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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

Renowned forensic scientist speaks at the UFS
2014-04-02


Forensic science is about the truth. At the presentation delivered by Dr David Klatzow, were, from the left: Tinus Viljoen, lecturer in Forensic Genetics, Dr Klatzow and Laura Heathfield, also a lecturer in Forensic Genetics.
Photo: Leonie Bolleurs 

It is necessary for more research to be done in the field of forensic science in South Africa. This is according to Dr David Klatzow, well-known forensic scientist, during a lecture delivered at the University of the Free State (UFS) last week.

The university is offering, for the first time this year, a BSc degree in Forensic Science in the Department of Genetics. This three-year degree is, among others, directed at people working for the South African Police Service on crime scenes and on criminal cases in forensic laboratories. Students can also study up to PhD level, specialising in various forensic fields.

There is no accredited forensic laboratory in South Africa. “It is time to look differently at forensic science, and to deliver research papers on the subject. In light of the manner in which science is applied, we have to look differently at everything,” Dr Klatzow said.

Dr Klatzow praised the university for its chemistry-based course. “Chemistry is a strong basis for forensic science,” he said.

A paradigm shift in terms of forensic science is needed. Micro scratches on bullets, fingerprints, DNA, bite marks – all of these are forensic evidence that in the past led to people being wrongfully hanged. This evidence is not necessarily the alpha and omega of forensic science today. DNA, which seems to be the golden rule, can produce problems in itself. Because a person leaves DNA in his fingerprint, it is possible that DNA is transferred from one crime scene to another by forensic experts dusting for fingerprints. According to Dr Klatzow, this is only one of the problems that could be experienced with DNA evidence.

“No single set of forensic evidence is 100% effective or without problems. Rather approach the crime scene through a combination of evidence, by collecting fingerprints, DNA, etc. It is also very important to look at the context in which the events happened.

“A person sees what he expects to see. This causes huge problems in terms of forensic science. For example, if a criminal fits the profile of the perpetrator, it doesn’t follow that this specific criminal is the culprit. It isn’t what we don’t know that gives us trouble, it’s what we know that isn’t so,” Dr Klatzow said.

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