Good Manufacturing Practice, a guideline for manufacturers of medications (including pharmaceuticals, biotechnology products, and active pharmaceutical ingredients) to assure that medications are of the required quality. The term cGMP is uniquely used in the United States and refers to current Good Manufacturing Practice.
GMP is also the name of the GNU Multi-Precision Library, which is an arbitrary precision numerical calculation programming library.
GMP exemptions are codified in the Classification Regulations 21 CFR 862 to 892.
Manufacturers should be aware of the GMP exemption status of their devices.
Component manufacturers are not routinely scheduled for GMP inspections; however, FDA encourages them to use the QS regulation as guidance for their quality system.
Feeds |
Contact