If anyone out there still doesn’t know, from November 2017 all licensed drug products sold in the U.S. must be serialized to comply with the U.S. Drug Supply Chain Security Act (USDSCSA). Similarly, from early 2019, the serialization of licensed drug products will be a legal requirement in Europe.

With the first DSCSA deadline just one-year away, pharmaceutical serialization and traceability is one of the most talked about topics across the industry and in this issue we’ve gathered some expert perspectives from across the supply chain.

To address the challenge of serialization from the contract development and manufacturing organization (CDMO) perspective, we called on Staffan Widengren, Recipharm’s director of corporate projects. He says for many CDMOs the challenge of ensuring a robust serialization process is enormous. For Recipharm specifically, 85% of its production will require serialization. So, with looming deadlines on the horizon, how can a CDMO and its customers work together to face these challenges head on? See what Mr. Widengren has to say beginning on page 50.

For a contract packager’s view on the topic, Gaurav Banerjee, director of technical services at Sharp Packaging Services offers what he thinks are the key steps in assessing a partner network’s readiness for serialization. Starting on page 54 he says in addition to getting an internal support structure in place, the sponsor company needs to critically assess external partners to ensure they have a clear view of their path to serialization readiness.

In addition to the content provided in this issue, serialization will also be one of the keynote presentations at the upcoming 15th Annual Contract Pharma Contracting & Outsourcing Conference and Tabletop Exhibition later this month. On the first day, Sept. 22, Chris Hauck, Allergan’s global serialization program director, along with Dawn Wang, manager of KPMG Life Science Advisory and the Allergan CMO workstream lead, will together present, “Serialization CMO Onboarding: Governance, Process and Lessons Learned.”

Mr. Hauck has extensive experience in pharmaceutical operations and currently is responsible for establishing serialization/track and trace compliance capabilities including internal packaging, third party supply, IT, and supporting business processes. The KPMG team, led by Ms. Wang, has been working with Chris on various workstreams at Allergan, including on the CMO workstream to get suppliers ready to serialize products for Allergan.

With the current and pending regulatory requirements impacting product serialization and track and trace requirements, these two experts will share with the audience why it is important to develop and execute appropriate compliance strategies and project governance to assure continued supply. For full conference information and the complete agenda, turn to the Conference Preview beginning on page 106.

And if you haven’t registered there’s still time! Visit conference.contractpharma.com and make sure you’re a part of the industry’s leading event dedicated to Pharma and Biopharma outsourcing. Hope to see you there!


Tim Wright, Editor
twright@rodmanmedia.com