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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 guidelines to increase diversity in student residences at the UFS
2007-06-08

As from 2008, the University of the Free State (UFS) will implement new policy guidelines for student residences so as to increase diversity on the Main Campus of the UFS in Bloemfontein.

These new policy guidelines were approved by the Council of the UFS today (Friday 8 June 2007) after consultations with a range of stakeholders, especially students currently in residences, student leaders and student organisations, with inputs received from alumni and parents as well.

According to a statement by the Chairperson of the UFS Council, Judge Faan Hancke, and the Rector and Vice-Chancellor of the UFS, Prof. Frederick Fourie, the guidelines are based on an educational rationale with a definite educational objective.

“What the UFS seeks to do with these new policy guidelines, is to overcome the racial divides of the past and equip students in residences with the knowledge and skills to understand people from other cultures, appreciate other languages and to respect differences in religion but also economic background,” Judge Hancke and Prof. Fourie said in their statement.

“This will give students in UFS residences a distinct advantage over many other work seekers in South Africa, because the workplace today is a very diverse place with people of many backgrounds,” Judge Hancke and Prof. Fourie said in their statement.
They said the UFS wanted to establish a new model of residence life in which students will voluntarily embrace diversity and learn about diversity so as to add value to their educational experience in a residence.

In the late 1990s the UFS made the first attempt to integrate its residences which led to violent clashes between white and black students. A compromise agreement was reached based on freedom of association but this has over the years led to the current situation of largely white and largely black residences.

To support students during the implementation of the new policy guidelines, the management of the UFS will establish several mechanisms and programmes for students to empower them, to build their capacity and to facilitate a smooth transition to a new model of student life in the residences.

Judge Hancke and Prof. Fourie said the decision is another important milestone in the ongoing transformation of the UFS and in the provision of quality higher education for all UFS students, and that the decision had been taken in the best interests of the students.

“This is a very carefully managed transition to bring about a non-racial character to our student residences in line with the Constitution and the ethos of a democratic South Africa,” Judge Hancke and Prof. Fourie said.

How the new policy will work in practice

As from 2008, the new policy aims to bring about an important shift in the way first-years are placed in a residence. From 2008 first-year students are to be placed to achieve a minimum diversity level of 30% in each junior residence.

In senior residences a mix of approximately 50-50 will be the goal from 2008.
Residences will be responsible for placing 50% of first-years, which gives them the scope to increase diversity. The university’s accommodation service will place the other 50%. All these placements must occur in accordance with the educational rationale and the related diversity objective.

If a residence cannot reach the diversity objectives, the university will use the 50% of placements that it controls to achieve sufficient diversity in a particular residence.

Support mechanisms for students

According to Dr Ezekiel Moraka, Vice-Rector: Student Affairs, students in the residences will not be left on their own to deal with the issues of diversity. The management of the UFS has identified several important areas where the process may need support, especially in the early stages of implementation. Students and student leadership will be involved in the further design and finalisation of the implementation details.

These areas where support will be finalised are the following:

  • Providing properly trained and qualified personnel (such as live-in wardens, residence heads etc.) to supervise the implementation of the policy on a 24-hour basis;
  • Ongoing orientation workshops for all students in residences to deal with diversity in a mature way;
  • Support to deal with language issues, including interpreting services so that language rights of all students can be respected; and
  • Assistance with the review of residence governance, administrative and other procedures that have been used in residences up to now.

“There can therefore be no doubt that the management is committed to the well-supported and successful implementation of this new policy and to giving the best possible education to all our students,” Judge Hancke and Prof Fourie said.

Media release
Issued by: Lacea Loader
Assistant Director: Media Liaison
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl.stg@ufs.ac.za
8 June 2007
 

 
 

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