Former AstraZeneca engineer and serialization specialist, Ian Haynes, looks at the first practical step contract manufacturing organizations need to take to implement a compliance strategy ahead of the impending serialization deadline.
Increasing concerns are being expressed by industry observers and top-tier pharmaceutical manufacturers that contract manufacturing organizations (CMOs) will not be ready to comply with emerging track-and-trace requirements.
This is a major worry for big pharma, and indeed any marketing authorization holders who depend on the CMO sector to manufacture their products. Their ability to comply with the emerging requirements is not only contingent upon in-house capability, but on the capability established within their extended supply chain, contract manufacturing, and indeed third-party logistics providers.
With more than 80% of sales for a typical pharma company being affected by these requirements by 2018, pharma companies are taking steps to protect their business by identifying and evaluating the risks within their supply chains. This situation highlights the role CMOs play and the importance of dealing with the risk they present.
CMOs are typically graded in terms of the likelihood that they will establish capability in time—some are held to ransom with early compliance deadlines set to force action. For others, where risk of failure is considered too high, plans are laid to move manufacture to more capable suppliers. In the case of low-value products, where capability is doubtful and tech transfer cannot be justified, range rationalization can be the chosen solution: the product may be manufactured until the deadline is reached and then abandoned.
In all three instances, the impact on the CMOs is significant, and whilst a small number of the more enterprising CMOs are identifying the business opportunity this situation presents and establishing capability early, it seems inevitable that some, maybe many, of those delaying implementation will fall by the wayside.
So why the delay? A roundtable meeting held earlier this year in Pennsylvania, to gauge the readiness of the drug industry, suggested a range of reasons. Amongst these was the suggestion that manufacturers may simply be at a loss as to how to get started with their implementation programs, and the solution proposed was to create a serialization tutorial/best practice guide. Similar arguments about a lack of useful guidance have been raised in other circles and industry working parties.
Detailed guidance and training events are, however, already available. A lack of guidance cannot be cited as the reason for the failure to enact a timely and credible response. We believe that the real reason is more fundamental.
The well-known change equation, refined by Kathie Dannemiller in the 1980s, informs us that even with a clear vision of a serialization-compliant future, clarity about the first practical steps is critical. Stakeholder engagement has long been cited by experienced industry commentators as the first, most important, and most difficult step.
Breaking down the unwillingness of senior stakeholders to engage in the challenge of serialization and indeed keeping them engaged through the twists and turns of the implementation program turns out to be the biggest challenge facing program managers today. We believe this is where the problems lie.
A recent LinkedIn discussion about serialization events asked “Which ones are useful and which ones are not?” Clearly, those that recognize the issue of stakeholder engagement and give clear practical advice on how to achieve it should be top of the list.
So the question is: are your stakeholders engaged yet? And if not, it’s high time to get them to that position—time is rapidly running out.
Ian Haynes is a serialization expert and thought leader in coding and serialization for the pharmaceutical industry. Along with partner Christoph Krähenbühl, he runs 3C Integrity, a specialist consulting firm that currently offers two-day training programs to fully prepare pharma companies of all sizes for implementation.