Serialization: A Road Map To Compliance

The implementation of serialization at a pharmaceutical manufacturing site is a worthy but seemingly monumental task. Although it has the potential to stop the global trade of illegal and counterfeit drugs, knowing the best way forward to successfully complete the conversion is often unclear. And, the disruption to normal business can be immense. It has been the buzz in the pharmaceutical community for the last five years, but with regulatory enforcement postponed, it has been easy for most pharmaceutical manufacturing companies to ignore, or at least de-prioritize.

One contract packaging company, the subject of the case study below, has taken the opposite approach. They decided to be proactive in the safeguarding process. They see it as more than just meeting regulatory requirements; they see it as an investment in the future. Serialization at their plant strengthens their brand’s focus on value, which they have carefully established over years. They want to continue to be the preferred contract packaging vendor of their current pharmaceutical clients, and they want to gain new business by being one step ahead of what those customers need. They see it as an important step in providing a seamless quality management system between their clients and the pharmaceutical packaging they do for them.