A Roadmap For Clinical Trials: QP Certification Of IMP

The 20th century marked a period of remarkable scientific breakthroughs in medicine, shaping the landscape of healthcare as we know it today. Among these advancements, clinical trials emerged as a cornerstone not only for the development of new drugs but also for the ongoing management of existing pharmaceuticals in the market. The journey of innovative medications from conception to market introduction involves extensive research and development, spanning a rigorous process to ensure safety and efficacy. Conversely, generic medicines undergo a streamlined evaluation process, primarily focusing on bioequivalence and bioavailability studies to establish their equivalence with the original patented drug.

Central to the approval and oversight of drugs intended for human use is the role of a Qualified Person (QP). Responsible for certifying each batch of Investigational Medicinal Products (IMPs) manufactured or imported within the European Union, a QP plays a pivotal role in ensuring compliance with stringent regulatory standards. In this blog post, we delve into the intricacies of QP certification for IMPs, outlining the requisite steps and regulatory requirements involved in this critical process.