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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

UFS responds to concerns around high costs of higher education
2015-10-15

 

Dear Students

UFS responds to concerns around high costs of higher education

There is an understandable and shared concern among students in the country around the high costs of higher education. As you know, this also is a matter of deep concern on our campuses, which the University of the Free State (UFS) has made a priority in discussions with student leaders - and through new strategies to relieve the burden of costs on poor students and their families. In fact, in the past two weeks, the UFS leadership has again engaged students on the matter of fees in the future.

This is what we have done so far. We have maintained our position as one of the universities with the lowest tuition fees in the country. As you would have seen from recent newspaper reports on the cost of a degree at various institutions over the past five years, the UFS has had consistently low fees. This is not an accident; both the University Council and the executive leadership of the UFS is of one mind that we must offer a high quality education at minimum cost to all our students, despite the rising costs of operating a large multi-campus university with 30 000 students. Our commitment to you is to continue to keep those costs to students as low as possible, without compromising on the quality of education.

In addition, we took a decision earlier this year to become the first university to drop application fees for first-year students. We are proud of that achievement, since so many students fall at this first hurdle as they contemplate post-school education and training. We also waived registration fees for postgraduate students and now Research Master’s and PhD students can study tuition free under certain conditions. We raised more than R60 million from the private sector to enable talented students, who do not receive NSFAS funding, to complete their degree studies at the UFS. We set aside some of the university’s own funds to enable even more students to access finance for their studies. And we now have a special office set aside to counsel and assist students to apply for more than one scholarship to support their studies. The university does not follow a policy of maximizing exclusions. It has endeavoured and succeeded to turn around the majority of its potential deregistration cases. During 2015 we had 2 700 students at the risk of being de-registered, but our serious efforts resulted in only over 200 instances of exclusion we could not mitigate. As is the practice for the past few years, these students’ debt for 2015 has been reversed.

But, we do not only look for funds from outside to support our students. Last year we set up a Staff Fund to which ordinary members of the academic and support staff can contribute from their own, and sometimes very modest, salaries to enable Kovsie students to finish their degrees. We have volunteers who work on the No Student Hungry (NSH) Bursary Programme to raise funds for students who cannot afford a regular meal. We have an open line to rural and township schools to nominate poor students with good results for support by the Rector’s Fund, and some of those students are now in their final year of studies. And many of our staff support individual students in their homes and with their families, without being asked to do so. This is what we call the Human Project and it remains central to the way in which we deal with students.

We will of course continue to make representation to government, the private sector, and individuals to increase funding, especially for first-generation students, and for families where more than one student is at university. We will continue to take to the road to raise funds from companies and foundations to finance our students. We will expand on-campus opportunities for limited working hours for students who wish to earn some money to support their studies. As we have said often before, no student who passes all their courses or modules will be turned away simply because they do not have the funds to study.

The UFS discusses and agrees to fee increases with our students well in advance of the next academic year. None of these decisions are taken without the agreement of the student leadership and thus far these engagements, while tough, have always been done in good faith and with the students’ interests at heart.

It is important for you to know that, with the declining government subsidy, in real terms, and the expanding needs of our students, we will not be able to keep the university running without fees - even though this source of revenue comes mainly through scholarships and bursaries. We need to compensate staff, purchase new library books and renew journal subscriptions (which is very difficult given the low value of the Rand), upgrade computers and software, pay rates and taxes, purchase laboratory equipment, pay the water and electricity bills, expand internet services, upgrade campus security, and hire more academics to keep class sizes reasonably small. It is important for you to know that the university has managed to avoid increasing student fees as a result of much higher municipal rates. Our lecturers are not the highest paid in the country and financially we run a tight ship. We consistently achieve unqualified audits and we are known to be one of the universities that manage its NSFAS contributions with great efficiency. We do this because of our commitment to ensure that our students are able to enjoy a high quality of education on a stable campus where there is a deep respect for all campus citizens.

Despite all these efforts, the most important message we wish to communicate, is that the door remains open for continued discussion with student leaders as we continue to find ways of keeping university education open and accessible to all qualifying students. At the same time, the UFS leadership is involved in discussions with government about how to best manage the escalating cost of higher education for our dents.

Thank you for your support and understanding at this time and be assured, once again, of our commitment to students as a matter of priority to the university leadership.

Best regards

Prof Jonathan Jansen
Vice-Chancellor and Rector

University of the Free State
19 October 2015

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