QP Essentials:EU Gateway to Clinical & Commercial Distribution of Cell Therapeutics

By Colin Grant
Regulatory & Quality Assurance Manager
Fisher BioServices 

A Qualified Person (QP) is an individual who is responsible for ensuring that drug products that are manufactured in or Imported into the European Union (EU) were manufactured and handled according to GMP and EU regulations. The concept of the Qualified Person was first established in 1975 and is a unique regulatory requirement that currently applies only within the European Union, but is being extended into other countries, such as Israel, in 2013.

Download this eBook to learn more about:

  • What is a QP and QP key responsibilities you should know about when you work with one

  • What is a QP release and why you need them for entering clinical trials in the EU

  • Key documentation required by a QP for importing therapeutics for distribution or for clinical trials


Download eBook Here