Serialization of medicinal products, especially in Europe, can incur significant costs for manufacturers owing to stringent regulations that require manufacturers to apply unique identifiers to each package. According to the Directive, 2011/62/EU and the associated Delegated Acts require that the identifier is printed clearly and has a data matrix code. Moreover, pharmaceutical companies that market authorization holders are also required to deliver serialization data from their products to a European Center.
To adhere to all these requirements, medicinal product companies require massive economic, organizational, and cultural effort. Owing to this, a number of companies are focusing on ways of spinning this as a form of a healthy return on investment opportunity. An instance is Molteni Farmaceutici, an Italian company specializing in the R&D and the production of pharmaceutical products. The company has recently collaborated with Rockwell Automation and is using serialization as a way to spur modernization practices in its manufacturing processes.
With the collaboration, Molteni Farmaceutici has achieved a highly scalable, flexible, and modular manufacturing execution solution that can allow the company to incorporate the widely different sets of regulations across European countries and other regions when it comes to marketing of medicinal products. For meeting the needs of their client, Rockwell Automation developed a complete solution for serialization. The solution combines several components that have been built on the platform of Molteni Farmaceutici’s off-the-shelf PharmaSuite and has all the necessary functionalities required to cater effectively to the specific requirements of the company.