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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

‘Sola Scriptura’ — Does Scripture still reign as authority?
2017-02-21

Description: Theology Open Day Tags: Theology Open Day

Thania Labuschagne, Nico Oosthuizen, and
Suthea van der Westhuizen.
Photo: Supplied


Reformation 500: Sola Scriptura [scriptural authority] and contemporary conflicts of interpretation was the theme for the Faculty of Theology and Religion’s official opening and annual Open Day on the Bloemfontein Campus of the University of the Free State (UFS). The faculty was recently renamed to be more inclusive of other denominations, as well as to be sensitive to the impact religion has on society, both in the past and presently.

In his welcoming address to first-year students, Prof Fanie Snyman, Dean of the Faculty of Theology and Religion, said, “I hope that you indulge in the theological dish served to you, and that it will create in you a deep hunger to know more.”

One first-year, Neo Kgaje, had this to say, “I first wanted to do Archaeology, but then I decided to follow my calling as a missionary and study Theology. I would like to serve in my own community in Botshabelo.”

Thania Labuschagne, former chairperson of the Sola Gratia student association, said, “The annual opening is always very special for me. We become part of a family here.” Her message for first-years was, “Maintain your passion for what you do. Make sure of your calling, and everything else will fall into place.”

Prizes awarded
Prizes were awarded to several students who excelled in the previous year. The best third-year student in 2016 was Suthea van der Westhuizen; best fourth-year BTh student, Thania Labuschagne; and Nico Oosthuizen was recognised as the best Master of Divinity in the fifth year.

The Director of Shepherd Centre for spiritual leaders, Dr Gerhard Botha, awarded certificates for the completion of a 9-module short learning programme presented by the centre.

"May you hunger to know more"—
Prof Fanie Snyman, Dean of the
Faculty of Theology and Religion

Current affairs addressed through scriptural analysis
While acknowledging that the debates around the authority of Scripture are complex and not easily resolved, Prof Hendrik Bosman from the Faculty of Theology at Stellenbosch University (SU) argued that it is an indispensable precept of Christian theology. However, it can no longer be taken as a given, since the authority of Scripture is increasingly vulnerable. He said, “Sceptic academics and critical theologians are challenging the more traditional ways of accepting the authority of Scripture.”

Prof Bosman highlighted the negative impact that certain claims of scriptural authority have had on the marginalised and vulnerable groups in society — “the suffering endured by people of colour, Jews, the LGBTQI community, and women due to prejudice and hatred. … [When reading the Bible], one must also be held accountable by the marginalised and the vulnerable in society.”

Prof Juliana Claassens (Faculty of Theology, SU) presented Beyond Revenge: Responsible Bible Reading Practices in a Traumatised Land. “As a community of believers who hold dear the principle of Sola Scriptura, what do we do with texts that revel in the downfall of the enemy and propagate revenge as a viable solution to the hurt and pain people are experiencing?”

Prof Claassens continued, “This question is particularly relevant given the deep wounds that many in this beautiful country of ours carry. … There is thus a real danger that expressions of violence survive and grow ever stronger with each utterance, until the violent ideas they propagate are considered to be normal.” Her recommendation? “Foster communities of care, focused on breaking down walls, instead of erecting them.”

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