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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

Ms Oprah Winfrey to receive an honorary doctorate in Education from our university
2011-06-10

 

Ms Oprah Winfrey

Invitation to the public (PDF document)
Invitation to UFS staff and students (PDF document)
Media accreditation (PDF document)
Street closures on 23 and 24 June 2011 (Bloemfontein Campus)
Map from the Bloemfontein Airport to the UFS (PDF document)
Map of the UFS (PDF document)


For more information, please contact:

Tel: 051 401 3000
E-mail: info@ufs.ac.za

Staff and students from our Qwaqwa Campus, please contact:
Dr Elias Malete's office
 


Our university will be awarding an honorary doctorate in Education to the global media icon, philanthropist and public educator, Ms Oprah Winfrey, on its Bloemfontein Campus on Friday, 24 June 2011.

Both the Council and Senate of our university gave strong support to awarding the honorary doctorate to Ms Winfrey.

By awarding the honorary doctorate, we want to recognise Ms Winfrey’s accomplishments and unparalleled work as a global media leader, as well as a philanthropist with vision and foresight in the field of education and development.

“It is a great privilege for us to be the first South African university to honour Ms Winfrey in this way and to be able to recognise a global icon of her stature,” says Prof. Jonathan Jansen, Vice-Chancellor and Rector of our university.

Ms Winfrey already holds honorary doctorates from Princeton University as well as Duke University in the United States, among others.

Reaching millions of viewers in more than 150 countries with her award-winning programme, “The Oprah Winfrey Show,” she has brought genuine change into the lives of ordinary people during its 25-year run.

Capitalising on the power of the media and her standing as a global icon, Ms Oprah Winfrey has brought a range of critical social and educational matters to the attention of her viewers. In 2000, she expanded her media reach through the successful creation of O, The Oprah Magazine, which then debuted in South Africa in 2002. Earlier this year, she extended her media influence through the launch of a US cable channel, OWN: Oprah Winfrey Network.

Her Book Club has had a dramatic and profound impact on the reading habits of America and those of people in other parts of the world, while her public charity, Oprah’s Angel Network, collected approximately $80 million over a period of twelve years in aid of building schools, women’s shelters and youth centres across the globe.

Through her private charity, The Oprah Winfrey Foundation, hundreds of grants have been awarded in support of empowering women, children and families, and The Oprah Winfrey Scholars Program, supports hundreds of university students, in the United States and elsewhere, who are committed to giving back and making a difference in their communities and country.

During a December 2000 visit to former president Nelson Mandela, Ms Winfrey pledged to build a school for girls in South Africa. This gift was to become the Oprah Winfrey Leadership Academy for Girls, which opened in 2007.

The Academy embodies her strong belief in the power of education to change the future. The Academy provides a unique educational opportunity to over 400 young girls, in Grades 7 through 12, from all over South Africa. These young women come from small rural towns and the big cities, but they share a common background in that they all come from poor families.

Ms Winfrey believes that the Academy can contribute to the development of a new generation of women leaders, deeply imbued with a sense of public service. The Academy stands as a beacon of hope in the educational landscape of this country.

More recently, Ms Winfrey has turned her attention to the failing public-school system in the United States and has brought the impact thereof on the lives of many people in America to the attention of the American public and policy-makers. Even more profoundly, she has highlighted how poor education entrenches poverty and social exclusion. In this sense, Ms Winfrey demonstrates the interconnection between education struggles in the USA and South Africa in powerful ways.

Both the Interim Director of our university’s International Institute for Studies in Race, Reconciliation and Social Justice, Mr John Samuel, and Prof. Jansen have worked for and with Ms Winfrey on matters of education at her school in Johannesburg, and in South Africa more broadly.

The South African public is invited to share in this occasion, and attend the award ceremony. A limited number of tickets will be available to the public from Wednesday, 15 June 2011 to Wednesday, 22 June 2011, and can be purchased from Computicket at an administrative cost of R10 a ticket.


Media Release

11 June 2011
Issued by: Lacea Loader
Director: Strategic Communication
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: news@ufs.ac.za

 

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