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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

Letter to students from Prof Jonathan Jansen about student protest action at the UFS
2015-10-21

Dear Students

Student protest action at the University of the Free State

I wish to make clear that the senior leadership of the University of the Free State understands and supports the demands from students and their leaders that higher education be accessible to all students, especially the poor. For the past six years we have done everything in our power to meet that commitment to students who are academically talented, but simply cannot afford to pay; that is why our tuition fees remain among the lowest in the country. Our efforts to raise private funding have enabled thousands more students to study at the UFS than would have been possible on the government subsidy only. Whether it is the Staff Fund contributions (yes, our staff empty their pockets to support student fees) or the No Student Hungry (NSH) bursary programme (yes, we raise funds for food bursaries), we will continue our drive to fund students who cannot afford higher education. Let me repeat, no student with a solid academic record will be denied access to studies simply because they cannot pay.

Now, to the matter at hand. There is a national demand from students for a 0% fee increment for 2016. The Minister’s response, after consultation with stakeholders, was that universities should cap their 2016 fee increases at 6%. Despite this initiative from government, the protests continue on virtually all campuses across South Africa for the ‘no fee’ increase.

Our response, as the UFS leadership, is to continue engaging the SRC as the chosen leadership of our students in trying to negotiate a settlement on the matter. We have worked around the clock to be available to student leaders to find some resolution on 2016 fees. While we understand the demands of students, as university leaders, we can only work with the government subsidy we receive. Any agreement reached, cannot and must not place the university at academic and financial risk in its ability to deliver public higher education to the country - if that happens, everybody loses. Still, no matter what happens in terms of the response from government, the leadership door at the UFS remains open to finding a mutually acceptable solution to all parties in these deliberations.

Students, we are deeply concerned by the violence, intimidation and threats from the small group of protesting students. These dangerous and demeaning behaviours, like disrupting classes and verbally abusing students and staff, undermine the legitimate quest of students for relief concerning tuition fees. Such behaviour is completely unacceptable and the university will take action where required. We must also remember that we have an obligation to all 30 000 students whose right to learn without fear of violence and intimidation must be respected.

In conclusion, over the past few years we have worked hard to build a culture of mutual respect and embrace as we worked through some very difficult challenges on campus. You would have noticed that the university leadership responded quickly and sympathetically to reason and respect in difficult situations of rage and demonstration. A minority of students, with some outsiders, have come onto the campus to break down that culture in which, while we might disagree, we continue to work on the basis of mutual respect. I urge all students that, as we engage of this important problem of enabling greater access to higher education, we continue to remain true to the core values of our Human Project.

Best Regards

Prof Jonathan Jansen
Vice-Chancellor and Rector
University of the Free State


Letter to students from Prof Jonathan Jansen about student protest actions at the UFS (Pdf format)

 

 

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