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Let’s dispense with the guarded and sterile language that has been so painful to observe as the industry ramps up ahead of impending pharmaceutical compliance dates. What CEOs need to know is that it’s highly unlikely their serialization programs are going to proceed on time and within budget. Leaders need to prepare to make some hard choices on the use of limited resources. Planning based on optimism of what is within your control is shortsighted and potentially dangerous.

As an entrepreneur and small business owner I’m an optimist. However, I can’t be the optimist with advice to my clients. My role is to ensure clients have accounted for risk and have plan B and C ready when plan A tanks in spite of best intentions.

Let me be slightly provocative. You can do all of the things the experts tell you, incorrectly assume it will all work perfectly, and quickly fail to meet timing and budget. Your comprehensive and expensive program management and validation plan will not ensure success if it does not account for uncertainty emanating from the volatility of the external environment. Let us explore and learn from a  few examples and make addressing uncertainty front and center for your CEO.

AIDC (Automatic Identification and Data Capture)

Let’s first address expert advice and teachings on AIDC and coding. Most internal and external experts provide practical, fact-based guidance on how to get an A+ when using GS1 keys and data carriers. Standards are good but we’ve come to know that even standards have interpretations that are tripping up companies (see Sidebar). But as an implementer you’re caught in a trap! Get it wrong and chaos ensues outside your four walls as product hits your trading partner systems and can’t be identified and captured. Spend too much time trying to get it right and you’ve blown your timing and budget.

My recommendation? Indeed make that simple one-page guide for the site or CMO. Communicate it broadly and frequently. Most important, be prepared to back it up with some pretty intense hand-holding to enable rapid corrections.

AIDC_SidebarThe CEO’s Questions: Do we have adequate above site resources and expertise to rapidly respond to issues across our internal and external supply network, while maintaining business continuity for existing requirements?

I really like this question because as a leader I can apply it to any area of the business involved in implementation when massive change is required or disruptive technology is being adopted. If it helps us find gaps or weakness ahead of time then we’ve been successful.

Endless Deconstruction of Regulations

Endless deconstruction is the continual re-evaluation of the regulatory interpretation. What makes this potently dangerous is that it’s performed within the context of hoping that what is expensive or difficult to achieve is not true. Hoping the difficult is untrue is a simple recipe for impacting shareholder value – negatively!

It’s also an industry problem. It stems from ignorance on the political and regulatory processes within a market. Large multinational companies understand that which is hidden in the developed economies. They have attorneys and lobbyists in Brussels and Washington keeping tabs on the pulse of the politico. Move to a developing economy and this understanding is in short supply. Brazil and RDC54 is the best example of this. The story behind this regulation would make an engaging Netflix miniseries. Most pharma’s know the Brazil situation and the latest tactical considerations of the current interpretation even though they’re clueless as to why this regulation came about.

Why is this level of understanding important? Because law makers and regulators across the globe are tuned into what’s happening and seeing tremendous opportunity to raise corporate tax revenue under the banner of patient safety, and by so doing stay in power. There’s nothing wrong with this political strategy for law makers and politicians – it is for the common good. But if you are ignorant to the underlying strategy and various agendas it will handicap your efforts to influence.

regulation_deconstructionThe CEO’s Question: Do we sufficiently understand the regulatory and political environment of the markets we serve in order to effectively influence today and comply when necessary in the future?

If you’re uncertain about this aspect and need help getting started or enhancing what you have, let’s chat.

Are you Ready for the Industry-Wide Exception Handling Nightmare?

The last topic to address is a hefty one. The exception handling nightmare I have predicted for years is still largely sidelined or avoided entirely. None of us in the trenches want to be responsible for an embargo of non-compliant product or a shortage. But that is exactly what is going to happen with serialization implementations.

This problem will affect any serialization solution where interoperability is required across 2 or more trading partners. Aggregation is rarely required by law, but becomes necessary due to the traceability and information requirements combined with the need to maintain an efficient supply chain. I expect the largest impact to fall on markets where the regulation requires or implies reliance on aggregated parent-child relationships across packaging levels. I say this because aggregated product is not opened and verified at every change of ownership on its journey to the patient. It’s the retail pharmacy that is most likely to encounter an exception when they’ve opened a homogeneous case and find the contents do not agree with the electronic record.

As a manufacturer you can’t avoid this problem even if you’re operations are six-sigma. So my advice is to plan for it and aggressively engage your trading partners. Start with the typical use cases on pick, pack and ship and then receipt, unpack, verify, etc. Suffice it so say all of the large wholesalers (US) are quite aware of exception handling problems with serialization – most of them have piloted with manufacturers and experienced a variety of root causes.

Exception_handling_shelter_fromthe_stormThe CEO’s Question(s): Are we ensuring our supply practices on serialization will adhere to the highest levels of accuracy? Do we understand the impact to our people and operations, our trading partners and our patients when product cannot be supplied due to serialization errors? What can we be doing today to ensure our serialized products make it to our patients efficiently and accurately?

The second question is intentionally broad for a reason. One overlooked area is that of the people within your four walls who will have to deal with the exceptions on a daily basis and identify root causes and implement CAPA. Do they have the additional hours in the day to investigate and remedy what will be a new, and somewhat pervasive, supply chain problem?

I hope this article has helped you and your leadership think more broadly about Serialization and the realities of implementation. We’d love to hear how your pro-activity on these topics has helped you anticipate and avoid delays and budget overruns.

Goodbye for now. Drive fast and take chances! OK, maybe that was a little too provocative.

Be safe and swing for the fence every time.