pharma, pharmaceutical

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company.

The most obvious include:

• Regulatory and legislative management and government affairs who will have to understand new emerging requirements and represent the company in external influencing and governance bodies.

• Packaging operations, where serialisation will have to be applied to the product packaging at one or more lines.

• Distribution operations, where in the more complex serialisation models, this operational impact will extend into these 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.

• IT, particularly for the more complex track and trace models, where significant IT capabilities will be required to manage serial numbers and tracking information related to the product and its movement.

The serialisation strategy of a company and the resultant serialisation service that delivers and maintains the capabilities required, needs to ensure that the requirements of legislation are thoroughly understood and that appropriate capabilities are defined to meet those needs. These capabilities must then be implemented effectively in a timely manner to ensure product supply is maintained. Once serialisation capabilities become available, companies can then look to leverage them for product security and other benefits that are not directly driven by legislation.

In this and subsequent articles, we will outline a series of tips, based on experience we have gained working on multiple serialisation programmes, to help develop and implement your serialisation strategy.

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Tip 1

Identify and interpret the emerging and evolving legislation

Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, incomplete and sometimes contradictory. Interpreting the legislation and predicting its impacts can present significant challenges, requiring specific serialisation knowledge as well as new legislative relationships with local legislators.

This is further compounded when considering the timelines allowed in the legislation. History has shown that timelines are often vague and subject to change. However, when implementation dates are finally set, they often do not allow enough time for robust implementation.

Given the uncertainties in requirements and timing, organisations need to ensure there is a clear way of communicating their considered view of the legislative requirements at any particular moment. Failing to do this will potentially result in individual functions or groups creating their own interpretations, which at minimum is wasteful of resources, but at worst results in capabilities being implemented which do not meet the eventual requirements of the legislation.

Tip 2

Understand the full impact of these multiple pieces of legislation on the company and product supply chain

Serialisation presents a potentially broad impact on a typical organisation. It is important to engage all of the potentially impacted parties early in the impact assessment phase to ensure that comprehensive solutions can be defined.

A further challenge is that multiple pieces of evolving legislation will often impact many of the same capabilities. Understanding these potential impacts and their likely evolution over time is key to ensuring effective solutions are defined and implemented in a timely manner.

This concludes the first article in the series. In following articles we will outline tips 3 to 10. We hope you find this information useful.

pharma, pharmaceutical

Tips for your Serialisation Strategy

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