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Over the past few years, the requirements for pharmaceutical production and control have fundamentally changed. For example, based on the implementation of the ICH Q8, Q9 and Q10 guidelines, more importance is assigned to process control and quality assurance. As a result, the final quality only serves the purpose of formal confirmation. Consequently, these changes also entail modifications in the requirements profile for the qualified person pursuant to Section 14 of the Medicinal Products Act/Art. 48 of Directive 2011/83/EC (hereafter referred to as Qualified Person/QP).

It is therefore consistent that in the future this development should be reflected in the legal requirements profile for Qualified Persons in Directive 2001/83/EC or in Sections 14 and 15 of the Medicinal Products Act.

In the short term, additional individuals with good qualifications could be recruited as QPs based on administrative practices adjusted to the new requirements in terms of recognition of degrees of higher education and practical experience. This would help slow down the trend of a broadening spectrum of QP job responsibilities for which only an increasingly small circle of individuals would be available.

Basic situation
The required qualifications and professional experience for the Qualified Person (QP) are stipulated by Article 49 of Directive 2001/83/EC, which was most recently comprehensively revised in 2004; however, the prerequisites in terms of education and practical activities of the QP remained unchanged. During the implementation of the amended EC Directive into German law, the Medicinal Products Act gave up on the previously applicable concept of the head of production, head of quality control and the person authorized to release a batch to the market and instead completely adopted the concept of the QP, which has been in existence since the first European Medicinal Products Directive 65/65/EEC.

As a prerequisite for recognition as a QP, pursuant to Section 15 para. 1 of the Medicinal Products Act, the required expert knowledge must be demonstrated in the form of a diploma, or certificate awarded on completion of a university course of study in pharmacy or subsequently listed curricula and possibly additionally completed coursework. Furthermore, according to Section 15 para. 1 of the Medicinal Products Act, "a period of at least two years' practical experience in the field of qualitative and quantitative analysis and other quality testing of medicinal products" is required.
While, according to the transitional regulations, the former heads of production continue to meet the qualification as a Qualified Person, all academicians who have become newly employed in pharmaceutical production since 2004 and who demonstrate the required expert knowledge pursuant to Section 15 para. 1 of the Medicinal Products Act cannot obtain the QP qualification today and are not recognized if they lack analytical experience.

Based on the limitation to practical analytical work, individuals exclusively working in production are excluded from working as a Qualified Person for formal reasons, even though in many cases they are more familiar with the processes than a person working in a quality control laboratory who has only dealt with a single aspect (e.g. HPLC). In this respect, there is an imbalance between the experience of a QP required in practice and the legal requirements.

To aggravate the situation, the German states' supervisory authorities interpret the area of responsibilities very restrictively. The "field of qualitative and quantitative analysis and other quality testing of medicinal products" is limited exclusively to the quality control departments, even though the second part of the sentence does leave some leeway for also taking into account e.g. in-process controls during these two years of work.

Furthermore, there are a number of special requirements in Germany for the practical experience for certain medicinal products and therapies in accordance with Section 15 para. 3 and 3a of the Medicinal Products Act that are not based on EC law and therefore additionally make the recruitment of QPs more difficult in Germany.

The vfa's position
The vfa believes that a revision of the existing regulations for the proof of expert knowledge of the QP is urgently required and that these regulations must be adjusted to the new conditions in pharmaceutical production and control. A modified administrative practice could serve as a transitional solution:

  1. Measures recommended immediately – More pragmatic interpretation of the expert knowledge requirements that are more strictly stipulated in the Medicinal Products Act compared to the European Directive (pursuant to Art. 49 (2) clause 6 of the EC Directive, evidence of adequate knowledge, if formal criteria are not met) and the require-ments for practical experience, e.g. for the recognition of newly created courses of study such as biochemistry or for QPs from other EU countries. This also takes into account the increasing need for flexibility on the part of employees in internationally active companies.

  2. Measures recommended in the short term – Elimination of the German special regulations for certain medicinal products and acceptance of coursework completed outside the academic pharmacy curriculum based on which non-pharmacists could demonstrate the required qualification al-so in Germany. For example, these courses could be offered as a master's degree program at universities (such as in Ireland) or as a certified continued education curriculum from commercial providers (as in Great Britain but with more broadly designed course content). Specific measures for continued professional education in master's degree programs/QP courses would meet the requirements much better than the generalized courses of the pharmacy curriculum.

The objective of these measures – Modification of the require-ments for qualification and professional experience, which are un-ilaterally oriented on analytical skills, toward a broader scope of knowledge and skills required today (especially production, quality control, quality assurance) in order to be able to meet the job re-sponsibilities to be covered by a QP in a qualified manner. Plans include a collaboration with the European pharmaceutical association EFPIA to develop the corresponding proposals, which should be addressed in the next pharma review during the European legis-lative procedure.