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11 February 2021 Photo UFS photo archive
The National Control Laboratory for Biological Products (NCL) Building.
There can be no compromise when it comes to the quality of medicines made available to the public.

The UFS-based National Control Laboratory for Biological Products (NCL) is a full member of the international WHO-National Control Laboratory Network for Biologicals and one of 12 laboratories worldwide contracted to perform vaccine testing for the World Health Organisation (WHO). The NCL is also 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 the South African Health Products Regulatory Authority (SAHPRA).

In its role as a 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. 

International testing standards

The laboratory received the status of a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) endorsed its quality-management systems as of a high standard according to the International Standards Organisation’s requirements.

With its international testing standards, the NCL must ensure that all its operations – 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.

The laboratory has all the quality systems in place to ensure high-quality test results. The certificate of Good Manufacturing Compliance received in 2019 indicates that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. This certification is very strict and means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world. The certification offers the South African Health Products Regulatory Authority, the WHO, and other national control laboratories around the world the confidence that the test results from the NCL can be trusted.

Licensed as pharmaceutical manufacturer

The laboratory is also licensed as a pharmaceutical manufacturer. Although the lab does not manufacture, it needs 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.

News Archive

UFS boasts with world class research apparatus
2005-10-20

 

 

At the launch of the diffractometer were from the left Prof Steve Basson (Chairperson:  Department of Chemistry at the UFS), Prof Jannie Swarts (Unit for Physical and Macro-molecular Chemistry at the UFS Department of Chemistry), Mr Pari Antalis (from the provider of the apparatus - Bruker SA), Prof Herman van Schalkwyk (Dean:  Faculty of Natural and Agricultural Sciences at the UFS), Prof André Roodt (head of the X-ray diffraction unit at the UFS Department of Chemistry) and Prof Teuns Verschoor (Vice-Rector:  Academic Operations at the UFS).

UFS boasts with world class research apparatus
The most advanced single crystal X-ray diffractometer in Africa has been installed in the Department of Chemistry at the University of the Free State (UFS).

“The diffractometer provides an indispensable technique to investigate compounds for medicinal application for example in breast, prostate and related bone cancer identification and therapy, currently synthesized in the Department of Chemistry.  It also includes the area of homogeneous catalysis where new compounds for industrial application are synthesised and characterised and whereby SASOL and even the international petrochemical industry could benefit, especially in the current climate of increased oil prices,” said Prof Andrè Roodt, head of the X-ray diffraction unit at the UFS Department of Chemistry.

The installation of the Bruker Kappa APEX II single crystal diffractometer is part of an innovative programme of the UFS management to continue its competitive research and extend it further internationally.

“The diffractometer is the first milestone of the research funding programme for the Department of Chemistry and we are proud to be the first university in Africa to boast with such advanced apparatus.  We are not standing back for any other university in the world and have already received requests for research agreements from universities such as the University of Cape Town,” said Prof Herman van Schalkwyk, Dean:  Faculty of Natural and Agricultural Sciences at the UFS.

The diffractometer is capable of accurately analysing molecules in crystalline form within a few hours and obtain the precise geometry – that on a sample only the size of a grain of sugar.   It simultaneously gives the exact distance between two atoms, accurate to less than fractions of a billionth of a millimetre.

“It allows us to investigate certain processes in Bloemfontein which has been impossible in the past. We now have a technique locally by which different steps in key chemical reactions can be evaluated much more reliable, even at temperatures as low as minus 170 degrees centigrade,” said Prof Roodt.

A few years ago these analyses would have taken days or even weeks. The Department of Chemistry now has the capability to investigate chemical compounds in Bloemfontein which previously had to be shipped to other, less sophisticate sites in the RSA or overseas (for example Sweden, Russia and Canada) at significant extra costs.

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

 

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