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The EU FMD deadline of Feb 9, 2019 is approaching fast, with only a year of implementation time left. While big pharma has largely implemented serialization, medium and small manufacturers, as well as CMOs and virtual pharmas, are lagging in beginning their implementation. Knowledgeable integration help is in short supply, as is associated hardware. The newly signed serialization regulation for Russia’s pharmaceutical market adds to the workload in EMEA.

Imagine you or a loved one gets sick. Typically, the first instinct most people have is to see if the illness goes away on its own—like a common cold. If it doesn’t go away or gets worse, you may take the next logical step and get help by visiting a doctor. After visiting the doctor, you receive a diagnosis and a prescription to help pave the way to recovery. Next, the prescription is filled at a local pharmacy and you start taking the medication to get better. This is a shared behavior for...

Last week, Systech participated in the FDA DSCSA Pubic Meeting, held in Silver Spring, MD at FDA headquarters.  The meeting was two days long and was aimed at discussing the possible characteristics of the Enhanced Drug Distribution Security (EDDS) phase under the Drug Supply Chain Security Act (DSCSA) beginning in November of 2023.  The meeting was broken down into four primary topics:

There is a lot of talk right now surrounding the upcoming solar eclipse happening on August 21, 2017, which will be primarily visible across the United States. However, the conversation is less about the eclipse and more focused on Amazon’s recent recall on several “suspect” eclipse glasses that were purchased through the eCommerce giant’s retailers. These “suspect” glasses, as they are being referenced, do not adhere with the ISO standard governing them. While Amazon has not released the names...

On May 4, 2017; THE event for everyone in the packaging industry will start in Düsseldorf, Germany.  THE event is Interpack 2017.

Pharmaceutical serialization has been around since 2005, with Systech being the first vendor to deliver a solution. The market has grown, and international standards are still varied and complex. Implementations and data constructs vary from vendor to vendor. These factors provide several challenges to businesses' supply chains.

Efforts are underway to help standardize.

On April 13, 2017, Automation World Senior Editor, Stephanie Neil wrote an article “Strengthening Supply Chain.” This...

Drug manufacturers who market drugs in Europe will need to begin applying unique identifiers and an anti-tampering device to their packaging by February 9, 2019. Most companies are already aware of these well-publicized requirements of the Falsified Medicines Directive (FMD) and the E.U. Delegated Regulation (EUDR). Systech offers packaging line management and serialization solutions that will allow you to easily meet these requirements. But you might not be aware of the other big requirement...