Qualified Person – More Than Just a Number!

Not everyone starts their career as a QP at a pharmaceutical company, but I was given this opportunity. It comes with a great deal of responsibility, but unfortunately, not everyone always recognizes that. Almost every QP has probably heard this at some point: “Being a QP is like a bird in a golden cage.” Or how about this one: “You don’t really have to do much, just sign your name.” The first time I heard a comment like that, it really stung. After hours of reviewing batch records, deviations, change controls, QC results, and filling out checklists, I was harshly confronted with the reality that there’s a perception that I “just sign my name.” And that’s not even mentioning the time pressure that often comes with it. There’s no room for uncertainty or questions.

With this blog, I’d like to recognize all QPs, as well as all other QA professionals who contribute to the release and certification of clinical and commercial batches.

With that so-called signature, you ensure the quality of the manufactured pharmaceutical product and, by extension, patient safety—whether the patient is a human or an animal. This is a responsibility that must not be downplayed. To be able to sign off with confidence, it’s important to gain a clear understanding of the components of your product and any unexpected issues these components encountered during the production process that may have affected the product’s quality. To ensure the quality of your product, it stands to reason that you’ll check certain clear criteria, such as the sterility of an injection solution. In addition, there are also less obvious criteria that can influence product quality, such as staff training and supplier qualification… Of course, as a QP or as part of the QA release team, you cannot single-handedly verify every link in the chain that has contributed to your product’s quality. Quality must be built in through well-functioning processes, validated standards, and quality awareness—factors that extend beyond just the QA department and the QP. Many issues are addressed or have already been identified and evaluated before the batch reaches the QA release team or the QP. But as long as people are involved in the production process, human errors will continue to occur. That is why every review step is a link in the chain to ensure production quality a little more each time, regardless of which department performs the review. The release and certification of a product batch can be considered the very last review round before the product actually reaches the patient. And even though it is the last one, it is certainly no less important.

In summary, every link in the chain and every person who contributes to high quality—and thus prioritizes the patient’s well-being and safety—deserves to be acknowledged, recognized, and thanked. From operators, QC lab technicians, and maintenance staff to quality assurance personnel: you are more than just that number in your personnel file. And to all QPs, you are more than just that number in the Belgian Official Gazette!