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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 and Mexico forge links
2006-03-30

Some of the guests attending the signing of the memorandum of agreement were in front from the left Prof Wijnand Swart (Chairperson: Centre for Plant Health Management at the UFS), His Excellency Mauricio de Maria y Campos (Ambassador of Mexico in Southern Africa), Prof Magda Fourie (Vice-Rector: Academic Planning at the UFS) and Dr José Sergio Barrales Domínguez (Rector of the University of Chapingo in Mexico).
Photo: Stephen Collett

UFS and Mexico forge links
The Centre for Plant Health Management (CePHMa) in the Department of Plant Sciences at the University of the Free State (UFS) is presenting its first international conference.  The conference started yesterday and will run until tomorrow (Friday 31 March 2006) on the Main Campus in Bloemfontein. 

The conference is the first on cactus pear (or prickly pear) in South Africa since 1995.  It coincides with 2006 being declared as International Year of Deserts and Desertification by the United Nations General Assembly. 

During the opening session of the conference yesterday a memorandum of understanding (MOU) was signed between CePHMa and the University of Chapingo (Universidad Autonoma Chapingo) in Mexico.  The signing ceremony was attended by the Ambassador of Mexico in Southern Africa, His Excellency Mauricio de Maria y Campos, the Rector of the University of Chapingo, Dr José Sergio Barrales Domínguez, and the Vice-Rector: Academic Planning of the UFS, Prof Magda Fourie, amongst other important dignitaries. 

“South Africa and Mexico have a lot in common where agricultural practices in semi-arid areas and the role of the cactus pear are concerned,” said Prof Wijnand Swart, Chairperson of CePHMa at the opening of the conference.

He said that the MOU is the result of negotiations between CePHMa and the Ambassador of Mexico in Southern Africa over the past 12 months.

“The MOU facilitates the negotiation of international cooperative academic initiatives between the two institutions.  This entails the exchange of students and staff members of the UFS, curriculum development, research and community service,” said Prof Swart.

“During the next two days, various areas of interest will be discussed.  This includes perspectives from commercial cactus pear farmers in South Africa, the health management of cactus pear orchards, selection of new cultivars of cactus pear, and the nutritional and medicinal value of the crop,” said Prof Swart.

In his welcoming message Prof Swart explained that in recent years there has been increased interest in the cactus pear for the important role it can play in sustainable agricultural systems in marginal areas of the world.  These plants have developed phenological and physiological adaptations to sustain their development in adverse environments. 

“The cactus pear can serve as a life saving crop to both humans and animals living in marginal regions by providing a highly digestible source of energy, water, minerals and protein,” said Prof Swart. 

“In an age when global warming and its negative impact on earth’s climate has become an everyday subject of discussion, the exploitation of salt and drought tolerant crops will undoubtedly have many socio-economic benefits to communities inhabiting semi-arid regions,” said Prof Swart.

“Plantations of cactus pear grown for fruit, forage and vegetable production, as well as for natural red dye produced from the cactus scale insect known as cochineal have, over the last two decades, been established in many countries in South America, Europe, Asia and Africa.  The crop and its products have not only become important in international markets, but also in local markets across the globe,” said Prof Swart. 

Detailed discussions on the implementation of the MOU will take place between CePHMa and the University of Chapingo after the conference. 

Media release
Issued by: Lacea Loader
Media Representative
Tel:   (051) 401-2584
Cell:  083 645 2454
E-mail:  loaderl.stg@mail.uovs.ac.za
30 March 2006

 

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