The U.S. Pharmacopeial Convention (USP) has pulled together a broad swath of stakeholders for a workshop this month on the complexities of protecting the supply chain.
The May 22-23 event in Rockville, MD will feature regulatory officials from Europe, South American, and Africa, and coverage of developing track-and-trace standards, among other topics. In looking to establish best practices for supply chain security, USP will solicit feed back on its proposed informational standard General Chapter <1083> Good Distribution Practices-Supply Chain Integrity.
With Chapter 1083, USP is providing guidelines covering all parties in a supply chain for securing API’s, pharmaceuticals, and medical devices against theft, diversion, and counterfeiting.
“The issues surrounding pharmaceutical supply chain integrity are not theoretical. On the contrary, they are very real, as evidenced by the discovery of counterfeit Avastin in various U.S. medical clinics in February and April,” says Praveen Tyle, Ph.D., executive vice president and chief science officer for USP.
“Legislative proposals circulating in Congress, continuing debate over product- versus- lot-level tracking, gray markets growing in the face of drug shortages, and other circumstances are converging, making it clear that the status quo is no longer adequate,” Tyle says.
The keynote presenter will be Ilisa B.G. Bernstein, director of FDA’s Office of Compliance, Center for Drug Evaluation and Research.
Approaches to supply chain regulation will be presented by representatives from California, Health Canada, Brazil, Argentina, the European Directorate for the Quality of Medicines, United Kingdom’s MHRA, the Turkish Ministry of Health, the Nigeria National Agency for Food and Drug Administration and Control, and the World Health Organization.
Other presentations will consider the impact of tamper-evident packaging and implementation issues related to new technologies from the perspectives of wholesalers, pharmacies, and pharmacists, USP said.
The goal of the Chapter 1083 guidance is to provide an overall or holistic approach to the complex supply chain security issue, which currently is addressed piecemeal in guidance from various sources and differently by individual companies. USP is encouraging common approaches and comprehensive public standards.
General Chapter <1083> will be part of the United States Pharmacopeia-National Formulary (USP-NF), which contains quality specifications for medicines and their ingredients in the United States–standards that are also are widely used internationally.