Broad-based cooperation vertically across the supply chain and horizontally across organizations and regions is important to help support the advancements in track-and-trace/product authentication technologies and QC analytical methods, CDER compliance official Richard Friedman emphasizes.
Track-and-trace technology will be very effective, Friedman commented in an early September Biopharm International podcast, “as long as there is cooperation among all members of the supply chain. You are only as strong as your weakest link in the supply chain.”
In this regard, he pointed out, “a set of harmonized global technology standards and practices will also be very valuable. We have talked about things like bar codes and RFID and all these other approaches, but there will need to be interchangeability and interoperability across states, countries and continents, so that there will be the ability to use these technologies to assure that a product remains integral throughout the supply chain.”
The compliance official took a positive view of efforts that individual states have made to adopt their own drug pedigree requirements as “promising incremental steps” toward a harmonized regulatory system.
“Many states have clearly recognized the importance of drug pedigree to ensure the security and thereby the safety of a drug throughout its distribution chain. These regulatory requirements across the US are very welcome. We hope that industry harmonization will follow and produce consensus around a number of agreed technologies for tracking and tracing of pharmaceuticals. It is important to help prevent divergence from the legitimate supply chain. I think that all these incremental steps are promising ones.”
[More on the advancement of authentication strategies and analytical methodologies and the industry/regulator/pharmacopeial initiatives to support them is provided for subscribers here. For further insights from Friedman on supply chain issues and developments see the September 9 companion stories.]
Editor’s note: IPQ has been closely tracking industry and regulator supply chain initiatives since its launch in the fall of 2007. For example, the November/December 2008 IPQ Report provides an in-depth analysis of the drug supply chain problems and the industry and regulatory efforts to address them on an individual company, regional and global basis. IPQ’s May/June 2008 Report focuses on hearings in the US Congress to reevaluate FDA resourcing and authorities in the wake of the heparin problems. USP, EMA, and ICH efforts on heavy metals are detailed in the IPQ May 2010 Report
The following are IPQ “In the News” stories that provide updates on recent developments in supply chain integrity efforts: