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Pharmaceutical Manufacturing and Packing Sourcer

Uncommon Codes

With deadlines approaching in Europe, the US, and other countries, pharmaceutical companies and CMOs on both sides of the Atlantic are scrambling to implement viable serialisation solutions to comply with regulatory requirements, such as the Falsified Medicines Directive and the Drug Supply Chain Security Act.

While a lot of time and resources have already been expended on line-site implementation, connecting the dots with sufficient infrastructure – both at the enterprise level and along the ensuing supply chain – is now critical. Today, serialisation compliance clearly affects aspects of a business far beyond the production line. From manufacturing through to the point of dispensation, great demands exist to exchange information between trading partners and stakeholders to address both regulatory requirements and business challenges.

Ensuring Unique Numbers


The life of a serialised product begins with the generation of a unique serial number. When producing medicines for markets where serial numbers are not created and managed by authorities, the need for generating and exchanging serial numbers depends on a pharma company’s size, structure, and business strategy.

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Pavel Lotkov is Product Director for Adents. Formerly with Eli Lilly, Pavel has more than 16 years of information technology experience and possesses a deep understanding of business operations at large pharma companies. As solution implementation and adoption lead, Pavel focused on regulatory requirements and business process analysis, risk impact assessment, system validation, and solution provider management. Pavel was instrumental in providing tactical and strategic support to Lilly’s functional areas impacted by serialisation.
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Pavel Lotkov
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