Pharmaceutical Quality affects every American. The Food and Drug Administration (FDA) regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (cGMPs) regulation for human pharmaceuticals. Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies ..
Category : FDA
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) ..
Clinical evaluation of devices that have not been cleared for marketing requires: an investigational plan approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA; informed consent from all patients; labeling stating that the device is for investigational use only; monitoring of ..