The Role and Duties of the EU Qualified Person (QP) | Part I

The concept of the Qualified Person (QP), first established in 1975, is a unique regulatory requirement which applies within the European Union (EU).

The only comparable situation exists within Member States of the European Economic Area (EEA) with whom the EU has reciprocal agreements.

Each holder of an Authorisation to Manufacture products for use in a Clinical Trial or products subject to a Marketing Authorisation, within Member States of the EU, must name a person or persons who are eligible to act in the capacity of QP.

The requirement for QP covers both Human and Veterinary Medicinal Products but not those intended for export outside the EU.

Particular conditions for formal qualifications and practical experience for eligibility to act as a QP are specified in the relevant EU Council Directives.

REGULATORY BASIS FOR THE QUALIFIED PERSON

The key regulatory documents concerning the QP are as follows:

(i) Directive 2003/94/EC - Principles and Guidelines of Good Manufacturing Practice for Medicinal Products for Human Use

(ii) Directive 91/412/EEC – Principles and Guidelines of Good Manufacturing Practice for Veterinary Medicinal Products.

(iii) Directive 2001/20/EC – Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use – Article 13.

(iv) Directive 2001/82/EC – Community Code Relating to Veterinary Medicinal Products – Title IV – Manufacture and Imports – Articles 44-57.

(v) Directive 2001/83/EC – Community Code Relating to Medicinal Products for Human Use – Title IV – Manufacture and Importation – Articles 40- 53

(vi) Eudralex Volume 4 – Good Manufacturing Practices 2002

Annex 13 – Manufacture of Investigational Medicinal Products

Annex 16 – Certification by a Qualified Person and Batch Release

NUMBER AND LOCATION OF QUALIFIED PERSONS

The provisions in Article 52 of directive 2001/82/ EC and/or Article 48 of directive 2001/83/EC only require a company or organisation to nominate one person on a Manufacturing Authorisation to carry out the duties of the QP provided that person is at the disposal of the company at all times and can carry out the required functions.

Some organisations may have a complex structure, or operate at several locations, or both, which would make it necessary, where justified, to nominate several QP’s on its Manufacturing Authorisation.

CONTRACTED QUALIFIED PERSONS

Smaller companies in some EU countries are permitted to employ a Contracted QP who provides a part time service.

In such cases the duties and responsibilities of a ‘Contracted QP’ are the same as those QP’s who are permanently employed; the QP is not an employee of the company but provides his services under contract.

Read also: Major Job Responsibilities of an Industrial Pharmacist

Resource Person: BARBARA PIROLA