Drug repackagers face unique challenges under the Drug Quality and Security Act (DQSA), driven by their distinctive position in the pharmaceutical supply chain. One major US drug repackager needed a solution with a wide breadth of features and comprehensive configurability to get in compliance with DQSA so they reached out to Systech for assistance.
Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson. The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.
GS1 Ireland and Enterprise System Partners (ESP) just published an interesting Serialization Industry Readiness Report 2017 . The report is based on their survey of drug manufacturers, CMOs, virtual manufacturers and others who will fall under the European Union Falsified Medicines Directive (FMD) when it goes into effect on February 9, 2019. The readiness survey was conducted between May and July 2017.
Systech is a member and strong supporter of GS1 Healthcare, the global group that promotes standardization in healthcare product and entity identification. On October 17, 2017 in Chicago, GS1 Healthcare held their fall Global Healthcare Conference.
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...