GMP Compliant versus GMP Certified: What’s the Difference?

In the world of dietary supplements, pharmaceuticals, and cosmetics, terms like “GMP Compliant” and “GMP Certified” are frequently mentioned. However, they can often be confusing, especially for businesses seeking to develop high-quality products. In this blog, we will break down the meaning of these terms, explore their implications, and provide insights into why knowing the difference between  GMP compliance and certification is important.

What is GMP?

Good Manufacturing Practices (GMP) are a set of guidelines and regulations designed to ensure the quality, safety, and consistency of products in various industries, including pharmaceuticals, cosmetics, and dietary supplements. The regulations aim to minimize risks such as contamination, mislabeling, and product variations that could impact consumer health or the efficacy of the product.

GMP regulations are defined by regulatory agencies like the U.S. Food and Drug Administration (FDA) and other international bodies depending on where the products are sold. To comply with GMP standards, a company must establish strict controls over its supply chain and manufacturing processes, including quality control of suppliers and their materials, facility design and cleanliness, employee training, and product documentation.

GMP Compliant: What Does It Mean?

Being GMP compliant means that a company or facility follows the guidelines in GMP regulations. Compliance implies that the manufacturing process adheres to regulatory requirements. Companies that are GMP compliant should be adhering to all of the required regulations to ensure that the products that they manufacture are safe and meet product quality standards for the consumer. 

However, GMP compliance does not necessarily mean that a company has been officially inspected or audited by a regulatory body. Instead, it indicates that the company is voluntarily adhering to the standards required by GMP regulations, but they have not undergone a formal certification process.

Many businesses, especially smaller manufacturers, may choose to state that they are GMP compliant rather than becoming formally certified due to cost or resource constraints. While being compliant is a good start, it is important to recognize that it does not carry the same weight as being certified.

GMP Certified: What’s the Added Value?

GMP certification takes things one step further. Companies that are GMP certified have undergone a rigorous inspection and audit process by a third-party organization or regulatory body, such as NSF, SQF, UL and others. This certification is a seal of approval that the company not only follows GMP guidelines but also meets the highest standards of manufacturing excellence and their compliance has been verified through an inspection and audit process. 

Achieving GMP certification involves:

• A full inspection of manufacturing facilities to ensure they meet all regulatory requirements.

• Verifying that all processes, from raw material sourcing to final product packaging, comply with GMP standards.

• Regular audits to ensure ongoing compliance, even after certification is granted.

GMP certification can provide a competitive edge in the marketplace. It assures customers, clients, and regulatory agencies that your products are manufactured to the highest standards of safety and quality. For businesses involved in custom formulations, having GMP certification can be especially crucial as it signifies trustworthiness and quality assurance. Certified facilities are more likely to attract business from larger companies looking for reliable partners.

FDA’s Role in GMP Compliance

The FDA performs random inspections of manufacturers against the GMP requirements for their industry. For dietary supplements, the GMP standard is defined by the FDA in 21 CFR Part 111. During a random inspection, the FDA Inspector ensures that the company complies with the applicable GMP standard and issues a Form 483 to document any non-conformances, which the company is required to resolve and respond to the FDA in writing with verification that the situation has been corrected. It is important to note that while the FDA inspects manufacturing facilities, it does not provide GMP certifications. By registering with the FDA, the company is acknowledging that it will comply with the applicable GMP standard, and the FDA performs inspections of manufacturers to verify compliance.

Why Does the Difference Matter?

Understanding the difference between GMP-compliant and GMP-certified is important when choosing a manufacturing partner or evaluating your own processes. Here’s why it matters:

1. Trust and Transparency: Certification provides an extra level of trust. While GMP-compliant companies may follow the rules, certified companies have been audited and verified by an independent body. This transparency can be critical in industries where consumer health is on the line.

2. Marketability: Being GMP-certified offers a significant marketing advantage. Certification acts as a badge of quality that can help differentiate your products and services in a crowded marketplace. It’s a clear signal to consumers and business partners that your facility operates at the highest possible standards.

3. Regulatory Benefits: While GMP compliance is enough to meet regulatory requirements, certification can offer additional benefits. Certified companies are less likely to face regulatory issues and are often more prepared for inspections by bodies like the FDA. Most major retailers also require third-party GMP certification for all manufacturers of products being sold in their system. 

At Canyonside Labs, we pride ourselves on adhering to the highest standards in product development and manufacturing. Our goal to be transparent with our customers was a driving force in our decision to become GMP Certified. You can learn more about our GMP Certification here. 

Conclusion: Trust the Experts

In conclusion, GMP standards are critical in today’s manufacturing landscape. While being compliant ensures that a company is following necessary guidelines, certification provides additional validation and can offer significant market advantages. Understanding the difference between the two can help you make informed decisions about your manufacturing processes or partners.

At Canyonside Labs, we are proud to be GMP certified by SGS and are currently in the process of attaining NSF certification in December of this year. Our deep industry knowledge and commitment to quality, validated by GMP certifications, ensure that your products are made to the highest standards. Contact us today to learn how we can help elevate your manufacturing processes.

For more information, feel free to get in touch with our team, and let’s discuss how we can meet your unique manufacturing needs.