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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

UFS Centenary ends with a weekend of festivities
2005-02-04

The University of the Free State ’s (UFS) Centenary celebrations will come to an end this weekend with a packed programme.

“We celebrated this momentous milestone of the UFS since 28 January 2004 and want to end the year on a high note,” said Mr Jan Ras, Centenary Coordinator.

The weekend will start on Friday 4 February 2005 when Prof Frederick Fourie, Rector and Vice-Chancellor, will open the UFS officially. This will be followed by an historic photo of all staff and students who are on campus that day. All staff will be wearing their academic gowns and the Centenary emblem will be depicted.

The annual Kovsie Engen Rag, with We thank you South Africa as theme, will take place on Saturday 5 February 2005 . The procession will start at 08:00 from the UFS Kovsie church and will move down Nelson Mandela Drive and right into Markgraaff Street exit until it reaches St Andrew’s Street. From here it will turn right into Kings Way where it will stop at the Art Market at 10:00 . Prof Frederick Fourie will then propose a toast on the procession. Afterwards the groups and orchestras will step out and the floats will move through the center of town around Hoffman Square and then back to the UFS campus.

According to Mr Ras a reunion for the Student Representative Council (SRC) will also take place this weekend. About 100 former SRC members are expected to attend the planned activities.

The weekend will be concluded on Sunday 6 February 2005 with a special service of devotion, hosted by all the interdenominational groups on the campus. The service starts at 18:00 for 18:30 in front of the Main Building of the UFS and will be a celebration of praise, thanks and worship, followed by a message from Dr Wollie Grobler. The evening will be concluded with a mass choir and a fireworks display.

“Members of the public are welcome to attend the service of devotion and are requested to bring a candle for the purpose of the mass choir. Although chairs will be arranged in front of the Main Building , people are requested to bring extra pillows and blankets to sit on,” said Mr Ras.

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