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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

Teachers should deal with diversity in education - Prof. Francis
2010-10-08

At the occasion were, from the left: Prof. Jonathan Jansen, Rector and Vice-Chancellor of the University of the Free State (UFS); Prof. Francis; and Prof. Driekie Hay, Vice-Rector: Teaching and Learning at the UFS.
Photo: Jaco van der Merwe

Prof. Dennis Francis, the Dean of the Faculty of Education at the University of the Free State (UFS), recently delivered his inaugural lecture on Troubling Diversity in South African Education on the Main Campus in Bloemfontein.

He urged teachers to be open to what “diversity” might mean in a particular context and how diversity relates to either inclusion or exclusion.

“An approach that promotes the inclusion of all must be based on an understanding of how exclusion operates in ways that may have typical patterns of oppression, but differ in the specific ways that exclusion is expressed and becomes normalised in that context,” he said.

“The good teacher thus seeks to understand how these forms of exclusion may develop in the school’s context and respond through taking thoughtful action to challenge them. It may require creating a climate that enables the silent to speak and recognising that not all groups communicate in exactly the same ways.”

He said teachers also had to affirm the experiential base of learners and students. He said there was an assumption that students would be more effective practitioners if their own experience were validated and explored.

“It is crucial that the students’ own history is treated as valuable and is a critical part of the data that are reflected,” he said. “Equally important is that such stories and similar activities are intentionally processed to enable students to make the connections between personal experience and relevant theory.”

He also urged them to challenge the ways in which knowledge had been framed through oppression.

“Schools are often characterised by messages that draw on one or another form of oppression. Thus, expectations are subtly or in some cases unsubtly communicated, e.g. that girls are not good at physics, or that, while white learners are strong in abstract thought, African learners have untapped creativity, and so on,” he continued.

“For someone to integrate into their role as educators a commitment against oppression means confronting obstacles that one may previously have shied away from, such as challenging authority, naming privilege, emphasising the power relations that exist between social groups, listening to people one has previously ignored, and risking being seen as deviant, troublesome or unpopular.”

Furthermore, Prof. Francis said dealing with diversity in education was always affectively loaded for both students and teachers. He said in South Africa one injunction from educators was to be “sensitive” and thus avoid risking engagement with the contentious issues around imbalances of power.

“If both students and teachers are to confront issues of oppression and power in any meaningful way, we need to design more purposely for the difficulties they will encounter, for example, creating a classroom environment that promotes safety and trust so that all students are able to confront and deal with prejudice and discrimination. Classroom environments will need to balance the affective and cognitive in addressing issues of diversity and social justice,” he added.

He also said that teachers should recognise the need to complement changing attitudes with attempts to change the structural aspects of oppressions.

“To prevent superficial commitments to change, it is important for students to explore barriers that prevent them from confronting oppressive attitudes and behaviours. In this way students are able to learn and see the structural aspects of oppression,” he said.

“Equally important, however, is to get students to examine the benefits associated with challenging oppression. A fair amount of time must therefore be spent on developing strategies with students which they will be able to use practically in challenging oppression.”

He also advised educators to affirm the capacity of staff and learners to act and learn in ways that do not replicate patterns of oppression.

“Many South African schools have survived both the harsh repression of apartheid and the continuing legacy of oppression of various kinds. Despite that, we are often as educators made aware of the ways in which young people in particular affirm themselves and each other in creative and confident ways,” he concluded.

Media Release
Issued by: Lacea Loader
Director: Strategic Communication (acg)
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl@ufs.ac.za  
7 October 2010
 

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