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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

Guest lecture: Mr Pretorius, CEO of McCarthy Limited
2004-11-05

The challenges facing business leaders in a rapidly changing South Africa

“The world we used to know does not exist anymore. Leaders are continually dealing with crisis and opportunities, in a high-pressure environment,” said Mr Brand Pretorius, honorary professor from the University of the Free State , delivering his 13th guest lecture on the challenges facing business leaders in a rapidly changing South Africa .

Mr Pretorius, CEO of McCarthy Limited, identified certain trends which are responsible for changes to the South African business environment. He said the South African business environment is ever-changing, fast moving, complex and unpredictable. “As business people we have to deal with the impact,” he said.

“Years ago we were globally isolated. Now we live in a shrinking borderless world with crumbling trade barriers. Globilisation of our economy is accelerating. For South African business leaders this creates a sea of export opportunities,” he said.

Although there are ongoing demands for substantial profit growth from shareholders, the days of focussing only on their interests are gone, said Mr Pretorius. Stakeholder commitment now enjoys high priority and business leaders have to deal with the challenges accompanying black economic empowerment and employment equity.

Customers are also well-informed and demanding. Business leaders could easily loose the loyalty of their customers because of a hyper-competitive environment with an oversupply of goods and services.

Mr Pretorius stated that staff want to be involved and are looking for meaning in their workplace. Employers also have to deal with HIV/Aids in their workplaces. Trauma, absenteeism and financial implications could have a great effect on the viability of a business.

Against these changes Mr Pretorius pointed out the challenges business leaders are facing. In doing so a number of questions arise. The external business climate is characterised by turbulence and change. Internally there is a need for stability and meaning. How do we handle both challenges effectively?

Because of changes strategy decay is taking place and past strategies become irrelevant. Mr Pretorius said that business leaders need to modify their business models to prevent the downfall of their companies.

It is important for leaders to know what is happening in their world. “Continuous innovation is a critical success factor. The reality is that innovation is the only insurance against irrelevance,” he said.

Because of a changed environment leaders must perform and transform, simultaneously. How do we strike a balance between focused transformation and the achievement of world class performance, asked Mr Pretorius? “We need to bring about meaningful and sustainable empowerment, in order to create an inclusive economy and society. Leadership and management profiles should reflect the diversity of our teams, however at the same time every effort should be made to stop the brain drain and retain the expertise of experienced white managers.”

He also stated that leaders have an important role to play in terms of employment creation and corporate caring. “Sustainable stability and prosperity will not materialise without efforts in this regard.”

Mr Pretorius said that above challenges could be addressed by developing the ability to focus on creating a better future, rather than defending the past, a long-term vision, facing new realities, enhancing the value of brands and mobilising IT and the Internet to serve the business and customers better.

Retaining a positive vision of the future, embracing change and transformation, building your business according to the right principles and values and aspiring to be the best are some of the guidelines, according to Mr Brand, for future business success. He stated that creating a value advantage above one’s competitors, customer satisfaction and retention and inspirational leadership will add to the success of one’s business.

“We are indeed living in the era of the ultimate challenges, but also the ultimate opportunities. Let me clearly state that I have hope – in my view the tide has turned. Every day I experience small miracles inspired by ordinary people making an extraordinary difference,” said Mr Pretorius.

 

Media release
Issued by: Lacea Loader
Media Representative
Tel: (051) 401-2584
Cell: 083 645 2454
E-mail: loaderl.stg@mail.uovs.ac.za
5 November 2004

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