Supply Chain Integrity Workshop
As the pharmaceutical supply chain grows increasingly complex, and the risks to drug quality and safety correspondingly proliferate, more attention and resources are being focused on securing the materials and assuring their authenticity and integrity as they make their way through the supply chain. USP developed a new informational/non-mandatory general chapter, <1083> Good Distribution Practices—Supply Chain Integrity, published in Pharmacopeial Forum 38(2), March–April, 2012 and posted on the USP website in January 2012. The new chapter offers recommended best practices for industry to help ensure the integrity of key areas of the supply chain; collect widely dispersed information; and ultimately protect consumers from poor-quality and counterfeit medicines. The workshop provided a forum for discussing comments received related to <1083> and gaining further industry insight and perspectives with a focus on future USP initiatives.
FDA's Ilisa B.G. Bernstein, Pharm.D., J.D., describes supply chain integrity; the challenges brought about by the globalization of the pharmaceutical industry; the role of track-and-trace technology; and the multi-layered approach proposed in USP's new general chapter on supply chain integrity.
- Current issues, regulations and solutions
- Perspectives and input for USP General Chapter <1083> and its improvement
- Opportunities and USP's role in supply chain integrity for assuring the quality of medicines
- Conversation among stakeholders in the pharmaceutical industry on strategies to improve supply chain integrity
Stakeholders interested in the Pharmaceutical Supply Chain:
- Logistics & Transportation Professionals
- Standard-setting Organizations
- Other Interested Parties
Registration is now closed.