This year’s results were very interesting because most of the responses came in during the critical time just before the 2015 DSCSA requirements were to go into effect. The questions asked were designed to elicit opinions on a wide range of topics, including the respondent company’s ability to meet the regulations on time, their technology choices and practices. This year the survey was constructed to ask questions that were specific for the respondent’s business, including:
- Pharma manufacturers, CMO/CPOs and repackagers,
- Wholesale distributors and 3PLs, and
A few questions about general topics were asked of all companies including those above, plus solution providers, academics and others that service the pharma supply chain, but are not direct actors there.
Here is a small example. In question 7, we asked manufacturers and repackagers if they have started working on adding the components necessary to serialize the drugs they manufacture or repackage? Fully sixty-five percent of the respondents said that they have:
But when we asked the other 35% of those respondents what has held them up from starting before now, they said things like:
- “We don’t manufacturer products so we can’t change the original packs”
- “Lack of FDA guidance”
- “Newer company & we’ll need to work with our CMO’s”
- “Have been focusing on 2015 requirements first”
And 30% responded with “We only make a small number of products so adding serial numbers won’t take very long”. At least one respondent even selected the response, “We expect the serialization deadline to be pushed out so why invest until we have to?”. Most of these responses are unrealistic and I think some of these folks might end up in trouble in November of 2017.
The survey report is filled with interesting responses like this. Make sure you get a free copy today.
And make sure you sign up for the remaining two free webinars in the series I am doing with Riya Cao of LSPediA. Next Tuesday we will take A Closer Look at Global Serialization and Aggregation, and two weeks after that we will cover A Closer Look at Serial Number Randomization. Register now for each one. I hope to see you online.