Excipients: Compliance with Compendial and GMP Requirements
By: WCS Consulting Inc.
Excipients are the substances that are in any pharmaceutical preparation besides the drug. From ingredients that improve drug delivery, to ingredients that improve stability of the drug to ingredients which improve the color and taste of the drug, each component has a key role in pharmaceutical delivery and must be evaluated as such
• Types of excipients
• Compendial excipient testing
• cGMP excipient testing
• Balancing the use of the various standards
• Challenges with excipient testing
• Cooperation with stakeholders in excipients
Why should you attend?
Excipients must be evaluated with each drug they are included with to ensure that they can be used safely while ensuring the drug can be used as intended.
However, there are a number of challenges with excipient testing. Balancing the needs of the various compendials, such as USP, EP and JP, with cGMP can be a challenge
Todd Graham is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area as well as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities
WCS Consulting Inc.