The Role of the Qualified Person in European Pharmaceutical Regulations - Pharmaceutical Technology

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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.


Pharmaceutical Technology
Volume 10, Issue 34

Differences in the United States' and European Union's good manufacturing practices (GMPs) "must not be considered substantial" according to the US Food and Drug Administration's current good manufacturing practices (cGMP) Harmonization Analysis working group (1). A report by the group, titled Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach, states that "there are many more similarities than differences seen among the various cGMP regulations, with existing differences often related to the commodity in question" (1). For example, the responsibilities of the quality control unit according to FDA's guideline 21 CFR 210/211 are comparable to the responsibilities of the head of manufacturing and the head of quality control as described in the European GMPs (2, 3). However, there is one major difference in the European pharmaceutical legislation—the additional personal responsibility and liability of the "qualified person" (QP) as defined in the superior European pharmaceutical directives. This function is unknown within the US pharmaceutical legislation as well as in almost all other countries outside the EU.

In today's international pharmaceutical supply chains, it is important to know the specific requirements in the various markets worldwide. In Europe, no single batch of a finished pharmaceutical product can be released without the certification of the QP.

Legal basis for QPs in Europe

The legal basis for the qualified person is detailed in the European Directive 2001/83/EC issued on Nov. 6, 2001, relating to medicinal products (4). This concept of having one individually responsible person for batch certification and release required at site is a basic concept of the European Pharmaceutical legislation, providing the competent national authorities a perfect recourse within a short timeframe in case of any issue with a batch certified and released by a particular QP. For veterinary products, the requirements are defined in the European Directive 2001/82/EC (5).

Qualification of the QPs

Article 48 of Directive 2001/83 requests that EU member states assure that each holder of a manufacturing authorization has "permanently and continuously at his disposal the services of at least one qualified person." In article 49, the required qualification, as well as the necessary experience of a QP, is defined. For investigational medicinal products, refer to article 13 of Directive 2001/20/EC and article 10 of Directive 2005/28/EC, and for veterinary medicinal products, please refer to Article 52 of Directive 2001/82 (6, 7).

The required qualification to become a QP in a member state of the EU is a completed four years theoretical and practical university study in pharmacy. A shorter study (e.g. of three years) recognized as equivalent by the member state concerned is also acceptable in some cases. A university study in medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology may also qualify the applicant. In this case, however, all missing basic subjects from the curriculum of a full pharmaceutical study must be completed by additional studies or training courses. The adequacy of these additional studies or training will be determined by the relevant national authority.

To qualify as a QP in Europe, the applicant must provide evidence about successful university studies in experimental physics; general, inorganic, organic and pharmaceutical chemistry; analytical chemistry, including analysis of medicinal products; general and applied (medical) biochemistry; physiology; microbiology; pharmacology; pharmaceutical technology; toxicology; and pharmacognosy (the study of medicines derived from natural sources).

In addition to coursework in these areas, the qualified person must have acquired practical experience during at least two years at one or more companies authorized to manufacture medicinal products in the EU. The practical experience should cover the topics of qualitative analysis of medicinal products, quantitative analysis of active substances, and testing and checking the quality of medicinal products. The duration of practical experience may be reduced to one year in case of a five-year university program or to a half year in case of a six-year university course.


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