The FDA’s Quality System Regulations (QSR) are a family of wide-ranging regulations meant for a number of industries, as well as a number of medical devices. They need to be applied using the manufacturer’s discretion on what constitutes a state-of-the-art practice.
The FDA has issued Quality System Regulations (QSR). The objective of putting in place Quality System Regulations is that they must be used as the guidelines by manufacturers to establish that their products meet appropriate specifications and requirements consistently.
These are issued alongside medical device Good Manufacturing Practices (GMP). The reason for this is to fortify the practices related to the two disciplines and related ones. The Quality Systems (QS) of the following FDA regulated industries are jointly called Current Good Manufacturing Practices (cGMP’s):
- Biologics, and
The important premise on which quality systems regulations are built is that a quality system has to contain broad guidelines that can be used across the industries for which they are formulated. 21 CFR 820 of the QS regulation thus has expansive guidelines for covering all these designated industries, and require their selective and subjective interpretation from manufacturers to select the one that suits them best. QS Regulations are, in this sense, a kind of canopy under which these industries have to operate their respective guidelines and best practices.
The FDA states that since their Quality System Regulations have what it terms an “umbrella approach” in that it applies to a swathe of industries and devices; it does not prescribe in very great detail the way in which a manufacturer has to produce a particular device. Rather, it requires manufacturers to develop and follow procedures and then fill up details in consonance with the latest or current state-of-the-art manufacturing for that particular device.
FDA’s 21 CFR 820 of the QS regulation’s broad guidelines
These are some of the broad areas that are covered in 21 CFR 820: