One could say that supply chain security is the most critical issue facing drug manufacturers today—and perhaps facing our healthcare system as well. The supply chain is at the heart of healthcare’s greatest problems—drug counterfeiting and adulteration, shortages of key medicines, and of course escalating medical costs. Without security of supply, none of these challenges can be addressed.

A few weeks ago, SmithKline Beecham’s Worthing West Sussex, U.K., site received an FDA warning letter related to, primarily, alleged failure to ensure microbiological contamination of products manufactured there. The site was inspected last March, and in April the Agency said that GSK's response to initial concerns lacked sufficient corrective actions.

A speaker at last week’s AIChE annual meeting joked about the nitty-gritty, technical nature of the conference’s Quality by Design topical track. QbD talks at some shows are a bit like Las Vegas, he said—more superficial than substantial—whereas at AIChE they were “more like M.I.T.”

In September, FDA sent a warning letter to Sichuan Pharmaceutical Co., an API manufacturer in China. The letter cited the manufacturer's failure to adequately guard against potential product cross-contamination:

Earlier this summer, we wrote about a talk by FDA CDER’s George Smith, the lead for the Agency’s 21 CFR Part 11 working group, regarding the “add on” surveillance of computer systems that FDA is now performing during the course of its regular site inspections. The point is to gather information about how Part 11 is being used within the industry.

Over the past several years, the ICH Quality Implementation Working Group has helped to develop and spearhead the adoption of ICH Q8, Q9, and Q10, guidelines which spell out the Quality by Design principles that (slowly but surely) drug manufacturers worldwide are taking to heart.

Earlier this year, Milwaukee Journal Sentinel reporters Raquel Rutledge and Rick Barrett conducted a four-month investigation into manufacturing issues at the Hartland, Wisconsin facility of H&P Industries, which (until a recent consent decree) produced hospital wipes, cough syrups, ointments, creams, and other health products.

I’ve been attending BIO for about five years now, but the 2011 conference in Washington, D.C. last week was more subdued than I’d seen it. There was no sign of Bono, Elton John, movie stars or NBA players on the show floor, no media circus of the kind generated by Arnold Schwarzenegger a few years ago.

Last December, after some delay, FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11 requirements. As such, the Agency is undertaking “add on” surveillance of manufacturers’ computer systems during the course of its regular inspections. At DIA 2011 in Chicago last week, FDA CDER’s George Smith, who heads up the Agency’s Part 11 working group, shared information on the status of these activities.

FDA’s Adverse Event Reporting System (AERS) is a database that allows physicians, patients, and others to call attention to post-marketing drug safety issues. Reporting in AERS is voluntary, and thus data far from reliable. Still, the statistics are used by FDA as a means of determining potential safety concerns of drugs on the market.