From The Editor

A Global Look At Product Protection

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By Trisha Gladd, editor, Pharmaceutical Online and BioProcess Online
Follow Me On Twitter @pharmaonline and @bioprocessol

Trisha Gladd

We all know that serialization deadlines are looming.  While some companies have serialization projects underway, others are still waiting to get theirs started. Whatever the situation, there are still many unanswered questions about product protection, both domestically through the Drug Quality and Security Act (DQSA) and internationally through each country's regulations, and some of these answers are very hard to find (while others are still to be determined).

I recently sat down with two lead serialization consultants from Enterprise System Partners, a global consulting and project engineering company specializing in serialization and MES within the life science industry, to discuss many of the questions they’re receiving from their customers. Liam O’Riordan and Linda Murphy provided some clarity around various aspects of domestic and international serialization legislation and what they mean to you.

Q: How are manufacturers preparing for the US January 1st 2015 lot tracing transaction history/information/statement deadline?

Murphy: Typically, we see our clients assessing how they currently communicate with downstream trading partners whether that is by email, fax, hard copy, or electronically from the impacted sites. Clients are assessing the impact on current warehouse and distribution operations such as the impact to shipping processes, impact to master data, and determining how best to manage the different communication mediums to distribution partners. The DSCSA gives some details on the data that needs to be included in the transaction history/ information/statement, but manufacturers are also watching closely for guidance from the FDA on standards for the interoperable exchange of transaction information/history/ statement in paper or electronic form. The FDA has less than one year (November 27, 2014) to publish this guidance, but the sooner the better as far as manufacturers are concerned.

Enterprise System Partners (ESP)