Serialization in the pharmaceutical industry requires the individual identification of each individual saleable unit. i.e. each vial or syringe or pack of tablets must have an individual serial number identifying the pack back to source, date and time of manufacture providing full traceability.
Previously legislation only required products to be identifiable to a manufactured batch which can consists of thousands of units. The imminent Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company resulting in a wide reaching programme of business change.
The objectives of Serialization are:
To Prevent the introduction, distribution and use of counterfeit medicines in the global market
To facilitate the detection of counterfeit medicines
To Provide accountability for the movement of products by the supply chain participants
To improve the efficiency and effectiveness of recalls
Business Areas Impacted by Serialization
There is a significant impact on Packaging operations where serialisation data will have to be applied to product packaging at one or more levels. In the more complex serialisation models, this operational impact will extend into the distribution operations in central and/or local markets, where information on individual sale and shipment transactions needs to be gathered and added to the serialisation information. Particularly in the more complex track and trace models, significant IT capabilities will be required to manage serial numbers and track information related to the product and its movement.
Other impacted business areas include:
Quality assurance and control
All these impacted areas need to be assessed for adoption of serialization and the appropriate solutions put in place. Given that these impacts affect many different functions and third parties, there is a high risk that solutions will not work well together unless the design of the overall solution is carefully managed and governed.
Managing Implementation of Serialization
Establish a programme of activity to build organisational and extended supply chain capability.
Be realistic about the emerging nature of these capabilities and build in adequate time and resource to effectively test and iterate solutions.
Design serialisation activities to closely couple related actions to minimise the possibility for errors due to abnormal events.
Design both the normal processes and the regularly occurring non-standard events to avoid product supply quickly grinding to a halt.
Ensure cross-functional teams are established to carefully design the interfaces between departmental and organisational boundaries.
Ensure adequate time is allowed for packaging design changes to be made to accommodate serialisation features required.
As with any other key element of the business. There should be a local senior level sponsor that will take complete ownership for Serialization on site or within the organization. A common misconception here is that it needs to be an IT or a Software discipline that should own Serialization. Serialization is a supply chain solution and function but the means of delivery is via Software and Technology. The ownership should be with the Supply Chain team. One could argue that all departments are in the supply Chain in some capacity. Serialization is a key differentiator in the Pharmaceutical industry and is only in its infancy. The spread and impact of Serialization will continue to grow. A dedicated team will be needed to both implement sand run Serialization as part of the daily work on each site.
Deliver Serialization into your organization with an eye on the market for the next 5-10 years not just to get a system in place.
Assign a senior level owner for Serialization.
Build a cross functional Team with the capability to manage and expand the footprint on Serialization within the business.
Ensure the Success of Serialization in the business forms part of the indivdual and collective goals and objectives for the team.
Respond swiftly and decisively to Regulatory requirements
Implement and practice the same level of control that is in place with other site systems.
For more Information and Guidance on the Implementation of Serialization please email is at firstname.lastname@example.org
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