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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

Kovsie community pledge to advance equality and eradicate racism
2015-04-15

Photo: Johan Roux

Photo Gallery 
Speech by JC van der Merwe

On Monday 13 April 2015, the University of the Free State drew a line in history. Staff and students united in a singular vision: equality.

Since March 2015, the Institute for Reconciliation and Social Justice, together with the SRC, has launched the No-to-Racism/Yes-to-Equality Campaign across all three campuses with tremendous success. This campaign has now reached a high point at which the Kovsie community pledge their commitment to entrenching a culture of equality at the university. The first pledge ceremony took place on 13 April 2015 at the Bloemfontein Campus. Kovsies thronged to place their inked thumbprints on pledge posters in an inspirational show of solidarity.

“The key to transformation,” Prof Jonathan Jansen, Vice-Chancellor and Rector of the UFS, said, “is putting yourself in the shoes of the other person.” When you look past yourself and acknowledge others’ experiences, the world starts to look different. A pledge, Prof Jansen continued, is a solemn promise – not only to stop bad behaviour, but to go forward resolutely with good behaviour. “You do not change a campus, you do not change a country, without being courageous,” Prof Jansen said.

The message from Mosa Leteane, President of the Student Representative Council (SRC), echoed the same belief. “Today,” Leteane said, “the UFS takes a bold and courageous step toward equality.” This new generation, which includes young people from all races, has started a new revolution. A generation that says no to discrimination and yes to equality. “We cannot afford to be ignorant or indifferent,” Leteane urged.

The remaining two campuses will also have an opportunity to publically pledge their support on the following days:
Qwaqwa Campus: Wednesday 15 April 2015
South Campus: Friday 17 April 2015

To enable the university to go beyond dialogues and consultation towards active decision-making, a University Assembly will be held on Tuesday 28 April 2015. The assembly will serve as a space for critical engagement among all university stakeholders to focus on issues such as symbols, policies, practices, and curriculum. Staff and students are encouraged to submit matters for discussion to JC van der Merwe (vdmjc@ufs.ac.za) before 22 April 2015.

The No-to-Racism/Yes-to-Equality Campaign is aligned with the declaration made by the UFS Council in November 2014, in which it states that “the Council of the University of the Free State believes very strongly in the human dignity, equality, and freedom of all people.”

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