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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

Researcher in Otorhinolaryngology advocates education in deafness and hearing loss
2015-12-17

Description: Dr Magteld Smith  Tags: Dr Magteld Smith

Dr Magteld Smith

The annual International Day of Persons with Disabilities falls on 3 December. Statistics reveal that 7.5% of the South African population suffer from some form of physical disability.

More than 17 million people in South Africa are dealing with depression, substance abuse, anxiety, bipolar disorder, and schizophrenia - illnesses that round out the top five mental health diagnoses, according to the Mental Health Federation of South Africa. The South African Federation for Mental Health is the umbrella body for 17 mental health societies and numerous member organisations throughout the country.

On disability, world-renowned author Helen Keller, who was both deaf and blind, once said that the problems that come with being deaf are deeper and more complex than those of blindness, and is a much worse misfortune. For it means the loss of the most vital stimulus - the sound of the voice that brings language, sets thoughts astir, and keeps us in the intellectual company of man.

According to Dr Magteld Smith, lecturer and researcher in the Department of Otorhinolaryngology at the University of the Free State (UFS), hearing loss of any degree at any age can have far-reaching psychological and sociological implications which affect an individual’s day-to-day functioning, and might prevent him or her from reaching their full potential. She says that even though advancements have been made in aiding deaf persons, there’s still considerable room for improvement. She’s making it her mission to bring about changing the stigmatisation around deafness, and the different choices of rehabilitation.

Dr Smith was born with bilateral (both ears) severe hearing loss, and became profoundly deaf, receiving a cochlear implant in 2008. Not letting this hinder her quality of life, she matriculated in 1985 at a School for the Deaf in Worcester. Today she is the only deaf medical-social researcher in South Africa.

Her research focuses on all aspects of deafness and hearing loss. Through first-hand experience, she knows that a loss of hearing can be traumatic as it requires adjustments in many areas of life which affect a person’s entire development. However, she has not let her deafness become a stumbling block. She has become the first deaf South African to obtain two Master’s degrees and a PhD, together with various other achievements.

Her work is aimed at informing and educating people in the medical profession, parents with children, and persons with various degrees and types of hearing loss about the complexities of deafness and hearing loss. She believes that, with the technological advancements that have been made in the world, deaf people can become self-sufficient and independent world changers with much to contribute to humanity.

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