Qualified Person (QP) in the EU: Role, Legal Framework and Key Duties

In the EU, each holder of a manufacturing authorisation must appoint at least one Qualified Person (QP). The role is defined in Directive 2001/83/EC and Regulation (EU) 2019/6, and further detailed in EudraLex Volume 4, notably Chapter 1 and Annex 16. Member States transpose these rules into national law, which may create procedural differences but must meet EU objectives.

The QP is personally responsible for certifying that each batch complies with GMP, the marketing authorisation and legal requirements before release. Annex 16 distinguishes between batch certification of finished products and GMP confirmation of intermediate steps. Only another QP may sign delegated certification tasks.

A comprehensive pharmaceutical quality system, including quality risk management, must be in place. Products cannot be sold before QP certification.

To perform the role effectively, the QP requires management support, access to all relevant information, and a clearly defined position within the organisation. Continuous training is mandatory to maintain up-to-date knowledge of products, processes and GMP developments.

15-02-2026