cGMP and GMP: What’s the Difference?

Posted on May 07, 2020


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GMP stands for Good Manufacturing Practices, and refers to a set of guidelines created by the Food and Drug Administration. The pharmaceutical industry has put these practices into place to ensure that all products are safe, pure, and high quality.

So, what are these guidelines, and how are they different from cGMP? We’ll go over all the specifics here.

GMP Vs. cGMP

The GMP guidelines are in place to ensure that whenever a company is manufacturing new products, it’s done so in the cleanest way possible. GMP guidelines guarantee that every utensil and surface used in the creation of each product was up to these certain set of standards. Following the GMP guidelines certifies that the entire process, from record keeping to packaging, is done correctly and precisely. In addition to these guidelines, every employee involved in the process has to have the proper credentials to partake in the production.

Both GMP and cGMP are put into place to guarantee quality—but there is a little difference between the two, as the “c” in cGMP suggests. The “c” is added to certify that every step used in producing a product was not only done under the guidelines of GMP, but also that every step was finished in the most current manner available. GMP rules and regulations are constantly improving and updating with technology. Because the production of new goods, the cleanliness of the process, and the neatness are all being improved, the “c” (for “current”) differentiator is necessary.

Another key difference between GMP and cGMP? The cost. cGMP mostly uses new, innovative technology, which can make it more expensive than regular GMP. cGMP goods undergo significantly more testing, as well as newer, more in-depth testing. cGMP also goes beyond proper production, and is put in place to ensure proper use of new manufactured goods. It goes above and beyond to make sure that the quality of the new pharmaceutical is used for exactly what it was created for. This is part of a current standard regulation that’s updated frequently, to make sure that pharmaceuticals aren’t, as they often are, misused.

The terms GMP and cGMP are somewhat interchangeable—because technically, when standards are updated, and new regulations are put into place, the new ones become the current, i.e., cGMP. However, cGMP regulations always refer to the newest technologies available at the time of production.

So, What Does Avanti Use?

Here at Avanti, we’re always making sure that our methods and guidelines are up-to-date, and adhere to the strictest possible regulations. That’s why we use cGMP. For over 40 years, we’ve provided API (Active Pharmaceutical Ingredient) Technology Development for Pharmaceutical and Biotechnology companies. Our well-established reputation in the industry for extreme quality in the development of pre-clinical and clinical candidates sets us apart from others.

Our experienced staff of chemists and lipid analysts are ready to meet your development needs. All the way from research and discovery to commercialization, our standards can’t be beat. Interested in learning more? Read about our cGMP Manufacturing here. If you’re ready to partner with Avanti for your latest research product, reach out to us.