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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

Is milk really so well-known, asks UFS’s Prof. Osthoff
2011-03-17

Prof. Garry Osthoff
Photo: Stephen Collett

Prof. Garry Osthoff opened a whole new world of milk to the audience in his inaugural lecture, Milk: the well-known (?) food, in our Department of Microbial, Biochemical and Food Biotechnology of the Faculty of Natural and Agricultural Sciences.

Prof. Osthoff has done his research in protein chemistry, immuno-chemistry and enzymology at the Council for Scientific and Industrial Research (CSIR) in Pretoria and post-doctoral research at the Bowman-Grey School of Medicine, North Carolina, USA. That was instrumental in establishing food chemistry at the university.
 
He is involved in chemical aspects of food, with a focus on dairy science and technology. He is also involved in the research of cheese processing as well as milk evolution and concentrated on milk evolution in his lecture. Knowledge of milk from dairy animals alone does not provide all the explanations of milk as food.
 
Some aspects he highlighted in his lecture were that milk is the first food to be utilised by young mammals and that it is custom-designed for each species. “However, mankind is an opportunist and has found ways of easy access to food by the practice of agriculture, where plants as well as animals were employed or rather exploited,” he said.
 
The cow is the best-known milk producer, but environmental conditions forced man to select other animals. In spite of breeding selection, cattle seem not to have adapted to the most extreme conditions such as high altitudes with sub-freezing temperatures, deserts and marshes.
 
Prof. Osthoff said the consumption of the milk as an adult is not natural; neither is the consumption of milk across species. This practice of mankind may often have consequences, when signs of malnutrition or diseases are noticed. Two common problems are an allergy to milk and lactose intolerance.
 
Allergies are normally the result of an immune response of the consumer to the foreign proteins found in the milk. In some cases it might help to switch from one milk source to another, such as switching from cow’s milk to goat’s milk.
 
Prof. Osthoff said lactose intolerance – the inability of adult humans to digest lactose, the milk sugar – is natural, as adults lose that ability to digest lactose. The symptoms of the condition are stomach cramps and diarrhoea. This problem is mainly found in the warmer climates of the world. This could be an indication of early passive development of dairy technology. In these regions milk could not be stored in its fresh form, but in a fermented form, in which case the lactose was pre-digested by micro-organisms, and the human population never adapted to digesting lactose in adulthood.
 
According to Prof. Osthoff, it is basically the lactose in milk that has spurred dairy technology. Its fermentation has resulted in the development of yoghurts and all the cheeses that we know. In turn, the intolerance to lactose has spurred a further technological solution: lactose-free milk is currently produced by pre-digestion of lactose with enzymes.
 
It was realised that the milks and products from different species differed in quality aspects such as keeping properties and taste. It was also realised that the nutritional properties differed as well as their effects on health. One example is the mentioned allergy against cow’s milk proteins, which may be solved by the consumption of goat’s milk. The nutritional benefits and technological processing of milk aroused an interest in more information, and it was realised that the information gained from human milk and that of the few domesticated species do not provide a complete explanation of the properties of milk as food. Of the 250 species of milk which have been studied, only the milk of humans and a few domesticated dairy animals has been studied in detail.

Media Release
15 March 2011
Issued by: Lacea Loader
Director: Strategic Communication
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: news@ufs.ac.za

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