Excipients: Compliance with Compendial and GMP Requirements Course

This course has been developed and is presented with the joint effort of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) and Cobblestone.

Excipients are crucial in the manufacturing and formulation of bio/pharmaceuticals, enabling medicines to be delivered to patients in need. Compliance with appropriate quality and regulatory requirements is essential for companies that manufacture, distribute, and use excipients. The United States Pharmacopeia-National Formulary (USP-NF) requires that official substances be prepared according to recognized principles of good manufacturing practice and from ingredients complying with specifications to ensure that the resulting substances meet the requirements of the compendial monographs. However, there is often less understanding by excipient manufacturers related to confirming that the excipient meets the pharmacopeia monograph.