In the recent webinaire on DSCSA compliance, industry leaders Joseph Lipari, Product Director, Systech, and John Lowry, CEO of Praxis Packaging, provided valuable insights into industry benchmarks, the evolving timeline, best practices and the critical role of Contract Manufacturing Organizations (CMOs) who provide a variety of services, including the production of components, assembly and final product manufacturing specially in the pharmaceutical industry.

Here are the key takeaways:

2025 Industry Benchmarks

Over 100 pharma organizations were surveyed to understand the complex challenges of pharmaceutical traceability in a recent Benchmark Study by Systech in collaboration with Contract Pharma. The webinar highlighted significant takeaways from the industry report related to the existing supply chain track and trace solutions and pain points within the industry:

• Data Integrity Gridlock (42%): The frequency of patches and releases is a major concern
• Rework (41%): Manual intervention leads to inefficiencies and increased costs
• Hidden Costs and Fees (34%): The need for transparent pricing and detailed breakdowns is crucial

Some key insights on user priorities were also shared from the report:

• Compliance and Reliability (81%): Paramount for users
• Seamless Data Exchange (61%): Essential for smooth operations
• Simplified Master Data Management (52%): Crucial for efficiency 

The Next Phase of DSCSA: A Shifting Timeline

Le DSCSA was enacted to create a more secure and transparent pharmaceutical supply chain. Prior to its enactment, various state-level initiatives aimed to achieve similar goals. The FDA has established a phased implementation plan for DSCSA, with specific deadlines for different stakeholders:

• Manufacturers and Repackagers: May 27, 2025
• Wholesale Distributors: August 27, 2025
• Large Dispensers (26 or more FTEs): November 27, 2025
• Small Dispensers (25 or fewer FTEs): November 27, 2026

The DSCSA timeline has been in constant flux since its inception in 2013. The original November 2023 deadline, subsequent stabilization in November 2024 and the latest broad exemption announcement in October 2024. To avoid regulatory issues and ensure compliance with serialization and traceability requirements, pharmaceutical companies must prepare well in advance of these deadlines. Polls during the webinar showed a wide range of readiness, from fully prepared to concerned. 

Praxis Case Study

Systech was selected by Praxis Packaging for track and trace solutions and now benefits from Systech’s full-stack portfolio. In addition to serialization, this comprehensive system includes Systech’s UniTrace  track and trace platform, a turnkey aggregation and rework station as well as Systech Insight™—for line intelligence and real-time performance monitoring. Praxis’ decision to switch vendors was driven by the need for a full-stack solution, cost savings and responsiveness.

John emphasized the importance of partnering with a single vendor for a streamlined process. The benefits include:

• Rapid customization of the serialization process
• Flexibility and responsiveness from both vendors and internal teams
• A CPO focused on quality, compliance, and product diversity
• Agility in managing rework, which is often a fire drill
• Combining primary and secondary packaging processes to leverage serialization solutions
• The importance of addressing the increased rate of rework, due to the ramp up of serialization

Best Practices: Navigating Complexity

To better be prepared to navigate the complexity of regulatory compliance such as DSCSA, Joe Lipari from Systech suggested the following:

• Avoiding multiple vendors to minimize complexity
• Supporting all compliance levels (L1-L5) and global regulations
• Partnering with deep industry experts
• Understanding packaging at the line level to build robust traceability solutions
• Addressing rework and exception management, which are major issues exacerbated by DSCSA
• Providing support to simplify complex processes.

Conclusion

DSCSA compliance is an ongoing journey that requires adaptability and strategic partnerships in which choosing the right vendor with a full-stack solution and a focus on responsiveness is essential. Addressing rework and exception management is critical for efficiency and cost control along with data integrity and aggregation playing vital roles in ensuring supply chain security and efficiency. 

To learn more, watch the on-demand webinar ici.