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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

Position statement: Recent reporting in newspapers
2014-10-03

 

You may have read reports in two Afrikaans newspapers, regarding recent events at the University of the Free State (UFS). Sadly, those reports are inaccurate, one-sided, exaggerated and based not on facts, but on rumour, gossip and unusually personal attacks on members of the university management.

Anyone who spends 10 minutes on our Bloemfontein Campus would wonder what the so-called ‘crisis’ is about.

We are left with no choice other than to consider legal action, as well as the intervention of the South African Press Ombudsman, among other steps, to protect the good name of the institution and the reputation of its staff. No journalist has the right to launch personal and damaging attacks on a university and its personnel, whatever his or her motives, without being fair and factual. In this respect, the newspapers have a case to answer.

But here are the facts in relation to the reports:

  1. No staff member, whether junior or senior, is ever suspended without hard evidence in hand. Such actions are rare, and when done, are preceded by careful reviews of our Human Resource Policies, labour legislation and both internal and external legal advice. Then, and only then, is a suspension affected. A suspension, moreover, does not mean you are guilty and is a precautionary action to allow for the disciplinary investigation and process to be conducted, especially where there is a serious case to answer.
  2. At no stage was the Registrar instructed to leave the university; this is patently false and yet reported as fact. We specifically responded to the media that the Registrar does outstanding work for the university and that it is our intention for him to remain as our Registrar through the end of his contract in 2016.
  3. The Rector does not make decisions by himself. Senior persons, from the position of Dean, upwards, are appointed by statutory and other senior committees of the university and finally approved by Council. No rector can override the decision of a senior committee, and this has not happened at the UFS even in cases where the Rector serves as Chair of that committee. The impression of heavy-handed management at the top insults all our committee structures, including the Institutional Forum – the widest and most inclusive of stakeholder bodies at a university – which reports directly to Council on fairness and compliance of selection processes.
  4. In the case of senior appointments, Council makes the final decision. Council fully supports the actions taken on senior appointments, including a recent senior suspension. The fact that one Council member resigns just before the end of his term, whatever the real reason for this action, does not deter from the fact that the full Council in its last sitting approved the major staffing decisions brought before it. The image therefore that the two newspapers try to create of great turmoil and distress at the university, is completely unfounded.

Even if we wanted to, the university obviously cannot provide details about staffing decisions, especially disciplinary actions in process, since the rights of individuals should be protected in terms of the Human Resource Policies and procedures of the UFS. But that does not give any newspaper the right to speculate or state as fact that which is based on rumour or gossip, or to slander senior personnel of the university. For these reasons, we have been forced to seek legal remedy and correction as a matter of urgency.

Make no mistake, underlying much of the criticism of the university has been a distress about transformation at the UFS; in particular, the perception is created that white colleagues are losing their jobs. The evidence points in the opposite direction. Our progress with equity has been slow and we lag far behind most of the former white universities; that is a fact. More than 90% of our professors are white; most of our senior appointments at professorial level and as heads of department are still overwhelmingly white. Reasonable South Africans would agree that our transformation still has a long way to go and only the mean-spirited would contend otherwise. But based on the two Afrikaans newspaper reports, an impression is left of the aggressive rooting out of white colleagues.

In the past few years the academic standard of the university has significantly improved. We now have the highest academic pass rates in years, in part because we raised the academic standards for admission four years ago. We now have the highest rate of research publications, and among the highest national publication rate of scholarly books, in the history of the UFS. We have one of the most stable financial situations of any university in South Africa, with a strong balance sheet and growing financial reserves way beyond what we had before. We now attract top professors from around the country and other parts of the world, and we have the highest number of rated researchers, through the National Research Foundation, than ever before. And after the constant turmoil of a number of years ago, we now have one of the most stable campuses in South Africa. Those are the facts.

The UFS is also regarded around the world as a university that has become a model of transformation and reconciliation in the student body. The elections of our Student Representative Council are only the most visible example of how far we have come in our leadership diversity. Not a week goes by in which other universities, nationally and abroad, do not come to Kovsies to consult with us on how they can learn from us and deepen their own transformations, especially among students.

Rather than focus on what more than one senior journalist, in reference to the article in Rapport of 21 September 2014, rightly called ‘a hatchet job’ on persons and the university, here are the objective findings of a recent survey of UFS stakeholders: 92% endorse our values; 77% agree with our transformation; 78% believe we are inclusive; and 78% applaud our overall reputation index.  Those are very different numbers from a few years ago when the institution was in crisis.

This is our commitment to all our stakeholders: we will continue our model of inclusive transformation which provides opportunities for study and for employment for all South Africans, including international students and colleagues. We remain committed to our parallel-medium instruction in which Afrikaans remains a language of instruction; we are in fact the only medical school in the country that offers dual education and training in both Afrikaans and English for our students - not only English. We provide bursaries and overseas study opportunities to all our students, irrespective of race. And our ‘future professors’ programme is richly diverse as we seek the academic stars of the future.

We are not perfect as a university management or community. Where we make mistakes, we acknowledge them and try to do better the next time round. But we remain steadfast in our goal of making the UFS a top world university in its academic ambitions and its human commitments.

END

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