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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

Twenty years of the constitution of South Africa – cause for celebration and reflection
2016-05-11

Description: Judge Azar Cachalia Tags: Judge Azar Cachalia

Judge Azar Cachalia

The University of the Free State’s Centre for Human Rights and the Faculty of Law held the celebration of the twentieth anniversary of the adoption of the South African Constitution on 11 May 2016 on the Bloemfontein Campus.  Students and faculty members celebrated and reflected on not only the achievements of the constitution but also on perspectives regarding its relevance in modern society, and to what extent it has upheld the human rights of all citizens of South Africa.

The panel discussion started with a presentation on the pre-1996 perspective by Judge Azar Cachalia of the Supreme Court of Appeal.  Judge Cachalia reflected on his role in the realisation and upholding of the constitution, from his days as a student activist, then as an attorney representing detainees during political turmoil, and currently as a judge: “My role as an attorney was to defend people arrested for public violence. My role as a judge today is to uphold the constitution.”  He stressed the importance of the constitution today, and the responsibility institutions such as the police service have in upholding human rights.  Judge Cachalia played a significant role in drafting the new Police Act around 1990, an Act which was to ensure that the offences perpetrated by the police during apartheid did not continue in the current democratic era. Further, he pointed out that societal turmoil has the potential to make society forget about the hard work that was put into structures upholding human rights. “Constitutions are drafted in moments of calm.  It is a living document, and we hope it is not torn up when we go through social conflict, such as we are experiencing at present.”

Thobeka Dywili, a Law student at the UFS, presented her views from the new generation’s perspective.  She relayed her experience as a student teaching human rights at schools in disadvantaged communities. She realised that, although the youth are quite aware of their basic human rights, after so many years of democracy, “women and children are still seen as previously disadvantaged when they should be equal”. She pointed out that, with the changing times, the constitution needs to be looked at with a new set of eyes, suggesting more robust youth engagement on topics that affect them, using technology to facilitate discussions. She said with the help of social media, it is possible for a simple discussion to become a revolution; #feesmustfall was a case in point.

Critical perspectives on the constitution were presented by Tsepo Madlingozi of University of Pretoria and University of London. In his view, the constitution has not affected policy to the extent that it should, with great disparities in our society and glaring issues, such as lack of housing for the majority of the poor.  “Celebration of the constitution should be muted, as the constitution is based on a decolonisation approach, and does not directly address the needs of the poor. The Constitutional Court is not pro-poor.”  He posed the question of whether twenty years on, the present government has crafted a new society successfully.  “We have moved from apartheid to neo-apartheid, as black elites assimilate into the white world, and the two worlds that exist have not been able to stand together as a reflection of what the constitution stands for.”

Prof Caroline Nicholson, Dean of the Faculty of Law, encouraged more open discussions, saying such dialogues are exactly what was intended by the Centre for Human Rights. She emphasised the importance of exchanging ideas, of allowing people to speak freely, and of sharing perspectives on important issues such as the constitution and human rights.

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