PROJECT MANAGEMENT

SERIALIZATION: A NEW APPROACH TO IMPLEMENTATION

JEAN-LUC LASNE Written by JEAN-LUC LASNE
06/04/2016

Drug serialization regulations have set the way forward for major changes in the pharmaceutical industry.

Since 2007, when Turkey mandated drug pack identification and aggregation and France mandated the use of a data matrix code to identify all drug packs dispensed in pharmacies, regulations have been appearing throughout the world to battle against drug counterfeit. These regulations have set the way forward for major changes in the pharmaceutical industry which will gradually lead to a fully fraud and counterfeit-proof global supply chain.

In-line code printing

The first step to implementing serialization is the in-line printing of the relevant code and information on each unit pack. The Turkish and French Pharma plants’ early requirements revealed the risks and difficulties linked to in-line printing of a 2D code and it took three years to deal with them. The major challenge was to obtain a high level of reliability at line level in order:

  • To ensure that packs are correctly printed so as to be read with no errors down the line and the supply chain
  • To avoid a decrease in packaging line output

The printing process, using either Thermal Ink Jet technology (TIJ) or laser marking devices, has reached a high level of reliability today, as have the cameras checking the printed code and data. The difficulty was not only how to print and check the codes but also how to maintain timely performance whilst changing the format on the packaging line. Unfortunately, due to the multiplication of product presentations and markets, batch partitioning is an ever-growing trend in the pharma industry, resulting in more format changes, especially for CMOs.

Mark & verify, a new in-line process for the pharma industry

In light of these difficulties, vendors have developed a new type of machine which is dedicated to marking 2D code and variable data – Mark&Verify Modules. M&V Modules integrate a marking device, a camera and an eject station. They aim to secure the printing process whilst facilitating the role of line operators when proceeding to a format changeover. Moreover, these modules are brought into the packaging line once they have been FAT tested, hence reducing the risk of production downtime when implementing serialization. In addition to product identification, industrial anti-counterfeit strategies also rely on product Integrity by means of Tamper Evident labels. Therefore, some Mark & Verify Modules integrate TE labeling machines. An appropriate M&V Module is the first step to the successful implementation of a serialization project.

Mass serialization and data exchange

The second step to implementing mass serialization involves data exchange

Currently, in France, traceability is carried out at batch level. The data matrix code, including the product code (GTIN), batch number and expiry date, is read with barcode readers in the pharmacy. In the future, the unit pack, identified with a unique serial number, will supply a method to prevent counterfeits and reimbursement fraud by making verification possible at the point of dispense. However, the serialization process starts at pharma production by generating, marking, capturing and consolidating data in a secure way. This step involves considerably more stakeholders within the pharma company than the first step – marking and verifying a 2D code and character strings. This stage mainly involves packaging personnel to implement packaging line modifications and item artwork modifications.

Different approaches to serialization implementation

There are two approaches to implementing serialization at a pharma plant level

  1. A bottom-up approach driven by packaging machine stakeholders
  2. A top-down approach driven by Information Technology stakeholders

 

Until now, the first approach has been the most common because it is a straight forward solution that most Mark&Verify Modules vendors provide. It relies on a local database at line level, with each packaging line having its own database and making the data available for the level above which has to then be defined. The second approach relies on a top-down analysis of corporate IT requirements, taking into consideration the features of in-line marking devices and cameras. Naturally, this requires corporate input and therefore all serialization projects should start with the establishment of an executive serialization team. Although the URS is more complex and time consuming to establish, with more time and capital investment required for the first pilot line, the Total Delivered Value (or Total Value of Ownership) using this top-down approach is far superior.

Software companies choose the top-down approach whilst packaging machinery manufacturers prefer the bottom-up approach. Both are complementary and have led suppliers to offer solutions which partially overlap. Currently, no supplier offers a solution which covers the full scope of a serialization application. However, if he collaborates with a relevant partner he will offer more than required.

It is as difficult for a software company to become a packaging machinery manufacturer as it is for a machinery supplier to become a software company. Therefore, the only way for a supplier to successfully implement a serialization project is to collaborate with its counterpart. Since the IT driven top-down approach is becoming more and more frequent among Pharma companies, it will probably require most machinery suppliers to step away from the data exchange part of the project.

For several reasons, implementing a serialization project is even more difficult for CMOs than for Big Pharma Companies.

Serialization – a huge challenge for CMOs

CMOs have to deal with an ever-increasing number of different sized batches and fortunately for them, an increasing number of customers. Format changeovers are becoming more frequent on their packaging lines, impacting productivity and costs, whilst the number of batches to serialize and the number of customers is making data exchange with event repositories more complex. Even though regulations are converging worldwide towards mass serialization, data exchange is likely to increase not only in volume but also in complexity as pharma companies shift from an integrated model to one increasingly relying on CMOs. The performance of their serialization process is key to a CMO’s success in the future.

Major changes within the Pharma industry and the Drug Supply Chain

The number of Pharma production plants and Pharma packaging lines to be equipped with serialization solutions is huge and requires the Pharma industry to invest billions of euros over the upcoming years. Moreover, serialization is leading the way to future applications and smart-apps involving or further involving healthcare systems, patients, medical doctors and Pharma companies. Drug serialization is only the beginning, other industries, especially those where counterfeit product put customers at risk, will follow.

JEAN-LUC LASNE
JEAN-LUC LASNE

Jean-Luc is the Business Development and Alliance Director of Adents in Europe. With more than 20 years of experience working with pharmaceutical companies, contract manufacturers or clinical research sites, he has acquired a deep knowledge of packaging and control technology as well as a a clear understanding of the impact of serialization on the production of pharmaceuticals.

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