The next major milestone under the Drug Supply Chain Security Act (DSCSA) will occur in November 2017 when manufacturers begin to apply identifiers to their products. But, DSCSA requirements don’t stop there. There are a series of milestones between now and 2023 when enhanced traceability is fully effective. Are you ready for serialization/DSCSA compliance?
On the heels of the Healthcare Distribution Alliance’s Distribution Management Conference & Expo, which gathered more than 500 manufacturers, distributors and consultants–we reflect on the key topics and issues that are keeping Healthcare Supply Chain leaders up at night.
From product traceability/DSCSA implementation to the need for wider data exchange across the pharmaceutical supply chain and other pharmaceutical distribution trends, Healthcare Supply Chain leaders came together to engage in operational and strategic discussions at this event.
Preparing for 2017 serialization/DSCSA compliance requirements…
Axway’s Matt Finch, Director of Healthcare Solutions Architecture, spoke on a panel about “Meeting the 2017 Serialization Deadlines” along with other serialization industry experts. The panel provided insight into what pharma manufacturers can do now to comply, regardless of their stage of readiness.
Here are three key insights from that discussion that provide practical guidance to keep in mind in the race to meet this year’s compliance milestone:
- Don’t wait to get to know your CMO: Contract Manufacturing partners play a key role in your serialization initiatives. Don’t underestimate the amount of time it takes to come to an agreement with your Contract Manufacturing partners. This can take as long as the whole integration. Reach out to your CMO’s now. Don’t wait. Have your process well defined and come to an agreement with your CMO. Understand your CMO’s limitations and abilities and make sure your strategies are aligned.
- Recognize the importance of integration: A solid integration strategy is key to a successful serialization implementation. Implementing a repository that connects your production lines, contract manufacturers, 3PLs and others in your network is a basic starting point for serialization projects. Establishing the right integration foundation is vital to facilitating connections and managing data flow between internal applications and your partner ecosystem. Make sure your solution provides the ability to integrate with a complex, global network of supply chain partners and the flexibility to add new partners as needed.
- Don’t make testing & validation an afterthought: Testing and validation of your serialization system are critical. Have you thought through your organization’s approach to testing and validating your serialization system? This is a critical step and should not be an afterthought. Having a sound strategy mapped out and agreed to in advance with your CMO partners will help ensure your organization is ready to meet the November deadline.
DSCSA implementation and its impact on distribution operations…
Axway sponsored an interactive roundtable discussion on the topic of “DSCSA Implementation and its Impact on Distribution Operations.” Discussion topics ranged from the integration of master data into existing databases, to aggregation, and serialized data storage and transfer challenges. Supply Chain leaders from a variety of healthcare distribution companies such as AmerisourceBergen, McKesson and GlaxoSmithKline, shared their perspectives and led the roundtable discussions. This provided a valuable education opportunity and forum to share lessons learned as the industry faces a series of stepping stones in DSCSA compliance between now and 2023.
A look ahead to 2023…
Although the immediate focus is on meeting 2017 DSCSA requirements, it is important for healthcare supply chain leaders to understand future DSCSA requirements around enhanced traceability well before they become fully effective in 2023. It is critical to understand what is required and when and how each DSCSA milestone is interrelated. The effects on your company, suppliers, partners, and customers can be far-reaching, so it is important to anticipate the implications.
For over a decade Axway has worked with leading healthcare companies to reduce the cost and complexity of compliance with global product serialization and traceability regulations. Axway Track & Trace provides organizations with visibility to the data they need to secure the integrity of their supply chain ecosystem to deliver improved quality and patient outcomes.
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