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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

Resource Manual on Trafficking in Persons for Judicial Officers sees the light
2012-03-27

 

Judge Connie Mocumi, President of the South African Chapter of the International Association of Women Judges (SAC-IAWJ), during the launch of the Resource Manual on Trafficking in Persons for Judicial Officers.
Photo: Leonie Bolleurs
27 March 2012

On Human Rights Day the Department of Criminal and Medical Law in the Faculty of Law at the University of the Free State (UFS) hosted the launch of the Resource Manual on Trafficking in Persons for Judicial Officers compiled by the South African Chapter of the International Association of Women Judges (SAC-IAWJ).

The manual, which will be used by members of the South African judiciary, will equip officials in adjudicating the multifaceted crime of human trafficking.

“Presiding officers must be sensitised about the complexity of the crime. Human trafficking has many faces and presents itself in different ways. A person may for example be trafficked for sexual exploitation, forced labour, the removal of body parts, as well as forced marriages. Expert knowledge is needed to handle these cases effectively in court,” said Dr Kruger, also responsible for the human trafficking initiative in the Unit for Children's Rights at the UFS.

Prior to the launch, a total number of 300 judicial officers, including six judges from the Southern African Development Community (SADC) received training on human trafficking. After receiving this training, the officers were sensitised to scrutinise domestic violence cases as well as inter-country adoption cases in order to identify possible human trafficking activities.

As keynote speaker at the launch, Dr Beatri Kruger from the Department of Criminal and Medical Law at the UFS, said that human traffickers were running operations like a well-oiled machine. They have abundant and sophisticated resources and often bribe corrupt officials to further their criminal activities. In South Africa, people combating human trafficking struggle with a lack of resources as well as comprehensive legislation. Most cases are prosecuted under the Children’s Act and the Sexual Offences Amendment Act of 2007. Unfortunately, this legislation still leaves a gap in the prosecuting of perpetrators. Only trafficking cases where where children are trafficked can be prosecuted under the Children’s Act. In terms of the Sexual Offences Amendment Act perpetrators can be prosecuted for trafficking persons for sexual exploitation only, and not for labour of other forms of trafficking. Therefore the comprehensive Prevention and Combating of Trafficking in Persons Bill 2010 needs to be finalised to cover all forms of trafficking.

There are more slaves today than at any time in the history of humankind. “To combat this serious problem, we need to follow a holistic approach,” said Dr Kruger. This includes prevention (raising awareness), effective prosecution and suitable punishment, the protection of victims, and partnering with all relevant stakeholders, including people in the communities. Community members are often whistle blowers of this crime.

The President of the SAC-IAWJ, Judge Connie Mocumi, handed copies of the manual, a three-year project, to judicial officers present at the launch. The manual covers, among others, the definition of trafficking in persons, trafficking in persons in South Africa and the Southern African region, a legislative framework, victims’ rights and criminal proceedings.

“It is critical that judicial officers appreciate the phenomenon of trafficking in persons in its broader socio-economic context. Therein lays the ability to deal competently with the often-nuanced manifestation of this scourge. The incapacity to recognise these nuances can deny victims access to justice. In that regard, the manual, amongst others, is to become an important empowering adjudication tool for judicial officers,” said Judge Mocumi.

More copies will be printed and be ready for distribution by the beginning of May this year.

Judge Belinda van Heerden, who also attended the launch, said: “There is progress on the judicial and legislative front to bring wrongdoers to book. This manual will go a long way in giving judicial officers insight into the problem.”

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