New Article - Qualifying Excipient Vendors Can Strengthen Supply Chain

An article that I co-authored with several other IPEC-Americas experts has just been published in Tablets and Capsules. This article outlines the importance of fully qualifying any alternate supplier of an excipient that you intend to use in your drug product.

The article stresses a number of the things that you must consider and the types of studies you need to run to ascertain if an excipient from a second source is truly interchangeable with your existing supplier's material. This must go way beyond just determining if the second source meets your specifications because that is rarely sufficient.

Things such as the compositional profile comparison and any differences that may occur in the stability of the drug product when using the alternative source excipient to that of your existing excipient must be understood.

If you are involved in qualifying alternative sources of excipients for your formulations, you will want to read this article!

Re: ‘Sourcing’: Qualifying Excipient Vendors Can Strengthen Supply Chain (tabletscapsules.com)