Clinical project teams often struggle deciding when to apply current Good Manufacturing Practices (cGMP) regulations upon developing a new drug. Good manufacturing practice (GMP) is used as a system for ensuring products are consistently produced and controlled according to quality standards. It is also designed to minimize the risks involved in pharmaceutical production that can’t be eliminated through testing the final product, according to the World Health Organization. The U.S. Food and Drug Administration’s (FDA) expectations when applying cGMP to investigational drugs is outlined in Title 21 of the U.S. Code of Federal Regulations
To read more about applying cGMP regulations, read the full article on Advarra’s website.