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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

Triumph of the Human Spirit – a symbol of hope
2015-08-24

Ahmed Kathrada discusses his latest book, Triumph of the Human Spirit.
Photo: Johan Roux

“A triumph of courage and determination over human frailty and weakness; a triumph of the new South Africa over the old.” – Ahmed Kathrada

Ahmed Kathrada, stalwart of South Africa’s liberation struggle, visited the Bloemfontein Campus on 18 August 2015 to launch his latest book, Triumph of the Human Spirit. Turning page after page, the reader travels back with Uncle Kathy – as he is fondly known – to revisit Robben Island with the more than 300 guests he has accompanied since 1994. With each photo – be it a celebrity or school child, head of state or famous artist, friend or royalty – the significance of the island is eternalised, right alongside Ahmed Kathrada.

Message of triumph
“Why this specific title for the book?” Prof André Keet, Director of the Institute for Reconciliation and Social Justice (IRSJ), asked during the book launch. “Robben Island,” Kathrada answered, “should not be remembered only as a place of suffering – that’s history. But the message of Robben Island is the message of triumph – triumph of the human spirit over all sorts of adversities.”

Speaking about Kathrada’s quiet but profound impact, Zaakirah Vadi, editor of the book, said “I think Uncle Kathy does not realise what an inspiration his own strength of spirit is”. The fight for human values and dignity was “honed and perfected in the cells of Robben Island,” she said. “It created the vision for a new South Africa and, as Uncle Kathy puts it, the triumph of the new South Africa over the old.”

UFS surprises Ahmed Kathrada with a birthday cake.
Photo: Johan Roux

Freedom was sacrifice
This triumph was not achieved without a cost, though. “No freedom comes on a platter,” Kathrada said. “Freedom was fought for. Freedom was sacrifice. Through the sacrifices of those who did not survive, we are still here to tell the story.”

And that is exactly what Triumph of the Human Spirit does. As Kgalema Motlanthe writes in the foreword, “This book serves as a preservation of history and a symbol of hope.”

Birthday celebration
Just as the event seemed to come to a close, members of the Student Representative Council carried a candle-lit cake – shaped in the number 86 – toward Kathrada. This surprise was organised by the UFS to celebrate his birthday on 21 August 2015. And, as the audience cheered and sang, Kathrada’s smile spread like a light across the hall.

 

 

 

 

 

 

 

 

 

 

 

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