As a traditional or virtual drug manufacturer, you’re probably relying on contract manufacturing organizations (CMOs) for things like formulation development, clinical production, commercial production, or other services. The use of CMOs grew six percent in 2014, and for good reason: CMO partnerships make good business sense. Relying on their operational and technological capabilities allows you to focus on your own strengths in research and development.
But I’ve seen first-hand that something vital to both your businesses – and to patients – could be falling through the cracks of that partnership: DSCSA serialization regulations.
Serialization Is Hard for Manufacturers – But Even Harder for CMOs
The FDA has put the ultimate responsibility for serializing drug products on you, the manufacturer, but your state of compliance can be completely at the mercy of your CMOs. And while serialization must be a joint venture, the manufacturer needs to control and lead the project. Here’s why:
- A CMO relies on you, their manufacturer customer, for guidance. If you’re confused, your CMO is only more so. As a service provider, I’ve encountered many situations where both parties are looking to the other for guidance, resulting in stalled projects and expensive miscalculations.
- Serialization demands responsibility and accountability. While agreements between you and your CMOs define regulatory accountability and quality responsibility, they don’t cover the details of serialization. CMOs are aligned to to take your designs and process specifications and execute on them. They are not aligned to take on responsibilities that were not initiated, agreed on, or defined.
- Serialization requires significant people and capital resources. These resources are available to manufacturers, but not necessary to CMOs, especially the small- and medium-size CMOs.
- CMO communications with manufacturers are notoriously loose – if not downright flawed. Poor communication in a serialization capacity will have major negative implications, including missed deadlines, overblown budgets, regulatory fines, and general disorganization.
Partner with LSPediA for CMO Management and Regulatory Compliance
The next set of DSCSA deadlines are on the horizon: Distributors will not purchase any non-serialized products beginning in 2019, but with inventory turns, the true stop-order date for non-serialized products is much sooner – which means you need to start your serialization efforts today.
- Conducting IT and process gap analyses
- Establishing a single source of truth for product master data
- Creating detailed roadmaps and project plans
- Ensuring CMOs stick to agreed-upon deadlines and responsibilities
- Designing and optimizing packaging, QA, and warehouse processes
And the benefits you gain by partnering with us go beyond the serialization process, extending across your organization to:
- Lower overall serialization spending by reducing the number of redesigns
- Mitigate compliance risks with comprehensive, gapless coverage tailored to your specific needs
- Shorten your project timeline by removing trial-and-error process
Contact us today and we’ll create a serialization strategy that’s right for your manufacturing business and tailored to your CMO partnerships.
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.