Supply Chain Security Pilot Program

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In Mid-May, FDA announced that is looking for firms capable of developing and implementing a pilot program to “explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain” in accord with the Drug Supply Chain Security Act (DSCSA). The announcement is not a solicitation for applications, but rather an attempt to gather a list of qualified companies with the capabilities to develop and implement pilot projects. Areas to be explored, the agency explains, include: ● development of the program structure ● determination of the scope of the pilot projects and what issues should be covered ● ensuring the pilot project design fulfills the requirement of the DSCSA ● development of an application process for potential participants ● determination of how participants should be enrolled and chosen for a pilot ● development of monitoring and reporting schedules ● development of project metrics and evaluation plans, and ● development of a communication plan. [For more on the DSCSA supply chain provisions, see IPQ “Monthly Update” Jan./Feb. 2015 pp. 15-18.]
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