In Belgium and the Netherlands, GMP regulations specify that no batch of a medicinal product can be released for sale or supply before a qualified person (QP) certifies that it meets relevant requirements. This QP controls the manufacturing process, performs quality control inspections and certifies the product. With the certification, the QP states that a product meets all GMP guidelines and requirements for marketing authorisation. Afterwards, the QP records the details of the control operations and analyses he or she performed in an appropriate register and signs them.
Many companies are not big enough to invest in a fulltime QP. Besides, regulations impose strong requirements in order to become QP-recognised, and it’s hard to find the right people. For all those companies, QbD offers QP services for long and short term assignments. Our QPs are readily available to provide temporary help, including staffing transitions, when people are unavailable due to holidays or illness, or to expand capacity during peak load periods.
QbD’s QPs have a profound knowledge of each step in the manufacturing process for which they take responsibility. They follow continuous training regarding product types, production processes and the GMP guidelines. Furthermore, they are up to date on the complete supply chain of active components, and intermediate and final products to perform a certification for your company. This ensures our QP is a core member of your quality committee.