An Overview of the Qualified Persons’ (QP) Role in the Release of Batches of Biological Medicinal Products – Technical Note

The Qualified Person, frequently shortened to “QP” in guidance documents, plays a unique regulatory mandated role within both the UK and EU for manufacturers of clinical and commercial medicinal products. The QP is professionally, personally and legally responsible for the certification of medicinal product prior to use in clinical trials, or release into the market. Only a QP has the legal authority to certify a batch for use as a medicine in the UK and/or EU.

In this technical note, we look at the role and responsibility of the QP and how their function is critical to the release of drug product to clinical trials or commercial release. Download this document to find out more.