USP Proposes Best Practices to Help Ensure Integrity of Pharma Supply Chains

The US Pharmacopeial Convention (USP) has proposed a set of recommended best practices to help the pharmaceutical industry improve supply chain integrity and reduce risks of counterfeit or mishandled medicines.

Improvements like these are long overdue. As I reported last spring, research from PwC concluded that many pharmaceutical supply chains have suffered from what amounts to benign neglect. As a result, they are inefficient, under-utilized and ill-equipped to cope with new medicines, cost pressures and health reform expectations.

Sure, in today's global economy relationships between suppliers and other business entities are often opaque and difficult to track, but clearly, it's time for the pharmaceutical industry to step up to better ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited and are transported to their intended destination with their quality intact.

Too many companies have discovered the hard way that "willful blindness" only increases their culpability in the eyes of Federal agents, regulators who now are cracking down on businesses that aren't compliant with the Foreign Corrupt Practices Act (FCPA).

Don't take that kind of risk. Resolve that this is the year to start better managing your multiple supplier master databases as you monitor and mitigate supplier risk in a global operating arena.

"There is incentive for all players in the pharmaceutical industrylarge and small companies, regulators and standards-setting bodiesto come to some agreement on hotbutton issues such as track and trace technology and, at the larger level, to codify what constitutes a solid, universal approach to global supply chain integrity," said Praveen Tyle, Ph.D., chief science officer for USP.

USP's proposed standard covers four main areas:


Importation. Details three primary initiatives importers should undertake to help prevent and detect potential risks: supply chain risk management, development of effective supplier partnerships and building a supply chain quality system.


Counterfeit Drugs and Medical Devices. Documents types of counterfeit drugs, medical consequences, and distribution and extent of counterfeit drugs and devices.


Best Practices to Combat Counterfeit Drug and Medical Devices. Covers topics including: packaging technologies (tamper-evident designs, authentication technologies and serialization), drug pedigrees, machine-readable data carriers (2D bar codes and RFID tags), repackaging guidance, information retention and security, international standards and best anti-counterfeiting practices.


Diversion and Theft. Addresses factors that raise the risk of theft of drug products, drug components and medical devices; security systems, devices and procedures that should be implemented to reduce risk; and critical information to be gathered following discovery of a theft.

USP is seeking broad feedback on these recommendations on supply chain integrity, which are posted at
http://www.usp.org/USPNF/notices/generalChapter1083.html.