Tag Archives: E.U. FMD

Serializing Product Groupings Under Global Regulations

A “product grouping” is any collection of saleable units of products that are bound together in some way.  They can be “bundles”, homogeneous or non-homogeneous cases, totes, pallets or something like these.  The pharma serialization regulations in some markets call out some of these groupings for special treatment, and some do not.  I’ll try to catalog what we know about product groupings in each of the current, known regulations. Continue reading Serializing Product Groupings Under Global Regulations

How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

Superhero right to leftLast week I published an overly long essay about how the supply chain provisions of the new U.S. Federal DQSA will and won’t protect the pharma supply chain.  Believe it or not, I had more to say on the subject, but because that essay was already too long, I withheld my additional thoughts until now.  Part 1 took another look at a number of supply chain crimes that have occurred over the last 5 to 6 years and attempted to determine how the new Drug Supply Chain Security Act (DSCSA) that is contained within the DQSA will add new protections that will or won’t help prevent crimes like them in the future.

In this Part 2 essay I want to look at the issue in a different way.  I’d like to compare the approach that Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 2

Sponsored: Transatlantic Alignment

Happy Martin Luther King day!  Today we have a special guest blog essay by Mark Davison of Blue Sphere Health in the U.K..   Mark is the author of the book, “Pharmaceutical Anti-Counterfeiting”, published by Wiley in 2011. – Dirk.

BPH.logo-lrg2Pharmaceutical traceability (in its various nuances of serialization, aggregation, track and trace, epedigree etc) has been proposed, debated, boosted and resisted for a very long time. The labyrinthine twists and turns have been examined in near real time on RxTrace and I won’t revisit them here. However, the passing of the Drug Quality and Security Act (DQSA) late last year opens a new chapter.  It means greater transatlantic clarity of future compliance requirements and (whether intentional or not) it also brings near synchrony of some key deadlines. Continue reading Sponsored: Transatlantic Alignment