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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

Afrikaans speakers should think differently, says Coenie de Villiers
2016-06-08

Description: Coenie de Villiers Tags: Coenie de Villiers

Coenie de Villiers was the speaker at the DF Malherbe
Memorial Lecture, held in the Equitas Building on the
University of the Free State Bloemfontein Campus on
24 May 2016.
Photo: Stephen Collett

Do not ask what can be done for your language, but what your language can do for others. With this adaptation of the late John F. Kennedy’s famous words, Coenie de Villiers stressed that the onus for the survival of their language rests with Afrikaans speakers.

According to the television presenter and singer, the real empowerment of Afrikaans does not necessarily take place in parliament. He was the speaker at the DF Malherbe Memorial Lecture, presented in the Equitas Building on the University of the Free State Bloemfontein Campus on 24 May 2016. The lecture by De Villiers, a UFS alumnus, was titled Is Afrikaans plesierig? ’n Aweregse blik.

Government not the only scapegoat
He used Kennedy’s famous phrase, Ask not what your country can do for you, but what you can do for your country, as framework. “I believe that, if we reverse our sights and do not ask what the world can do for Afrikaans, but ask for a change what Afrikaans – and in particular each and every user thereof – can do for others, then we have, in good English terms, ‘a fighting chance’ that Afrikaans will not only survive, but that it will thrive.” He said it would be too easy to just blame the government’s language policy and/or its lack of application for the language’s uncertainties.

Speakers should act correctly
He said the actions of speakers, sometimes motivated by a love for the language, often causes more damage. “It is not the language that should squirm under the microscope. It isn’t Afrikaans that is being tested: it is us, the speakers, writers, thinkers, doers, and tweeters of the language that are being measured.”
De Villiers believes one should stand up for your language without hesitation or fear, but not necessarily in the middle of the road, and never in such a way that you abandon the moral compass of humanity.

Language will live on

He told the audience that Afrikaans speakers should maintain their language every day with the merit, humanity, and respect that they believe the language – and they themselves – deserve. The language will “live on as long as we use it to laugh, and talk, and sing, and do not kill it off with rules and directives.”

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