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Global body re-affirms UFS lab’s vaccine testing status

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

Student leaders 2012/13 announced

2012-08-30

Ready for the task - Sabelo Khumalo, SRC President of the Qwaqwa Campus and William Clayton, SRC President of the Bloemfontein Campus.
Photo: Johan Roux
31 August 2012

The 2012/13 elections for the Student Representative Councils (SRC) of the University of the Free State were completed successfully and show meaningful support for the changes in student governance adopted by students across campuses over the past two years.

The SRC elections at the Qwaqwa Campus were completed on 23 August 2012, while the elections at our Bloemfontein Campus took place on 27 and 28 August 2012.

The SRC Elections at our Bloemfontein Campus showed a voter turnout of 4516 votes (30.8%), with the elections at the Qwaqwa Campuses showing 1753 votes (46%) – both campuses reached the required quorums and the IEA (Bloemfontein Campus) and IEC (Qwaqwa Campus) declared the elections free and fair and announced the results as a true reflection of the will of the student bodies at the campuses.

The full SRC at Bloemfontein Campus now consists of 62% black and 38% white, and 53% female and 47% male members.

In the Qwaqwa elections, SADESMO achieved 46, 38% of the vote, with SASCO, PASMA and NASMO each achieving 30,23% and 8,39% and 14,26%, respectively.

The successful elections at Bloemfontein Campus show that the detailed transformation of student governance introduced by students at the Campus in 2010 and adopted by the university in 2011, succeeded in mobilizing greater participation of students in governance and representation. These changes in the main included a shift to independent candidacy for elective portfolios (12 seats) and organizational candidacy in nine sub-councils that holds ex officio seats on the SRC. Changes also included the establishment of student representative seats in faculty governance and management forums and the adoption of a reviewed Central SRC Constitution. Ex officio seats hold full and equal constitutional authority in the SRC.

Students at Qwaqwa Campus introduced additional portfolios to its SRC, including ex-officio seats for academic affairs, arts and culture, commuter students, Rag Community Service, religious affairs, residences and sports.

A joint sitting of the Campus SRCs will establish the Central SRC 2012/13 on 9 September 2012.

As a further opportunity for participation in and the development of student governance and representation, the current Central SRC herewith also announces its recent adoption of a student governance advisory programme, namely the UFS Student Elders Council (SEC).

The SEC is established as a combined programme between the Central SRC and the Dean of Student Affairs and will consist of selected senior student leaders from all campuses who completed their terms of office, apply and are appointed to the Elders Council by the Central SRC.

The Council will serve as an advisory structure to the Central SRC and other student structures in support of the continuous development of student governance and representation of the student body at the university.

The SEC will advise the Central SRC to be constituted following the constitution of the respective Campus SRCs.

The SRC members at the Bloemfontein Campus are:

President: Mr William Clayton

Vice-President: Mr Bonolo Thebe

Secretary: Ms Karis-Robin Topkin

Treasurer: Mr Pieter Coetzee

Arts & Culture: Ms Chanmari Erasmus

Accessibility & Student Support: Ms Gene McCaskill

First-generation Students: Ms Tanya Calitz

Legal and Constitutional Affairs: Ms Nokuthula Sithole

Media, Marketing & Liaison: Ms Neo Chere

Sport: Mr Tshepo Moloi

Student Development & Environmental Affairs: Ms Thabisile Mgadi

Transformation: Ms Koketso Mofokeng

Dialogue & Ex officio: Associations Council: Mr Anesu Ruswa

Academic Affairs & Ex officio: Academic Affairs Council: Ms Nombuso Ndlovu

Residence Affairs & Ex officio: Residences Council: Mr Johann Steyn

City Residence Affairs & Ex officio: Commuter Council: Mr Michael van Niekerk

Postgraduate Affairs & Ex officio: Postgraduate Council: Mr Fadeyi Akinsuyi

International Affairs & Ex officio: International Council: Ms Tumelo Moreri

Student Media Affairs & Ex officio: Media Council: Mr Jamal-Dean Grootboom

RAG Community Service & Ex officio: RAG Fundraising Council: Mr Jaco Faul

RAG Community Service & Ex officio: RAG Community Service Council: Ms Keneue Mahloana

The SRC members at the Qwaqwa Campus are:

President General: Mr S Khumalo

Deputy President: Mr P T Lenka

Secretary General: Mr D Khethang

Treasurer General: Mr S I Sithole

Media & Publicity: Mr S N Ntombela

Politics & Transformation: Tbc

Student Development & Evironmental Affairs: Tbc Academic Affairs: Mr T Molawude

Arts & Cultural Affairs: Mr T Nkohli

Off-Campus Students: Mr B Mtshali

RAG, Community Service & Dialogue: Ms S F Mlotya

Religious Affairs: Ms D C Khau

Residence & Catering Affairs: Ms Z Mzolo

Sports Council: Mr S Mngomezulu

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