is anyone here to confirm that GMP include design controls? GMP exempt means that is exempt of design controls as well? So why the regulations list only some devices, unless GMP and design control are not the same which i think they are. Thanks in advance
Just to clarify, "GMP" and "design controls" are both concepts, without tangible reality, and people are free to decide for themselves what those concepts mean to them. However, they exist in reality only when they are defined, as in a regulation or a standard, and applied per the definitions. It is possible for different regulations and standards to define these concepts differently. ISO 13485 is a quality management system standard that includes design controls, as well as a lot of what was in the old FDA GMP regulation. Some people may think ISO 13485 is GMP; others may not. I have no idea what ISO thinks; I only know that it didn't call it a good manufacturing practice standard.
To reiterate, there is no longer an FDA GMP regulation, only a quality system regulation that includes the regulations that were once the GMP regulation, plus additional regulations. Design control regulations are among those that were added to the old GMP regulation to create the QSR. Given this history, I personally do not think design controls are part of "GMP," if for no reason other than there is no longer a GMP regulation for them to be part of. Of course, it gets confusing because there are still product codes that are called "GMP exempt." I think it is also confusing to refer to the QSR as "GMP," because design and manufacturing are two very different activities.
I think the FDA's design control regulations should have stood on their own, rather than being combined with the GMP regulation to create a quality system regulation. Further, if these regulations are really supposed to include the design of both product and process, those two should have been the subject of separate regulations as well. I don't know if it was done this way to confuse things, or whether those who created the QSR were confused. I know I am far from the only person who thinks CDRH itself has never really understood design control, and that it has failed to fully implement the design control regulations.