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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

Council concerned over health crisis
2009-06-08

The Council of the University of the Free State (UFS) has come out in support of doctors and health professionals attached to its Faculty of Health Sciences who expressed their concerns about the health crisis in the Free State.

At its meeting on Friday, 5 June 2009 the Council said it shared the concerns of health professionals that the quality of patient care and the quality of training being provided at the health faculties across the country are being compromised.

Earlier last week doctors and other health professionals of the UFS Faculty of Health Sciences issued a statement highlighting the seriousness of the crisis in health care provision in the Free State Province, warning that the system was on the verge of collapse.

According to the Council of the UFS, a petition will be addressed to the Minister of Health and the Minister of Education calling for urgent steps to be taken to correct the deteriorating situation in the province’s health care system.

In other decisions, the UFS Council also decided to confer an honorary doctorate on Judge Louis Harms, the Deputy President of the Supreme Court of Appeal in Bloemfontein.

Judge Harms is an international specialist in the field of Intellectual Property Law and has been actively involved in legislation and international agreements on intellectual property law, including the Designs Act, Trademarks Act and Patents and Copyrights Acts.

The motivation quotes one of his fellow jurists as saying that: “Harms is one of the greatest South African lawyers of the last 50 years. He is an intellectual giant who has made an impressive and profound contribution to the development of South African law: He is erudite, visionary, astute and principled.”

An honorary doctorate will also be conferred on geologist and expert on the geology of the Karoo Supergroup, Mr Johan Loock, for his distinguished efforts towards promoting the earth sciences and specifically geology, particularly in the context of the Free State.

Mr Loock has had two Karoo fossils named after him, which is a particular honour in the scientific world of palaeontology. He was employed by the UFS for 32 years and has close ties with the Free State in terms of his wide field of research interests.

The motivation further states that “the man affectionately and respectfully known as Oom Loock, or Malome, has selflessly given of his vast knowledge, expertise and insights into the physical and cultural heritage of the Free State to all who would learn from, and with, him”.

A Council Medal will be awarded to Prof. Johan Grobbelaar from the Department of Plant Sciences at the UFS. During his time at the UFS he has been a pioneer in many areas, including the first research expedition to Marion Island, the first PhD about research on Marion Island, the establishment of the Institute of Environmental Sciences as well as the establishment of the Centre for Environmental Management.

Council also decided to refer a report from the iGubu consultants regarding aspects of diversity in student residences to the Executive Committee of the Council so that the benefit of the participation of the rector-designate Prof Jonathan Jansen could be obtained and for further participation and consultation with relevant stakeholders.

In another decision the Council also extended the term of appointment of Prof. Tienie Crous as Dean: Economic and Management Sciences for an additional term of five years.

The Council furthermore appointed Prof. Hugh Patterton as the director of the strategic academic cluster dealing with advanced biomolecular research and Prof. Wijnand Swart as Director of the strategic academic cluster dealing with technologies for sustainable crop industries in semi-arid regions.

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