One of the often-forgotten facets of a pharmaceutical serialization project is the requirement to revalidate the packaging line and process during implementation. If companies need to purchase and implement new equipment to accommodate serialization, revalidation is expected. But, like many companies, if retrofitting of existing equipment takes place, validation may not be thought of early enough in the project. In either case, you may end up in a rush to write and execute several...
Blockchain, as a technology, has the potential to redefine how business is conducted. Its capacity to be a trusted and secure digital record or ledger has significant real-world applicability. Many different industries are ripe for disruption including any industry involved in supply chain operations. One industry that looks prime for the adoption of blockchain is pharmaceuticals.
From now through November 2020, the deadlines for meeting the Drug Supply Chain Security Act (DSCSA) happen every year. The pace of change has accelerated and companies need to remain vigilant to stay compliant. Fortunately, there are three important new DSCSA resources that became available in the last two weeks.
The face of shopping has changed. No longer are we heading to malls, or even main street to look for electronics, toys, books, personal goods or even food, but instead simply opening a browser. According to studies, shoppers now make 51% of their purchases online, and the reasons for this are varied. We are using our mobile devices for everything now, including shopping. Our confidence in online security is going up, and e-marketing is getting smarter and more targeted.
If you’ve searched online for information about the dangers and risks of counterfeit alcohol, chances are you’ve encountered Safeproof.org. They’ve been researching, writing and informing the industry and consumers about counterfeit or fake alcohol—creating awareness and tracking the global trends. We reached out to Safeproof.org’s Daniel Dachille to ask some questions about these issues, and the answers are eye-opening!
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.
Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019. If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.
It’s difficult to keep up to date on all the milestones and requirements of the Drug Supply Chain Security Act (DSCSA). Because the law contains 10 years’ worth of deadlines and detailed requirements for every segment of the supply chain, it’s easy to get lost and miss what your company should be working on now. Fortunately, most companies need only focus on what is coming up next, while keeping an eye on the long-term requirements. Toward that end, Systech has just introduced the first...
Last week, I received a notice from the manufacturer of my car that the front passenger side airbag of my make, model and year had an issue and recall notice. However, the replacement part would not be available until Spring. Until the part is replaced, nobody can sit in the front passenger seat due to the significant dangers if this airbag were to deploy. What an annoyance, but how great is it that the manufacturer found me to provide the information and warning?