Being hit by counterfeit medicines, patent violations, security issues, and improper handling of medicines, the U.S. Pharmacopeial Convention (USP) is beginning a campaign to develop supply chain visibility best practices for that industry. The main goal for the USP is to ensure that medicines can be traced back to their original manufacturer and ensure they arrive at their intended destination without tampering or damage, all while verifying that they are not adulterated or counterfeit throughout the move.
USP has published its supply chain integrity recommendations
and is seeking feedback from pharmaceutical companies, transportation management service providers, carriers, and other with experience in supply chain management.
The proposed standard will not be mandatory and is intended to serve merely as a core guidance outlining the requirements for an effective supply chain management solution. USP said that there is no existing broad consensus around track-and-trace technologies which prevents the industry from having an established way to verify products and shipments.
"There is incentive for all players in the pharmaceutical industry—large and small companies, regulators and standards-setting bodies—to come to some agreement on hot-button 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. "While some pockets of information are available via FDA guidances, trade organizations and other sources, an overall approach is lacking. USP can move forward something more concrete than a technical report, as part of a mechanism that can be regularly updated to best meet the needs of all."
The proposed standard covers three key issues:
- Importation: Three initiatives for importers to prevent and detect risks when selecting partners and building a supply chain system.
- Counterfeit drugs and devices: This would add descriptions of counterfeit drugs and devices, and ways to detect them initially and throughout the process.
- Diversion and theft: This would establish a list of factors that raise the risk of threat and provide devices and procedures to help deter theft.
USP is a nonprofit public health organization that develops standards for medicines and their ingredients, and most of its published standards are enforced by the Food and Drug Administration.
The standards draft will be a topic of a USP workshop
May 22 to 23, 2012, where additional industry input will be sought.