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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

Heidedal-based foundation and UFS host inaugural music concert
2015-12-04

ROC children rock in marimba music
Photo: Valentino Ndaba

Reach Our Community (ROC) Foundation in conjunction with the University of the Free State’s Odeion School of Music (OSM) held its first-ever music concert last month. Children who form part of the foundation’s Afterschool Care programme showed their impressive music skills to their parents and guardians in attendance.

ROC provides support to orphaned and vulnerable children from early childhood through to adolescence in the Heidedal community in Bloemfontein. The foundation strives to address the challenges resulting from factors such as poverty, unemployment, HIV/Aids, single parenting, lack of guardianship, and physical and sexual abuse. In the Afterschool Care programme, the children engage in educational, cultural, and recreational activities.

Going the extra mile

Since 2008, the UFS has successfully partnered with ROC through service learning and community engagement in which students from across all seven faculties participate. Two Music Education and Practice students from the OSM took it upon themselves to continue after their curriculum requirements were met.

Amy Viljoen- now a final-year BMus student, together with fellow student, Petre du Plessis, and their lecturer and programme coordinator, Gerda Pretorius, established the music class project in Heidedal in 2014. The students embarked on weekly trips to ROC, and would spend an hour working on the recorders and marimbas with children from ROC.

This year, Viljoen and Kara-Lynn Crankshaw, a final-year BA Music student, spent eleven months teaching the children music practice and theory, culminating in a concert that both the community and students can be proud of.

“I wanted to do something that was not only meant for educational purposes, but to give back to the community,” said Viljoen.

After having to gather extra chairs because of the influx of community members at the ROC hall, the founder, Patrick Kaars, said he had not expected such a turn-out. “It exceeded my expectations, and it was a dream come true. It meant so much to the children to be exposed to music, and to explore their own capabilities and talents.”

More children will learn how to play other instruments. Currently, the instruments used for the children’s training were purchased second-hand in order to cut costs. New music education specialists, who will join the programme in 2016, will also work with Pretorius to gather additional equipment, and compile learning material.

Kaars is also thrilled about the potential expansion to the music group, now that the concert has become an annual event. The OSM is also in the process of establishing a Centre for Music Development at ROC.

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