectively. Specific regulations vary between industry and by country—for instance, the FDA manages them for the US—but GMP guidelines will always adhere to the following principles:

• Quality Assurance and Control: Manufacturers must have comprehensive quality management systems (QMS) and standard operating procedures (SOPs) that outline procedures for creating quality goods and include a practice of regularly testing and checking samples of finished products for quality defects that could potentially harm the buyer.
• Sanitation and Hygiene: The cleanliness of personnel, equipment, and materials is vital to meet GMP regulations. Proper sanitation procedures should be based on identifying potential contamination risks and developing processes for risk management to prevent cross-contamination.
• Premises and Equipment: Manufacturing facilities should be located in appropriate environmental conditions that are free of contamination risks and deviations from safety protocols. The layout of the facilities should be easy to maintain and conducive to error-free production. Equipment should only function for its intended use and should also be regularly maintained to maximize safety for workers and the products it creates.
• Raw Materials: Production materials should be sourced from a reputable supplier with incoming starting materials regularly checked for flaws. Materials should be stored in clean, climate-controlled spaces to reduce the potential for spoilage.
• Personnel: An effective GMP plan requires a team that is willing and capable of upholding safety standards to make the best product possible. All employees, whether they’re on the shop floor or not, should be trained in hygiene and safety to meet the standards set by GMP.
• Validation and Qualification: Equipment and systems should be regularly qualified to be used as intended and create high-quality products, then validate processes and procedures to make sure their output consistently meets these standards as well.
• Complaint Management: All manufacturers should have a well-designed complaint management system that documents complaints, reasons for the infractions, and how the complaint was resolved.
• Recordkeeping: Documentation is required in GMP and is an integral part of effective quality assurance. Traceable activities, like manufacturing and quality control, should all have corresponding documentation that is easy to access and understand and is signed off on by qualified personnel.
• Inspections and Audits: Internal inspections and audits should be performed regularly to make sure that the facility is meeting GMP standards. Inspections should be thoroughly documented with details like what was inspected and when and which processes or materials need to be improved. This way, immediate corrective actions can be taken and the risk of violating GMP regulations can be mitigated.

What are GMP standards?

GMP standards are set by regulatory agencies to ensure the safety of a finished product. These standards mostly focus on the pharmaceutical industry, but the principles are easily carried over into other manufacturing-focused industries. They're different from GMP guidelines as they’re more frequently updated and analyzed. GMP standards allow manufacturers to set goals that will not only ensure their customers’ safety but also guarantee a high-quality final product. To uphold GMP standards, make sure your manufacturing business is taking the following steps:

• Require compliance training. Make sure every individual in the company is informed on GMP regulations with compliance training upon hiring and regular retraining, especially when standards change. Employees should be trained on best manufacturing practices, sanitation, labeling, and complaint management. Keeping employees familiar with GMP standards will allow them to alert management if there are processes that can be improved in a way that will uphold GMP standards.
• Conduct regular audits and inspections. Consistently performing audits and inspections will simulate a full FDA audit without the risk of penalization if any infractions are found. Errors can be corrected and resolved immediately and root causes of these issues can be evaluated and addressed.
• Validate processes and equipment on a regular basis. Validation is a documented performance of activities that are done frequently on equipment that is used regularly. Including validation in routine GMP, check-ins will ensure the processes are contributing to a high-quality finished product. Validation should be performed on any task with a risk factor, from equipment use to sanitation.

Why is GMP important?

Good manufacturing practices keep both your manufacturing company and its customers safe. GMP emphasizes preventive measures that mitigate even the smallest risks to your product and, ultimately, your buyers. By monitoring product quality, keeping premises and equipment sanitary, training employees, and conducting audits as outlined by GMP regulations, you will encourage an attitude of continuous improvement that will guarantee that your product is of the highest quality.

Integrate quality beyond your QMS to ensure good manufacturing practices throughout your organization. Learn how.