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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

Regional Conference on Trafficking in Human Beings
2007-06-29

Trafficking in Human Beings:
National and International Perspectives

Date: 17th August 2007
Address: CR Swart Auditorium, University of the Free State, Bloemfontein, South Africa.

Every year thousands of children and adults become victims of trafficking and abuse in South Africa and throughout the southern African region. Victims are trafficked for a myriad of reasons: sexual exploitation, including prostitution and pornography; illegal labour, including child conscription; domestic servitude; illegal adoptions; body parts/organs; and forced marriages.

The Unit for Children’s Rights, Department of Criminal and Medical Law, University of the Free State (UFS), together with the Centre for Continuing Legal Education at UFS, will host a Regional Conference on Trafficking in Human Beings. The conference will bring together key role-players from the South African government as well as crucial international non-governmental organizations (NGOs) in the region.

Trafficking in human beings, especially women and children, is a serious violation of the human rights of the victims, as well as an extremely profitable source of income to organized crime, and needs the attention and intervention of both governmental and non-governmental institutions in South Africa.

Speakers will include representatives from the United National Office on Drugs and Crime (UNODC), the International Organization for Migration (IOM), the National Prosecuting Authority (NPA), the South African Law Reform Commission, the Unit for Children’s Rights-UFS, and NGOs Molo Songololo and Terre Des Homes, that work with child trafficking victims in South Africa and around the world.

The media are invited to report on the conference, and interview speakers and presenters Attached find programme. For more info contact the following persons.

1. Beatri Kruger - 051 401 2108 / email: krugerh.rd@mail.ufs.ac.za  
2. Susan Kreston - 051 401 9562 / email: krestons.rd@mail.ufs.ac.za  
3. Elizabeth Snyman – 051 401 2268 / email: snymane.rd@mail.ufs.ac.za  

Programme

Trafficking in human beings:
National & international perspectives


Presented by The Unit for Children’s Rights, Department Of Criminal & Medical Law , Faculty of Law, in Conjunction with The Centre for Continuing Legal Education, University of the Free State.

Funded through the Generosity of the United States Department of State

17 AUGUST, 2007 – CR SWART AUDITORIAM

8:00-8:30 Registration & Tea
8:30-8:45 Opening & Welcome
Prof. JJ Henning, Faculty of Law
8:45-9:40 Overview & Global Perspective
Prof. Susan Kreston - Unit for Children’s Rights, Faculty of Law-UFS

9:40-10:00 TEA

10:00-10:45 International Perspectives & the Role of Organized Crime in Trafficking
Wiesje Zikkenheiner, Associate Expert
United Nations Office on Drugs & Crime, Pretoria
10:45-11:45 Identifying and Assisting Victims of Trafficking
Marija Nikolovska, Project Officer
International Organization for Migration, Pretoria

11:45-12:30 LUNCH

12:30-1:15 Prosecuting Trafficking Without Trafficking Laws
Adv. Nolwandle Qaba, Sexual Offences & Community Affairs Unit
National Prosecuting Authority, Pretoria
1:15-2:15 Recommendations for New Legislation in South Africa
Lowesa Stuurman - South African Law Reform Commission, Pretoria

2:15-2:30 TEA

2:30-2:50 The Role of Terre Des Homes in Fighting Trafficking in Children
Judith Mthombeni– Terre Des Homes, Pretoria
2:50-3:50 Trafficking in Children in South Africa – A Front Line Perspective
Patrick Solomon - Molo Songololo, Cape Town
3:50-4:00 Closing Remarks
Adv. Beatri Kruger
Department of Criminal & Medical Law - UFS

 

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