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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

National Arts Council opens doors for students in Drama and Theatre Arts
2017-06-29

Description: National Arts Council opens doors for students  Tags: National Arts Council opens doors for students

Four postgraduate students from the University of the
Free State received bursaries from the National Arts
Council this year. They are, from the left: Gerrit Fourie,
Maryn Hattingh, Prof Pieter Venter, Programme Director
of drama at the UFS, Stella Nortier, and Franco de Wet. 
Photo: Esté Strydom

Thanks to bursaries from the National Arts Council (NAC), many students are finding it easier to study Drama and Theatre Arts, the discipline is able to offer more job opportunities, and it provides an opportunity to those who probably would never have had the chance. This is according to Prof Nico Luwes, Head of the Department of Drama and Theatre Arts at the University of the Free State (UFS).

This year, several students from the UFS, including 12 undergraduates and four postgraduates, are again beneficiaries of NAC bursaries to the value of roughly R206 000 – about R150 000 of which will be used for undergraduate studies and R56 000 for postgraduate studies. The UFS was awarded the same amount for undergraduate students in the previous year, but didn’t then receive NAC bursaries for postgraduate studies.

Good relationship with NAC over many years
The UFS has received NAC bursaries since 2005, and Prof Luwes says the university’s good relationship with the council runs over many years. “They are very happy with the feedback on our students’ achievements,” he says.

“Although Dramatic Arts is a matric subject, the provincial department of education does not support students with education bursaries for this subject. With bursaries from the National Arts Council, students can thus study to become theatre artists, and work as teachers for the Dramatic Arts in schools.”

Alumni stand out in entertainment industry
Prof Luwes says his department provides students the opportunity to do performances and practical exams in English, Afrikaans, and Sesotho. This is done to give all students an equal opportunity to excel. “In addition, several of our alumni have achieved success in the entertainment industry, and our staff members often feature in professional performances at arts festivals.”

Undergraduate students who were awarded NAC bursaries:
•    Jolene Swartz
•    Boitumelo Mohutsioa
•    René Lombard
•    Mandisa Wiso
•    Thapelo Mabona
•    Charlize Oberholster
•    Thembisile Baai
•    Naledi Maolusi
•    Mbuyiselo Nqodi
•    Vuyiswa Mxasa
•    Deandi Scholtz
•    Dylan Britz

Postgraduate students who were awarded NAC bursaries:

•    Gerrit Fourie
•    Maryn Hattingh
•    Stella Nortier
•    Franco de Wet

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