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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

Inaugural lecture: Prof André Pelser
2004-06-04

Tendencies and changes in the South African population structure in future decades.

Within the next five years South Africa will for the first time in the past century enter a period where the death rate will exceed the birth rate, largely due to the impact of HIV / AIDS.

According to sociologist Prof André Pelser, sociologist at the of the University of the Free State’s (UFS) Department of Sociology, the death rate exceeding the birthrate is only one of three demographic trends which will fundamentally change South Africa’s population structure in the following decades.

He was speaking at the UFS in Bloemfontein during his inaugural lecture as professor this week.

Prof Pelser said that according to some models the South African population will decrease within the next five decades by between 10 and 26 percent.

A second important trend which will impact on the population structure is the progressive ageing of the population.

He said the group above 65 years is the only age category in the South African population which will witness sharp increases in the next few decades.

In the next 50 years, the group younger than 15 years will reflect a decrease of 39% and those older than 65 years in South Africa will increase by approximately 110% in the next two decades.

“The systematic “greying” of the South African population will create the same economic and welfare issues as those with which governments in some more developed countries are already grappling,” said Prof Pelser.

A third trend affecting the South African population structure is the constant decrease in life expectancy.

Life expectancy at birth for the total population is projected to decrease from approximately 62 years at the beginning of the 1990’s to 43 years in 2015-2020, with sharp differences between the various population groups.

These tendencies and changes to the South African population structure have serious implications, he said.

For example, he said, the reduction in life expectancy could compromise national development objectives.

“It is estimated that more than a quarter of the economically active population will be infected with HIV by 2006,” said Prof Pelser.

The increase in the population, in age category 65, will place a financial burden on government and the economically active sector.

“Especially worrying is the fact that ever-increasing proportions of the state budget will be allocated to health and welfare services and this at the expense of other priorities like education, infrastructure, criminal justice system and trade and industry, to name but a few,” he said

“A comprehensive and integrated strategy is thus vitally important in addressing the overarching issues caused by changes in the population structure,” said Prof Pelser.

 

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