The Complete Guide To GMP Certification In The USA

person in lab coat completing GMP Certification reports

According to a recent in-depth study, good manufacturing practices certification (GMP) is one of the gold standards by which global governments judge modern companies across differing industries. GMP certifications instruct companies on creating manufacturing processes that consistently yield high-quality, safe products for consumers. 

In recent years, becoming GMP-certified has become increasingly important, as has remaining GMP-certified and compliant no matter the industry a manufacturing company operates within. This is especially true in industries that manufacture pharmaceuticals, supplements, and other health products. 

If a business has obtained a certificate of GMP, it can be relied upon to produce products manufactured under severely controlled conditions to ensure consistent, reliable quality. Yet how does a company secure certification for good manufacturing practices? Getting GMP certified is a process that often involves understanding and meeting regulatory requirements alongside knowing why GMP certification is important and its benefits.

What Is GMP? GMP Certifications In The USA 

GMP certification is a stringent and usually voluntary process companies can choose to undergo. According to Chapter IV for food and Chapter V for drugs and devices of the Federal Food, Drug, and Cosmetic Act, GMP refers to Good Manufacturing Practice regulations. 

GMP regulations are part of the certification and require manufacturers, packagers, and processors of medical devices, drugs, some foods, and blood to take protective steps to ensure their products are effective, pure, and, above all, safe. 

Those who undertake GMP certification need to know that according to GMP regulations, companies need to minimize or eliminate instances of errors, contamination, and mix-ups by taking a high-quality approach to manufacturing processes. 

Ultimately, GMP certification protects consumers against purchasing dangerous or ineffective products. For companies where GMP certification is mandatory, failing to comply with GMP certification regulations can result in recalls, fines, seizures, and even prison time. 

GMP Regulations

To properly understand GMP certification, you need to understand GMP regulations as they go hand in hand. GMP regulations have been created to address issues like sanitation, cleanliness, record keeping, personnel qualifications, equipment verification, complaint handling, and process validation. If a company obtains GMP certification, it will have proven that they have manufacturing processes in place to combat issues within these areas. 

However, GMP requirements are often open-ended, allowing manufacturers in different industries to decide on their own how to best implement necessary controls to comply with regulations. 

Although this provides companies with flexibility, it does mean manufacturers often need to interpret the requirements in a manner that makes sense to them, which is where complications can arise. That’s why businesses are often recommended to undergo a GMP certification course tailored to their industry to broaden their knowledge of GMP regulations and requirements, put them into practice, and secure certification. 

man and woman in white lab coats inspecting a GMP certified manufacturing facility in the USA

Why Is Good Manufacturing Practices Certification Important? 

When you obtain GMP certification, you prove to the world that you care about transforming your manufacturing processes and intend to set a benchmark for excellence within your business. This helps you identify areas for improvement and showcases your dedication to customer satisfaction and regulatory compliance.

With GMP certification, you foster a sense of community in your business with the common goal of continuous learning and progress within your industry to put forth the best products possible. 

By implementing GMP principles, you create a platform for operational excellence and ensure your company’s products repeatedly and routinely meet the highest industry quality standards. 

These industry standards cover every aspect of the manufacturing process. This means that your business proves it is sourcing raw materials, creating, packaging, and labeling final products efficiently, effectively, safely, cleanly, and productively (more on this later). Ultimately, through GMP certification, your business is standardizing processes and best practices to minimize risks, increase efficiency, improve customer satisfaction, and enhance product quality. 

In The USA, Who Issues GMP Certificates? 

In the US, GMP certification is issued directly by authorized third parties, not the FDA itself. For a business to achieve GMP certification, it must undergo a thorough audit (more on this later). If an audit isn’t passed because of deficiencies or violations, these regulatory issues must be addressed before GMP certification can be granted. 

For most industries, GMP certification lasts for three years before a US-based company needs to renew it. Although frustrating for some, this limited timeframe is necessary to ensure companies maintain high standards in manufacturing and production processes. 

Those who achieve GMP certification are often considered leaders in their industry. They gain a competitive edge over competitors who have not undergone the certification, and this certification also helps companies avoid potential fines. 

How Do You Get GMP Certification? The GMP Certification Requirements

To obtain GMP certification, you must meet regulatory requirements to ensure your product’s quality, safety, and integrity. The requirements you’ll need to meet cover several aspects of the manufacturing process, including the following: 

    • Personnel: Manufacturers must employ qualified and trained personnel with the skill set and professional know-how needed to perform their assigned work duties safely and effectively. This includes manufacturers providing employees and teams with ongoing training to ensure employees understand their responsibilities. 

    • Facility and equipment: Manufacturers must possess equipment and facilities that are designed, maintained, and operated to prevent mix-ups, contamination, and cross-contamination. 

    • Quality control: Manufacturers must implement stringent quality control protocols to guarantee compliance with specified standards. This encompasses thoroughly examining raw materials, in-process samples, and final products for identity, potency, purity, and quality.

    • Documentation and record keeping: Manufacturers must keep adequate documentation and up-to-date records of their manufacturing processes, batch records, procedures, and specifications. They must also maintain these records and make them available for review during inspections and audits. 

    • Complaint handling and product recalls: Manufacturers must establish protocols for addressing customer grievances and orchestrating product recalls. This entails conducting thorough investigations into complaints, implementing suitable corrective measures, and promptly informing regulatory bodies if required.

If you believe your business has met the above requirements, it must undergo a GMP certification audit with a third-party company. During the audit, the certification body will assess your company’s compliance with GMP standards and verify that you meet the above requirements. If you pass the GMP audit, you will receive GMP certification. 

To ensure you pass, it’s often best to be prepared for the audit and what it will entail. One of the best ways to ensure you have the best chance of gaining GMP certification is to ensure your workforce receives proper training. 

What Does a Certified GMP Course Cover? 

Once you have decided you want your business to be GMP certified, one of the best starting points is to enroll in a course covering GMP certification and all it entails, as mentioned earlier. 

A comprehensive course will detail how GMP standards, regulations, and requirements guide manufacturing processes to minimize contamination and defects that can severely impact end users. Those who undergo a GMP course will glean industry-specific knowledge – since there is no one-size-fits-all approach – that helps employers and employees enact GMP standards in their workplace. 

After undergoing a GMP certification course, a business can better understand GMP practices and the necessary skills and tools to gain certification and meet production and manufacturing product challenges head-on. 

female lab technician performing a test in a US GMP certified facility

Begin The Process Of Earning a GMP Certification 

GMP certification is crucial, and now you know why. It positions you as an industry leader and helps you meet consumer needs, abide by FDA regulations, and beat out the competition. Not to mention, GMP certification helps your business improve its manufacturing processes’ safety and efficiency. So, if you’re ready to be GMP certified, begin by preparing yourself and your business through industry-specific GMP training courses. 

About Cobblestone’s GMP Training Courses

At Cobblestone, we offer numerous accredited GMP course topics as well as our own GMP professional certification program to assist you in understanding the FDA’s regulations across industries, whether it be in pharmaceuticals, medical devices, or food. 

Contact us today, and we’ll help you enroll in a course or program to match your GMP needs. Our courses are available for individuals and groups, and in addition, we offer customized company- and team-wide training programs. 

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