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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

“To forgive is not an obligation. It’s a choice.” – Prof Minow during Reconciliation Lecture
2014-03-05

“To forgive is not an obligation. It’s a choice.” – Prof Minow during the Third Annual Reconciliation Lecture entitled Forgiveness, Law and Justice.
Photo: Johan Roux

No one could have anticipated the atmosphere in which Prof Martha Minow would visit the Bloemfontein Campus. And no one could have predicted how apt the timing of her message would be. As this formidable Dean of Harvard University’s Law School stepped behind the podium, a latent tension edged through the crowded audience.

“The issue of getting along after conflict is urgent.”

With these few words, Prof Minow exposed the essence of not only her lecture, but also the central concern of the entire university community.

As an expert on issues surrounding racial justice, Prof Minow has worked across the globe in post-conflict societies. How can we prevent atrocities from happening? she asked. Her answer was an honest, “I don’t know.” What she is certain of, on the other hand, is that the usual practice of either silence or retribution does not work. “I think that silence produces rage – understandably – and retribution produces the cycle of violence. Rather than ignoring what happens, rather than retribution, it would be good to reach for something more.” This is where reconciliation comes in.

Prof Minow put forward the idea that forgiveness should accompany reconciliation efforts. She defined forgiveness as a conscious, deliberate decision to forego rightful grounds of resentment towards those who have committed a wrong. “To forgive then, in this definition, is not an obligation. It’s a choice. And it’s held by the one who was harmed,” she explained.

Letting go of resentment cannot be forced – not even by the law. What the law can do, though, is either to encourage or discourage forgiveness. Prof Minow showed how the law can construct adversarial processes that render forgiveness less likely, when indeed its intention was the opposite. “Or, law can give people chances to meet together in spaces where they may apologise and they may forgive,” she continued. This point introduced some surprising revelations about our Truth and Reconciliation Commission (TRC).

Indeed, studies do report ambivalence, disappointment and mixed views about the TRC. Whatever our views are on its success, Prof Minow reported that people across the world wonder how South African did it. “It may not work entirely inside the country; outside the country it’s had a huge effect. It’s a touchstone for transitional justice.”

The TRC “seems to have coincided with, and maybe contributed to, the relatively peaceful political transition to democracy that is, frankly, an absolute miracle.” What came as a surprise to many is this: the fact that the TRC has affected transitional justice efforts in forty jurisdictions, including Rwanda, Sierra Leone, Cambodia and Liberia. It has even inspired the creation of a TRC in Greensborough, North Carolina, in the United States.

There are no blueprints for solving conflict, though. “But the possibility of something other than criminal trials, something other than war, something other than silence – that’s why the TRC, I think, has been such an exemplar to the world,” she commended.

Court decision cannot rebuild a society, though. Only individuals can forgive. Only individuals can start with purposeful, daily decisions to forgive and forge a common future. Forgiveness is rather like kindness, she suggested. It’s a resource without limits. It’s not scarce like water or money. It’s within our reach. But if it’s forced, it’s not forgiveness.

“It is good,” Prof Minow warned, “to be cautious about the use of law to deliberately shape or manipulate the feelings of any individual. But it is no less important to admit that law does affect human beings, not just in its results, but in its process.” And then we must take responsibility for how we use that law.

“A government can judge, but only people can forgive.” As Prof Minow’s words lingered, the air suddenly seemed a bit more buoyant.

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