Counterfeit drugs have become an increasing global threat over the last few decades. More and more regulatory authorities, including those of Argentina, Brazil, India, South Korea, Saudi Arabia and Turkey as well as those of Europe and the USA, have adopted or will adopt requirements for the use of globally unique drug identifiers and serialization in order to protect the supply chain.
End-to-end verification system
Prerequisite for the protection against falsified medicines is the unique assignment of a serial number in conjunction with individual production data as data matrix code (product identification GTIN/NTIN/PPN, expiration date and batch number). This unique serial number ensures the authenticity and integrity of medical products together with seal labels at the top and bottom of folding boxes serving as a protection against manipulations.
Millions of serial numbers – generated by pharmaceutical companies or provided by authorities – have to be organized, printed and sent to national verification processes. Finally, the serial numbers will be scanned on the folding box of prescription drugs in pharmacies in order to start the verification against the central database. Only if the serial number is valid and the medical product is thus authenticated, it will be handed over to the consumer.
Experts expect approximately 90 percent of prescribed medications worldwide to bear a serial number by 2020.
Track & Trace solution requirements
To fulfill these legal requirements and process workflows, pharmaceutical and biopharmaceutical companies need a reliable Track & Trace solution which should provide the following features:
- Compliance with international anti-counterfeiting requirements
- Support of GS1 labeling information
- Management and randomization of serialization numbers in operations
- Management of modular aggregation for e.g. item, bundle, pallets
- Integration with centralized Track & Trace repositories using standards like EPCIS
- Handling of packaging orders and batch information
- Dialogs to create, discard, aggregate and disaggregate units and hierarchies
- User management including rights management & audit trail
- Recording and reconciliation of used and unused serialization numbers
System architecture according to ANSI/ISA S95
According to the internationally accepted ANSI/ISA S95 standard, an efficient Track & Trace solution should integrate level 4 with the packaging equipment and line controllers on shop floor level 2 via standard interfaces.
Level 4 comprises the Enterprise Resource Planning (ERP) for the administration of material master data as well as the Central Repository which is typically responsible for the generation and randomization of serial numbers. The Track & Trace solution must be able to submit these numbers to different line systems of level 2. Please note that in some scenarios no level 4 repository might be required, so that the level 3 Track & Trace solution should also be able to generate serial numbers and act as a long term archive for these numbers at least at site level. Afterwards, the used serial numbers including their status need to be sent back to the Central Repository.
In case of a contract manufacturer (CMO) the customer (Marketing Authorization Holder, MAH) will act similar to the central repository and provide serial numbers to be used by the CMO for his products and reported back to the MAH.
This architecture has to ensure the seamless information exchange in both directions. For example, the production can be immediately stopped due to missing or inconsistent data without manufacturing unusable, i.e. incorrectly serialized products.
Benefits of a Track & Trace and MES integration
The Track & Trace solution can also be directly integrated into a Manufacturing Execution System (MES) on level 3. The benefits:
- Seamless integration of Electronic Batch Records (EBR) and serialization order
- Batch Record Reports (BRR) include serialization data
- Only one graphical user interface for the operator
- Fully automated stock creation
- Central maintenance of material master data
The ERP system links business process areas such as procurement, resource planning, sales, human resources, and finance by means of a common data basis. The central number management system providing the serial numbers is also located on the same level 4. Imprinting individual packages with serialization numbers is one sub-process on level 2.
Implementation challenges for Track &Trace solutions
The implementation of Track & Trace projects will be a great technical and personnel challenge for pharmaceutical and biopharmaceutical companies since it will be touching all departments. Due to missing standards, serialization solutions have to be adapted to existing processes in the internal value chain according to individual project execution methods in the companies. Suppliers have to integrate requirements such as coding, inspection, integration, and data management into existing processes. In addition, pharmaceutical manufacturers fear to generate higher one-off and running costs caused by production outage, additional equipment and upgrades due to the high complexity of fully integrated information systems. It can take about two years from the first planning via process analysis and supplier search through to the implementation and verification of the Track & Trace solution including employee training.
Standardization of data exchange: Open-SCS Working Group
To accelerate the project execution, the development of an open standard is of significant importance. This standard should cover the data exchange during packaging serialization for the entire business transaction. This is one of the main targets of the Open-SCS Working Group, a working group hosted by the OPC Foundation to which Werum IT Solutions is also committed. Open-SCS will define global serialization use cases across all levels. This includes interfaces between levels 2 to 3 and 3 to 4 for level 2 plant (line and equipment) and supply chain packaging serialization activities (distribution centers (DC) and warehouses) and level 3 functions (plant and warehouse operations management).