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Global, common approach to pharmaceutical supply chain integrity the focus of workshop
Date:4/17/2012

cesSupply Chain Integrity. The proposed general chapter will be part of the United States PharmacopeiaNational Formulary (USPNF), which contains quality specifications for medicines and their ingredients in the United States (these standards also are widely used internationally). The proposed standard covers four areas: importation, counterfeit drugs and medical devices, best practices to combat counterfeit drugs and medical devices, and diversion and theft. Based on feedback provided at the workshop and through other channels, USP will consider whether changes to its proposed standard are needed.

The keynote presenter at the workshop will be Ilisa B.G. Bernstein, Pharm.D., J.D., director (acting), Office of Compliance, Center for Drug Evaluation and Research, FDA. Broad areas to be addressed at the workshop will include Supply Chain Members: Role, Responsibilities and Risks; Industry Perspective on Safeguarding the U.S. Drug Supply; and USP: Role, Processes and General Chapters.

Specific sessions and topics will include:

  • Regulations and Guidance Impacting the Supply ChainRepresentatives from North America (California State Board of Pharmacy, FDA and Health Canada), South America (Brazil, Argentina), Europe (European Directorate for the Quality of Medicines, World Health Organization, United Kingdom MHRA and Turkish Ministry of Health) and Africa (Nigeria National Agency for Food and Drug Administration and Control) will present regulatory supply chain approaches from around the world.

  • Regulatory Issues and StandardsTopics will include an FDA update on standardizing numerical identification for prescription drug packages, FDA unique device identification and GS1Global Standards (both unique identification numbers and track and trace standards).

  • Technologies and EnablersDifferent presentations on track and trace, including global efforts and industry's response, pilot studies and best practices will be featured.'/>"/>

Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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