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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

SRC elections of our Bloemfontein Campus
2011-07-26

The Student Council elections of our university at the Bloemfontein Campus will take place on 29 and 30 August 2011. These official election dates were announced by Mr Rudi Buys, Dean: Student Affairs, on 25 July 2011.

Nominations open on Wednesday, 27 July 2011 and the elections, which are constituted according to the SRC Constitution, shall be handled by the Independent Electoral Agency, which shall be instituted by the SRC Constitution with this in view.
 
“The elections introduce a new era in student leadership and governance, because student representation will now constituted in such a way that affords the majority of students the opportunity to vote directly for their representatives. Senior leadership structures are extended in the new Constitution, in order to allow more students to hold senior positions,” states Mr Buys.
 
The SRC elections follow on the approval of a new Constitution that was accepted by our Council on 3 June 2011.
 
The Constitution was drafted over a period of eight months by the Broad Student Transformation Forum (BSTF), consisting of students, in order to design a new dispensation in student structures. The BSTF, which decided on new models of student representation in collaboration with independent facilitators, consists of more than 70 student organisations and residences. The changes to the Constitution were decided on and accepted by the BSTF, after recommendations from four student study groups, which investigated student leadership and governance in depth, at national as well as international level, were taken into account. The study groups visited nine (9) other SA universities, as well as investigated student representation at internationally renowned universities like Cornell, Yale and Stanford in the United States of America.
 
Ms Modieyi Motholo, Chairperson of the Interim Student Committee, says that she is very proud of what the students have achieved with the new Constitution. “I wish to accord recognition to all the students who lead the process for all their hard work. Constitutional revision is a strenuous process and it is nothing short of a miracle that the students could not only reconstruct the Constitution, but also have it accepted in less than a year.”
 
The important changes include, amongst others:

  • Candidates no longer stand on behalf of parties in the elections, but as independent candidates for 10 predetermined portfolios for which students can vote directly;
  • Students also directly vote for a President and a Vice-President;
  • Nine (9) SRC members serve ex-officio as SRC members by virtue of being chairpersons of nine additional student councils established by the Constitution. Amongst others, the councils include a postgraduate student council, an international student council, a student media council and a student academic affairs council;
  • More stringent eligibility requirements are set for candidates, namely that students who wish to run in the elections has to, amongst others, sustain an academic average of more than 60%, and hold proven student leadership experience (which could be verified by the Independent Electoral Agency).

 
“With the SRC elections, students have the opportunity to firmly entrench the changes in student governance on which they have decided on by  themselves firmly, as a sustainable model for democracy at our Bloemfontein Campus. It speaks volumes that the number of leadership positions for which candidates can make themselves available, in essence has been increased by the number of additional student sub-councils from 21 to 67, because it brings about much more direct representation for different students across the campus,” says Mr Buys.
 
“I firmly believe that the upcoming student council elections will be a success,” says Motholo. “I wish the students, who are prepared to sacrifice a year of their lives in service of the student community as a member of the SRC, all of the best.”
 
The Qwaqwa Campus’ election schedule shall be announced within the next week, as well as the date of the institution of the Central Student Council (CSC).

Media Release
26 July 2011
Issued by: Lacea Loader
Director: Strategic Communication
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: news@ufs.ac.za
 
 

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