Articles by David Colombo

1. Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements? 10/5/2020

   The initial requirements of the Drug Supply Chain Security Act (DSCSA) were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities.

2. Next Steps For Serialization In The Pharma Supply Chain 7/22/2019

   The industry has made unprecedented progress and addressed several challenges to ensure compliance with global pharmaceutical serialization and traceability requirements. While these requirements contain further regulatory milestones on the horizon, manufacturers, distributors, pharmacies, and other parties in the pharmaceutical supply chain must systematically adopt serialization in their normal business operations.

3. Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now 7/18/2018

   DSCSA has had far-reaching implications in the manufacturing, packaging, and distribution of pharmaceuticals in the U.S. The law's mandates are all scheduled to go into effect by Nov. 27, 2023. 

4. Serialization Data – Who Needs It And Why? 11/18/2016

   As pharmaceutical manufacturers continue to implement serialization capabilities, there is often a failure to recognize key stakeholders within the organization who will require access to serial number data. For some organizational roles, access to serialization data will be needed on a routine basis to perform on-going activities, while for other roles the need may be required as part of an unplanned event, such as a recall, product complaint, or inquiry. To date, the majority of attention for defining requirements and qualifying solutions has resided with the serialization program/project team and has been concentrated on the data exchange between manufacturer and contract manufacturer enterprise systems and between enterprise systems and packaging site/line systems.

5. Are You Prepared For The EU’s Falsified Medicines Directive? 7/21/2016

   Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s Falsified Medicines Directive (FMD) standards immediately, leveraging previous efforts for compliance with other market regulations.

6. How To Streamline Serialization Implementations With Your CMOs 3/10/2016

   Managing CMO serialization implementation is a multifaceted process that requires thorough review and planning across functional teams to best understand all the components necessary for success. Thus, it is important for companies to recognize the barriers they will likely encounter during serialization implementation with CMOs — and plan accordingly.