What is a CGMP Certification? Here’s What You Need to Know

Have you been entertaining the thought of pursuing business in the supplement industry? Then it’s about time that you learn about CGMP certification as well. Knowing how delicate food quality and safety are for everyone, it is essential to meet (or even exceed) the quality standards and requirements to protect your brand and your customers from health risks.

The idea of CGMP may seem a little challenging to understand. We unpacked the essential things that you have to know about the Current Good Manufacturing Practices as defined by the Food & Drug Administration. This is to give you a better picture of what it takes to provide quality standard services and products to the market.

First, what do you mean by CGMP?

Current Good Manufacturing Practice (or CGMP) refers to the regulations set by the FDA to ensure the identity, strength, and quality of products before making them available in the market. This serves as a systematic procedure that assures proper design, monitoring, and control of manufacturing processes and facilities.1 By doing this, companies are able to establish a top-notch quality management system, obtain high-quality raw materials, and maintain reliable testing measures. This also prevents the instances of contamination, errors, mix-ups, and failures that may bring negative results to the end-users. 

The emphasis of the letter “C” in the CGMP which stands for “current” also reminds manufacturers of their obligation to implement systems and technologies that are up-to-date to be able to comply with the set guidelines.

Why CGMP is important?

No one knows better the product than the manufacturers. Therefore, it is the primary responsibility of the company to test and ensure the efficacy and safety of the health supplement or pharmaceutical products being manufactured. Under the CGMP regulations, the entire manufacturing process – including the product design and packaging – has to abide by the conditions set by the guidelines. In short, the CGMP adds another layer of security to the products sold to the market.

So, how does the FDA regulate CGMPs?

People are becoming more conscious of their health and food intake these days. With numerous health supplements made available in the market, the FDA makes sure that the entire supplement industry is being constantly monitored to keep the safety of the people.

To do this, FDA-registered facilities, such as the ones we have in Omnium Group located in Hauppauge, New York, Apex, North Carolina, and Huntington Beach, California are regularly inspected by FDA to ensure compliance with the CGMP standards. An FDA inspection checklist will be utilized upon inspection and should the FDA employee find anything that does not follow the required standards, immediate action will then be taken. Usually, companies that are found not to follow the conditions under CGMP are fined and given a minimum period of time to settle their problems.

However, it is also important to note that the Current Good Manufacturing Practices are just the minimum requirements. Full-service manufacturing and private labeling companies like Omnium Group has been implementing risk management approaches that exceed the minimum standards – such as utilizing high-speed equipment and new packaging technology for counting, filling, capping and sealing, liquid capsules, and liquids.

How to Acquire CGMP Certification?

Now, we are down to the most important question: how can you obtain a CGMP certification? The application process must be completed in order to get the certification. Usually, this is processed by an authorized person in the company like the production manager, QA manager, QC manager, or even the managing director.

Aside from documents needed to be presented upon application, getting the CGMP certification can come with a certain cost (and this could add up if we include the program registration fee, annual certification fee, not to mention that the certificate is usually valid for only three years).

To save you from all the hassle, you can opt to partner with an established manufacturer that can do custom formulation for your products and provide packaging services like us,  The Omnium Group. By working with us, you can either customize your own formula or adapt one of the products in our extensive inventory which are already covered under CGMP certification.

Exciting, right? What product do you have in mind? Contact us now and let’s discuss how we can start bringing your vision to life.


1 Facts About the Current Good Manufacturing Practices (https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps)

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