If you are considering doing business in the supplements industry then you definitely need to know about GMP Certification. Without a true GMP Certification, you cannot have a successful business selling supplements for human ingestion.
The FDA currently monitors the entire supplement industry and they are doing this monitoring very closely. With more people becoming more aware of their bodies and the role that their nutrition and wellness plays in their health, they are becoming more open to supplementation.
As the industry continues to grow in popularity with more companies coming on stream and more consumers purchasing and consuming supplements, the FDA has beefed up their monitoring in an effort to ensure that end-users are getting only the best quality products. As such compliance is essential to success in the industry.
GMP certification for dietary supplements is offered by a number of global certification bodies. What is GMP certification anyway, what do the letters stand for?
What Does GMP Stand for?
GMP stands for Good Manufacturing Practices and is simply a list of guidelines for the processes, procedures, and documentation that assures that the label on a product portrays a true representation of the actual constituents of the product.
This is true for the ingredient’s quantity as well as its quality, composition, strength, purity, and identity. Products that are made in facilities with this certification are held to the highest standards and provide consumers with the guarantee that they are ingesting only the best quality supplements on the market.
One of the bodies that are well renowned for offering GMP certification is HSA – The Health Services Authority. The GMP certification offered by HSA – the Health Services Authority is for companies that manufacture medicinal products or therapeutic products that have active pharmaceutical ingredients.
This is the certification authority that Supplement Manufacturing Partners has chosen to receive their GMP Certification from. This and all other GMP certifications for the industry are enforced by the USFDA – the United States Food and Drug Administration.
Companies that have this certification bear this label to say that they manufacture supplements that are made to the highest quality and standards the world over. The certification also means that their manufacturing plants are monitored ongoing and all processes within the facility are properly controlled.
The certificate doesn’t just cover the manufacturing of the actual product but also ensures the quality control of administrative aspects such as those of personnel qualifications, record keeping, complaint handling, cleanliness, and sanitation along with process validation among other things.
Acquiring GMP Certification
In order to get this certification, there is an application process that must be completed. The application for GMP certification has to be made by an authorized person within the company seeking the certification.
This is usually one with responsibility such as a Production Manager, a Quality Assurance Manager, a Quality Control Manager, or the Managing Director.
The GMP Certificate is granted after a facility has been audited and has been found to have demonstrated that they are complying with the standards required to fulfill the requirements of the GMP certification.
The certificate is usually valid for a period of three years and will be issued in the name of the registered company. The certificate will show the scope of the certification as well as the name and the address of the company’s manufacturing site.
Fees Associated with GMP Certification
There are a number of costs associated with receiving a GMP Certification and they can easily add up. But you have options if you find that you cannot afford these fees. The best option is to choose a supplement manufacturer like us here at SMP Nutra that will do private label supplements for you in our GMP compliant facility.
But we still want to inform you about the fees as we want you to make an informed decision – There is a program registration fee as well as an annual certification fee which is paid directly to the certification body.
The registration fee and annual fees are fixed fees and are non-negotiable. Then there are the fees for the audit process. The audit process will have to be done by a third-party and their fees will be paid directly to them for their services.
The good thing about the latter is that these are fees you can negotiate directly with these companies to find the most cost-effective service to meet your needs. Estimated costs for a third-party audit run from $1600 upwards for a full 8-hour workday. The number of days required to complete the audit will depend on the size of your company.
A small to medium-sized company in the United States can take on average four days to be audited so expect to spend upwards of $6400 for an audit. If you are a foreign company and speak a different language you can expect an audit to last longer and cost even more.
What to do if Your Company is not GMP Compliant?
So you want to manufacture and sell your own supplements but this whole process of GMP certification is not one that you can afford at this time?
That doesn’t mean you have to wait until you can save enough money and get your own manufacturing facility. You can opt to have an already established manufacturer of supplements such as Supplement Manufacturing Partners can provide you with your own brand of supplements.
By choosing us to create your private label supplements you will have your own supplement line providing your customers with top-quality supplements that carry the GMP certification label.
Here at Supplement Manufacturing Partners, we meet all of the FDA label regulations and we are 100% compliant with our manufacturing processes. Allowing us to serve you by providing you with the supplements for your brand is the smart choice… the choice that will help get your brand name into households across America and the Globe sooner rather than later. What do we have to offer you, your company and your brand?
- Top-quality GMP Certified products
- Compliance with all FDA guidelines for labeling and more
- Ongoing quality control closely inspecting our manufacturing processes
- The operation of a facility that is environmentally friendly
- The manufacture of products that are of pharmaceutical-grade quality
GMP certification is of the utmost importance in the supplement industry as it is today, but it can be a long and costly process especially if you are just entering into the industry.
What SMP Nutra Can Provide For You
If you are looking at getting into the market faster and with less overhead, then let us do all the hard work for you.
We have the expertise, the line staff, the state of the art equipment and all the necessary approvals and certifications so you don’t have to worry about that stuff. We don’t cut corners and you will never regret choosing us to take your supplement brand to market.
Choose Supplement Manufacturing Partners to provide you with your very own brand of supplements ready to hit the market. We do it all from manufacturing to packaging and fulfillment. We are known to be the best at what we do and would be ready waiting to join you on your supplement manufacturing journey.