Dr Claude Farrugia, coordinator of the Pharmaceutical Manufacturing Sector Group within the FOI, who is also president of the Malta Qualified Persons Association, explained that the concept had been raised ever since the FOI created a consultative committee on the pharmaceutical manufacturing sector in 2003.

“Very early on, when the group was set up, we tried to identify the problems that the industry was facing, with one of them being the lack of appropriately qualified personnel to fill certain key positions within the companies, such as production managers, quality assurance managers and chemists. As Government was pursuing a policy for the expansion of the industry in Malta, it was clear that there was going to be keen competition for a number of key individuals with appropriate qualifications”, he explained.

When asked how the course had actually come about, Dr Farrugia replied: “At a certain stage, the sector group set up its own focus group on education and we developed the draft outline of a course that was consistent with recommendations chosen in other EU countries and that would suit the needs of certain qualified people within the industry.”

This course was sometimes, albeit inappropriately, referred to as the “Qualified Persons Course”. The pharmaceutical industry requires properly qualified people to release medicines in accordance with certain guarantees that have to be supplied, such as quality, safety and efficacy, according to EU standards. The person who approves the documentation and eventually approves batches of the medicine as fit for public consumption is called a “Qualified Person”. This course attempts to address the educational requirements of both the individuals who have to carry out this specialised task, and of other key personnel in the manufacturing sector who interact with the qualified person.

“Together with Malta Enterprise, we then approached a number of departments at university and at a certain point the decision was taken to strengthen contact with the Chemistry Department. Following the support confirmed by Investment, Industry and IT Minister Austin Gatt, and during a meeting between Chemistry Department head Alfred Vella and Education, Youth and Employment Minister Louis Galea, it was decided that the course development should go ahead”, Dr Farrugia explained.

The Science Faculty within the university then appointed a Board of Studies composed of representatives from the university, the FOI and the Malta Qualified Persons Association. The course proposal was examined at various levels throughout the university’s structure and was eventually approved, with Government also providing partial funding to support the course.

“Laboratory facilities will be set up at the university so that students can have hands-on experience in practical matters. The course will lead to a post-graduate diploma in Applied Chemistry but will not provide the automatic QP qualification, as a further two years of work experience in the pharmaceutical sector is required”, he said.

Other relevant issues have been discussed with the Medicines Authority, which has also expressed its approval of the course set up, which is very detailed and includes a mini project to be completed as a final assignment. A first degree in Chemistry, Pharmacy or a related area is required to follow this new post-graduate course. The fees are Lm3,500 for tuition fees and Lm500 in bench fees, covering a two-year, part-time period of study, and these have been approved by legal notice.

“The course is going to go in-depth into certain areas, some of which may have already been touched upon at Bachelor degree level. At a later stage, perhaps with the introduction of more modules, the course’s applicability will start to spread with other industries”, Dr Farrugia added.

When a medicinal product starts to “exist” within the EU, whether through manufacture or importation from outside the EU, it has to be released by a Qualified Person (QP).

Moreover, the company marketing the product must have a market authorisation within the EU. The product is then distributed by wholesalers, who require the services of Responsible Persons (RP). In Malta, the RP has to be a pharmacist while the QP can be a chemist, biologist, doctor, pharmacist or a vet, provided that the individual has studied a number of basic subjects outlined in the legislation.

Initially, when the law was put into place, people who had been carrying out this work for six months were allowed to continue in their role but were asked to apply for eligibility interviews. However, as from June 2005, the criteria for the official approval of a QP requires the person to have had two years’ experience in the field, as well as being successful in the eligibility interview.

In addition, the introduction of EU legislation has led to greater stringency in the definition of a pharmaceutical manufacturing process.

“This was the phase where problems started setting in, as pharmaceutical products have certain regulatory requirements. For example, if a label containing key information is affixed to the product, this process is considered a manufacturing activity and would need to be conducted at a licensed manufacturing plant, certified as compliant with Good Manufacturing Practices, with the product having to be released by a QP.

“Wholesalers who were importing products from outside the EU or from the EU itself but with re-labelling or repackaging requirements, were experiencing difficulty in locating QPs. These companies can now sub-contract their activities to a licensed manufacturing firm who has these QPs or else they can decide to set up an in-house manufacturing GMP-certified facility. This further increased the need for QPs locally,” he explained.

Dr Farrugia said that the university had taken into consideration the number of students that would eventually register for the course. The FOI also hopes that this successful example of industry-academia cooperation will foster the continued development and expansion of the course to allow for the possibility of people who work in different industries to subscribe to the course in the future.