The Role of the Qualified Person in European Pharmaceutical Regulations

The authors provide a brief overview of the European pharmaceutical regulation with regard to batch certification by a qualified person and batch release for the European market.
Oct 02, 2010
By Pharmaceutical Technology Editors
Volume 34, Issue 10

Interpretations of the role of QPs

Most of the responsibilities of the qualified person are not defined in the EU Guide to GMP or its Annexes, but are laid down in superordinated European Pharma Directives. According to European Law, these Directives have to be transposed into national laws and regulations in the individual member states. Although the role and status of the QP should be the same in all EU member states, it is apparent that there are differences in the ways in which QPs are trained and appointed, and in the possible delegation of duties, even though their basic role is the same.

There are member states with a long tradition of natural scientists as heads of quality control, assurance, and operations with only the limited resources of industrial pharmacists such as the United Kingdom. Here, the professional scientific bodies—Institute of Biology, the Royal Pharmaceutical Society, and the Royal Society of Chemistry—perform the initial and the ongoing continuous training of natural scientists to qualify as QPs based on a study guide jointly developed and adapted. Furthermore, these societies are required by the authorities to assess the eligibility of their members for QP status and to run an indicative register of QPs.

A totally different approach is taken by France, which strictly requires the their version of the QP, the "pharmacien responsible," to be a pharmacist and a member of the board who will not perform any of his or her duties personally, but delegate within the quality organization.

The European QP Association has therefore issued a Good Practice Guide summarizing the duties and responsibilities of QPs in the EU (11). Annex 1 of that Guide specifies the different requirements per European member state.


The concept of the qualified person according to EU regulations is unique. It does not exist in the US or in any other state outside of the European Union. The personal responsibility and liability of the QP is a very specific requirement. Every qualified person needs to be registered or appointed or approved with the competent authority of the EU member state in which he or she is operating. Therefore not only the pharmaceutical company for which he or she is acting, but also the registered qualified person, is personally responsible for his or her duties.

Bernd Renger, PhD, is vice-president of quality control at Vetter Pharma-Fertigung, Germany, and chairman of the European QP Association (EQPA) advisory board, and Oliver Schmidt* is the general manager at Concept Heidelberg, Rischerstra e 8, 69123 Heidelberg, Germany, tel. 06221 / 84440, fax 06221 844464,

*To whom all correspondence should be addressed.

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