Factors to consider as your organization works to conform to the serialization guidelines.
Still looking for a serialization solution? Implementing a mandated system may seem like drudgery. In this case study, you will learn how one contract packaging company took a different mindset and embraced the benefits of track and trace capability.
Determine your plan now for serialization readiness to put the worries of DSCSA costs and timelines behind you and patient safety back where it belongs — at the forefront.
Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.
Has laser coding reached its limits? No. This paper provides evidence and demonstrates that there is still huge potential for laser coding to remain the ideal choice in the pharmaceutical sector.
Item-level serialization gives each box or bottle of medication its own identity. This can be tracked at every stage of the supply chain – from the production line to the pharmacy and right through to the patient. This enhances the sense of ownership you have with your products, a marker of authenticity that verifies the quality of the contents. Any queries or complaints from pharmacy staff, medical professionals or patients can be traced right back to the individual box.
There exists two key methods for controlling serious outbreaks of transmissible diseases: therapeutic countermeasures and transmission control through isolation and containment.
Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s Falsified Medicines Directive (FMD) standards immediately, leveraging previous efforts for compliance with other market regulations.
Managing CMO serialization implementation is a multifaceted process that requires thorough review and planning across functional teams to best understand all the components necessary for success. Thus, it is important for companies to recognize the barriers they will likely encounter during serialization implementation with CMOs — and plan accordingly.
Evolving track-and-trace rules in key markets are driving pharmaceutical industry demand for adaptable contractors with regional expertise.
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