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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

Judge Albie Sachs and Candice Mama discuss traumas of the past and forgiveness in the present
2015-08-05

 

Judge Albie Sachs embraces Candice Mama for her courage in confronting Eugene de Kock, who killed her father.

Two generations. Two stories of triumph. Two South Africans who have displayed immense courage.

Public Dialogue on Trauma, Memory, and Representations of the Past

Judge Albie Sachs and Candice Mama exchanged their experiences of past trauma and subsequent transformation in a public conversation. The event was co-hosted by Prof Pumla Gobodo-Madikizela and The Institute for Justice and Reconciliation (IJR) in Cape Town on Thursday 30 July 2015.

The event was the first instalment in a series entitled Public Dialogue on Trauma, Memory, and Representations of the Past. The theme of the discussion was ‘Intergenerational Dialogue on Trauma and Healing’.

"The aim of these public dialogue events we are co-hosting with IJR is to place the issues of trauma and memory, and the strategies that individuals and communities use to heal, in the public sphere," Prof Gobodo-Madikizela, Senior Research Professor in Trauma, Forgiveness, and Reconciliation Studies at the University of the Free State (UFS) said.

Judge Albie Sachs and Candice Mama in conversation

Former Constitutional Court Judge, Albie Sachs, talked about his participation in South Africa’s liberation struggle, the loss of his right arm in an assassination attempt, and meeting the man responsible – Henri van der Westhuizen. Despite years of exile and extended periods of solitary confinement, Judge Sachs maintains that “we need to acknowledge our history, not be trapped by it.” Judge Sachs also remarked, though, that “we’re seeing too much lamentation, not enough activation.” In a heartrending gesture, Judge Sachs embraced Candice Mama in a hug for her courage in confronting Eugene de Kock, who killed her father.

How poignant then, when Mama said, “I wanted to embrace the brokenness within him,” when she spoke about her meeting with De Kock. By the time I met with Eugene, I could meet him as a human being, not as a villain.” Mama believes that forgiving someone translates into an investment in the person you are forgiving and in your own sanity. She also emphasised the importance of dialogue to move our country forward: “When we share our stories with each other authentically, walls break down.”

This is a stance that Prof Gobodo-Madikizela supports strongly: “When we listen to one another, something unexpected emerges; we encounter the human in each other,” she said. “When we listen with open hearts to each other, we see and experience each other’s humanity.”

Building a bridge between research and society

Referring to the research aspect of the event, Prof Gobodo-Madikizela said that, "in establishing the series of public dialogue events, our vision is to create a bridge between scholarly research and the community at large, on the one hand, and a visual conscience of society, on the other." The UFS is collaborating with the IJR on this research project, which is funded by the Andrew W. Mellon Foundation. The endeavour is led by Prof Gobodo-Madikizela, who also serves as Board Member of the IJR.

 

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