Serialization System SOPs

In a video interview with Pharma Commerce, Michael Rowe, Two Labs’ senior director of DSCSA/serialization compliance services, describes how the HDA Distribution Management Conference (DMC) covers a broad spectrum of topics within the pharmaceutical supply chain, with a special focus on current regulatory and operational challenges. One of the major topics at this year’s conference was the Drug Supply Chain Security Act (DSCSA), which prompted several discussions and roundtable sessions.

The DSCSA has significant implications for the pharmaceutical supply chain, especially in terms of enhancing traceability, safety, and efficiency in drug distribution. At the DMC, various presentations and dedicated roundtable sessions were held to address its impact, compliance requirements, and the ongoing industry adaptations necessary to meet its mandates. These discussions provided insight into the challenges and solutions that stakeholders in the pharmaceutical supply chain are encountering as they work to ensure compliance with DSCSA regulations.

Overall, the DMC served as an important platform for exploring the evolving landscape of drug supply chain security, with the DSCSA at the forefront of many conversations. Given its complexity and importance, the conference highlighted the need for continued collaboration and knowledge sharing among industry professionals to navigate the regulatory landscape effectively.

Rowe also comments on where he believes industry stands in terms of DSCSA readiness; some of the supply chain disruptions that stakeholders are reporting; and much more.

A transcript of his conversation with PC can be found below.

PC: What topics are at the top of the agenda for Two Labs?

Rowe: I think the major dynamic that's going on in the short term is the increased engagement from FDA doing DSCSA inspections, as well as state regulators, and how they're starting to engage in DSCSA, is really giving a lot of clients pause to say, “we set up these DSCSA SOPs a couple of years ago. Have we updated them appropriately? What're the growing trends? Can we actually execute on these SOPs that we built?”

I think the biggest thing that we heard at the conference, and is resonating with a lot of our clients—as well as prospective clients—is we kind of did almost a copy-paste. Not that we have done copy-paste projects with our clients, but rather, we've had clients where we've inherited SOPs that have been kind of a copy-paste job, where it just outlines what the law is, but it doesn't really share in detail how you actually document your process, how you prove to a regulator that you're following it.

I think there're a lot of folks taking a pause and saying, “okay, we feel like we've got all the data infrastructure in place, how do we actually document what we're doing?” I think right now, the hot topic in the industry is SOPs, because as state regulators engage, as FDA engages, they're asking and they're saying, “prove to me that you can do a verification within one day. How many verifications have you been doing? Can you share a documentation with me? Is your serialization system validated?”

When you do a verification, you're using your serialization database. How do you know that that's an accurate database? I think a lot of companies are going to be going back and say, “alright, we've been in a rush-build mode. How do we maintain this?”