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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

B. Iur. programme in Occupational Risk Law first of its kind in the country
2010-11-26

The University of the Free State (UFS) will offer a B.Iur. degree programme in Occupational Risk Law from 2011.

This programme of the Faculty of Law is the first of its kind to be offered in South Africa and positions the UFS in the forefront of this field of study.

The programme is designed to develop and qualify professionals, knowledgeable in the field of occupational risk law as prescribed by South African legislation and international best practices. It further offers a qualification based on a well-researched basis of applicable legal principles, combined with safety, health, environmental and quality risk management principles applicable to employers and employees in a specialised industry.

The B.Iur. (Occupational Risk Law) has been developed by experts within the parameters of international comparability, according to research-based identification of career demands and requirements in the fields mentioned.

By introducing this programmesignificant progress will be made towards achieving the nationally stated objective of legal safety, health and environmental quality assurance in the workplace and within the broader community. The programme will also encompass the values and standards prescribed by the Institute of Safety Managers. This will provide them with a further step towards the regulation of the professional en ethical standards in the field of legal safety, health and environmental quality assurance.

With the programme, the UFS not only creates a unique opportunity for stakeholders and learners to add meaningful value to their careers, but also exerts a meaningful influence on the industry and society in terms of the acquisition of a most appropriate type of qualification. The B.Iur. (Occupational Risk Law)degree therefore offers a meaningful contribution towards the industry through addressing the increasing demand for career opportunities in the field of legal safety, health and environmental quality compliance.

The new programme is the result of an agreement between the faculty and its partner, IRCA Global. The university officially launched its partnership with IRCA Global, an international supplier of risk management solutions pertaining to safety, health, the environment and quality in 2008. As part of the agreement, the UFS will offer short learning programme, a diploma and a degree in Risk Management.

IRCA Global is a South African company in the international risk control and SHEQ environments with filials in Africa, Australia, India, Eastern Europe, and South America.

In the interim IRCA Global has continued with the marketing of the programme, with the result that hundreds of potential students are waiting for the launching of the programme. The faculty is geared towards offering the programme in e-learning. New modules will also be offered with the help of IRCA’s trained and skilled facilitators. The faculty also utilises the partnerships entered into with IRCA to appoint practising specialists as part-time lecturers for the occupational risk law component of the programme as well as to develop a new specialist component amongst the permanent staff.

The programme is already active and students can register for the first semester 2011 (study code 3324, programme code M3000). Direct your enquiries to Cora-Mari de Vos at 051 401 3532 or devosc@ufs.ac.za.

The programme consists of fundamental modules of the LL.B. and B.Iur., as well as short learning programmes in the Faculty of Law and specially developed core modules in occupational risk law. The B.Iur.in Occupational Risk Law enables successful candidates to enrol for applicable Post Graduate Diplomas or a cognate Honours Degree. Obtaining one of these qualifications provides the platform to articulate to Magister degrees. Horizontal articulation possibilities exist with the accredited Baccalaureus of Law (LL.B.) which is presented by several institutions in the country.

Media Release
Issued by: Lacea Loader
Director: Strategic Communication (actg)
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl@ufs.ac.za
26 November 2010

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