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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

New SRC: Records of support and a victory for women
2014-09-04


Ms Mosa Leteane and Ms Louzanne Coetzee
Photo: Johan Roux

While campuses across South Africa regularly report falling voter turnout in campus elections of student representatives, the University of the Free State, in its recently completed SRC elections, registered record levels of support across our campuses with a total voter turnout of 44%. At the Bloemfontein Campus 34,4% of students voted (5052 votes) and 53,3% (1583 votes) at the Qwaqwa Campus.

Also, for the first time under the new SRC constitution, students elected a woman to lead the student body – Ms Mosa Leteane was elected as President. Another first was the election of a blind woman to the SRC – Ms Louzanne Coetzee. She will be responsible for student accessibility of our Bloemfontein SRC. This marks a victory for women in student governance.

Mr Tulasizwe Sithole was elected as the President of the SRC at our Qwaqwa Campus.

The election of Ms Leteane as President underscores the progress achieved for gender equality with near half of her SRC consisting of women (48%).

These successes are all the more significant, since this is the 4th year of elections under newly adopted SRC constitutions that allow for broader participation of diverse student constituencies in student governance.

This means that the crucial 3-year mark to test a new approach and method in governance and elections was not only successfully reached, but also in its 4th year shows the constitution as one that sustains its impact to deepen democracy and citizenship among our 30,000-strong student body.

“The results of the SRC elections across campuses show that our students are not only ready to lead our campus communities on issues relating to justice, freedom and democracy beyond our societal legacies of race and gender, but do so also for the student movement nationally. We’re immensely proud of our students, who show courage and resilience to choose leaders not for expediency, but for significance, and to lead not for some, but for all”, the Dean of Student Affairs, Rudi Buys, said.

The Qwaqwa SRC was installed on 2 September 2014, while the Bloemfontein SRC will be installed on 5 September. The Central SRC will be established on 14 September by joint sitting of the two SRCs.

The SRC members 2014/15 at the Bloemfontein and Qwaqwa Campuses are as follows:

Bloemfontein Elective portfolios:
President: Ms Mosa Leteane
Vice Pres: Mr Waldo Staude
Secretary: Ms Dineo Motaung
Treasurer: Ms Maphenye Maditsi
Arts & Culture: Mr Stefan van der Westhuizen
Accessibility & Student Support: Ms Louzanne Coetzee
First Generation Students: Ms Mpho Khati
Media, Marketing & Liaison: Ms Lethabo Maebana
Legal & Constitutional Affairs: Mr Lindokuhle Ntuli
Sport: Ms Dominique de Gouveia
Student development & Environmental Affairs: Mr Victor Ngubeni
Transformation: Mr Tumelo Rapitsi

Bloemfontein Ex officio Portfolios
Dialogue & Ex officio: Associations Student Council: Mr Piet Thibane
Academic Affairs & Ex officio: Academic Affairs Student Council: Mr Jonathan Ruwanika
Residence Affairs & Ex officio: Campus Residences Student Council: Ms Melissa Taljaard
City student Affairs & Ex officio: Commuter Student Council: Ms Kerry-Beth Berry
Post graduate Affairs & Ex officio: Post Graduate Student Council: Ms Masabata Mokgesi
International Affairs & Ex officio: International Student Council: Mr Makate Maieane
Student Media Affairs & Ex officio: Student Media Council: Mr Samuel Phuti
RAG Community Service & Ex officio: RAG Fundraising Council: Mr Johan du Plessis
RAG Community Service & Ex officio: RAG Community Service Council: Mr Manfred Titus

Qwaqwa Elective portfolios:
President General: Mr Thulasizwe Sithole
Deputy President: Ms Zethu Mhlongo
Secretary General: Mr Vukani Ntuli
Treasurer General: Mr Langelihle Mbense
Media & Publicity: Ms Nongcebo Qwabe
Politics & Transformation: Ms Nkosiphile Zwane

Qwaqwa Ex officio Portfolios
Student Development & Environmental Affairs: Mr Ndumiso Memela
Academic Affairs: Mr Simon Mofekeng
Arts & Cultural Affairs: Ms Samkelo Mtshali
Off-Campus Students: Mr Khanyisani Mbatha
RAG, Community Service & Dialogue: Mr Njabulo Mabaso
Religious Affairs: Mr Mfundo Nxumalo
Residence & Catering Affairs: Ms Ntombifuthi Radebe
Sports Council: Mr Luvuno

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