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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

UFS’s Unit for Children’s Rights instrumental in helping human trafficked victim
2010-03-29

Adv. Beatri Kruger.
Photo: Leonie Bolleurs
“Wheeling and dealing is part of our daily life. But what if the ‘product’ bought or sold is not a spanner or a cell phone, but a living human being? Disturbing news came to the fore... apart from other places in the country, and for that matter all over the world, it was discovered that people are treated like commodities here in Bloemfontein as well,” said Adv. Beatri Kruger from the Unit for Children’s Rights at the University of the Free State (UFS).

Adv. Kruger was instrumental in completing and availing the first comprehensive Research Report on Human Trafficking in South Africa to the public on 23 March 2010. As a member of the Reference Group advising on interim research reports on human trafficking, she contributed to the report. The report proves to be an extremely valuable tool for, among others, government departments and non-governmental organisations that use it as a guideline in planning interventions to combat human trafficking.

The Unit for Children’s Rights is also one of the founding members of the Free State Human Trafficking Forum (FHF). To react on and fight the disturbing reality of human trafficking more efficiently, a number of concerned role players such as Child Welfare and other non-governmental organisations, police officials, prosecutors, social workers, health practitioners, private businesses, churches and community organisations joined forces and formed the FHF. The Unit for Children’s Rights hosts monthly meetings at the UFS to facilitate the coordination of this multi-disciplinary counter-trafficking team.

Adv. Kruger is very excited about some of the successes of the FHF; such as the story of Soma (not her real name). This Indian woman was recruited in India by an Indian couple who are staying in South Africa, by promising her a good job in South Africa. However, instead of finding the promised job, Soma was extensively exploited for labour purposes. With the help of a “good Samaritan” she managed to escape from the perpetrators and fled to the police. Soma was removed to ensure her safety and accommodated in a safe place in Bloemfontein. Counselling and other services were rendered to her by an organisation which is also a member of the FHF. One of the challenges facing Soma and the service providers was that Soma speaks a foreign dialect and for weeks a trusted interpreter could not be found.

This obstacle rendered communication with her to the bare minimum. The perpetrators were arrested but unfortunately the new comprehensive counter-trafficking law is not in force yet. Therefore the perpetrators could only be convicted of some offences in the Immigration Act. However, due to good police investigation followed by shrewd consultations, the perpetrators agreed to pay for the victim’s return flight to India as well as for the flight ticket of the investigating officer to escort her to safety. The Unit for Children’s Rights did networking with Ms Maria Nikolovska of the International Organisation for Migration (IOM), who agreed to assist in the safe reintegration of Soma in India. Soma is now on her way back home.

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