What is cGMP and Why It Important?

At SteelFit® we create the highest quality, most effective, best-tasting products on the market. Our products are formulated for optimum results both onstage and off and are designed for all health and wellness enthusiasts, from fitness competitors to weekend warriors and everyone in-between.

Physician formulated with clinical doses of the most cutting edge, research validated, patented ingredients all our products are closely analyzed by our in-house quality control team along with our board-certified physician and his team at VPR Sciences for safety, quality and efficacy.

SteelFit® products are produced in a state-of-the-art facility located in South Florida. Our manufacturing site is NSF-cGMP certified and utilizes the latest measuring, blending, quality control and packaging technologies to help deliver the finest quality sports nutrition supplements to our customers. If it’s on the label, it’s in the product; with all product batches lab-assayed for purity.

What exactly is cGMP and why is it important? Keep reading to find out more.

What is cGMP?

cGMP stands for Current Good Manufacturing Practices. They are a set of regulations and guidelines created by the Food and Drug Administration (FDA), the governing body in the United States overseeing food, drug, and cosmetic product safety. cGMPs detail the processes to create systems that ensure proper design, monitoring, and control of manufacturing processes and their facilities.

Adherence to the cGMP regulations helps ensure quality, potency, purity, and identity of products (i.e. supplements) by requiring that manufacturers sufficiently regulate manufacturing operations. Part of abiding by cGMP includes establishing robust QA/QC management systems, procuring high-quality raw materials, creating comprehensive and detailed operating procedures, detecting and investigating observed quality deviations, and maintaining reliable testing laboratories. The elaborate system of controls cGMP sets forth, assuming it’s actually implemented all the way, helps prevent occurrences of errors, deviations, “mix-ups”, or contamination in drugs and dietary supplements. In other words, cGMP helps certify that what the bottle claims on the label is actually in it.

cGMP requirements were first established in 1963 by the United States Congress following the near-sale of thalidomide in the United States after it had led to over 10,000 birth defects and infant deformities in Europe.

The cGMP requirements were originally designed to be flexible, so as to allow individual manufacturers to decide how they wanted to implement the guidelines and regulations in their respective facilities. The upside to this flexibility is that companies may adopt newer, more advanced technologies, to consistently strive to achieve the highest quality possible. Remember, the “c” in cGMP stands for current, so manufacturers should strive to always use the most accurate, precise, and reliable equipment of the times.

Why is cGMP important?

The reason cGMP is so important is that you really have no way to detect through sight, smell, or touch what is in your supplements, if they will work, or if they are even safe for consumption. Basically, you have no way of knowing or determining if the product you’re taking actually contains what it claims to include.

To help assure that what you’re taking is what it’s supposed to be, cGMP requires testing of a product, but not every single product in every single batch is tested. Typically, testing is conducted only on a small sample of a given batch (e.g. testing 50 bottles in a 2,000-bottle batch of pre-workout).

Why is this done?

Well, products tested in the sample are destroyed following testing. The remainder is held aside to be sold to consumers, assuming everything from the sample passes spec. This ultimately saves money and allows products to be sold at a relatively reasonable price — testing is very, VERY expensive.

This is why it’s so critical that drugs, dietary supplements, etc. are produced in accordance with cGMP regulations. Following cGMP assures the utmost quality of your products by designing quality and precision in every step of the manufacturing process. By using the most up to date equipment, well-maintained facilities, reliable and reproducible processes, and thoroughly trained employees, manufacturers help ensure your products are effective, and, more importantly, SAFE!

In the end, the cGMP regulations help reduce the number of occurrences of product recalls, hazardous effects and inevitable lawsuits that go hand-in-hand with defective, poorly manufactured products.

How to Determine if a Company is Following cGMP?

The U.S. FDA inspects pharmaceutical manufacturing facilities all over the world, including facilities that produce bulk, raw materials, as well as the ones that manufacture full-fledged, finished products. Facility inspections follow a standard procedure, with an extensively trained staff conducting the inspection.

Additionally, the FDA uses reports from the public and the pharmaceutical industry itself to be alerted to possibly defective products. Upon receiving a report, the FDA will identify which facilities need to be investigated or inspected to ensure full compliance with the cGMP regulations.

How does cGMP differ from other Testing Procedures?

cGMP isn’t the only quality assurance/quality control practice available to manufacturers. Quite the opposite, in fact, as there are a number of different testing and quality measures manufacturers can choose from.

The reason cGMP is a cut above other is that cGMP is mandatory for manufacturers of those particular products covered in the Food, Drug and Cosmetic Act. Other quality assurance organization, such as the International Organization for Standardization (ISO), are not mandatory, which means manufacturers aren’t required to follow them or enact their procedures. But, most of the guidelines and regulations are the same, more or less across the different organizations. The only differences are in the allowable thresholds in the various quality tests that products go through. cGMP includes ALL of the guidelines detailing good laboratory practice, process validation, comprehensive corrective and prevent action (CAPAs), vendor qualification, and design/management reviews.

If manufacturers fail to abide by cGMP, it can bring about immediate sanctions for the industry in questions, while this isn’t necessarily the case with ISO and other quality control associations.

Are non-cGMP supplements safe to use?

Until now, we’ve highlighted the importance of cGMP, and why you should seek out products made by companies the following cGMP, but what about those “other” companies, who either don’t follow cGMP or adopt one of the other quality control standards?

Are those products safe, or should they be avoided at all costs?

Well, if a company is not utilizing the cGMP regulations, any product it makes is technically considered “adulterated” under the law. This means that the product in question was NOT manufactured in accordance with cGMP, but that doesn’t necessarily mean something is wrong with the product.

If you happen to be one of those consumers who is using supplements, pharmaceuticals, or other products made by a company not following cGMP, the FDA typically advises that you consult your doctor or prescribing physician before changing or stopping the use of the product.

Supplements manufactured in violation of cGMP may still meet its labeled specifications, and the risk that it’s ineffective, unsafe, or hazardous could be minimal, but you never can know for certain. Essentially, this means the advice of the FDA will be on a case by case basis when it comes to products not complying with cGMP and whether or not you should continue using them.

Actions taken against companies with poor cGMP practices are frequently carried out to prevent the creation and distribution of unsafe or ineffective drugs. Only in rare cases, does the FDA outright halt the distribution or manufacturing of products in violation of cGMP.

Takeaway

cGMP provides a “guardian angel” of sorts for consumers, especially in the “wild, wild west” arena that is the supplement industry. Supporting only those companies that employ cGMP (like SteelFit®), helps ensure your safety when using any sports nutrition supplement and serves as notice to those companies not following cGMP that their non-compliance of the regulations will not be supported. After all, where you spend your hard-earned money is the most effective action you can take.

References

  1. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm
  2. Velagaleti R, Burns PK, Gill M, Prothro J. Impact of current good manufacturing practices and emission regulations and guidances on the discharge of pharmaceutical chemicals into the environment from manufacturing, use, and disposal. Environmental Health Perspectives. 2002;110(3):213-220.
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