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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

Gender bias still rife in African Universities
2007-08-03

 

 At the lecture were, from the left: Prof. Magda Fourie (Vice-Rector: Academic Planning), Prof. Amina Mama (Chair: Gender Studies, University of Cape Town), Prof. Engela Pretorius (Vice-Dean: Humanties) and Prof. Letticia Moja (Dean: Faculty of Health Sciences).
Photo: Stephen Collett

Gender bias still rife in African Universities

Women constitute about 30% of student enrolment in African universities, and only about 6% of African professors are women. This is according to the chairperson of Gender Studies at the University of Cape Town, Prof Amina Mama.

Prof Mama was delivering a lecture on the topic “Rethinking African Universities” as part of Women’s Day celebrations at the University of the Free State (UFS) today.

She says the gender profile suggests that the majority of the women who work in African universities are not academics and researchers, but rather the providers of secretarial, cleaning, catering, student welfare and other administrative and support services.

She said that African universities continue to display profound gender bias in their students and staffing profiles and, more significantly, are deeply inequitable in their institutional and intellectual cultures. She said women find it difficult to succeed at universities as they are imbued with patriarchal values and assumptions that affect all aspects of life and learning.

She said that even though African universities have never excluded women, enrolling them presents only the first hurdle in a much longer process.

“The research evidence suggests that once women have found their way into the universities, then gender differentiations continue to arise and to affect the experience and performance of women students in numerous ways. Even within single institutions disparities manifest across the levels of the hierarchy, within and across faculties and disciplines, within and between academic and administrative roles, across generations, and vary with class and social background, marital status, parental status, and probably many more factors besides these”, she said.

She lamented the fact that there is no field of study free of gender inequalities, particularly at postgraduate levels and in the higher ranks of academics. “Although more women study the arts, social sciences and humanities, few make it to professor and their research and creative output remains less”, she said.

Prof Mama said gender gaps as far as employment of women within African universities is concerned are generally wider than in student enrolment. She said although many women are employed in junior administrative and support capacities, there continues to be gross under-representation of women among senior administrative and academic staff. She said this disparity becomes more pronounced as one moves up the ranks.

“South African universities are ahead, but they are not as radically different as their policy rhetoric might suggest. A decade and a half after the end of apartheid only three of the 23 vice-chancellors in the country are women, and women fill fewer than 30% of the senior positions (Deans, Executive Directors and Deputy Vice-Chancellors)”, she said.

She made an observation that highly qualified women accept administrative positions as opposed to academic work, thus ensuring that men continue to dominate the ranks of those defined as ‘great thinkers’ or ‘accomplished researchers’.

“Perhaps women simply make realistic career choices, opting out of academic competition with male colleagues who they can easily perceive to be systematically advantaged, not only within the institution, but also on the personal and domestic fronts, which still see most African women holding the baby, literally and figuratively”, she said

She also touched on sexual harassment and abuse which she said appears to be a commonplace on African campuses. “In contexts where sexual transactions are a pervasive feature of academic life, women who do succeed are unlikely to be perceived as having done so on the basis of merit or hard work, and may be treated with derision and disbelief”, she said.

She, however, said in spite of broader patterns of gender and class inequality in universities, public higher education remains a main route to career advancement and mobility for women in Africa.

“Women’s constrained access has therefore posed a constraint to their pursuit of more equitable and just modes of political, economic and social development, not to mention freedom from direct oppression”, she said.

Prof Mama concluded by saying, “There is a widely held agreement that there is a need to rethink our universities and to ensure that they are transformed into institutions more compatible with the democratic and social justice agendas that are now leading Africa beyond the legacies of dictatorship, conflict and economic crisis, beyond the deep social divisions and inequalities that have characterised our history”.

She said rethinking universities means asking deeper questions about gender relations within them, and taking concerted and effective action to transform these privileged bastions of higher learning so that they can fulfil their pubic mandate and promise instead of lagging behind our steadily improving laws and policies.

Media Release
Issued by: Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt.stg@ufs.ac.za  
02 August 2007
 

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