By Desmond Hunt, Ph.D., Senior Scientific Liaison at USP
As the pharmaceutical industry continues to globalize, the challenges of securing complex supply chains and protecting patients from counterfeit medicines have mounted, as have the consequences of lapses in security or proper handling. In an effort to encourage comprehensive public standards across the pharmaceutical industry, the U.S. Pharmacopeial Convention (USP) is proposing a set of recommended best practices that will help 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.
Supply chain integrity involves minimizing risks that arise anywhere along the supply chain, from sourcing pharmaceutical raw materials to their manufacture and distribution. The new standard being proposed is not mandatory, and is contained in the proposed USP General Chapter <1083> Good Distribution Practices-Supply Chain Integrity. The proposal is intended to serve as a guideline document outlining the essential elements of an effective strategy. The proposed standard covers four main areas: importation, counterfeit drugs and medical devices, best practices to combat counterfeit drugs and medical devices, and diversion and theft.
The draft general chapter and comments submitted to USP will be a central topic of a Supply Chain Integrity Workshop that USP is convening May 22-23, 2012, in Rockville, Md. This will be a further opportunity to provide input, including whether additional information needs to be included in the chapter.
Some highlights of the workshop include:
- Supply Chain Members: Role, Responsibilities and Risks
- The Role of Logistic and Transportation Providers in Supply Chain Integrity
- FDA Update: Track and Trace
- Technologies: Impact and Implementation Issues for Wholesalers, Pharmacies, Pharmacists
- Regulations and Guidances Impacting the Supply Chain
More information about the workshop is available at www.usp.org/meetings-courses/workshops/supply-chain-integrity-workshop.