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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 on energy-saving mode
2009-09-15

The University of the Free State (UFS) has undertaken several measures to reduce energy consumption on the Main Campus in Bloemfontein.

“Part of Eskom’s strategy is that all the main universities must reduce their electricity consumption. Because the university is the second biggest user of electricity in Bloemfontein we have to cut our consumption according to the new energy policy,” said Prof. Niel Viljoen, Chief Director of Operations at the UFS.

“Electricity is also expensive and if we look at global warming and everybody’s responsibility, I think we all have a moral obligation to save energy,” said Prof. Viljoen.

“The energy crisis of January 2008 and beyond, with its load-shedding limitations, was a major driver for the government to introduce the Power Conservation Scheme,” said Mr Anton Calitz, the UFS’s electrical engineer.

The measures put in place by the UFS include amongst others:

The introduction of a solar water-heating system in the residences, which is a first of its kind in Bloemfontein.
An investigation is also being launched into alternatives and the effective heating of rooms in the residences.

Feasibility studies are currently being conducted to determine whether energy saving can be achieved with radiation panels.

Energy-saving lights have been installed in the following buildings: the Architecture Building, Genmin Lectorium, Geology lecture halls, Winkie Direko Building, George du Toit Building, Sasol Library, Francois Retief Building, as well as in the residences. This measure has resulted in massive energy saving.

Energy meters for the Library, Computer Laboratory Building, François Retief Building and Steyn Substation are being planned as the first phase.

Real-time metering will result in every UFS computer user being aware of power consumption on the campus.

New lift motors and control systems that reduce energy consumption have been installed at the Agriculture and the George du Toit Buildings.

In the Computer Laboratory Building the temperature adjusting point for the venues is set at 22 °C and, in the case of new projects, green guidelines are applied.

It is expected that the government and local authorities will bring more pressure to bear on the UFS to save energy. Applications for increased capacity will possibly be linked to energy-saving targets.

This trend will continue until 2014 when additional power stations will be put into operation.

“Our aim is to save 10% on energy consumption,” said Prof. Viljoen.

“Heavy financial penalties will be imposed if a 10% saving is not achieved,” added Mr Calitz.

On average, our energy consumption per day this year is 128,964 kWh as compared to last year’s 119,752 kWh.

Media Release
Issued by: Mangaliso Radebe
Assistant Director: Media Liaison
Tel: 051 401 2828
Cell: 078 460 3320
E-mail: radebemt.stg@ufs.ac.za  
14 September 2009

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