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JUL-AUG 2017

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16 INTECH JULY/AUGUST 2017 WWW.ISA.ORG By Bill Lydon D uring the 2017 ISA Food and Pharmaceu- ticals Industries Division (FPID) Sympo- sium, I attended an informative presen- tation by John Woodburn on the implementation of serialization and lessons learned. Woodburn's career at Sanofi spans more than 10 years and includes roles as deputy director of engineering, automation platform, and as North American re gional project leader for serialization. Before working at Sanofi, he spent eight years as an engi - neering manager for Johnson & Johnson and two years as a project manager for Pfizer. Woodburn gave an overview of a major seri- alization program that includes 58 sites in 21 countries, installed on more than 350 packaging and distribution lines. This centrally managed program uses one common solution architec- ture for all sites, and uses globally standardized equipment at the line level. The global program started in 2010 as a pilot and was implemented in Turkey in 2011 (28 pack lines and a terminal in the distribution center). It was formed by the industrial affairs organization to incorporate representatives from all stakeholder groups, in- cluding quality, supply chain, information tech- nology (IT), manufacturing, and engineering. The program management methodology in place includes rollover scheduling of the imple- mentation, estimation for each year based on regu- lation compliance, and key milestones tied to regu- lation. The organization identified risks for market readiness, including late site capital request sub- missions and approvals, on-time delivery of corpo- rate and site-based solutions, and vendor capacity to deliver equipment and software. The serializa- tion program is regulatory and driven by country: Korea (2015), Saudi Arabia (2017), U.S. (2017), and Europe (2019). Aggregation is required in Turkey, China, Argentina, India (tbc), and U.S. (2023). Industry requirements As government agencies and the pharmaceutical and life sciences industries take measures to reduce drug counterfeiting, diversify products, and in - crease patient safety, drug manufacturers are faced with the challenge of implementing serialization and tracking systems. Globally, plans are underway to require track-and-trace documentation. Manu - facturers will have to provide an electronic record that contains information regarding each trans - action. This requirement will result in a change of ownership from a manufacturer's sale of a given Serialization implementation Key challenges and lessons learned

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