GMP Refresher Training

GMP stands for "good manufacturing practice". GMPs apply to all drugs and other medical products that are manufactured for public consumption. In the United States, GMPs are developed by the Food and Drug Administration (FDA). It is important to take refresher courses on GMPs since failing to comply with them may result in regulatory action by the FDA.

Training Topics

• GMP refresher training topics include the history of GMPs, regulations and guidelines, equipment, quality management systems, laboratories and testing, FDA inspection processes, supplier controls, storage and distribution, and risk management. Training should also cover the Federal Food, Drug and Cosmetic Act, which outlines the scope of the authority granted to the FDA with respect to GMPs.

Training Courses

• Training courses typically last between one and two days and cost between $500 and $600. It is expected that participants will have several months experience with GMPs.

Adulteration

• It is also important to note that even if a manufacturer meets all FDA manufacturing guidelines, it may still be subject to regulatory action on behalf of the FDA if the product somehow become adulterated during the manufacturing process. Adulteration is a legal term that essentially means that the end product is not fit for consumption according to federal regulations. This should be part of any GMP refresher course.