With the enactment of the Drug Quality and Security Act, changes are currently being phased into the drug industry and will continue for several more years. This is going to seriously affect the supply chain and the way business is conducted. So what are you doing about it? Let’s go over track and trace pharmaceuticals information and offer some helpful advice on developing an effective strategy.
Overview
Starting in 2017, drug manufacturers must mark packaging with the following information:
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Serial number
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Lot number
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Product identifier
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Expiration date
These things are mandatory and this allows for tracing, verifying and serialization.
Tracing
Soon, drug manufacturers must share transaction information with everyone they do business with. In addition, there are no laws concerning data formats, so this could sometimes be confusing unless everyone gets together and decides on which formats to use.
Verifying
In case there are any problems with a product inquiry, companies in the supply chain must be able to document all information within a 24-hour period. Product dispensers are given 48 hours. It’s important for businesses to have the capabilities of storing and retrieving this information on short notice.
Serialization
With track and trace pharmaceuticals regulations in effect, everything must have a unique serial number. This includes individual products and cases of products. Drug manufacturers are first to be affected (November of 2017). But in time, everyone along the supply chain will have to comply. However, even now, they must be aware of serial number issues in case of product returns.
Developing a Track and Trace Pharmaceuticals Strategy
Perhaps one of the most important things to do, is discuss the matter with everyone in the company. You should consider a track and trace project and someone appointed as project manager.
Training
Try to implement training or education and take advantage of conferences and workshops on the subject. This can help to get everyone on the same page.
Written Statement
Develop a written statement of your track and trace pharmaceuticals strategy. This should be similar to a mission statement and include everything required, along with plans for meeting those requirements.
The Value of Professional Help
Many companies today are outsourcing their packaging for greater efficiency. However, now there are even more reasons to outsource, when you choose a service capable of serialization. The top companies offer end to end serialization solutions for your business and they are in full accordance with the Drug Quality and Security Act. This is the best strategy for maintaining compliance and operating with fewer problems.