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Written by: Ruud Nieuweboer, SAP Life Science Consultant

With the coming ISO IDMP (2016) and Serialization (> 2017) legislation, many pharmaceutical companies are struggling to comply. Some follow an ostrich tactic and some are facing the complexity head on. The latter discover that hidden in this complexity, there are  opportunities in streamlining internal processes (ISO IDMP) and increasing revenues (Serialization).

How, you might ask?

In short, what is ISO IDMP? It stands for Identification of Medicinal Products.  ISO(1) has created five new standards. With these standards it will be possible to better track patient safety issues across countries/ brands and analyze the data for root cause analysis. A key element is the unique identification of the product and all of its substances.

"ISO IDMP will break silos and is a catalyst for harmonizing data."

ISO IDMP is all about data, most of the data is scattered and stored in various systems and controlled documents. For globalized companies, updating their data to a global standard will be a huge task. But, experiences from current projects learn that ISO IDMP will break silos and is a catalyst for harmonizing data. In the end this will result in a streamlined static master data process, where the advantages are numerous. Like reducing costs in administrative processes, better insight in shared materials where for instance substantial supply savings can be achieved. In a harmonized environment, data is also better interpretable especially when static and dynamic data is combined. Here Serialization steps in, this covers the dynamic spectrum of the data.

“With a serialized infrastructure a pharmaceutical company will gain more supply chain insight and become more attractive as a CMO or distributor.”

Serialization is another burning topic within the industry. The key thing about serialization is adding a unique number to the unit of issue (one or more levels beyond the batch level) for prescription drugs. The individual ‘packed product’ needs to be tracked throughout the supply chain to ensure at the point of dispense that the product is genuine and not counterfeit. The legislation will result in many changes  to be made to artwork, controlled documents, it-systems and packaging lines, against high costs without apparent savings or benefits. Is that really true?

The big pharma companies are already in third gear and have the funding and power to make these complex projects work. Most big pharma companies are even participating in the fora that discuss the future operating models for serialization. The mid-size market however is looking for ways to manage these projects at low cost, for example by sharing a platform, or taking a close look at the physical supply chain to see where changes can be made to minimize impact. Although the mid-market is feeling the pressure a business case can be made. Due to a serialized infrastructure a pharmaceutical company will gain more supply chain insight and become more attractive as a CMO or distributor. Investing in a serialized infrastructure is a strategic choice to effectively stay ahead of your competition.

ISO IDMP and Serialization are two main drivers for increasing patient safety, but both also have a big impact on the pharmaceutical companies process and IT infrastructure. The deadlines are deceiving, as they appear to be in the far future. The reality however is that the lead time of these types of projects is long. If the legislative pressure isn’t enough to start now, why not focus more on the possible benefits and create a business case?