Will enable Delpharm to maintain existing standards and ensure the adaptability of their solutions for future equipment
Delpharm, a French pharmaceutical contract manufacturer, has announced details of a company wide project to comply with current and pending regulatory requirements pertaining to drug serialisation and aggregation.
Delpharm has installed serialisation and aggregation software from France-based Adents on several pilot lines at four different sites in France and Belgium. Adents’ solution is now operating on more than 80% of the lines equipped for serialisation and aggregation.
Throughout the world, the emergence of new laws and regulations pertaining to drug serialisation is mandating most pharmaceutical manufacturers to implement unit level serialisation and aggregation processes on their packaging lines.
As a leading contract manufacturer in France and among the top five of all European CMOs, Delpharm must provide an exceptional level of flexibility, responsiveness and quality to serve the specific production needs of multiple world-class pharmaceutical companies, while ensuring compliance with current and emerging regulatory requirements, the firm said.
To ensure the production of pharmaceuticals for China, South Korea and Brazil, Delpharm has implemented serialisation and aggregation on several pilot lines in its French sites of Lille, Tours and Huningue, and in its Belgian site of Drogenbos. These lines are already equipped and operating. Additional lines will be upgraded during 2016. Deployment on the remainder of lines will occur in phases depending on future regulatory requirements and customer needs.
In just a few years, Delpharm has built a network of more than 10 sites following the acquisition of production sites belonging to various pharmaceutical companies. As the production installations are constantly evolving to maintain the highest level of service, the contract manufacturer has defined flexibility and cost as decisive criteria in the evaluation of different serialisation solutions available on the market. The level of interoperability and configurability provided by the solutions chosen by Delpharm enable the contract manufacturer to maintain existing standards and ensure the adaptability of their solutions for future equipment.
Christophe Devins, founding partner and CEO of Adents, commented: ‘The project parameters were numerous and complex, both in terms of time of implementation and the level of flexibility needed, given the heterogeneity of the production environment and regulatory requirements related to multiple countries. However, the unparalleled modularity of the Adents Pharma Suite enabled us to quickly and easily meet their requirements.’