What is a QP?
Updated: Dec 11, 2018
A Qualified Person is, according the European legislation (Directives mentioned here below), a person allowed to certify batches of medicinal products, prior their physical release to the market or clinical investigators.
This certification is valid throughout the entire European Union (EU).
Each manufacturing authorization holder in the Union has to name at least one Qualified Person (QP).
The ultimate responsibility for the quality, safety, and efficacy of a medicinal product lies with the Marketing Authorization Holder (MAH) or Sponsor of a Clinical Trial.
However, the QP is personally responsible for ensuring that each individual medicinal product batch has been manufactured and checked in compliance with
- the laws in force in the Member State where the certification takes place,
- the specifications and requirements of the Marketing Authorization (MA) or current approved Investigational Medicinal Product Dossier (IMPD) and with
- the European Good Manufacturing Practices (GMP).
Certification can only be performed by a QP of the manufacturer and/or importer described in the MA or IMPD.
Every Qualified Person has a unique number assigned to him by his national Health Authorities. He is their contact person in the Company and must be reachable at any time.
Based on the here above mentioned-European Directives, each Member State defines its own criteria (educational background, training and occupational experience) to be approved as a Qualified Person. Originally, this function was mostly reserved to Industrial Pharmacists but other degrees are now accepted as long as candidates demonstrate equivalent education.
For more information, please consult the following references:
- Directive 2001/83/EC relating to medicinal products for human use, https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
- Directive 2001/82/EC relating to veterinary medicinal products https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-5/dir_2001_82_cons2009/dir_2001_82_cons2009_en.pdf
- Directive 2001/20/EC relating to clinical trials https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf
- Eudralex volume 4, Annex 16: Certification by a Qualified Person and Batch Release https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/v4_an16_201510_en.pdf