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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

Wayde the next big star, says Michael Johnson
2016-08-15

Description: Wayde with record Tags: Wayde with record

Wayde van Niekerk won South Africa’s first gold medal
at the Olympic Games in Rio de Janeiro.

Photos: Gallo Images

"Usain Bolt will be retiring soon, this could be the next star." That is how the legendary Michael Johnson explained the feat by the Kovsie athlete Wayde van Niekerk. Van Niekerk broke Johnson’s 17-year old world record in the 400m when he won gold in 43.03 at the Olympic Games in Rio de Janeiro on Sunday night (Monday morning, SA time). It was also South Africa’s first track gold medal in 96 years.

Johnson, whose record was beaten by 0.15, described the way in which the 24-year-old South African outperformed the 400m field as ‘a massacre’. The American won two Olympic 400m titles.

"The UFS congratulates Wayde and his youthful coach, our own Tannie Ans.”


"Van Niekerk is so young, what else can he do? Can he go under 43 seconds? It is something I thought I could do, but never did,” Johnson said on www.bbc.com. Van Niekerk thanked Johnson in a BBC Sport interview for setting an example. “I just went out there and did my best tonight,” the BA Marketing student from the University of the Free State (UFS) said.

Greatest UFS achievement in 114 years – Prof Jansen

“This is by far the greatest achievement of any UFS student in 114 years,” said Prof Jonathan Jansen, Vice-Chancellor and Rector of the UFS. “And that he broke one of the world’s toughest athletic records with his trademark grace and humility, makes him a role model to millions of South African youth.

“The UFS congratulates Wayde and his youthful coach, our own Tannie Ans.”

The 74-year-old Botha has been coaching Van Niekerk since 2012.  “She's an amazing woman," Van Niekerk said to www.sport24.co.za about her. “I'm just grateful that I can trust in her work and I think it speaks for itself.”

 

"Van Niekerk is so young, what else
can he do? Can he go under
43 seconds?”

Bolt and Twitter full of praise for South African inspiration

Bolt, who won his third consecutive 100m crown in Rio, interrupted his own media interviews at the Olympic stadium to congratulate Van Niekerk.

Twitter also erupted as many praised the UFS star. Gary Player, who is the manager of the SA golf team at the Olympics, tweeted:  “What a run! What a man! Congrats @WaydeDreamer #proudlySA #GOLDMEDAL #RSA”.

AB de Villiers, the South African One Day International cricket captain, also congratulated him: “What a special feeling waking up to the news of @WaydeDreamer winning the 400m and breaking the world record. Great inspiration to so many!”

 

Description: Wayde running Tags: Wayde running

More articles:
Wayde van Niekerk makes sprinting history
UFS community proud of Wayde’s hat trick of awards
Wayde nominated with SA’s best
Wayde one of the Adidas faces for Rio 2016
NBC tells Wayde’s story
Wayde, Karla crowned as KovsieSport’s best
UFS congratulates Wayde van Niekerk and other students for their national and international
Kovsies Wayde van Niekerk wins gold at the IAAF World Championship



 

 

 

 

 

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