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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

UFS Music rises to academic prominence
2007-10-18

 

From the left are: Ronella Jansen van Rensburg, Hanna van Schalkwyk, Elene Coetzer en Lizabé Lambrechts

Four postgraduate students gave prominence to the Music Department of the University of the Free State by having four academic articles published by accredited journals, and a fifth published in an international online journal.

It is the first time that a tertiary music institution in South Africa has had so many postgraduate studies published in one year, says Prof Martina Viljoen.

The students who worked under Prof Viljoen's supervision are Hanna van Schalkwyk, senior lecturer in singing at UFS; Ronella Jansen van Rensburg, part-time music lecturer and founder of the Sentraal-Kultuurakademie (Central Culture Academy); Elene Coetzer, also a part-time lecturer and involved in the Mangaung String Project; and Lizabé Lambrechts, who is still studying full-time.

Hanna and Ronella attained their master's degrees and Lizabé honours.

Hanna's research on the unique and at times unorthodox philosophy in singing and method of the pedagogue in singing Sarie Lamprecht (1923-2005) is published in the Tydskrif vir Geesteswetenskappe (Journal for the Humanities).

The study documents interviews held with Lamprecht over more than two years as well as conversations with her most prominent students.

Ronella's study on the relationship between emotional intelligence and musical performance anxiety is divided into two successive articles in the journal Musicus.

Dr Adelene Grobler, Epog director at UFS, was Ronella's co-supervisor.

Elene conducted a qualitative investigation into the Mangaung String Programme in which the social value of this teaching programme is emphasised.

She documented the responses of learners, parents and teachers who are involved in the project. Her article is published in the Journal of the Musical Arts in Africa.

Lizebé reached out to pop culture for her research and wrote about no less a person than the controversial shock-rock-icon Marilyn Manson.

Her study serves as a model analysis for educational work that focuses on popular culture as a didactic instrument.

In this respect Manson's music, which is frequently slated as vulgar or disturbing, is shown as aggressive social comment.

Lizabé's article, which throws light on Manson's bisexual identity, was published as a full-length monograph in the first edition of the overseas online noncejournal.

In 2005 the Department of Music also excelled when it was the first academic music institution in South Africa that published international congress proceedings as a subsidised collection.

The collection contained eminent international authors and was published under the guest editorship of Viljoen.

Die Volksblad – 1.10.07

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