QP Qualification Requirements in different Member States

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This survey of EQPA members focuses on the professional route to becoming a QP and related topics. EQPA is grateful again for its members' strong engagement resulting in a wealth of data, which can now be analyzed. As usual in such surveys the outcome can only reflect the variety of responses received. Responses from different participants may differ only slightly or sometimes, even conflict. Given the responses result from individual experiences, the authors have no desire to filter them in any way.

The qualification requirements for becoming a QP are one of the most discussed topics in the industry but a good overview of how the legal requirements, defined in article 49 of directive 2001/83/ EC and article 53 of 2001/82/EC have been transposed and implemented at the national level has hitherto been lacking. Not unexpectedly, the seemingly harmonized requirements end up in a huge variety of national interpretations and flavours.

EQPA is regularly approached with questions about how the qualification requirements for QPs, as defined in directives 2001/83/EC and 2001/82/EC, are implemented in the different member states.

A lot of personal bias may drive those questions as well as the answers given. For many years, EQPA has sought an overview without real success and so this survey was set up to do so, based on the collective knowledge and experiences of its membership. Members gave strong feedback with a lot of additional comments on how different national measures divert from or add to directive 2001/83/EC art. 48-51, or directive 2001/82/EC art. 52-54. We have been able to collect responses from nearly every EU and EEA member state as well as from Switzerland, Israel, and the United Kingdom. Responses from other countries were also received and although these cannot be easily compared, they find their place in our knowledge data base.

QPs are expected to be qualified by education at university degree level (directive 2001/83/EC art 49.2 or directive 2001/82/EC art. 53.2 respectively) and by demonstrating additional defined minimum practical experience (directive 2001/83/EC art 49.3 or directive 2001/82/EC art 53.3 respectively). EQPA members are clearly the experts in this topic as they know exactly how they themselves met both expectations. For the purposes of the remainder of this discussion only directive 2001/83/EC will be referred to.

Educational requirements

Dir 2001/83/EC in article 49.2 defines the educational requirements for becoming a QP. The paragraph tries to reflect the immense variety of educational schemes existing across the EU.

Directive 2001/83/EC Article 49.2.
"A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. However, the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level. Where two university courses or two courses recognized by the State as equivalent co-exist in a Member State and where one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognized equivalent shall be considered to fulfil the condition of duration referred to in the second subparagraph in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognized as equivalent by the State in question."

We now take a deep breath. This is not easy to understand - let´s see how this ends up in the different member states.

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The different subjects that need to be covered by the university course are listed in the next paragraph of the article. In summary the subjects appear to be taken from the curriculum pertaining to pharmacy. Surprisingly, defined quantitative measures such as the minimum number of hours of lecture per subject are not defined and so member states are free to diverge.

Table 1: Countries included

According to the directive, following the attainment of an acceptable university degree a QP candidate has to prove practical experience according to article 49.3:
"3. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products."

The requirements can be summarized as a combination of
A. A university diploma in a broad range of natural sciences normally of four years duration but, if considered equivalent nationally, a minimum of three years duration
B. Between six months and up to two years of practical experience in quality control, dependent of the length of your theoretical studies, and
C. The practical experience has to be acquired at the premises of MIA¹ Holder.

These three requirements will now be compared to the feedback from QPs.

In discussions with industry representatives, it is often claimed that only a pharmacist can be accepted as a QP thus limiting the availability of sufficient numbers of QPs. Despite this impression, nearly all member states do in fact accept the listed variety of university education. Many countries even accept more than the directive seems to allow such as degrees in biotechnology, medical sciences and environmental or chemical engineering. Portugal and France are the only EU member states that together with Norway and Israel, two associated countries (via EEA² or ACAA³), limit the educational requirements of the QP to a diploma in pharmacy. In the case of Portugal an additional course and certification as a Specialist in Pharmaceutical Industry granted by the professional Association "Pharmaceutical Industry College" is required.

Table 2 shows a nice pattern of interpretation of the educational requirements.

Table 2: Accepted diplomas and degrees per country

Allowing a university education other than pharmacy is one side of the coin and organizing official courses for those QP aspirants is the other side. Only a minority of countries have established official educational courses aimed at closing the subject gaps, as indicated by the blue shading in table 2 above. In all other countries the closing of educational gaps is left to the applicant who is then assessed for eligibility on an individual basis.

Interestingly, the majority of countries allow basic university degrees outside the range listed in the directive, as indicated below the blue line in table 2. These countries presumably assess the curriculum contents rather than the title of the degree. Other countries limit requirements based on the name of the degree and presumably then assess curriculum content against the directive requirements.

There is no reason, why a pharmacist should not take a role in the pharmaceutical industry. Formally in most countries pharmacists as well as colleagues with a natural sciences background can take on the role of a QP. The question is in practice, how open access to the QP role is for those with other science-based education. Figure 1 shows how QPs responded as to which educational attainment allowed them to successfully become QPs.

It can easily be concluded that everything is possible in reality although, not surprisingly, we see the 100 % share by pharmacists in France and Portugal having already established that only pharmacists can become a QP in those countries (see table 2). A number of other countries have a share of 70 % of pharmacists or higher. On the other hand, responses from Ireland, UK and Switzerland show only a minority of QPs base their educational knowledge on a degree in pharmacy. Taken altogether there is more or less an equal 50:50 split across the EU. Assuming that all these systems are working and all QPs are knowledgeable and competent we might be surprised by the variability between countries based on one single definition in the directive. It is a good illustration as to how much variability can occur with a harmonizing directive.

Length of university study

The next criterion defined in article 49 is the minimum length of university study in order to become a QP (see above). According to the feedback countries handle this requirement very differently.

Although the directive reads that four years is the anticipated minimum university education period and that shorter periods may be an exception, several countries set the minimum expectation down to three years of study. On the other extreme, pharmaceutical studies last 6 years in France and since only pharmacy is accepted in order to become a QP, the minimum duration of university study becomes 6 years by default.

Minimum years of university study country

3

IE, (IT), NL, PL, SL, UK

3,5

(DK), LV, (NL), RO

4

BE, BG, CY, DE, DK, ES, FI, GR, HU, IS, IT, SE

5

AT, CH, CR, CZ, MT, NO, PT

6

FR

Table 3: Minimum length of unversity study required

Practical experience

How practical experience is demonstrated country
A. The practical experience does not need to be demonstrated in one or more undertakings which are authorized to manufacture medicinal products. NL, BE, DK, PO, RO,
AT, DE, HU, IT, UK,
MT, ES
B. The practical experience is strictly limited to QC laboratory related activities. DK, AT, DE, IT, CZ, PL, FR, UK, RO, SL, ES,
LV, GR, BG, MT
C. Quality Assurance activities can replace QC laboratory related activities (fully or partly). DK, NL, PT, FI, GR, CH, ES, UK, MT, SE,
IE, RO, FR, DE
D. Quality Assurance activities can replace QC laboratory related activities (only partly). PT, DE, FI, UK, HU, IE, LV, NL, CR, CY, RO,
AT, BG, CZ, MT, DK
E. Manufacturing related activities can replace QC laboratory related activities. ES, PT, FI, NL, UK, RO, BG, IT, GR, CH, MT,
CR, UK, DE, BG, CY, DK, CZ, BE, IE
F. Other activities are accepted to demonstrate practical experience. CH, UK, PT, ES, NL, DK, DE, RO, CR, IE, IT,
FR, NO, BE

Table 4: Accepted practical experience per country (a country can be mentioned more than once)

University studies alone fulfil only part of the requirements for becoming a QP. Practical experience within a manufacturer´s organization(s) is also required. The survey sought to find out how this is managed in the different member states (see Table 4).

Arguably, the literal interpretation of directive 2001/83 is that only choice B meets the requirements, assuming this experience is gained at an authorised manufacturer. The directive's wording states:
"… practical experience over at least two years, in one or more undertakings which are authorized to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis and of the testing and checking necessary to ensure the quality of medicinal products…."

Figure 1: Share of QPs with pharmacy education by country

The feedback shows that, at least from the perception of QPs, practically every country has interpreted this paragraph flexibly. Accounts by QPs in Germany and Austria shared previously with the authors, showed that practical QC experience alone within a MIAH over a period of two years is literally required but despite this, deviating feedback has been collected from these same countries in the survey. The authors conclude that unless you interpret the wording extremely liberally, the practical experience requirement is not implemented across the EU as written in the directive.

EQPA has argued for many years that practical experience should be defined much more broadly than Quality Control alone, and should be an appropriate combination of experience in different areas. It is very interesting to see that in practice many countries already do this and include experience in manufacturing (> 27 % of all responses!). This is not the case in all countries and appears to deviate remarkably, at least from a literal point of view, from the wording of the requirement. Only 39 % of responses confirm that QC experience alone at a MIAH is acceptable. The countries allowing the least deviation from the directive's wording include AT, DE, IT, CZ, FR, LV, SL.

Additional steps that need to be undertaken and shorter practical experience in relation to the length of studies

There is no requirement in the directive that member states should establish any certified or official course to systematically close the subject gaps of those university courses undertaken by QP aspirants that did not study pharmacy. A number of countries have established such courses though. Portugal and United Kingdom make these courses mandatory for any QP including pharmacists, while other countries make them mandatory for QPs who have not studied pharmacy. Some countries expect the individual to organize the closing of subject gaps themselves. This is probably the worst scenario because it may be difficult to undertake university courses for selective subjects only.

The directive allows the expected period of practical experience to be shortened when the duration of university education exceeds 4 years. The duration of practical experience can be shortened by 1 year, when the studies have lasted 5 years and to shorten by 1.5 years, when the studies have lasted 6 years, leaving, in this case, only 6 months of practical experience. Several countries use this flexibility routinely whereas others only use it in certain circumstances such as in the case of pharmacists. Other countries always require 2 years of practical experience irrespective of the length of university course undertaken. This kind of correlation of theoretical training to the expected length of practical training is worthy of further discussion. Both parts of the QP curriculum focus on very distinct areas of experience and knowhow. In practice and quite understandably given the importance of the QP role, even experienced QPs are expected to undertake at least 3 months of introduction training when joining a new employer. It is difficult to balance this against new QPs being deemed qualified to undertake the QP role with as little as 6 months practical experience, particularly when that experience has, arguably, only partial relevance to the role.

Overview

Based on our new knowledge we have compiled below all of the variables discussed above by country. Considering that different study curricula for pharmacists and non-pharmacists apply, a rather bewildering pattern emerges as to how aspiring QPs may find their way into the job. The reader is intentionally left alone with this overview:

Figure 2: The route to becoming a QP - light blue shading means flexible application; > means duration can be longer

Other national expectations for QPs not mentioned in the directive

In some countries specific language skills are a pre-condition. Directive 2001/83/EC is silent on this. The simple and obvious logic is that the QP has to understand the Quality System and documentation he is working with. Again, there is no harmonized approach (see Table 5).

Table 5: Language skill requirements

In some cases, the language requirement may not be linked to the role of the QP but to the acceptance of foreign studies. For example, a pharmacist who has studied outside of Germany and wants those studies to be acknowledged for the purposes of becoming a QP needs first to be acknowledged as a pharmacist. To become a pharmacist minimum German language skills at grade B2 are mandatory.

What is missing

The survey results show that the definition of the educational andpractical experience, as laid down in article 49 of the directive, is vague and is very flexibly interpreted at the national level. It is a typical compromise resulting in a low level of harmonization.

The results of the survey illustrate in practice just how variable the educational requirements are in terms of content. It is certainly not helpful to base the study requirements on the name of the degree or diploma and some countries do allow a broader list of qualifications than those given in the directive. Not only should the subjects of study be harmonized but a minimum number of hours spent on each of them should also be established. Furthermore, important subjects like medicines legislation, Ph. Eur., GMP and related guidelines should be added.

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The directive provides a set of requirements on education and practical experience in order to become a QP. One might conclude that a QP would be accepted to work with any kind of product. In practice, nearly all QPs find themselves accepted for only a subset of medicinal product groups. National approaches often provide an additional filter of "suitability" in addition to "eligibility" which, although understandable, arguably goes beyond the directive. QPs meeting national expectations for solid dosage forms are distinguished from QPs accepted for investigational medicinal products or biologics for example. Such differentiation from a professional point of view is undoubtedly appropriate and should find adequate reflection in the directive. Many real life situations require a QP to have much more experience than the minimum of two years (or shorter). Furthermore, any revision of this article of the directive should much more clearly include activities broader than QC. Another area of improvement to the current directive could be the establishment of an EU- wide QP repository. Survey participants from nine countries (AT, BE, CY, GR, IE, MT, PL, PT, RO) confirm that national "QP" or "eligible QP" registries exist today. In addition, Slovenia is working on establishing such a data base and Italy is handing out personalized certificates (without expiry date) to QPs confirming their eligibility. In other countries you can only remain a QP while you are actively registered on a MIA.

In several member states API manufacturers (sometimes all, sometimes for biotech only) require a QP. If so, presumably a MIA is similarly required. This is another opportunity for harmonization at EU level as to whether or when a QP and MIA are required by an API manufacturer and whether the same educational or experience expectations apply.

Summary and conclusions

The requirements to become a QP are defined in directive 2001/83/EC article 49 for the entire EU. One might expect that this single source of requirements in a directive would result in a harmonized environment after implementation. We believe that this survey provides relatively robust data for the first time to enable an assessment of the real life situation across the EU in this respect and it reveals huge variability.

During national transpositions widely deviating interpretations of these seemingly harmonized requirements have arisen and still apply. The resulting colourful pattern of applied rules looks quite confusing. Twenty years since directive 2001/83 left the QP requirements unchanged from those established forty-six years ago in directive 75/319/EEC, a new eff ort to review, clarify and simplify the requirements is due. Deviation from the common rule should be limited. A few new additional elements should be considered for EU-wide harmonization. Areas for discussion should include tailoring the duration of practical experience to match the complexity of the manufacturing environment the QP is to work in and harmonized requirements for specific product groups may be considered. QP registries would provide transparency on eligible QPs and their areas of suitability.

About the Author:
Dr Ulrich Kissel, is Chairman of the European QP Association.

Source:
¹ MIA = Manufacturing and Import Authorization; MIAH = Manufacturing and Importation Authorization Holder
² EEA: European Economic Area
³ ACAA: Agreement on Conformity Assessment and Acceptance (of industrial products)


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