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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

Workplace discrimination and unfair practices explored in new book
2017-09-13

 Description: Denine read more Tags: Denine Smit, Labour law, employee relations, bullying, vulnerability, research, Damain Viviers 

Dr Denine Smit
Photo: Supplied

Two law scholars, Dr Denine Smit and Dr Damian Viviers, from the Faculty of Law at the University of the Free State (UFS) recently launched a book titled Vulnerable Employees, which was inspired by their interest in researching, creating awareness and providing a legal exposition in relation to employees who are vulnerable and experience prejudice and dignity violations in the workplace. These include workplace bullying, appearance-based discrimination, those who are gender fluid or have mental-health conditions.
“Dr Viviers, who is also a former student of mine, and I, have been working together for years and share a common understanding in relation to our various topics of interest. We often share the same train of thought. This is how we came to work together to produce this book,” said Dr Smit.


Research focused on employee challenges in the workplace
The book expands on the field of knowledge regarding certain categories of employees who, as a consequence of various mutable, immutable and semi-immutable characteristics, as well as behavioural experiences, are rendered vulnerable in their employment relationships. The book draws on various social, psychological and other empirical considerations, as well as comparative legal research from foreign and international law, in order to expand on the legal position under the South African legal framework governing these conditions. While the book first and foremost constitutes a compendium of research to be used for this purpose, it also serves as a practical guide for all legal practitioners, human resources managers, other labour stakeholders and the judiciary.

Book draws strength in other academic fields
Vulnerable Employees was launched on 28 July 2017 at the UFS library, to an audience of academics and students, with a panel discussion made up of the authors and two other panellists. One of the panellists was Dr Katinka Botha, a leading psychiatrist in the Free State who has a wealth of experience in this field. “Her selection as a panellist was motivated by the various significant inter-disciplinary considerations and intersections between psychology, psychiatry and law, contained in the book,” said Dr Smit. 
“Dr Botha’s expertise was invaluable in shedding light on mental-health considerations during the panel discussion.” 
Mr Lesley Mokgoro, the other panellist, is a leading labour law practitioner, as well as director and head of the Dispute Resolution Practice Group at Phatshoane Henney Attorneys. “His years of experience working with all role players in the employment domain, as well as his extensive legal knowledge and expertise, made him uniquely qualified to serve on the panel and deliver an opinion of the practical and academic value of the book,” said Dr Smit.


Workplace policies key to securing employee rights
There are a number of growing trends in the workplace that could shape the practice of labour law or workplace policies. Dr Smit said the need for employers to regulate workplace culture, particularly in relation to bullying, harassment and unfair discrimination, in line with the South African legal framework, was a fundamental need in all workplaces. Effective workplace policies may be used to clearly outline the relevant “dos and don’ts” to employees, as well as the procedures and processes that may be followed in order to address such conduct. Workplace policies serve to advance legal certainty and efficiency, since the rights and obligations of all role players are clearly demarcated, or should be, in terms of a well-drafted and considered policy. 
The book is one of several publications produced by Dr Smit in collaboration with Dr Viviers on the topic of workplace discrimination and the law. The two scholars are working on another book to be published at the end of 2017.

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