Current Good Manufacturing Practice (cGMP)
Current Good Manufacturing Practice (cGMP) is a set of regulations put forth by the FDA to ensure that business organizations, manufacturers, and packagers of pharmaceutical products, medical devices, blood, and certain foods proactively guarantee that their products are effective, safe, and pure. The goal of cGMP is to increase product quality by developing systems that proactively guarantee proper product design and control of manufacturing processes and facilities.
cGMP applies to facilities and buildings, production, equipment, process controls, laboratory controls, packaging, and labeling, and returned or salvaged drug products. It applies to the pharmaceutical, biotechnology, medical technology, and medical devices industries.
The types of products that must comply with cGMP include: pharmaceutical products, medical devices, biotechnology products, food and beverage, and dietary supplements.
For example, if a pharmaceutical company is selling epinephrine, a vital drug for the treatment of anaphylactic shock, patients will be assured of the safety and efficacy of this life-saving drug because the company is cGMP compliant. This is important as it helps to ensure that the products are safe and effective for patients, and also provides a level of accountability and oversight for the manufacturers to ensure that they are adhering to the regulations set forth by the FDA.