The good news: The worldwide pharmaceutical industry has agreed that improved patient safety and drug supply-chain integrity are vitally important goals, and serialization regulations are necessary to achieve them.
The bad news: There are no global standards for businesses to follow, leaving organizations to navigate the maze and implement appropriate systems and processes on their own.
Having consulted with many global manufacturers to help them understand and overcome serialization obstacles, here are the biggest challenges as I see them:
- Implementation deadlines: Unit- and case-level serialization is required in the U.S. by November 2017, while the E.U deadline is set for 2019. China and Korea put that requirement in place in 2015 and 2016 respectively. In other words, it’s a world of staggered timelines and a juggling act for anyone trying to stay on top of it all.
- Data Sandards: While some countries are following GS1 standards for creating serial numbers and identifying, capturing, and sharing data, many are not. Coordinating all those formats will require strong oversight and sophisticated systems that are prepared to cope with the conflicts.
- Global partners: It’s not just your company dealing with this global tangle – all of your partners and customers are busy creating their own ways to do business in a rapidly changing regulatory environment. An overarching strategy and communication plan are musts when dealing with such a mish-mash of systems and processes.
Simplify Global Serialization, With the LSPediA Toolkit
LSPediA approaches each serialization project in a unique way – according to the needs of your organization. Our Serialization Toolkits are built on industry best practices and can be deployed as a customizable template, regardless of which country you operate in, ensuring your organization can:
- Lower overall serialization spending by reducing the number of redesigns
- Mitigate compliance risks and reduce recalls with comprehensive, gapless coverage tailored to your specific needs
- Shorten your project timeline by removing trial-and-error process
Plus, our Services offerings cover a wide range of needs, including serialization strategy planning and gap analysis, RFQ and vendor selection, contract manufacturing organization (CMO) management, regulatory compliance and remediation, technology services including process/workflow analysis and requirements definition, and enterprise resource planning (ERP).
For smarter implementation, faster onboarding, and complete control of your global serialization effort, contact me today. We’ll discuss how we can create a customized solution that fits your organization’s needs.
LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.