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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 cardiologists and surgeons give children a beating heart
2015-04-23

Photo: René-Jean van der Berg

A team from the University of the Free State School for Medicine work daily unremittingly to save the lives of young children who have been born with heart defects by carrying out highly specialised interventions and operations on them. These operations, which are nowadays performed more and more frequently by cardiologists from the UFS School of Medicine, place the UFS on a similar footing to world-class cardiology and cardio-thoracic units.

One of the children is seven-month-old Montsheng Ketso who recently underwent a major heart operation to keep the left ventricle of her heart going artificially.

Montsheng was born with a rare, serious defect of the coronary artery, preventing the left ventricle from receiving enough blood to pump to the rest of the body.

This means that the heart muscle can suffer damage because these children essentially experience a heart attack at a very young age.

In a healthy heart, the left ventricle receives oxygenated blood from the left atrium. Then the left ventricle pumps this oxygen-rich blood to the aorta whence it flows to the rest of the body. The heart muscle normally receives blood supply from the oxygenated aorta blood, which in this case cannot happen.

Photo: René-Jean van der Berg

“She was very ill. I thought my baby was going to die,” says Mrs Bonizele Ketso, Montsheng’s mother.

She says that Montsheng became sick early in February, and she thought initially it was a tight chest or a cold. After a doctor examined and treated her baby, Montsheng still remained constantly ill, so the doctor referred her to Prof Stephen Brown, paediatric cardiologist at the UFS and attached to Universitas Hospital.

Here, Prof Brown immediately got his skilled team together as quickly as possible to diagnose the condition in order to operate on Montsheng.

During the operation, the blood flow was restored, but since Montsheng’s heart muscle was seriously damaged, the heart was unable to contract at the end of the operation. Then she was coupled to a heart-lung machine to allow the heart to rest and give the heart muscle chance to recover. The entire team of technologists and the dedicated anaesthetist, Dr Edwin Turton, kept a vigil day and night for several days.

Prof Francis Smit, chief specialist at the UFS Department of Cardiothoracic Surgery, explains that without this operation Montsheng would not have been able to celebrate her first birthday.

“After the surgery, these children can reach adulthood without further operations. Within two to three months after the operation, she will have a normal active life, although for about six months she will still use medication. Thereafter, she will be tiptop and shortly learn to crawl and walk.”

Mrs Ketso is looking forward enormously to seeing her daughter stand up and take her first steps. A dream which she thought would never come true.    

“Write there that I really love these doctors.”

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