The previous post ‘Understanding the five pharmaceutical supply chain stakeholders’ reviewed the different stakeholders and how they are connected together to support serial number authentication and traceability. This post discusses the importance of GS1 standards and the wider impact to the enterprise, beyond just printing a 2D DataMatrix barcode label.
The choice of GS1 Standards for pharmaceutical product identification and marking has been driven by a broad number of factors, notably:
Patient safety – globally unique codes for certainty of product identification
Interoperability – the solution must work across markets, stakeholders and sectors
Simplification – a single solution that can be used across all levels of packaging with the option to choose the appropriate symbology
Technical suitability – robustness of the data carrier and the ability to print in-line
Cost-effectiveness of solutions – appropriate to the needs of users
Flexibility and future compatibility – part of an ongoing standard which will not be superseded
A proven solution – already used in retail and other sectors worldwide.
By taking advantage of GS1 standards, interoperability of data with contracted partners can be achieved, enabling information to be shared based on four types of events:
What products are impacted?
When did this time-stamped event occur
Where was the product and where is it now?
Why was this observed and at which process step?
However, there is more to serialisation than simply printing a label and affixing it to a package; while the root of the serialisation programme is at the packaging line level, successful execution requires a holistic approach.
Reviewing the systems and data landscape
The European Medicines Verification Organisation (EMVO) is the guarantor of patient safety in Europe, responsible for advancing the formation of the European Medicines Verification System (EMVS). The EMVS ensures the implementation of a functioning, secure, inter operable and cost-effective system to support the obligations of the various stakeholders of the life science supply chain across Europe. Manufacturers or Marketing Authorisation Holders (MAH) will need to report their product data in this system, which will then be further distributed to the various National Systems (NVMS) in the countries where the products are distributed and sold.
In today’s global supply network serialisation is, at heart, a network data exchange problem: pharmaceutical companies will be required to connect their internal systems to the centralised EU data repository by 9thFebruary 2019. Once connected, the data repository will contain the product master data and batch-specific information. The net result is that any serialisation programme will require an effective coordination plan involving both upstream and downstream trading partners to enable traceability of products in the supply chain.
The role of ERP and WMS
EMVO requires manufacturers to supply a wide variety of master data including regulatory, manufacturing and logistical data. In practice, most manufacturers locate different data in different systems, such as enterprise resource planning (ERP) , warehouse management systems (WMS), quality review documents (QRD) and more. That means organisations will need to verify the readiness of their ERP system as a master data repository, and may also need to upgrade their WMS, since the impact on warehouse activities is often overlooked. Operations such as receiving returns, picking, packing, shipping and rework will all increase in complexity, and it will become too labour-intensive and costly to scan and manage compliance data by hand. Managing the warehouse flow with paper and/or manual legacy systems will no longer be an option.
This creates an imperative to centralise the management and monitoring of serialised product data at the edge of the supply chain, to reduce operational risk. It therefore pays to evaluate whether existing WMS or ERP systems can go beyond merely capturing data to providing architectural support for the functionality, scalability and product timing complexities of serialised distribution and warehousing.
Many wholesalers will expect manufacturers to aggregate serialised product at the item level to parent containers with a serial shipping container code (SSCC) identification. This introduces inventory tracking and management challenges that increase the risk of delays to warehouse operations. To maintain compliance without sacrificing efficiency, companies will need scanning technology to capture changes to aggregation hierarchies and then send the updates back to the serialisation system of record.
For more information download the brochure