USP Releases Proposed Standard on Supply Chain Integrity and Counterfeits
The US Pharmacopeia (USP) released new proposed standards last week that are aimed at securing global supply chains and preventing counterfeit medicines from propagating.
The standards-composed of a series of best practices-would ensure that:
- products are traceable to their original manufacturers;
- product integrity is ensured in both substance and identity; and
- product quality is maintained from manufacturer to consumer
Further, the best practices would ensure these goals by addressing four principle areas:
- the importation of products, including the management of supply chain risk, and development of supplier partnerships and supply chain quality systems;
- counterfeit products and the scope of the problem;
- best practices to confront the counterfeiting of drugs and devices through packaging, pedigrees, intelligent tagging, security, and other international best practices; and
- risk reduction, prevention, and response
Comments on the proposal, General Chapter 1083, Good Distribution practices-Supply Chain integrity, are due on 31 May, 2012.