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Global body re-affirms UFS lab’s vaccine testing status

13 May 2019 | Story Zama Feni | Photo Charl Devenish

Dr Quinton Meyer and Marlena Visagie — National Control Laboratory Deputy Director, Dr Quinton Meyer (right), and Marlena Visagie, Quality Assurance Manager, at the laboratory within their facilities at the University of the Free State.

The University of the Free State-based National Control Laboratory for Biological Products (NCL) has maintained its esteemed status as a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) further endorsed its quality-management systems as of high standard according to the International Standards Organisation’s requirements.

The Director of the NCL, Professor Derek Litthauer, said their laboratory – which is also approved by the World Health Organisation (WHO) – has again achieved the international testing standards. The cherry on top was that the NCL also received a certificate of Good Manufacturing Compliance (GMP) from the South African Health Products Regulatory Authority (SAHPRA).

NCL is for Africa and the World

Some of the factors that make the NCL an esteemed institution, is the fact that it is one of 12 laboratories worldwide to perform vaccine testing for the WHO; the NCL is the only vaccine-testing laboratory in the country that performs the final quality-control testing of all human vaccine batches marketed in South Africa on behalf of SAHPRA.

For example, Prof Litthauer said that the influenza vaccine batches currently available on the South African market, were tested by the NCL for quality before authorising their release for sale to the public. This process is followed for all human vaccines used in SA.

“In our role as vaccine-testing laboratory for the WHO, the NCL helps to ensure that the vaccines purchased through the WHO prequalification programme for international distribution to resource-limited countries, meet the high standards of quality, safety, and efficiency.
The NCL was one of the first full members of the WHO NCL Network for Biologicals, which consists of full and associate members of regulatory authorities from more than 30 countries.

The NCL systems are world-class

Prof Litthauer said this achievement is recognition that their laboratory complies with specific international standards with respect to its quality-management system.
“In practice, it means that the laboratory has all the quality systems in place to ensure high-quality test results. The GMP certification is a further step, meaning that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. It is a very strict certification.”

He further mentioned that the NCL is also licensed as a pharmaceutical manufacturer. “Although we do not manufacture, we have to comply with manufacturing standards.”
“It is rare for a pharmaceutical testing laboratory (such as the NCL) outside of a manufacturing context to qualify for both certifications. It means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world,” he said.
The certification provides the South African Health Products Regulatory Authority, the World Health Organisation, and other national control laboratories around the world, with the confidence that the test results from the NCL can be trusted.

There can be no compromise for quality

The NCL Quality Assurance Manager, Mrs Marlena Visagie, said, “It is essential that the NCL complies with the highest international quality-assurance standards to ensure that all the lot-release operations, such as manufacturing review and quality testing, are performed in a reliable and reproducible manner.”

“There can be no compromise when it comes to the quality of medicines which are made available to the public,” she said.

“What makes this special, is that the NCL does not only comply with international ISO/IEC standards for pharmaceutical testing, but also with the additional GMP standards required by a pharmaceutical manufacturer. This means that the NCL must ensure that all its operations, including everything from the way documents are compiled and stored, to the maintenance of equipment and infrastructure as well as staff competency, are performed according to international guidelines.”

All NCL staff share vision of excellence

Prof Litthauer said the NCL has a staff complement of 15 technical, administrative, and support staff. Four staff members have PhDs, and the rest of the technical staff have master’s or bachelor’s degrees or are trained as medical technologists. “At the moment, our biggest problem is to get enough suitable space to expand our testing,” he said.

Prof Litthauer said, “All the staff members at the NCL share the vision of excellence, which makes this kind of achievement possible.”
The NCL will host the third annual meeting of the WHO NCL Network in November of this year and will then be reassessed again by the WHO as part of the normal three-year cycle of assessments.

News Archive

“My time at the UFS was the golden gem of my career”

2016-07-04

Description: Zig Gibson Tags: Zig Gibson

Prof Alan St Clair Gibson
Photo: Oteng Mpete

“My time at the University of the Free State (UFS) was the golden gem of my career. I have worked at medical schools or biomedical research centres in the United Kingdom, United States and at some of the top medical schools in South Africa, but working at the UFS was one of the highlights of my career,” says Prof Alan St Clair Gibson, Head of the UFS School of Medicine.

After spending just over two years at the UFS, Prof St Clair Gibson resigned from the institution in June 2016 and will take up the position of Dean: Health and Human Performance Sciences at the Waikato University in New Zealand in mid-July, where he will assist to establish a new faculty for all the health-science disciplines. “It was a privilege to work at the UFS. I come from a strong research background and wanted to grow research at the university, which I achieved. I came to the UFS because of the Academic and Human Projects and am proud of what has been achieved at the School of Medicine during the time I was here,” he said.

Prof St Clair Gibson highlighted some of these achievements, including the development of a management infrastructure across the disciplines of the school. “The establishment of an executive management committee for the school, as well as research champions in departments, highlighted the importance of proper governance and strategic management. By developing data dashboards, my management team and I could develop an understanding of research income and productivity, how the school works, what the role of teaching and learning is, and how the school could benefit in terms of third-stream income from the many contracts obtained by its academic staff. As a result, contracts and the financial management model of the school have also been reconfigured to the benefit of the university so that the institution and school can benefit from it,” he said.

His strong belief in an open-door policy has made staff feel part of the environment and it has created an atmosphere of equality and inclusivity. He believes in staff development and has, for instance, established leadership and management courses for heads of departments. Another factor to be proud of is the increase in the number of young researchers who recently joined the school, such as Prof Ross Tucker, who is one of the foremost sport scientists in the country. “It is a fact that staff retire or resign in all schools and departments of any university. It is also true that these departures offer opportunities to bring new academic and professional staff into the UFS. In fact, for the first time virtually every department in the School of Medicine now has a full-time Head of Department and 46 new staff were appointed since January 2015,” said Prof St Clair Gibson.

“I am especially proud of contributing, together with the senior leadership of the UFS, to stabilise the relationship with the Free State Department of Health (DoH). With the assistance of these parties, as well as my executive management team, we could find a better way of working together to the benefit of the school and the province.’’

Transforming the student profile to be representative of the country’s demographics is another milestone Prof St Clair Gibson will remember. “The intake of black and white students is of such a nature that we now have a much more balanced ratio of black and white undergraduate students than before.”

“I wanted to stay longer to see the effect of all the changes I made at the school, but the deanship is an offer I cannot refuse. I would have liked to see a steadier increase in the number of permanent clinical staff and have worked hard with both the UFS management and the DoH to try and achieve that; but more work needs to be done.”

I have worked with a number of fantastic staff members at the school, who are determined to do good in a challenging environment. I am amazed at the energy of the university leadership and how the Human and Academic Projects are executed. My wish for the university is to maintain and grow its standards and for the School of Medicine to maintain its reputation as one of the best schools in the country. I will always be a proud alumnus of the UFS,” he said.

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