What is cGMP?
The manufacturing processes that are utilized must be in compliance with current Good Manufacturing Practices (cGMP), which are a set of regulations enforced by the U.S. Food and Drug Administration to ensure that the procedures and controls used for producing and testing biopharmaceuticals are appropriate. The cGMPs are designed to ensure that the resulting drugs are safe, properly identified, pure, and are of the correct strength and the highest possible quality.