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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 hosts tenth SASRIM conference filled with highlights
2016-08-23

Description: SASRIM conference book Tags: SASRIM conference book

A new OSM book entitled Musics of the Free State:
Reflections on a Musical Past, Present and Future
will be launched on 25 August 2016 as part of the
South African Society for Research in Music’s
conference, hosted by the UFS.

Photo: Supplied

Bridging the gap between music thinking and music making. This is one of many aims of the South African Society for Research in Music (SASRIM), whose 2016 annual conference will be hosted by the Odeion School of Music (OSM) at the University of the Free State (UFS). It marks the tenth anniversary of SASRIM and the congress, from 25 to 27 August 2016, features many highlights. This includes the Arnold van Wyk Centenary Gala Concert and the launch of the OSM book Musics of the Free State: Reflections on a Musical Past, Present and Future. Keynote speakers will be Stephanus Muller from Stellenbosch University and Guthrie Ramsey from the University of Pennsylvania.

Society encourages multiple facets of music research
Research forms a crucial part of music and therefore SASRIM looks at perspectives on thinking and performing the boundary between music thinking and music making. The society also encourages the submission of a wide variety of proposals, including those exploring alternative formats, multiple facets of music research and practice on the African continent, and disciplinary intersections. Contributions that reflect on the first decade of the society’s existence or any aspect related to Van Wyk are especially welcome.

New OSM book receives sterling international review

Musics of the Free State is a nuanced and
richly endowed study of musical practices in
South Africa, which deserves the international
dissemination it will now receive”.

“It will deeply repay close reading far beyond Bloemfontein.” That was some of the praise that Musics of the Free State received from Prof Harry White from the University of Dublin in the International Review of the Aesthetics and Sociology of Music 47 (1). According to him the book, edited by Prof Martina Viljoen from the OSM, “is a nuanced and richly endowed study of musical practices in South Africa, which deserves the international dissemination it will now receive”.
The book will be launched on 25 August 2016 in the Odeion foyer after the Arnold van Wyk Centenary Gala Concert.

Gala concert commemorate celebrated SA composer
The gala concert on 25 August 2016 at 18:00 will be recited by OSM staff members and the OSM Camerata in the Odeion Auditorium. The programme for a special concert, presented in collaboration with Fine Music, has been curated to celebrate the centenary of the birth of South African composer, Arnold van Wyk. Tickets are available at Computicket or at the door.

The concert, which will also serve as the annual OSM Dean’s concert, will be broadcasted live by Fine Music Radio.

See the following links:

More information about SASRIM 2016.
To listen to the broadcast of the Arnold van Wyk Centenary Gala Concert (then click the button to listen live).
A complete review by Prof White on Musics of the Free State will be available soon.
Copies of Musics of the Free State can be purchased from the OSM at OSM@ufs.ac.za.

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