Excipients: Compliance with Compendial and GMP Requirements

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 pharmacopoeia monograph. Co-sponsored by IPEC-Americas and the Center for Professional Advancement (CfPA); partners in training and education (T&E). To address this issue, the International Pharmaceutical Excipients Council (IPEC) and the Center for Professional Advancement (CfPA) have developed a comprehensive 12-hour accredited course. The training includes an introduction to pharmacopoeias, with an emphasis on the USP-NF and Ph. Eur., and a global perspective that touches on other pharmacopeias. The course covers the content, organization, and use of the pharmacopoeias, as well as regulatory considerations for excipients. It reviews practical examples of compliance with compendial requirements and explores the development and revision processes for compendial monographs with real-life case studies. The course also examines efforts toward compendial harmonization by IPEC, the Pharmacopoeial Discussion Group (PDG), and the International Council for Harmonisation (ICH). Finally, the course explores approaches to compendial surveillance, opportunities for advocacy, and compliance with the requirements in the pharmacopoeias. This course will assist the global bio/pharmaceutical industry, including innovator, generic, biotechnology, contract manufacturer, and consumer-care companies, seeking a greater understanding of compliance requirements for excipient suppliers, particularly with the USP-NF and Ph. Eur. Engage in an interactive and stimulating learning experience that will help you develop the skills you need to excel in your field.