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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 in partnership with USA ’s Council on Economic Education 
2006-02-01

A visit to the campus of the UFS was part of the recent NCEE workshop.  Standing from the left are Prof Soehendro (Chairperson:  National Education Standardisation Body of Indonesia), Prof Herman van Schalkwyk (Dean:  Faculty of Natural and Agricultural Sciences at the UFS), Prof Elena Reshetnyak (Vice-Dean for International Programs, Kharkiv Polytechnic Institute, Kharkiv, Ukraine) and Mrs Annely Minnaar (local coordinator of the NCEE and professional officer of the UFS Department of Agricultural Economics).  Seated are from left Prof  Sutjipto ( Chairman of the Indonesian Council on Economic Education) and Dr Patty Elder (Vice-President of the NCEE's national programme).
Photo: Stephen Collett


UFS in partnership with USA ’s Council on Economic Education 

A group of 50 teachers in Economics, learning facilitators and lecturers from eight countries attended a ‘train the trainers’ workshop this past week in Bloemfontein.  The workshop forms part of the outreach programme of the National Council on Economic Education (NCEE) in the United States of America’s (USA) effort to improve the quality of the training in Economics of teachers and lecturers across the world. 

The UFS and the Free State Department of Education are the NCEE’s first partners in Africa.  “The initiative started in the Free State because of the connection that existed between the UFS and the NCEE,” said Prof Klopper Oosthuizen, from the UFS Department of Agricultural Economics and initiator of the cooperative agreement with the NCEE.

Three faculties at the UFS are involved in the cooperative agreement namely the Faculty of Natural and Agricultural Sciences, the Faculty of the Humanities and the Faculty of Economic and Management Sciences.

A group of 84 teachers and learning facilitators in the Free State attended the ‘train the teacher’ workshop at the UFS in December 2005 in an effort to improve the quality of Economics classes at schools in the Free State.  The last national workshop will take place in June 2006 in Bloemfontein.  During this workshop a group of 40 teachers and learning facilitators in the Free State will be trained by the NCEE.    

“Because of the success with the programme in the Free State Dr Patty Elder, Vice-President of the NCEE’s national programme, announced during last week’s workshop that the initiative will now be extended to the other provinces in the country,” said Prof Oosthuizen.  According to Prof Oosthuizen discussions around a strategy to get the other provinces on board of the programme also took place between Dr Elder and Prof Herman van Schalkwyk, Dean of the UFS Faculty of Natural and Agricultural Sciences.  Prof van Schalkwyk will take the lead in this regard.  

“The presence of Dr Elder and the executive directors of similar education networks in the Ukraine and Indonesia is an indication of the NCEE’s seriousness with the programme in Africa,” said Prof Oosthuizen.

Prof Oosthuizen explained that South Africa is competing to obtain funds from the NCEE to have a total South African representation in the workshops in the following one-year training period. 

South Africa has a good chance of establishing the network quickly because of the presentation of the last national workshop in Bloemfontein in June 2006.  “We are going to try to have as much South African representation as possible at this workshop,” said Prof Oosthuizen.

Concurrent with the workshop in June 2006, a programme will be developed that will be attended by at least five other provincial education departments and representatives of five other universities.  These representatives will then be able to observe on a first-hand basis how this action learning takes place and how the participating countries plan to establish and expand their networks,” said Prof Oosthuizen.

“The NCEE has been working together with international partners since 1992 to strengthen their Economics teaching systems.  They have already succeeded in increasing literacy in Economics of schools in the USA and more than 20 East Block countries.  More than 1,5 million learners in the East Block countries have already been served by this initiative,” said Prof Oosthuizen.

According to Prof Oosthuizen the focus of the NCEE has since 2004 moved away from the East Block countries to Africa, Asia, Latin America and the Middle East.  The representatives that attended last week’s workshop were from South Africa, Egypt, Jordan, Palestine, Indonesia, Mexico, Paraguay and Uruguay.  Countries such as Egypt, who was also present at last week’s workshop, are eager to start a similar network. 

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

 
 

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