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11 February 2021 Photo UFS photo archive
The National Control Laboratory for Biological Products (NCL) Building.
There can be no compromise when it comes to the quality of medicines made available to the public.

The UFS-based National Control Laboratory for Biological Products (NCL) is a full member of the international WHO-National Control Laboratory Network for Biologicals and one of 12 laboratories worldwide contracted to perform vaccine testing for the World Health Organisation (WHO). The NCL is also 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 the South African Health Products Regulatory Authority (SAHPRA).

In its role as a 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. 

International testing standards

The laboratory received the status of a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) endorsed its quality-management systems as of a high standard according to the International Standards Organisation’s requirements.

With its international testing standards, the NCL must ensure that all its operations – 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.

The laboratory has all the quality systems in place to ensure high-quality test results. The certificate of Good Manufacturing Compliance received in 2019 indicates that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. This certification is very strict and means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world. The certification offers the South African Health Products Regulatory Authority, the WHO, and other national control laboratories around the world the confidence that the test results from the NCL can be trusted.

Licensed as pharmaceutical manufacturer

The laboratory is also licensed as a pharmaceutical manufacturer. Although the lab does not manufacture, it needs 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.

News Archive

Medical team performs first hybrid procedure in the Free State
2014-12-08

The days when a heart operation meant hours in an operating theatre, with weeks and even months of convalescing, will soon be something of the past.

A team of cardiologists from the University of the Free State’s (UFS) Faculty of Health Sciences once again made medical history when they performed the first hybrid procedure in the Free State.

The Department of Paediatric Cardiology, in conjunction with the Department of Cardiothoracic Surgery, performed this very successful procedure on a 45-year-old woman from Kuruman.

During the procedure of 30 minutes, the patient’s thorax was opened up through a mini thoracotomy to operate on the beating heart.

“The patient received an artificial valve in 2011. Due to infection, a giant aneurism developed from the left ventricle, next to the aorta. Surgery would pose a very high risk to the patient. Furthermore, her health was such that it would contribute to problems during open-heart surgery,” explains Prof Stephen Brown, Head of the UFS’s Department of Paediatric Cardiology.

“After the heart was opened up through a mini thoracotomy, the paediatric cardiologists performed a direct puncture with a needle to the left ventricle cavity. A Special sheath was then placed in the left ventricle to bypass the catheters. Aided by highly advanced three-dimensional echocardiography and dihedral X-ray guidance, the opening to the aneurism, located directly below the artificial aorta valve, was identified and the aneurism cannulated.”
 
During the operation, a special coil, called a Nester Retractor, was used for the first time on a patient in South Africa to obtain stasis of extravasation and ensure the stability of devices in the aneurism.

“This is highly advanced and specialist work, as we had to make sure that the aneurism doesn’t rupture during manipulation and the devices had to be positioned in such a way that it doesn’t cause obstruction in valve function or the coronary artery. The surgical team was ready all the time to switch the patient to the heart-lung machine should something go wrong, but the procedure was very successful and the patient was discharged after a few days.”

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