You may have seen manufacturers use terms such as “GMP compliant,” “GMP certified,” or similar in an attempt to show that their products are of good quality. This might make you wonder what GMP is and why it matters.
In this article, we discuss everything you need to know, including why GMP is important for supplements.
What is GMP?
GMP stands for Good Manufacturing Practice. It is a system that is designed to ensure products that manufacturers offer meet up to existing quality standards. GMP regulations apply most especially to food, drugs, medical devices, and dietary supplements.
The first regulations in the United States were enacted in 1963 and applied to finished pharmaceutical products. They were thought necessary after the drug thalidomide, which resulted in thousands of birth defects in Europe, was almost sold in America.
These regulations are aimed at ensuring that certain products do not end up harming those who buy and use them. Manufacturers have to take deliberate steps to make this a reality. They must also be able to prove the actions taken.
The Food and Drug Administration (FDA) is responsible for the enforcement of GMP regulations. NSF International (previously known as the National Sanitation Foundation), an independent organization, develops the standards and registers manufacturing companies that meet them.
Why is GMP Important?
As you might have gleaned from the foregoing section, GMP regulations are mainly aimed at protecting the health and wellness of consumers. However, they not only protect users but also manufacturers. They may also help companies avoid getting sued by their customers.
GMP is vital because it is not easy for consumers to tell what products would harm them by appearance. The system helps to ensure that these users do not have to bother at all. Without it, many people would easily fall prey to poor quality or harmful products.
The regulations spell out what each step of the production process should be like. It doesn’t just focus on an aspect, such as testing. They call for properly trained and qualified members of staff and the use of quality equipment.
Some of the other good manufacturing practices for food and supplements include:
- Clean production environment
- Avoidance of harmful chemicals in formulations, cleaning agents, and machine lubricants, among others
- Proper control of pests in and around a production facility using safe agents
- Prevention of out-of-place matter from mixing with product
Manufacturers must be seen to observe these good practices to be able to obtain GMP certification.
Process of Certification
Before manufacturers can get GMP-certified, they have to do a lot to ensure that they impress the regulators. The failure to get the key things right would result in these companies being denied the certification.
The inspection of a production facility is a crucial part of the process. The regulators must be shown that the premises are clean and in hygienic conditions. A manufacturer needs to ensure that everything in its premises is in accordance with the GMP guidelines.
To help them get the process right, serious manufacturers usually document everything they need to do to ensure compliance ahead of time. They carry out their own thorough internal inspections while also keeping records in preparation for third-party inspections or audits as part of the certification process.
GMP vs. cGMP
Often, you may hear people using GMP and cGMP one for the other. This is not fully correct, however. There are slight differences between them.
The “c” is the most obvious thing that splits the two. In effect, cGMP stands for Current Good Manufacturing Practices.
The idea here is that what used to be good manufacturing practices (GMP) in the past may no longer be so in the present time. Thus, cGMP suggests that a firm abides by “current” best practices, such as the use of the latest technologies.
It appears the major difference between these two certifications is in terms of equipment used by a business. A producer that has cGMP certification usually uses high-tech production methods.
Apparently, cGMP assures an even better quality, compared to standard GMP. But either of these is a good sign of quality food products or dietary supplements.
GMP vs. Other Quality Standards
Besides Good Manufacturing Practices, there are other standards geared toward ensuring quality products. An example is the ISO certification.
Most of these quality measures are similar to a great extent – they only have slight differences.
However, a key difference between GMP and other quality standards is in terms of necessity. It is more important for manufacturers of classes of products regulated by the FDA to be GMP-certified. The other quality standards are not mandatory but only helpful.
With this exposé, we hope you now know the importance of choosing GMP or cGMP-compliant supplements. This certification gives some peace of mind on the quality and purity of health products.