Friday, May 11, 2012

When is a Pilot not really a Pilot?

First a quick note- Congrats to EXLPharma for putting on a successful serialization and traceability conference in Philadelphia this week.   The existence of such focused workshops and conferences is yet another positive sign the industry is doing the necessary legwork to connect with industry peers and gather what's been learned to date.

The topic for this post came in part from this week's conference.   A very popular trend among pharma's taking on serialization is to run a 'pilot' to gain education and experience with how to operate in a serialized world.   I am all for the concept of pilots and agree they provide invaluable experience.   However I have a growing concern that these 'pilots' are too focused at the packing line level alone and not with core process integration.  As an analogy, my view is that serialization needs to be as core to a packaging/distribution processes as batch records and QA checks. 

Take this simple scenario:  How many pharma companies running pilots today would actually stop an order from shipping solely because a serialization related issue exists?    Or even go one step back:  How many companies would even know they have an issue with their serialization data prior to shipping product? 

In a still largely unregulated world- the reality is product supply, getting product out the door, will always trump serialization.   I completely understand this- in an unregulated environment- but highlights my concern that companies are not designing their serialization solutions to directly integrate with their core packaging and distribution processes. We all know it will have to be that way eventually- so why not at least plan for it from day 1?   

The interesting twist on this topic is that outside of pharma, high tech as a perfect example, the integration of serialization with core manufacturing and distribution processes is found in the earliest business requirement documents- and this in an industry that's not being told they have to do it.

The industry is already hyper-sensitive about process efficiency impacts due to serialization (which I'll expand on in an upcoming post) yet hasn't even reached the point in the maturation of serialization solutions where process impacts may be the greatest. 

My suggestion is to plan for a fully integrated serialization world, even if it means you dont stop shipments until required, by having the technical components to identify serialization issues and the SOPs to handle these exception scenarios.  This will help companies ensure that January 1st, 2015 (or whenever) is truly a non-event.

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