The quality systems for products regulated by the US Food and Drug Administration (FDA), including food, drugs, biologics, and devices, are known as current good manufacturing practices (cGMP’s). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of products by requiring that manufacturers of medications and devices adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.
cGMP requirements for devices was first authorized in 1978 in part 820 (21 CFR part 820) by section 520(f) of the Federal Food, Drug, and Cosmetic Act. In 1990, the FDA undertook the start of the revision of the cGMP regulation to add the design controls authorized by the Safe Medical Devices Act. Also, FDA believed that it would be beneficial to the public and the medical device industry for the cGMP regulation to be consistent, to the extent possible, with the requirements for quality systems contained in applicable international standards, primarily, the ISO 13485. Part 820 revision went into effect in 1997.
The FDA has proclaimed that some categories of medical devices are exempt from cGMP regulations. These devices are outlined in the Federal Register and codified in 21 CFR 862 to 892. Please note that exemption from cGMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).
For more information, please visit www.fda.gov.