Excipients: Compliance with Compendial and GMP Requirements

Irwin Silverstein, Ph.D.

Joseph A. Albanese, Ph.D.

Course description

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.

To address this issue, the International Pharmaceutical Excipients Council (IPEC) and Cobblestone have developed a comprehensive accredited course. The training includes an introduction to pharmacopeias, 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 pharmacopeias, 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 Pharmacopeial 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 pharmacopeias.

This course will assist the global bio/pharmaceutical industry, including innovator, generic, biotechnology, contract manufacturer, and consumer-care companies, in seeking a greater understanding of compliance requirements for excipient suppliers, particularly with the USP[1]NF and Ph. Eur.

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

Upon completion of this course, you will be able to:

• Describe the content, organization, and revision process of the major pharmacopeias, including USP-NF, Europe (Ph.Eur.), Japan (JP), India (IP), and China (ChP)
• Identify the GMP quality system and compendial requirements for the manufacture of excipients
• Describe the regulatory expectations for approval of pharmaceutical excipient suppliers and the approval of incoming excipients
• Describe the role of pharmacopeias in the global bio/pharmaceutical and excipient industries
• Describe the processes for compendial surveillance and take advantage of opportunities for influencing monograph and other compliance requirements Identify the customer and regulatory expectations for non-monograph excipients