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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

Free State Arts Festival and the Department of Afrikaans and Dutch, German and French (UFS) launches first crossword tournament in SA
2016-06-14

History will be made at the Free State Arts Festival, which will this year be held in Bloemfontein from 11 to 16 July. For the first time ever in South Africa, a Crossword Tournament will be presented for the public, where Afrikaans word and language lovers can test their knowledge and speed against other competitors.

With the help of the Department of Afrikaans and Dutch, German and French, as well as Xword, the RSG Crossword Tournament will be presented on the university’s campus. In several knockout rounds on Friday 15 July, contestants will have to complete three different types of crosswords compiled by the experienced crossword team at XWord.  Points will be awarded according to a formula measuring accuracy and speed. The top ten contestants will go through to a semi-final on Saturday 16 July, after which three finalists will be selected to compete against each other in the Grand Finale. 

Apart from the coveted title, DIE RSG BLOKRAAIKAMPIOEN, prizes which are up for grabs include a year’s access to the news platforms of Netwerk24 for all three finalists, a variety of dictionaries from Pharos and Longman-HAT, a wide range of crossword books published by LAPA, and many more.

Interested persons can find more information about the RSG Crossword Tournament at www.xword.co.za. Links are also provided to free crosswords which can be printed to practice ahead of the tournament. Interested people are requested to send their names, cellphone numbers, and Email addresses to Albe Grobbelaar at XWord in advance in order to facilitate the planning for the expected number of participants. The address is albegrobbelaar@gmail.com

The cost for participants is R50, which is payable on the day of the elimination rounds at the venue on campus, South Block 1. The entrance fee includes a copy of XWord’s popular book, AfriBlokkies Blokkiesraaisels.

(Further inquiries: Albe Grobbelaar – 082 447 1900)

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