The purpose of this ballot is to create an American National Standard (ANSI) to define Good Manufacturing Practices (GMPs) for excipient manufacture for use in pharmaceutical products. It sets the baseline requirements for GMPs applicable to all excipients. To assure patient safety, excipients require more rigorous GMP controls in addition to the baseline requirements. The draft standard includes the critical elements of a quality management system for excipient manufacture and the GMP principles in IPEC PQG GMP Guide, 2006. It will assist in the determination of adequate facilities and controls for excipient manufacture with sufficient quality and purity to ensure suitability for intended use. |
