Taking the First Steps: Where to Focus and What Resources Are Needed
Both U.S. and European mass serialization regulations require an integrated flow of information across the end-to-end supply chain, with related technology components for labelling, data capture, control and reporting. Irrespective of the regulations and the business drivers for a safe and secure supply chain for the life sciences, there is one thing that none can dispute – this is not an easy task!
In common with other industries (electronics and automotive, in particular), the pharmaceutical industry now includes a multitude of players across an increasingly outsourced network of transformation and distribution partners. As such, when defining strategies and approaches for something as important as an information system to share data at the product and transaction level, it is critical to take a holistic view. Although current mandates and programs are initiated at the finished product manufacturing point, it is prudent to consider future needs for a more granular perspective, to include visibility to product ingredients and components and potentially final consumption and/or return and destruction. (An important point as the FDA has emphasized the value of serialization for product recall).
In my previous writings on the subject, I suggested that a cross-functional team should address these challenges and issues, developing detailed process maps and overviews to identify check and choke points. These should be reviewed for potential hazards and development of proactive remediation strategies. This is still the best way to review each of the different supply chain models and evaluate the risks and opportunities across the flow of materials, flow of information, and the related change of ownership across the cash-to-cash cycle.
The requirements for compliance with the DSCSA (and related EU Falsified Medicine Directive) are extensive. The best approach is to establish a dedicated project team, including cross-functional representation for consultation and ensuring that all key stakeholders are part of the requirements definition and review process. Collaborating with all participants across the product lifecycle will enable a more holistic view of data sources, as well as users of data that could facilitate process transformation. Entering a mass serialization program is costly, both in terms of cash and resources. Careful consideration of both direct as well as indirect benefits of such a program will facilitate a richer return on investments (ROI) proposition.
Entities – internal as well as external – that could be included in identifying issues, opportunities and potential constraints include (but are not limited to):
Internal participants:
- Procurement and finance personnel
- Product development/product management
- Marketing and sales
- Customer service and support
- Manufacturing
- Environmental health and safety
- Packaging
- Quality and industry compliance and validation
- Risk management
- Storage and distribution
- Information technology personnel and partners
- Legal entities (internal and external legal counsel need to understand implications of data sharing, confidentiality and intellectual property protection)
External supply chain participants
- Suppliers (direct and indirect suppliers of raw materials, components and packaging materials)
- Outsource manufacturing partners, packaging and repackaging facilities
- Logistics service providers (carriers, freight forwarders, customs house brokers, trade and finance partners)
- Distributors, pharmacies and dispensers (specialty pharma and within clinical operations)
- Customers (distributors as well as final consumers)