What it Means to be GMP-Certified

There’s nothing more important in your company than quality control with something you are selling. That is why it’s important to make sure your manufacturing is GMP-Certified, or good manufacturing practice certified. This is a system that makes sure your products are being controlled and produced to the proper quality standards.

GMP Certified Logo

This is especially important in something being consumed by a customer, such as a pharmaceutical product or dietary supplement in which not every aspect can be tested. Take a closer look at why GMP-certification is so important and how to make sure your manufacturer has it.

What does GMP cover?

Good manufacturing practice certification covers all aspects of the production process, from the original materials to the equipment to the staff involved in the process. Systems are put in place to provide documentation proving how each process was done and staff is following detailed, written procedures the whole time.

Each time a product is made, there is a written procedure and documented proof of how a task was performed. Everything from the equipment and raw materials to the personal hygiene of the staff and the training endured is all up to GMP standards. These regulations were put into place by the US Food and Drug Administration.

Working with a GMP certified company

When you choose a facility to work with for manufacturing your product, you should make sure they are GMP certified. You can check a few things to make sure you are choosing a good manufacturing facility. First, find out if they are registered with the FDA since it’s a simple process for a manufacturer to do.

Next, find out if the facility was inspected by the FDA in the last couple of years since they will have to prove to the FDA that their facility is using current GMP standards. They should have a rating with the FDA that they can provide to you and an acceptance letter that shows how they were scored.

Why GMP-Certification is Important

The pharmaceutical quality of medicines and supplements is regulated very carefully, as it affects the lives of nearly every American. Manufacturing facilities must be designed and monitored properly, and the products they create must follow identity, strength, quality, and purity guidelines. Your drug or supplement must be what you say it is, be as strong as you claim, and not be contaminated or adulterated in any way.

It is nearly impossible to determine if a drug or supplement is safe or effective simply by looking at the pill. This is why GMPs are so necessary — they protect consumers from potentially harmful medicines and supplements that they cannot detect themselves.

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What does it mean for your product?

When a product has the CGMP or GMP seal/certification, it means that a product was made in an FDA approved facility. This does not mean that the product is confirmed as safe or federally approved, but when a supplement company puts this stamp on their labels or website, it does say that the FDA approved the facility that was putting the manufacturing practices into place.

It’s up to the company to comply with the law of GMP regulations in the manufacturing of the product. There isn’t an actual approval process that the Food and Drug Administration does on dietary supplements, but by putting the requirements in for the CGMP, it ensures the product is prepared, manufactured, and properly stored to the quality standards. It’s the responsibility of the manufacturer or distributor to ensure the dietary supplement is safe.

When you choose a company to work with to manufacture your dietary supplement, the best place to start is to confirm they have a GMP certification and to ask more about their FDA approvals. Then you can ensure you are doing as much as you can to ensure your customers are getting a quality product.

What Happens if a Product Does Not Meet These Standards?

If a product does not meet the GMP standard, this does not necessarily mean it is harmful. A violation of GMP regulations can occur for many reasons, and the action taken depends on the nature and severity of this violation. It’s one thing for a product to have a dangerous contaminant hidden inside, and another thing entirely for a piece of machinery that produced the product to be the source of the violation.

If a drug or supplement does not meet GMP standards the production company generally recalls the product or stops selling it to fix the problem. Sometimes this is voluntary; sometimes it is prompted by a request from the FDA. In serious cases, the FDA can file for a seizure or injunction. A seizure case would allow the confiscation of the product by law enforcement, and an injunction can order the company to correct their violations.

BioThrive’s Commitent to GMP Regulations

BioThrive Sciences adheres and exceeds all GMP regulations, from supplement formulas to packaging designs. With 20 years of experience in the private label supplement business, we know how to create a product that you will be proud of.

To order your private label supplements from BioThrive Sciences, call 1-844-263-3657 or fill out our online contact form to request a quote.