IPEC Webinar - The concepts of what should be included in Quality Agreements have been explained in the 2009 IPEC Quality Agreement Guide and Templates. However, with new regulatory requirements and more complex supply chains, the Guide was recently revised by a team of IPEC experts to provide practical and detailed guidance on how to meet current challenges.
Pharmaceutical excipients are substances other than the pharmacologically dynamic medication or prodrug which are incorporate into the assembling procedure or are contained in a completed pharmaceutical item measurements form.
Pharma companies are responsible for excipient quality, but they face challenges, including quality and a regulatory environment that discourages development of new, pharma-specific excipients.