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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

Shortage of quantity surveyors discussed at UFS
2006-03-24

During the recent visit of the Association of South African Quantity Surveyors (ASAQS) to the University of the Free State (UFS) were from the left Mr Egon Wortmann (Director: ASAQS), Prof Basie Verster (representative of the Free State on the ASAQS and head of the Department of Quantity Surveying and Construction Management at the UFS), Mr  Greyling Venter (Chairperson:  Free State branch of the ASAQS), Prof DG Brümmer(Vice-President:  ASAQS) and Mr  Patrick Waterson (President:  ASAQS).
Photo supplied

 

Shortage of quantity surveyors discussed at UFS

 “The South African building industry is experiencing an unprecedented high level of economic growth and prosperity.  This is causing a definite shortage of registered quantity surveyors,” said Mr Egon Wortmann, Director of the Association of South African Quantity Surveyors(ASAQS) during the association’s recent visit to the Department of Quantity Surveying and Construction Management at the University of the Free State (UFS).

 “This shortage is especially noticeable in local and national governments where unqualified and inexperienced staff, consultants and/or facilitators are now appointed,” said Mr Wortmann. 

 In doing so, the authorities that have adopted this approach are according to Mr Wortmann actually acting illegally and are not in compliance with the legal and statutory requirements of South Africa.  “These unprofessional practices are unproductive, it leads to frustration and is strongly condemned by the ASAQS,” he said.

 “The service delivery of these unqualified and unregistered service providers is often sub standard and does not comply to the legal requirements of the profession.  It may also result in the tarnishing of the image and high professional standards set by the quantity surveying profession,” said Mr Wortmann.

 “Universities offering programmes in quantity-surveying and construction management are also negatively affected by the high levels of activity in the building environment.  Suitable lecturing staff are leaving the academic institutions as they are attracted to better opportunities being offered in the building industry. The ability of the tertiary institutions to attract young academics, to train them and to keep them in the longer term, is therefore almost impossible”, said Prof Basie Verster, head of the Department of Quantity Surveying and Construction Management at the UFS and representative of the Free State on the ASAQS.

 According to Prof Verster the UFS supplies more than its quota of qualified quantity surveyors to the South African building industry.  “Although more than 460 students are registered in construction related programmes at the UFS, we are as the ASAQS’s concerned about the shortage of students that can enter the construction industry.  In our case, we  are experiencing a shortage in black female students,” he said.

 “Of the 460 postgraduate students, 38% are black of which 20% are female students.  Graduates do also not necessarily stay in the country.  As the UFS’s programmes are accredited overseas, a lot of our students leave the country for working opportunities elsewhere,” said Prof Verster.

 Mr Patrick Waterson, President of the ASAQS, appealed to quantity surveyors to, when they are approached, consider academic careers or to make themselves available to lecture on a part time basis.  “I also appeal to quantity-surveying practices, construction companies and developers to consider taking part in training activities,” he said.

 The ASAQS has over the years developed a proud tradition within the quantity-surveying profession. Consequently membership of this organisation is a sought after goal for many members within the building environment. International agreements with various countries are also in place whereby it is mutually agreed that local as well as overseas qualifications are mutually acceptable on a reciprocal basis. 

 A more recent addition to the list of agreements is the reciprocity agreement entered into with the Royal Institution of Chartered Surveyors which makes it possible for South African based quantity surveyors to practice in over 120 countries worldwide.

 Media release
Issued by: Lacea Loader
Media Representative
Tel:   (051) 401-2584
Cell:  083 645 2454
E-mail:  loaderl.stg@mail.uovs.ac.za 
23 March 2006

 

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