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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

Weideman focuses on misconceptions with regard to survival of Afrikaans
2006-05-19

From the left are Prof Magda Fourie (Vice-Rector: Academic Planning), Prof Gerhardt de Klerk (Dean: Faculty of the Humanities), George Weideman and Prof Bernard  Odendaal (acting head of the UFS  Department of Afrikaans and Dutch, German and French). 
Photo (Stephen Collett):

Weideman focuses on misconceptions with regard to survival of Afrikaans

On the survival of a language a persistent and widespread misconception exists that a “language will survive as long as people speak the language”. This argument ignores the higher functions of a language and leaves no room for the personal and historic meaning of a language, said the writer George Weideman.

He delivered the D.F. Malherbe Memorial Lecture organised by the Department Afrikaans at the University of the Free State (UFS). Dr. Weideman is a retired lecturer and now full-time writer. In his lecture on the writer’s role and responsibility with regard to language, he also focused on the language debate at the University of Stellenbosch (US).

He said the “as-long-as-it-is spoken” misconception ignores the characteristics and growth of literature and other cultural phenomena. Constitutional protection is also not a guarantee. It will not stop a language of being reduced to a colloquial language in which the non-standard form will be elevated to the norm. A language only grows when it standard form is enriched by non-standard forms; not when its standard form withers. The growth or deterioration of a language is seen in the growth or decline in its use in higher functions. The less functions a language has, the smaller its chance to survive.

He said Afrikaans speaking people are credulous and have misplaced trust. It shows in their uncritical attitude with regard to the shifts in university policies, university management and teaching practices. Afrikaners have this credulity perhaps because they were spoilt by white supremacy, or because the political liberation process did not free them from a naïve and slavish trust in government.

If we accept that a university is a kind of barometer for the position of a language, then the institutionalised second placing of Afrikaans at most tertiary institutions is not a good sign for the language, he said.

An additional problem is the multiplying effect with, for instance, education students. If there is no need for Afrikaans in schools, there will also be no  need for Afrikaans at universities, and visa versa.

The tolerance factor of Afrikaans speaking people is for some reasons remarkably high with regard to other languages – and more specifically English. With many Afrikaans speaking people in the post-apartheid era it can be ascribed to their guilt about Afrikaans. With some coloured and mostly black Afrikaans speaking people it can be ascribed to the continued rejection of Afrikaans because of its negative connotation with apartheid – even when Afrikaans is the home language of a large segment of the previously oppressed population.

He said no one disputes the fact that universities play a changing role in a transformed society. The principle of “friendliness” towards other languages does not apply the other way round. It is general knowledge that Afrikaans is, besides isiZulu and isiXhosa, the language most spoken by South Africans.

It is typical of an imperialistic approach that the campaigners for a language will be accused of emotional involvement, of sentimentality, of longing for bygone days, of an unwillingness to focus on the future, he said.

He said whoever ignores the emotional aspect of a language, knows nothing about a language. To ignore the emotional connection with a language, leads to another misconception: That the world will be a better place without conflict if the so-called “small languages” disappear because “nationalism” and “language nationalism” often move closely together. This is one of the main reasons why Afrikaans speaking people are still very passive with regard to the Anglicising process: They are not “immune” to the broad influence that promotes English.

It is left to those who use Afrikaans to fight for the language. This must not take place in isolation. Writers and publishers must find more ways to promote Afrikaans.

Some universities took the road to Anglicision: the US and University of Pretoria need to be referred to, while there is still a future for Afrikaans at the Northwest University and the UFS with its parallel-medium policies. Continued debate is necessary.

It is unpreventable that the protest over what is happening to Afrikaans and the broad Afrikaans speaking community must take on a stronger form, he said.

 

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