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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

Dr Makutoane to present research on world stage in US
2017-06-14

“If the SBL has acknowledged you,
it means the research you are doing
is solid. There are people out there
who want to listen to my paper.”

To present a research paper at an international conference of about 10 000 people and where 100 sessions are taking place at the same time is what dreams are made of for an academic. This is no longer a dream for the humble Dr Tshokolo Makutoane who will share his knowledge at the annual meeting of the prestigious Society of Biblical Literature (SBL).

Dr Makutoane, a senior lecturer at the Department of Hebrew at the University of the Free State (UFS), will be a speaker at the conference in Boston, in the US, from 19-21 November 2017. This after receiving a remarkable travel grant from the SBL to present his paper, titled The Contribution of Linguistic Typology for the Study of Biblical Hebrew in Africa: The Case of Sesotho Pronouns.

Description: Dr Makutoane to present research on world stage in US Tags: Dr Makutoane to present research on world stage in US

Dr Makutoane, senior lecturer at the Department of
Hebrew at the University of the Free State, was
speechless when he heard he will be presenting a
paper at the annual meeting of the Society of Biblical
Literature in Boston in the US.
Photo: Jóhann Thormählen

Scholars from around the world participate
His paper is part of a thematic session on “Theoretical Approaches to Anaphora and Pronouns in Biblical Hebrew” in which scholars from Canada, the US, Australia, Europe and Israel will participate.

The research Dr Makutoane will be showcasing in Boston is about teaching Biblical Hebrew in Africa, and more specifically, pronouns, to Sesotho-speaking students.

“SBL is one of the largest organisations in the world and if you get the opportunity to present a paper there, it is one of the highest honours in our context you can have,” Dr Makutoane said.

“If the SBL has acknowledged you, it means the research you are doing is solid. There are people out there who want to listen to my paper.”

According to the SBL website (https://www.sbl-site.org) more than 1 200 academic sessions and workshops will take place at the conference, co-hosted by the SBL and the American Academy of Religion.

Highlight of researcher’s entire career
Receiving the grant and attending the conference for the first time is the highlight of Dr Makutoane’s career. “I feel very grateful, honoured and humbled. I was speechless when I heard about it. I couldn’t help myself and actually cried,” he said.

The grant, given to only four SBL members – the other three are from Samoa, Nigeria and India – is intended to support under-represented and under-resourced scholars who demonstrate a financial need.

Dr Makutoane thanked his mentors, Prof Jacobus Naudé and Prof Cynthia Miller-Naudé, who assisted him with the application. Naudé is a senior professor at the Department of Hebrew and Miller-Naudé a senior professor and head of the department.

Dr Makutoane, who studied Theology at the UFS and is a minister at the NGKA Rehauhetswe church near Bloemfontein, is also grateful to his church that gave him the opportunity to study at the UFS and be able to work at the university.

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