As the pharmaceutical industry becomes increasingly global, so has its supply chain. The complexity of the chain is such that more and more stringency and oversight is needed to ensure product safety and integrity. Recent examples, including contaminated heparin, have pointed out this problem emphatically.
As a result, companies and regulators are increasingly looking at more and better analytical methods for characterizing key raw materials used in the manufacture of pharmaceuticals. This is one means (by no means the full solution) that can be used to better assure the safety of supply. This article describes how the heparin monograph and analytical methods have been upgraded in response to this issue by the FDA and USP working together.
Along this same light, I've written here often about SAFC's internal program to better characterize raw materials that it is supplying in its cell culture products for use by the biopharmaceutical industry in manufacturing of recombinant protein drugs. This is a program that has strongly resonated with the industry due to the issues described. See here, here, here and here for more on this topic from this blog.
Posted by Bruce Lehr December 4th 2010.