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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

Almost 2000 degrees and diplomas conferred at Winter Graduation
2015-06-26

Live streaming will be available on: http://livestream.ufs.ac.za/

The 2015 Winter Graduations are almost underway. The highlight on the university calendar for every graduate will take place on the Bloemfontein Campus on 1-2 July 2015. On 1 July 2015, diplomas will be awarded by the Centre of Financial Planning Law (331 in total) and the School of Open Learning (376 in total). On 2 July 2015, a total of 1 220 master’s and doctoral degrees will be awarded to graduates from all seven faculties.

A highlight at this year’s Winter Graduation is the awarding of three honorary degrees by the university. Ambassador Lakhdar Brahimi, Dr Mercy Oduyoye and Mr John Samuel will receive honorary degrees.

On 17 August 2012, Ambassador Brahimi was appointed by the United Nations as the new peace envoy to Syria, replacing Kofi Annan. He is also a member of the Commission on Legal Empowerment of the Poor, the first global initiative to focus specifically on the link between exclusion, poverty and the law. Prof Heidi Hudson, Head of the Centre for Africa Studies at the UFS, will receive the honorary degree on his behalf.

Dr Oduyoye is widely regarded as one of the most influential women theologians Africa has produced in recent history. Currently, she directs the Institute of African Women in Religion and Culture at the Trinity Theology Seminary in Legon, Ghana.

Mr John Samuel, who will receive an honorary award, is also scheduled to be a guest speaker at the two ceremonies on 1 July 2015.

Wednesday 1 July 2015:

John Samuel will be the speaker at both ceremonies. He is one of South Africa’s leading education experts with international and national experience, covering a period of more than forty years. He was involved in the founding of the South African Campaign: Public Participation in Education Network (PPEN), established the Centre for Education Policy Development, the Joint Working Group (for The National Party Government and the ANC), the National Education Conference, and the National Education and Training Forum. He also made leadership contributions to the First Education and Training White Paper, the Transformation Strategy for the National Education Department, and the first Green Paper on Higher Education.

John is also Senior Programme Director of the WK Kellogg Foundation in the USA. He has also been the Chief Executive of the Nelson Mandela Foundation, and the CEO of the Oprah Winfrey Leadership Academy for Girls.

Thursday 2 July 2015:

Nataniël will be the speaker at both ceremonies. Nataniël is a singer, songwriter, and South African entertainer, who has crossed from the alternative circuit to the stage. For the past 10 years, he has become well-known for his outspoken Kaalkop column in SARIE magazine. His solo career was launched in 1987 and, since then, he has released 16 albums, staged more than 70 original theatre productions, and published 15 books. Over the past two decades, Nataniël has gained the title of South Africa’s leading exponent of the solo stage act. He manages Kaalkop Studio, his lifestyle retail company, and records on his own independent label, Nataniël House Of Music. He is an ambassador for Child Welfare SA, and also heads his own charitable foundation, The Nataniël Progress Project.

 

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