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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

Inter-country adoptions can offer relief
2009-08-12

 
At the occasion were, in the front: Prof. Hennie Oosthuizen, head of the Department of Criminal and Medical Law, UFS; back: Adv. Mariëtte Reyneke, head of the Unit for Children’s Rights and senior lecturer in the Department of Law of Procedure and Law of Evidence, UFS, Judge of Appeal Belinda van Heerden, and Adv. Beatri Kruger, also from the Unit for Children’s Rights and senior lecturer in the Department of Criminal and Medical Law, UFS.
Photo: Stephen Collett 


Inter-country adoptions must not be taken lightly; however, in some instances it is suitable and can bring relief to a child. These were the words of Katinka Pieterse from Abba Adoptions, which specialises in inter-country adoptions.

She was one of the expert presenters at a recent workshop on inter-country adoptions that was recently presented by the Unit for Children’s rights in the Department of Criminal and Medical Law in the Faculty of Law at the University of the Free State (UFS).

Judge of Appeal Belinda van Heerden, an expert in the field of Child and Family Law, gave an overview as well as a Southern African perspective on this controversial topic. The Hague Convention sets international standards to protect children from the inherent dangers that accompany inter-country adoptions. The South African law must be aligned with these international standards by incorporating specific stipulations as well as the Hague Convention into legislation applicable to children. There must also be acted in the best interest of the child, said Judge van Heerden. The authorities have safety measures in place to protect children from these dangers. The starting point remains that inter-country adoptions are only considered once one cannot find suitable care in the country of origin.

Prof. Sheryl Buske from the Charlotte School of Law, North Carolina in the United States of America in particular emphasised the dangers of human trafficking that can take place when inter-country adoptions do not adhere to international safety standards. She also pointed out new developments such as the role of surrogate mothers and the adoption of embryos.

The workshop was attended by a large variety of role players, varying from academics, lawyers, social workers, non-governmental organisations, law students and representatives from governmental institutions. Consequently, light was shed on the topic from a number of angles which will be of value to the respective role players. Jurists from Lesotho also expressed their gratitude for the insight they received.

The workshop was of great value to the university because it served the community with expert presentations on this new and sensitive topic. The guidelines and pitfalls that were discussed and pointed out at the workshop cleared uncertainties and brought new insight to the different professions and role players in the field. Furthermore, the bond between the academia and practice were developed and strengthened by the establishment of further cooperation between the parties.

Media Release:
Lacea Loader
Deputy Director: Media Liaison
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl.stg@ufs.ac.za  
11 August 2009

 

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