The IQPC Pharmaceutical Traceability Forum is an interactive event that focuses on global serialization regulations and guidelines in the pharmaceutical industry. It provides a great venue for candid discussions about the challenges of implementing serialization and tracking technologies for pharmaceutical products throughout the entire supply chain. Some of the major challenges discussed in the sessions included how to ensure that inaccurate data transfers are caught and corrected and packaging & labeling mistakes. They also discussed aggregation/de-aggregation, and how to find a serialized pedigree for saleable returns.
Compliance Challenges & Breakthroughs
Because the industry is creating the process for implementation and the solutions needed for regulation compliance, it seems that nobody has an absolute “best practice” yet for solving these various challenges. Currently, the DSCSA guidelines primarily speak to the supply chain, but lack the guidance requirements for the dispensaries. At the end-of-the-day, both the FDA and the industry’s goal is to ensure patient safety.
Representatives from industry giants, to small/virtual manufacturers, came straight from a two-day FDA workshop. While there, the FDA worked with solution providers to discuss what their views, system preferences and major pain points were.
From what I learned in these sessions, there is currently no real roadmap for regulation compliance in this industry. The 2023 deadline will provide a strong foundation and understanding of new laws. But more importantly it will create processes needed to provide accurate product traceability for the pharmaceutical supply chain.
The IQPC Forum gave me the rare opportunity to witness members of a competitive industry sitting down at roundtables and discussing difficult topics. By sharing their individual trials and tribulations, the industry is working together. Hand-in-hand, it can lay down the solid foundation needed to track products throughout the entire supply chain. This, hopefully, can solve a major national crisis.