Issue link: https://www.e-digitaleditions.com/i/977310
10 May 2018 Tablets & Capsules who must comply with their clients' requirements along with the requirements in each of their clients' markets. Meeting global requirements Because of these varying local standards, manufactur- ing and packaging companies will need to develop and apply a global strategy for generating and assigning serial numbers that's compatible with multiple in-house pro- cesses. Companies must also establish processes to man- age and store these serial numbers. To meet these needs, a serialization and aggregation solution must be highly flexible and modular. It must be able to mass-serialize the packaged product, verify the codes, and apply labels or tamper-evident seals to the packaging. Also, the software controlling the entire process must be easily integrated into existing IT infrastructures and the data must be retrievable at any time, providing producers and dispens- ing points an exact overview of all the steps in the manu- facturing process. to clearly indicate whether a package has been previously opened or tampered with. Many other countries are developing and implement- ing serialization laws as well. In the Middle East and Northern African (MENA) region, efforts to ensure drug traceability are already underway. Saudi Arabia, for instance, initiated the first phase in March 2015, with obligatory data matrix codes on pharmaceutical packag- ing. Phase two—actual serialization—came into effect in 2017. While phase one only required a machine to print data matrix codes, phase two required producers and packers to have machines for serialization as well as an IT infrastructure to generate the serial numbers. Russia and other Eastern European and Eurasian countries will be introducing similar regulations and laws within the next few years. These various national and regional anti-counterfeiting laws all have the same purpose, but they contain some fundamental differences that impact the requirements for both local pharmaceutical companies and importers. The EU, for instance, assigns special importance to tam- per-evident seals, while other regions such as the US focus on aggregation very early in the implementation process. While these serialization laws might be seen as regional, they all have a global impact. Large pharmaceu- tical companies often operate manufacturing facilities in many different countries and export their products all around the world. For these companies, it would be very short-sighted to equip packaging lines to meet the requirements of just a single local standard. For example, if a large generic producer from the MENA region sells its products not only in the local mar- ket but also in Europe and the US, its packaging must conform to several different serialization standards despite the fact that most of the products are packaged regionally. The same applies to contract packaging organizations, Photo 2: A holistic serialization solution will be able to print and verify labels on bottles and apply "helper codes" to bottle bottoms or caps, if required.