Pharmaceutical Quality Management

The Importance of a Pharmaceutical Quality Management System in Compliance

For every 5,000 to 10,000 experimental compounds considered by the U.S. Food and Drug Administration (FDA), it is likely that only one will be approved by the agency, according to the Pharmaceutical Research and Manufacturers of America. Given the high odds against a new drug’s approval, pharmaceutical companies face tremendous pressure in making sure that their submissions are compliant. A pharmaceutical quality management system is a basic requirement and a critical element of regulatory compliance.

MasterControl QMS Toolkit: A Quality Manager’s Guide