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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

Ford foundation funds higher education redesign
2005-06-23

 

The Ford Foundation has pledged a grant of almost R280 000 for redesigning higher education delivery at three campuses in the Free State.

According to Prof Magda Fourie, Vice-Rector: Academic Planning at the University of the Free State (UFS), the three campuses that will be affected by the strategic reconfiguration of higher education delivery are the Qwaqwa campus at Phuthaditjhaba and the Vista campus of the UFS in Bloemfontein and the Welkom campus of the Central University of Technology (CUT).

Prof Fourie says the three campuses were all affected by the restructuring of higher education, in line with the National Plan for Higher Education.

The Qwaqwa campus of the UFS that was part of the former University of the North was incorporated into the UFS in January 2003.  Likewise the Bloemfontein campus of the former Vista University was incorporated into the UFS in January 2004.

The Welkom campus of the CUT was also part of the former Vista University and was incorporated into the CUT in January 2004.

“These incorporations pose a challenge in that we have to think creatively about the best ways of using these three campuses to service the higher education, training, skills development and human resource needs of the Free State,” Prof Fourie said.

“The grant from the Ford Foundation will primarily be used to draw up strategic funding proposals for the three campuses.  The Qwaqwa campus of the UFS is a priority to us given the poverty and unemployment in a largely rural area of the Free State,” said Prof Fourie.

“A detailed consultation process will be undertaken in the Qwaqwa campus sub-region which will hopefully result in a comprehensive and a coherent suite of higher education activities being established on this campus,” said Prof Fourie.

“It is envisaged that the Qwaqwa campus will become a centre of excellence in the area of rural development.  This vision is based on a focused integration of the core functions of a university – teaching, research, and community service – around the issue of rural development,” said Prof Fourie.

Prof Fourie said that various educational offerings including among others short courses, bridging and foundation programmes, and degrees could be offered, with a particular focus on providing courses of relevance to students from the local rural community and students from elsewhere with an interest in focusing on rural development studies.

She said the redesign of the three affected campuses is being managed as a project of the Free State Higher Education Consortium (FSHEC) consisting of all the higher education institutions operating in the Free State.

“The aim of the project is to establish how the Qwaqwa and Vista campuses of the UFS and the Welkom campus of the CUT can be used effectively to meet regional education and training needs, to serve the strategic priorities of the two higher education institutions and contribute to the sustainable development and poverty alleviation of the region,” she said.

The planning for the Vista campus of the UFS is still in an early stage.  “We are looking at the possibility of developing this campus into a hub of education and training opportunities for Bloemfontein and Free State region.  Further plans will be communicated later in the year,” said Prof Fourie.

Media release

Issued by:  Lacea Loader
   Media Representative
   Tel:  (051) 401-2584
   Cell:  083 645 2454
   E-mail:  loaderl.stg@mail.uovs.ac.za

23 June 2005
 

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