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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

MBA Programme - Question And Answer Sheet - 27 May 2004
2004-05-27

1. WHAT MUST THE UNIVERSITY OF THE FREE STATE (UFS) DO TO GET FULL ACCREDITATION FOR THE MBA PROGRAMMES?

According to the Council on Higher Education’s (CHE) evaluation, the three MBA programmes of the UFS clearly and significantly contribute to students’ knowledge and skills, are relevant for the workplace, are appropriately resourced and have an appropriate internal and external programme environment. These programmes are the MBA General, the MBA in Health Care Management and the MBA in Entrepreneurship.

What the Council on Higher Education did find, was a few technical and administrative issues that need to be addressed.

This is why the three MBA programmes of the UFS received conditional accreditation – which in itself is a major achievement for the UFS’s School of Management, which was only four years old at the time of the evaluation.

The following breakdown gives one a sense of the mostly administrative nature of the conditions that have to be met before full accreditation is granted by the CHE:

a. A formal forum of stakeholders: The UFS is required to establish a more structured, inclusive process of review of its MBA programmes. This is an administrative formality already in process.

b. A work allocation model: According to the CHE this is required to regulate the workload of the teaching staff, particularly as student numbers grow, rather than via standard management processes as currently done.

c. Contractual agreements with part-time staff: The UFS is required to enter into formal agreements with part-time and contractual staff as all agreements are currently done on an informal and claim-basis. This is an administrative formality already in process.

d. A formal curriculum committee: According to the CHE, the School of Management had realised the need for a structure – other than the current Faculty Board - where all MBA lecturers can deliberate on the MBA programmes, and serve as a channel for faculty input, consultation and decision-making.

e. A system of external moderators: This need was already identified by the UFS and the system is to be implemented as early as July 2004.

f. A compulsory research component: The UFS is required to introduce a research component which will include the development of research skills for the business environment. The UFS management identified this need and has approved such a component - it is to take effect from January 2005. This is an insufficient element lacking in virtually all MBA programmes in South Africa.

g. Support programmes for learners having problems with numeracy: The UFS identified this as a need for academic support among some learners and has already developed such a programme which will be implemented from January 2005.

The majority of these conditions have been satisfied already and few remaining steps will take effect soon. It is for this reason that the UFS is confident that its three MBA programmes will soon receive full accreditation.

2. WHAT ACCREDITATION DOES THE UFS HAVE FOR ITS MBA PROGRAMME?

The UFS’s School of Management received conditional accreditation for its three MBA programmes.

Two levels of accreditation are awarded to tertiary institutions for their MBA programmes, namely full accreditation and conditional accreditation. When a programme does not comply with the minimum requirements regarding a small number of criteria, conditional accreditation is given. This can be rectified during the short or medium term.

3. IS THERE ANYTHING WRONG WITH THE ACADEMIC CORE OF THE UFS’s MBA PROGRAMMES?

No. The UFS is proud of its three MBA programmes’ reputation in the market and the positive feedback it receives from graduandi and their employers.

The MBA programmes of the UFS meet most of the minimum requirements of the evaluation process.

In particular, the key element of ‘teaching and learning’, which relates to the curriculum and content of the MBA programmes, is beyond question. In other words, the core of what is being taught in our MBA programmes is sound.

4. IS THE UFS’s MBA A WORTHWHILE QUALIFICATION?

Yes. Earlier this year, the School of Management – young as it is - was rated by employers as the best smaller business school in South Africa. This was based on a survey conducted by the Professional Management Review and reported in the Sunday Times Business Times, of 25 January 2004.

The UFS is committed to maintaining these high standards of quality, not only through compliance with the requirements of the CHE, but also through implementing its own quality assurance measures.

Another way in which we benchmark the quality of our MBA programmes is through the partnerships we have formed with institutions such as the DePaul University in Chicago and Kansas State University, both in the US, as well as the Robert Schuman University in France.

For this reason the UFS appreciates and supports the work of the CHE and welcomes its specific findings regarding the three MBA programmes.

It is understandable that the MBA review has caused some nervousness – not least among current MBA students throughout the country.

However, one principle that the UFS management is committed to is this: preparing all our students for a world of challenge and change. Without any doubt the MBA programme of the UFS is a solid preparation.

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