In the world of pharmaceutical packaging, the implementation of the Drug Supply Chain Security Act (DSCSA) has become a focal point for industry professionals. Aladin Alkhawam, a seasoned expert with a career spanning various roles in pharmaceutical packaging operations, offers a unique perspective on the challenges and intricacies of this regulatory landscape. Alkhawam, who now runs his own consulting service, has dedicated recent years to focusing on the DSCSA regulation, which is set to take full effect soon.
HCP: How did you get into the industry… Did you always know you wanted to work in pharma?
Alkhawam: Interestingly enough, not at all. My focus when I went to college was actually electrical engineering—that’s what I wanted to do. But I met someone who worked at a pharmaceutical company and was leaving his role. I jokingly said I might apply for his job, and he encouraged me to do so. He was in the planning department, and sure enough, I applied and got the job as a planner. From there, I moved into the packaging department—all while still in college and not yet graduated. I really enjoyed the fast-paced environment, working with people, and the operational side of packaging. That led me to switch gears—I completed a two-year associate degree in electrical engineering, then shifted to business management. I’ve been in pharmaceutical and packaging since then, which has been my entire career.
HCP: In early days, did you focus on package development or were you always more on the serialization/ traceability/ regulation side of things?
Alkhawam: I initially started my career in packaging, specifically focusing on operations within the packaging department. While I supported the development of new packaging for products and delivery systems, my primary responsibilities were centered around packaging operations. This included implementing new packaging lines, overseeing packaging expansions, and ensuring smooth execution of operational projects.
HCP: And now you're focusing on DSCSA, which is a huge topic with a lot of moving pieces. Maybe you could share a status update of what's going on there.
Alkhawam: Sure. The DSCSA requirements were signed into law in 2013 by President Obama, giving the pharmaceutical industry about ten years to implement them. There were a few deadline extensions along the way—one due to COVID, and another because many manufacturers weren't ready. Implementation was phased: first came serialization, which involves placing a serial number on each product; then aggregation, which creates the parent-child relationship between items like bottles, cases, and pallets; and finally, end-to-end traceability, which involves sending associated data to wholesalers.
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