IPEC (International Pharmaceutical Excipients Council) is an organization of diverse stakeholders that share a common objective: safe and effective production of excipients for usage in manufacturing. Although, what is an excipient? A pharmaceutical excipient is defined as a substance other than the pharmacologically active drug which is included in the manufacturing process or contained in a finished pharmaceutical dosage form.
We know why a medicinal chemist or pharmaceutical manufacturer should care about IPEC but what do they need to know?
It is the legal responsibility of the user to understand and account for all excipients used in their manufacturing process. This includes the manufacturing quality, testing, and distribution of the excipient according to FDA standards and GMP/GDP guidelines. Using materials labeled as compendia simply because it tests to the compendia analytical requirement is insufficient. The original material must have been manufactured, tested, stored, packaged, and managed in conformance to appropriate excipient GMP requirements.
If your current supplier is unable to discuss the excipient pedigree or to allow your Quality group to conduct an audit of their manufacturing and quality systems, reach out to someone else who can because failed attention can have dire consequences.
So ask yourself – are you using materials suitable for your company’s quality expectations?