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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

Minister Jeff Radebe commends UFS for measures taken to address racial prejudices
2013-10-21

 

18 October 2013


  Photo Gallery
Minister Jeff Radebe lecture: YouTube video

Mr Jeff Radebe, Minister of Justice and Constitutional Development, last night delivered a lecture in the Prestige series of the Dean: Faculty of Law, at the Bloemfontein Campus of the University of the Free State (UFS).

In a packed hall with, among others, university students, staff and members of the judicial system, Minister Radebe said that many other academic institutions should look to the UFS when they deal with the challenges of racism in its various manifestations in their midst. “I commend the university for taking drastic measures to address the challenges of racial prejudices in its own backyard,” he said.

“Government can and must provide leadership, but it is the collective efforts of all our people that will ensure that we bridge the racial and historical divides that stand in contrast to our noble virtues as entailed in the Constitution,” the Minister said.

On the topic “Access to Justice” the Minister said that the Department of Justice and Constitutional Development has channelled more than 80% of its nearly R16 billion budget to the Access to Justice programme.

Minister Radebe talked about the reintroduction of the Sexual Offences Courts, which attests to the unrelenting resolve to eliminate the scourge of gender-based violence. “Fifty-seven of the department’s Regional Courts are being upgraded to operate as dedicated Sexual Offences courts during the 2013/2014 financial year. We believe that these sexual offences courts will help address the growing challenge of sexual offences in the country, particularly against vulnerable groups.”

The Minister also pleaded with law teachers to avail themselves to preside in the courts in our country to complement the decreasing number of presiding officers that are drawn from the attorneys’ and advocates’ profession. These services are normally rendered by the Commissioners pro bono as part of an endeavour to bring justice to all the people, including the poor.

A challenge that the UFS could help resolve,is the transformation of the legal profession. “We need to increase the number of Law students and in turn increase the number of attorneys and advocates in the pool from which we derive candidate judges,” Mr Radebe said.

The Legal Practice Bill and the transformation of the State Legal Service are the most important initiatives underway by which the Institutions of Higher Learning will make a contribution. “The Bill seeks to establish a single regulatory structure, which will be responsible for setting the norms and standards for all legal practitioners. Members of the public, as primary beneficiaries of the legal profession, will also be represented in this structure. Other important objectives of the Bill are the removal of barriers of entry to the profession for young law graduates who aspire to pursue a legal career, and the introduction of measures aimed at ensuring that fees chargeable for legal services are reasonable and within reach of ordinary citizens,” he said.

The Minister concluded: “Our courts must reflect both the race and gender demographics of our country and so must the university communities in their various capacities as a microcosm of the society we seek to build.”

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