Contract Manufacturing Organizations

Pharmaceutical Contract Manufacturer (CMO)

In order to use synergy effects in production and thus save costs, Marketing Authorisation Holder (MAH) often commission specialised contract manufacturers (CMO) to produce their drugs. These enable a differentiated and efficient design of pharmaceutical production through specific production and filling techniques.

In order to contain counterfeit pharmaceuticals, the authorities have established internationally uniform standards (Directive 2011/62/EU and the Delegated Act) for the serialization of prescription drugs. Since 2019, every pharmaceutical package must therefore be marked with a unique and counterfeit-proof serial number. The EU directive provides four indications: PPN/NTIN (01 GTIN), expiry date (17 EXP), batch number (10 LOT) and an individual serial number (21 SN). In addition, the packaging must have tamper evident protection.

For pharmaceutical contract manufacturers, this results in new requirements for the serialization of drug packaging:

  • The data exchange of serial numbers and order picking information with the customer (MAH) must be automated and must be able to be carried out in accordance with compliance requirements.
  • It must be assumed that the systems, processes and formats for data transfer differ. For this reason, complete compatibility for data exchange with all common systems from e.g. Arvato, SAP, rfXcel, Tracelink, Unitrace and Tracekey is required.
  • In order to implement a continuous and secure process, bidirectional data transfer to the production-related systems (Manufacturing Execution Systems/MES) is required. In the concrete application case this means the transmission of the print data to the production line (line or site controller) and the processing of the log data.
  • For traceability and tracking of communication via serial numbers, documentation of all processes in the system is indispensable.

How can the implementation be done?

The IT infrastructure must therefore ensure simple and efficient data exchange with other systems. It requires a system that supports communication both with the client's systems and with its own printing facilities. SecIdent Pharma fulfills exactly these requirements and offers a solution for secure serialization that is precisely tailored to the pharmaceutical industry.

The requirements resulting from the Counterfeiting Directive offer CMOs the unique opportunity to make a greater contribution to value creation through the holistic and secure process, thereby expanding their business model.