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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

Graduates encouraged to emulate the greats
2016-07-06

Description: z 2016 Winter grads Tags: z 2016 Winter grads

The University of the Free State Winter Graduation ceremonies
took place on 29 and 30 June 2016 on the Bloemfontein Campus.

Photo: Johan Roux

Trevor Manuel and Max du Preez among the recipients of honorary doctorates at UFS graduation 

Take up the challenge, make things happen, and emulate the greats. This was the overwhelming theme of messages from speakers to graduates at the Winter Graduation ceremonies of the University of the Free State (UFS).

According to Prof Joel Samoff, Professor in Africa Studies at Stanford University (USA), the graduands are the “new generation of analysts, researchers, and practitioners”, and should “assume the responsibility for keeping your senior colleagues on a productive path.” Prof Samoff, who received an honorary doctorate from the UFS on 30 June 2016, was the guest speaker at the afternoon graduation ceremony on 29 June 2016.

The UFS awarded a total of 482 Master’s and doctoral degrees on 30 June 2016 – 53 doctorates and 429 Master’s degrees – in the Callie Human Centre on the Bloemfontein Campus. On 29 June 2016, diplomas were awarded in the School of Financial Planning Law, as well as certificates and diplomas in education on the South Campus.

“You are smarter
than you think.
Smarter than other
people think you
are, and smarter
than the country
thinks you are.”


Rise above South African standards


According to Prof Jonathan Jansen, Vice-Chancellor and Rector of the UFS, South Africans have become use to a low standard of human decency, entertainment, and academics. He encouraged the graduates to rise above it.

“You are smarter than you think. Smarter than other people think you are, and smarter than the country thinks you are.”

Make impact like honorary doctorates


Dr Khotso Mokhele, UFS Chancellor, asked the recipients of honorary doctorates, Prof Samoff, Max du Preez, Trevor Manuel and Dr Reuel Jethro Khoza, and of the two Chancellor’s medals, Antony Osler and Marguerite van der Merwe (née Osler), to face the graduates at the morning ceremony on 30 June 2016. “I challenge you to look at them and to emulate them,” he said. “May it transform you to be like them in 10, 15 or 20 years.”

Dr Mokhele thanks Prof Jansen as leader


Dr Mokhele made special mention of Prof Jansen, who will step down as Vice-Chancellor and Rector on 31 August 2016, as these were his last UFS graduations. He thanked Prof Jansen for his major contribution to transformation at the UFS. “You are not only a Vice-Chancellor, but also a project leader,” Dr Mokhele said.

 

Click here to see a photo gallery of the graduations.

Click here to see a list of distinctions and special awards.

 

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