A frequent term thrown around most manufacturing companies is GMP (also called cGMP). While most people seem to have a vague understanding of what Good Manufacturing Practices (GMP) are, many do not have a clear grasp of what the requirements are. To start with, GMP is a system that provides assurance to customers that products are made with proper design, monitoring and control of the manufacturing process. It also ensures that medical devices are consistently produced and controlled to the pre-identified quality standards appropriate for their intended use. This is something that is strictly enforced by the FDA.
GMP are the Good Manufacturing Practice regulations given by the US FDA. In cGMP, the “c” stands for “current”, which is intended to remind manufacturers that they must be using technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment that may have been cutting-edge 10 or 20 years ago may not be adequate by today’s manufacturing standards.
GMP are in place to protect the users of the medical device by ensuring they receive devices of the highest quality. This applies to the manufacture, processing, packaging and storage of all medical devices. GMPs are written in general terms, and represent the minimum requirements that a manufacturer should develop for their own specific quality program. Some of the basic requirements include: adequate facilities; trained personnel; approved procedures for sampling, inspecting and testing; monitoring environmental conditions; samples of all materials and products; validated test methods; detecting and investigating product quality deviations; and records that detail the completion of required steps.
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