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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

SA women’s Hockey players give a recount of Hockey World League
2015-07-02

Nicole Walraven and Liné Malan
Photo: Hatsu Mphatsoe

Three of the star players of Kovsies Hockey formed part of the South African Women’s Hockey team, which competed at the Hockey World League (HWL) tournament in Spain.

Hatsu Mphatsoe, student assistant at the Department of Communication and Brand Management, spoke to Nicole Walraven and Liné Malan. Tanya Britz will be returning only at a later stage to South Africa.

As key players in the Kovsies women’s team, Malan and Walraven (along with Britz) have a new wealth of knowledge that could assist the team in their forthcoming USSA tournament. Here are some of the sentiments they had to share:

What was your reaction when you first received the news that you’d be representing the country in Spain?

Liné: “It was a shock to me, I honestly didn’t expect it. At the same time, I was extremely excited to be granted the opportunity to represent my country, and prove my worth to the team.”

Nicole: “I was so excited and felt honoured! To represent my country at such a big tournament is amazing. I was very nervous, but excited.”

How has playing at an international level improved your personal performance and mentality of the game/sport?

Nicole: “Playing at such a high level has helped my hockey immensely. It has helped me read the game better, it has upped my self-confidence, and it has also improved my ability to deal with pressure.”

Liné: “Playing at an international level looks much easier than it is. It is a much faster game, the pressure on the ball is much higher, and the individual skills are on a different level. It has helped me to lift my game, and make decisions much quicker. It has honestly benefitted me as an individual, and I’ve learnt so much from the experience.”

Now that you’ll be going to play at the USSA tournament, what new perspectives do you wish to bring to the team in order to improve its overall performance there?

Nicole: “The importance of teamwork as well as adapting the game plan according to the situation and the opposition. Constant hard work and a never-give-up attitude are vital. One quote that stood out from the tournament is ‘1MT, 1MT’ which stands for ‘1 More Thing, 1 More Time’.

Liné: “Going to USSA, I now have a better understanding of what pressure is, and how to make better decisions. We will still make use of our Kovsies brand of Hockey, which is our passing game, and apply all aspects to the best of our ability.”

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