Serialized products have been around in many industries for decades. Examples of products that have been produced using serial numbers are Cars (the VIN), TV's, Computers, Cellular Phones (IMEI), Airplanes etc. In general, the serial numbers have been deployed in order to link various things to the end product, like raw material and intermediate components, service contracts and events, owner details etc. etc. Very few of these have been used to help reduce counterfeiting.
One thing I often hear is that Aggregation is too complicated to install or that it makes the production process too inefficient. My instant reaction, quite honestly is "Rubbish!!" - being English helps sometimes. :-) In my previous role together with my excellent team and partners (one of whom I now work for) I oversaw and physically installed many or the 80 or so serialization solutions employed. 100% of these contained full aggregation, unit to pallet. The challenge of n
As most readers will know, one of the key rationales for numerous global governments creating their serialization regulations was to fight counterfeits which had been implicated in millions of patient deaths globally. Sadly though, as these regulations take hold and we start to see results - Europe, even though they are not tracing product, have already found 100's of falsified packs in multiple countries and of multiple drugs. So, it's working, right? Well not really! Just
Return product processing The next two segments of the DSCSA will regulate the processing of returned products. These are anticipated to go into effect on Nov. 27, 2019. After which, if nothing changes, it will become illegal to return non-verified products into inventory that are designated for re-sale, unless, they are either verified or grandfathered in (see later). This has serious potential ramifications as the total value of returned products equates to over $4 billion
Over 18 months since the DSCSA (Drug Supply Chain Security Act) came into effect, manufacturers continue to struggle with Post-Serialization Depression (PSD). Even with the FDA providing one additional year of grace period—over 18 months since the DSCSA (Drug Supply Chain Security Act) came into effect for manufacturers—many pharmaceutical companies suffer from Post-Serialization Depression (PSD) or, amazingly, have still not completed their implementation projects. With resp