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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

Protection of Information bill- opinions from our experts
2011-11-28

Prof. Hussein Solomon
Senior Professor in the Department of Political Science at the University of the Free State. 

In recent years, given their failure to effectively govern, the ANC has become increasingly defensive. These defensive traits have become particularly acute in light of the various corruption scandals that members of the ruling party involve themselves in.
 
Given the fact that for now they are assured of an electoral majority (largely on account of their anti-apartheid credentials), coupled with the fact that they have managed to make parliament a rubber stamp of the executive as opposed to holding the executive accountable, it is the media which has increasingly held the ruling party to account by exposing such corruption and incompetence in government.
 
The passing of the information bill, therefore, is not merely an attack on the media, but an attack on the pivotal issue of accountability. Without accountability, there can be no democracy.
 
By defining national interest broadly, by refusing to accept a public interest clause in the bill, the ANC increasingly shows its disdain to South Africa's constitution and its citizens.
 
More importantly, as former Minister of Intelligence and ANC stalwart Ronnie Kasrils pointedly makes clear, the ANC is also betraying its own noble struggle against the odious apartheid regime. It was the media which played a key role in exposing apartheid's excesses, it is the same media which is coming under attack by the heirs of PW Botha's State Security Council - Minister of State Security Siyabong Cwele and his security apparatchiks whose mindsets reflect more Stalin's Gulag's than the values of the Freedom Charter.
 
The passing of this bill is also taking place at a time when journalists have had their phones attacked, where the judiciary has been deliberately undermined and parliament silenced.
 
Democrats beware!

 
Prof. Johann de Wet
Chairperson: Department of Communication Science 
 
The ANC’s insistence on passing the Protection of State Information Bill in its current form and enforcing it by law, means that the essence of our democratic state and the quality of life of every citizen is at stake.
 
Yes, our freedom as academics, researchers, mass media practitioners and citizens comes into play. Freedom implies the right to choose and is, along with equality, an underlying principle which helps make democracy happen. While the South African state needs to protect (classify) information which could threaten its security and/or survival, the omission of a public interest clause in the Bill at this stage effectively denies a citizen the right to freedom of information.
 
 Freedom of information, along with press freedom, freedom of speech, freedom of assembly, freedom of association and religious freedom, are essential to democracy. These freedoms are granted because they conform to basic liberal ideas associated with (Western) democracy and which resonate with South Africa’s liberal constitution, such as (1) belief in the supreme value of the individual (and thus not of the state); (2) belief that the individual has natural rights (rights which belong to all human beings by nature – such as the right to life and to control government)) which exist independently of government, and which ought to be protected by and against government; and (3) recognition of the supreme value of the individual. 
 
One wonders how many cases of South African government corruption and mismanagement would have been uncovered by investigative journalists over the past number of years if this Bill in its current form was on the statute books. This Bill represents a backward step from the promise of democracy of having an informed public. The former National Party government had similar laws in place and one does not want to go there again. The infamous Information Scandal in South Africa of some thirty years ago, or Muldergate as it has come to be known, reminds one of what governments can do when it works clandestinely.
 
What South Africans need, is more information on what government structures are doing and how they are doing it with taxpayers’ money, not less information. While information in itself does not equal communication or dialogue, it is an indispensable part thereof, and the need for dialogue based on verifiable information is urgent for meeting vexed challenges facing South African communities. Academics in all fields of specialisation are constantly in need of untainted information to pursue answers and/or offer solutions to where South Africa should be moving in all spheres of life.

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