Why GMP Certification Matters
We started our company with a basic philosophy: use only the best raw materials to produce the highest quality dietary and nutritional supplements possible. Today, Paragon continues to take pride in knowing that our technical experts use the most advanced methods to ensure the identity, purity, quality, strength and composition of raw materials and finished nutritional products. One way we ensure the quality of the products we produce is by following Good Manufacturing Practices (GMP). But it’s not enough to just follow these best practices, we also spend a great deal of time, cost and effort to maintain our GMP certification from our industry’s leading quality organizations. Read on to learn more about the GMP certification and why you should demand your supplement manufacturer maintain one.
What is GMP?
GMP stands for “Good Manufacturing Practice,” but don’t let the simple name fool you. The certification ensures that the products you are consuming are consistently produced and controlled according to the strictest quality standards in the industry. By design, this system of certification is meant to minimize any risks in production that cannot be eliminated through testing of the final product.
GMP standards represent the industry’s best practices and establish the highest level of controls as required by the FDA. As such, they cover all aspects of production, including raw materials, the premises where production occurs, equipment and even the training and personal hygiene of staff members. It is essential that all procedures contributing to the final product(s) be documented and there must be proof that the correct procedures are consistently followed during every step of the manufacturing process.
Typically, GMP is ensured through effective use of a quality management system.
Who Regulates GMP Guidelines
In general, regulatory agencies are usually in charge of setting and overseeing the guidelines for good manufacturing practices. In the United States, the Food and Drug Administration (FDA) is the agency in charge of overseeing the regulations and controls that govern GMP for dietary supplement manufacturers.
Recently, FDA commissioner Scott Gottlieb said, “We know that most players in this industry act responsibly. But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and see dangerous products. One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products.
Failure to comply with GMP guidelines can lead to monetary fines, seizure of your business, product recalls, and even jail time.
Paragon GMP Certification
As a manufacturer of dietary supplements, we maintain GMP certifications from the Natural Products Association (NPA), NSF International, and UL. All 3 organizations offer third-party GMP certification programs for the manufacturing of dietary supplements and dietary ingredients. The programs are consistently updated to ensure their standards represent the industry’s best practices and follow the latest FDA specifications. GMP Certification is awarded only to companies that meet a high level of compliance to the organization’s GMP Standard as verified through comprehensive third-party inspections of facilities and GMP-related documentation.
However, becoming certified is just the beginning. In order to maintain Paragon’s GMP certification, we are required to remain active members, comply with all supplier membership requirements, maintain compliance to the GMP standards and terms of certification, pay an annual certification fee, and most importantly be re-audited on a consistent basis.
At Paragon, we take our mission of being the highest quality producer of dietary supplements very seriously. As such, we take great pride in being GMP Certified. This mission ensures we build quality into every nutritional product we manufacture and starts from the moment your raw ingredients arrive at our facility. We encourage you to request a copy of our GMP certification and view the rest of our certifications from our industry’s leading quality organizations.