A few months ago, the government of the Russian Federation adopted Order Number 791-r, which appears to have significance for pharma serialization there. The primary deviation from the pharma serialization specification that has dictated the government pilot in Russia since early 2017 is the addition of two new data elements to the datamatrix barcode on secondary packaging. For the pilot, the datamatrix barcode contained:
One of the often-forgotten facets of a pharmaceutical serialization project is the requirement to revalidate the packaging line and process during implementation. If companies need to purchase and implement new equipment to accommodate serialization, revalidation is expected. But, like many companies, if retrofitting of existing equipment takes place, validation may not be thought of early enough in the project. In either case, you may end up in a rush to write and execute several...
From now through November 2020, the deadlines for meeting the Drug Supply Chain Security Act (DSCSA) happen every year. The pace of change has accelerated and companies need to remain vigilant to stay compliant. Fortunately, there are three important new DSCSA resources that became available in the last two weeks.
Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019. If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.
President of the Russian Federation, Vladimir Putin, signed a new law the last week of December 2017 that is important for pharmaceutical manufacturers distributing products to or manufacturing in Russia. It establishes January 1, 2020 as
The EU Falsified Medicines Directive (FMD) deadlines are now live. It is now time to reflect on this massive undertaking, and look at some “lessons learned”. We say this, because we are hearing grumblings in the field that serialization implementation projects are still ongoing. Additionally, the data integration requirements require live data connectivity to repositories like the EU Hub. Finally, when companies create new packaging lines, they will need to be equipped for...
Serialization forms the new basis for the ongoing effort to secure the supply chain—most significantly the pharmaceutical supply chain, but also increasingly in other sectors. However, it is only the foundation on which other technologies are built to add this sought-after security. Serialization goes far beyond placing a number on a box. These associated technologies, and the terms used to describe them, are explained here.