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insights LIFESCIENCELEADER.COM MARCH 2014 66 he industry is uncovering a lot of unexpected complex- ity that may have a dramatic effect on manufacturers," says Rob Young, Accenture's life scienc- es North America lead for serialization. Compressed timelines are the biggest concern, followed by added requirements. For example, the California Board of Pharmacy requirement — the de facto U.S. standard before the federal man- date was enacted — called for complete unit-level traceability for dispensers in 2017. The new federal mandate extends that deadline to 2023, but requires prod- uct identifiers to be added to each pack- age and homogeneous case of product by November 2017. It also adds interim steps, so that the first deadline manufac- turers must meet is Jan. 1, 2015. By 2015, manufacturers must incor- porate product transaction data into a single document that is available, either electronically or on paper, each time ownership is transferred. This document must include transaction data listing lot- level information, a complete transaction history, and a transaction statement and must be maintained for six years after the transaction. By November 2017, that information must be available electroni- cally, and the product identifier must be affixed or imprinted on the label at the product and case level. In light of these changes, "Big compa- nies are moving faster now. They rec- ognize they have only a limited time in which to get things done," Greg Cathcart, CEO of Excellis Health LLC, says. "They can't slow down." While the federal mandate avoids a state-by-state legislative patchwork, it extends serialization requirements to entities that otherwise would not have been affected. As an example, Cathcart cites large and regional wholesalers that could manage the California require- ment by deploying solutions to sites that shipped to that state, but which now must deploy solutions for their entire net- works. "In some cases, this will increase the number of sites affected by as much as 75 percent," he says. Healthcare pro- viders unaffected by the California man- date now must develop track-and-trace plans for their inventories. Some regional healthcare providers, for example, have more than a dozen pharmacies they must prepare for serialization. PHARMA FOCUSES ON NEAR-TERM REQUIREMENTS "At Pfizer, we've been preparing for the California mandate for several years, so we are able to leverage that work to pre- pare for the federal mandate," says Peggy Staver, director, product integrity. The Pfizer team is continuing to deploy seri- PHARMA MANUFACTURING alization throughout Pfizer packaging lines and is building out a cloud-based IT solution that integrates with the com- pany's contract manufacturers to ensure Pfizer meets the November 2017 compli- ance deadline for lot-level serialization. "For the pharmaceutical industry to meet the 2015 deadline, there's a great deal of work that must be done in a short time frame," Staver says. "Within Pfizer, there are some near-term requirements we need to work toward. We're moving forward with the development of our IT enterprise solution and are reassessing the effects of the new law on our packag- ing lines' serialization plans. While some capital investments required to meet the 2023 deadline may be deferred, we're not slowing in any way." Stephen Kovary, senior director, oper- ational excellence in supply chain and technical operations at Daiichi Sankyo, Inc., says Daiichi's approach to serializa- tion and data aggregation hasn't been affected. However, he adds, "We have reevaluated our implementation sched- ule and have delayed some of those activ- ities based on meeting the new federal legislative date of November 2017, ver- sus the California Board of Pharmacy dates of January 2015 and January 2016. Our focus has shifted to the federal lot- level pedigree requirement, which has a January 2015 due date." SERIALIZATION — PHARMA FACES 2015 DEADLINE By G. Dutton Serialization – Pharma Faces 2015 Deadline G A I L D U T T O N Contributing Editor Pharmaceutical executives are hustling to finalize plans to implement the Drug Quality and Security Act, which became law last November. Although that law was seen as allowing extra time to serialize packaging lines, it actually moves up some deadlines and adds additional requirements that are causing pharmaceutical companies to adjust their serialization strategies and implementation timelines. T " 0 3 1 4 _ P h a r m a _ M a n u f a c t u r i n g 3 . i n d d 1 0314_Pharma_Manufacturing3.indd 1 2 / 1 9 / 2 0 1 4 2 : 4 6 : 3 2 P M 2/19/2014 2:46:32 PM