Latest News Archive

Please select Category, Year, and then Month to display items
Years
2017 2018 2019 2020
Previous Archive
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

Bullying in schools: Everyone’s problem
2005-06-03

From left:  Prof Gerhardt de Klerk, Dean: Faculty of the Humanities; Prof Corene de Wet; Prof Rita Niemann, Head of the Department of Comparative Education and Educational Management in the School of Education and Prof Frederick Fourie, Rector and Vice-Chancellor of the UFS

It is not only learners who are the victums of bullying in schools, but also the teachers. Prof. Corene de Wet from the Department Comparative Education and Educational Management at the University of the Free State reported, against the background of two studies on bullying in Free State secondary schools, that bullying is a general phenomena in these schools.

Prof. de Wet, who delivered her inaugural lecture on Wednesday night, is from the Department Comparative Education and Educational Management which resorts under the School of Education at the University of the Free State. She is the first women who became a full professor the School of Education.

Prof. de Wet says, “A student is being bullied or victimized when he or she is exposed, repeatedly and over time, to negative action on the part of one or more students. Bullying always includes the intentional use of aggression, an unbalanced relationship of power between the bully and the victim, and the causing of physical pain and/or emotional misery.

In some Free State schools there are victims and perpetrators of direct and indirect verbal, as well as emotional, physical and sexual bullying.

“Adults who say that bullying are part of the growing-up process and parents who set not only academic expectations but also social expectations to their children cause that victims are unwilling to acknowledge that they are being bulled. Many parents are also unaware of the levels of bullying their children are exposed to.

“Some of the learners were at least once a month the victim of direct verbal harassment, 32,45% were assaulted by co-learners and 11,21% of them were at east once per week beat, kicked, pushed and hurt in any other physical way. Free State learners are very vulnerable to bullies at taxis and on the school yard they are mostly exposed to bullies in bathrooms.

“Learners are usually bullied by members of the same gender. However, racial composition also plays a role in some Free State schools. A grade 12 girl writes, ‘There are boys in my school who act means against black people. When the teacher is out they take a red pen and write on the projector and spray it with spirits. It looks like blood and they would say it is AIDS and my friends and I have it.’

“Educators must take note of bullying in schools and must not shrug it off as unimportant. Principals or educators could be find guilty of negligence. A large number of educator respondents, 88,29%, indicated that they would intervene in cases of verbal bullying and 89,71% would intervene if they saw learners being physically bullied. However, only 19,97% of the learners who were victims of bullying were helped by educators/ other adults from their respective schools.

“The learners’ lack of trust in their educators’ abilities and willingness to assist them in the fight against bullying has important implications for education institutions. The importance of training must be emphasised.

Learners bully their educators to undermine their confidence. In Prof. de Wet’s study on educator-targeted bullying in Free State schools 24,85% of the respondents were physically abused by their learners, 33,44% were the victims of indirect verbal bullying, and 18,1% were at one time or another sexually harassed by their learners. These learner offences may lead to suspension.

“Educators are not only victims of bullying; some of them are the bullies. The South African Council for Educators prohibits bullying by educators. It is worrying that 55,83% of the educators who participated in the research project verbally victimised learners, 50,31% physically assaulted learners and a small percentage was guilty of sexual harassment.

“Every educator and learner in South Africa has the right to life, equal protection and benefit of the law, of dignity, as well as of freedom and security of the person. These rights will only be realised in a bully-free school milieu.

“To oppose bullying a comprehensive anti-bullying programme, collective responsibility and the establishment of a caring culture at schools and in the community is necessary,” said Prof. de Wet.
 

We use cookies to make interactions with our websites and services easy and meaningful. To better understand how they are used, read more about the UFS cookie policy. By continuing to use this site you are giving us your consent to do this.

Accept