The Impact of the FDA GMP Regulation
1990 ◽
Vol 9
(1)
◽
pp. 105-106
Keyword(s):
The Past
◽
The impact of the Food and Drug Administration's Good Manufacturing Practice Regulation for Medical Devices is explored ten years after its promulgation. The main purpose of the regulation was never to be specific and exacting in interpretation, but rather to serve as a framework for the development of individualized quality assurance programs. The manufacturer is ultimatelly responsible for implementation. The role of the quality assurance professional is to be a persuasive advocator of compliance. Issues which were emphasized in the past are noted. What we can expect in the future is explored.