Clinical Supply Packaging Articles

11. EU Reg. 536/2014's Expiry Label Requirement Forces Us Backward, Not Forward 9/14/2022

    In a world shifting toward advanced technology, the new EU Regulation No. 536/2014's Annex VI is forcing us back into the paper age; specifically, the new requirement to print the expiry date on the primary container label, not just the external carton label. This article describes what is now required, how we got here, and how we can move the industry forward.

12. The Process Map To Ensure Biopharma Raw Materials Supply 8/16/2022

    In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.

13. How To Turn Your Clinical Supply Chain Pandemic Learnings Into New Best Practices 3/10/2022

    Pivoting, navigating, and problem solving in real time during the pandemic has led to many real-time lessons that have evolved into adapted best practices in the global clinical supply space. This article discusses the new demand curve, packaging operations, IRT considerations, and more.

14. Clinical Trials: Envisioning A Future Where Technology Expedites Your Investigational Product's Labeling & Shipment 10/14/2021

    When you assess other industries and companies like Amazon, Tesla, and Coca Cola, each has a commanding use of innovation and technology to ensure they have what they need, when they need it, and that how it gets from pick-to-pack is swift and error-free. Some clinical trials operatives may say, “but they are not required to follow the GMPs” or “we work in a highly regulated industry.” To those, I say: that's an excuse.