What is E-Pedigree Serialisation

If you are not in the pharmaceutical business, but are looking to learn you may have a bunch of questions. These questions can seem like stupid things from those who are more knowing of the field, but to us laymen they are important and essential information. We want to understand all there is to know about pharmaceutical packaging companies and packing services. We want to know about clinical storage and distribution as well as blister pack packaging. But before all that, you must know a little about e-pedigree serialisation.

What is e-pedigree serialisation? It is simply the need to know all of the information about a drug product and its history. That includes the sales history of the drug, the trade of the drug, the names and addresses of anyone who’s ever been a part of a transaction that involved the drug. All of this is necessary when it comes to a pedigree.

Then, of course, the e part of e-pedigree goes for electronic. That means that all of this information must go into an electronic document. That can make for easier access and availability for all of the information necessary. More parties can see that information and make appropriate actions necessary when they have seen it. That makes for a better pharmaceutical environment over all.

In fact, the government has made it so that it is next to impossible not to have an e-pedigree for any drug product. Specifically, in the 2006 Compliance Policy Guide for the Prescription Drug Marketing Act, the U.S. Food and Drug Administration (or the FDA) made stated that all of this information was necessary for the marketing of these drugs. The statement goes as follows: “A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.

All of this is to say that in the pharmaceutical world, it is best to have all of your information as transparent as possible. This helps to prevent any litigation against your work and helps to make all processes and transactions smoother.

Congrats, you know know a little bit more about the pharmaceutical world. What do you want to learn next?