Extractables and Leachables Add Complexity to the Supply Chain

Parenteral drug manufacturers continually face the challenge of managing extractables and leachables (E&Ls) in their drug products. It is an ongoing problem because materials changes made all the way through the supply chain. The elastomers for tubing and seals, the plastics for containers, and the glass used in syringes all can affect the E&L profile of a parenteral drug. That means that new contaminants can be introduced at any time, and their identification and reactivity must be determined. That in turn means that extensive analyses must be carried out to ensure patient safety.

Clearly, increased awareness throughout the supply chain is critical to gaining some level of control over E&Ls. A recent article in the Pharmaceutical Sciences, Manufacturing & Marketplace Report examines advances in testing and controlling E&Ls.

But has the pharmaceutical industry done a good enough job at educating suppliers on this important issue? What do you think should be done to improve the understanding of suppliers far down the supply chain? What has your company done when working with your suppliers?

If you haven’t already, be sure to sign up for the eNewsletter so that you can read what experts in the field have to say. Then let us know what you think. Also check out the Pharmaceutical Technology/Biopharm International Marketplace.

Cynthia Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report