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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

UFS boasts with most advanced chemical research apparatus in Africa
2005-11-23

Celebrating the inauguration of the NMR were from the left Prof Frederick Fourie (Rector and Vice-Chancellor of the UFS),  Dr Detlef Müller (Development Scientist and Manager:  Africa and Asia of Bruker in Germany, the supplier of the NMR), Prof Jannie Swarts (head of the head of the Division Physical Chemistry at the UFS) and Prof Herman van Schalkwyk (Dean:  Faculty of Natural and Agricultural Sciences at the UFS). Photo: Lacea Loader

UFS boasts with most advanced chemical research apparatus in Africa 

The University of the Free State’s (UFS) Department of Chemistry now boasts with some of the most advanced chemical research apparatus in Africa after the latest addition, a nuclear magnetic resonance (NMR) spectrometer, was inaugurated today by the Rector and Vice-Chancellor, Prof Frederick Fourie.  The NMR is used to analyse molecular structures. 

Last month the Department of Chemistry celebrated the installation of the most advanced single crystal X-ray diffractometer in Africa.  The diffractometer provides an indispensable technique to investigate among others the solid state of compounds for medicinal application.

“Three years ago the UFS executive management realised that, if we want to build a university of excellence, we should invest in research.  We started to think strategically about chemistry and decided to bring the apparatus at the Department of Chemistry on a more competitive standard.  Strategic partnerships were therefore secured with companies like Sasol,” said Prof Fourie during the inauguration ceremony.

“The installation of the NMR symbolises the ability of the UFS to turn academic areas around.  I hope that this is the beginning of a decade of excellence for chemistry at the UFS,” said Prof Fourie.

”The catalogue value of the Bruker 600 MHz NMR is approximately R11 million.  With such an advanced apparatus we are now able to train much more post-graduate students,“ said Prof Jannie Swarts, head of the Division Physical Chemistry at the UFS.

”The NMR is the flagship apparatus of the UFS Department of Chemistry that enables chemists to look at compounds more easily at a molecular level.  Research in chemistry is critically dependent on NMR, which is a technique that can determine the composition of reactants and products in complicated chemical reactions, with direct application is most focus areas in chemistry,“ said Prof Swarts.

”Parts of the spectrometer consists of non-commercial items that were specifically designed for the UFS Department of Chemistry to allow the study of unique interactions in e.g. rhodium and platinum compounds,” said Prof Swarts.

According to Prof Swarts the NMR enables chemists to conduct investigations on the following:

To evaluate for example the complex behaviour of DNA in proteins as well as the analysis of illegal drugs sometimes used by athletes. 
It provides an indispensable technique to investigate compounds for medicinal application for example in breast, prostate and related bone cancer identification and therapy, which are currently synthesised in the Department of Chemistry.  
It can also be applied to the area of homogeneous catalysis where new and improved compounds for industrial application are synthesized and characterised, whereby Sasol and even the international petrochemical industry could benefit. This analytical capacity is highly rated, especially in the current climate of increased oil prices.
The NMR can detect and identify small concentrations of impurities in feed streams in the petrochemical industry, e.g. at Sasol and also the international petrochemical industry.  These minute amounts of impurities can result in metal catalyst deactivation or decomposition and can cause million of rands worth in product losses.
It is indispensable for studying the complexity of samples that is non-crystalline. These materials represent the vast majority of chemical compounds such as solvents, gasoline, cooking oil, cleaning agents and colorants as examples. 

According to Prof Swarts the general medical technique of MRI (magnetic resonance imaging) in use at larger hospitals, is based on NMR technology.

”The NMR apparatus enabled the Department of Chemistry to characterise complex molecules that were synthesised for the multi-national company, FARMOFS-PAREXEL, and to negotiate research agreements with overseas universities,” said Prof Swarts. 

Media release
Issued by: Lacea Loader
Media Representative
Tel:  (051) 401-2584
Cell:  083 645 2454
E-mail:  loaderl.stg@mail.uovs.ac.za
22 November 2005
 

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