Pharmaceutical CGMPs For The 21st Century: A Risk-Based ApproachSource: MasterControl
The following questions and answers were prepared by MasterControl Inc., a leading provider of quality management software solutions for FDA-regulated industries and ISO-adherent companies.
Q: What is the “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century: A Risk-Based Approach”?
A: It’s an initiative announced by the Food and Drug Administration (FDA) in August 2002, designed to evaluate, improve, and modernize – to bring to 21st century level – the agency’s approach to reviews and inspections related to the manufacturing of human and animal drugs and select human biological products, such as vaccines. As part of this initiative, both the pharmaceutical and the chemistry, manufacturing, and controls (CMC) regulatory programs were evaluated.