Countdown to Cali-serialization

Coordinating with Contract Manufacturers/Packagers: Contract manufacturing and packaging organizations (CMOs/CPOs) will be required to meet the needs of a larger customer base for ePedigree and serialization solutions. To successfully achieve an effective and validated solution, CMOs will need to limit the technologies and system solutions that they implement and offer to their customer base, or else it will make their production lines drastically over complicated. There is a significant amount of design work for the production lines that is involved to satisfy the requirements of the implemented serialization and ePedigree solution. For both the contracted organization and the company to be satisfied, the needs of both parties need to be rationalized and balanced to form a successful compromise that fulfills all requirements. By now larger customers, such as big pharma, will have already leveraged their significant business relationships to try and force their specific systems on CMOs; CMOs will push back, yet are more likely to consider the preferences of early adopters and significant business partners.

It’s clear that California serialization and pedigree legislation will force pharmaceutical manufacturers to initiate and implement a plan of action in 2013 in order to meet the January 1, 2015 deadline. Many large-sized pharma companies appear to be well on their way; however, smaller and mid-sized virtual pharmaceutical manufacturers need to quickly mobilize resources and ramp up implementation. Without robust internal functional groups, smaller pharma should look to their external partners for guidance, as well as other experts and resources in this field.

Ultimately, many questions still remain for the industry and the CBoP’s regulation. Here are a few issues yet to be decided:

• How will the regulation be enforced and serialization monitored by the California Board of Pharmacy?
• What is the definition of an “offense”; is each saleable unit that is un-serialized or without a correct ePedigree considered a single offense?
• Will extensions be given for those companies that are unable to meet the deadlines? Specifically, if a company acquires a new pharmaceutical company in 2014, which has not made any effort to serialize their products, will there be an exclusion or extension for the acquiring company to allow additional time for them to get the new products compliant?  
• What is the policy for grandfathering inventory that was brought into the CA supply chain prior to January 1, 2015?

References:

1 Weaver, Christopher. “Illicit Botox Sparks Alert.” The Wall Street Journal. http://online.wsj.com/article/SB10001424127887324731304578193990868029934.html . December 23, 2012.

About the Authors
Bill Connell is Vice President and Supply Chain Practice Leader at Maxiom Group. He brings extensive skill and experience in supply chain strategy, design and business process development at both small and large clients. Bill has over 25 years of industry experience and consulting, most recently as Senior Vice President of Global Supply and Operations at Iroko Pharmaceuticals/Iroko Cardio. Bill has worked on projects including ePedigree, supply chain network design and optimization, contract manufacturer (CMO), third party logistics (3PL) and distributor selection. He received his MBA from the Indiana University of Pennsylvania and his BS from University of Maine. Bill can be reached at bconnell@maxiomgroup.com.

William (Bill) McLaury is the Head, Pharma Supply Chain Strategy for Novartis Pharmaceuticals.  He is responsible for developing and aligning Pharma Supply Chain strategies globally as an integral part of Technical Operations and for the development of a Supply Chain Academy curriculum. Previously, Bill was Executive Director, Pharma Supply Chain North America for Novartis. He was responsible for the supply of all of Novartis’ branded pharmaceutical products in North America, leading the groups with operational responsibility for production planning, warehousing, transportation, distribution, international trade management and product portfolio management.

Julia Wiest, Senior Supply Chain consultant, provides clients with supply chain project management, supply chain functional expertise and support.  Julia comes to Maxiom Group from Johnson & Johnson, where she was a supply chain project coordinator at the Ethicon Inc. medical device franchise.  She has a BBA, specializing in Finance, from the University of Michigan and an MBA, concentrating in Supply Chain Management.

To be published in the April 2013 issue of Pharmaceutical Manufacturing magazine.