More and more countries are introducing regulations for the serialization of pharmaceuticals. South America is no exception. With around 422 million inhabitants, the continent has a population similar to the European Union and, with its emerging markets, is developing into an attractive market for exporters. Following our article on serialization in Brazil, here we summarize […]
With consolidated shipment data (German: WBDL), hospitals can be relieved of a lot of work. Due to the EU Falsified Medicines Directive (FMD), just like in conventional pharmacies, all packaging of prescription drugs in hospital pharmacies must be scanned twice to guarantee their authenticity. The first time at delivery and then again at dispensing. WBDL […]
For Marketing Authorization Holders (MAH) and Contract Manufacturers (CMO) in the pharmaceutical industry, serialization is a recurring topic. Each batch must be provided with codes, which must be generated beforehand. For companies with high production frequency and generally more resources, this is usually not a problem. Since it is a regular task, one does not […]
Read More… from Serialization Simplified – tracekey Serialization Manager
Beginning November 27th, 2023, FDA’s Drug Supply Chain Security Acts (DSCSA) requirements will change. In the future, pharmaceutical products in the USA will be required to be traceable at the lot and package level. Moreover, part of the regulation also states that all parties must participate in data exchange, verification, and tracking of pharmaceuticals. For […]
The cloud has become omnipresent. Whether we are streaming media, communicating with friends and colleagues, or simply storing data. Almost everything is done via cloud providers. But it often sounds like a buzzword to make something more interesting than it actually is. What exactly is the cloud? What types are there? And is it secure? […]
There are many reasons for marketing authorization holders (MAH) or contract manufacturers (CMO) to inevitably deal with serialization during ongoing operations. May it be to increase production capacity, to connect to a new business partner or any other of many possible reasons. These new conditions can raise some questions. Do I simply increase capacity with […]
As the country with the largest population, China also has one of the largest pharmaceutical markets in the world. In 2020 nearly 35 billion U.S. dollars were generated in pharmaceutical imports, and the trend is upward. In order to counteract counterfeiting and protect patients, the regulations of pharma serialization in China were adjusted in the […]
How does the cooperation between tracekey and the Level 1-3 providers work? We talked to one of our customers, Stegemann Lohnverpackung & Logistischer Service e.K. and the line manufacturer and Level 3 provider Mettler Toledo about our joint processes and work. The complete implementation of pharmaceutical serialization requirements, such as the EU FDM, includes not […]
Read More… from Case Study: Stegemann (CPO) together with Level 3 partner Mettler Toledo
Efforts are being made worldwide to stop the dangerous trade of counterfeit medicines. To tackle this problem pharmaceutical serialization laws have now been enacted in numerous regions all over the world. Depending on the statutory requirement, serialization in the pharmaceutical industry is enforced differently. What all regulations have in common is the assignment of a […]
Alert Management & EMVO AMS | Alerts keep the industry busy – ever since the start of the active commissioning of the serialization activity. The system, which is supposed to protect patients from counterfeit medicines, produces many error messages from the very beginning when verifying medicines in the pharmacy. These are almost exclusively false positive […]