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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

Shimlas: Unbeaten Varsity Cup Champions!
2015-04-14

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    Photo: Johan Roux
    Spotlight Photo: Spektor Photography
    Photo gallery

The UFS Shimlas rugby team made history on Monday 13 April 2015 when they won their first ever Varsity Cup tournament, beating North-West University (NWU) Pukke 63-33 in the final.

Not only did Shimlas make history by winning their first-ever tournament title since the inaugural tournament in 2008, but they did not lose a single game in the 2015 Varsity Cup, thus claiming the cup in front of their home crowd at Shimla Park in Bloemfontein.

Shimlas outscored their traditional intervarsity rivals with nine tries to four. Pukke put the first points on the scoreboard with a penalty kick. The home side started off slowly in the first half. However, Shimlas’ lock, Johan van der Hoogt, did score the first try of the match followed by flyhalf and player that rocks, Niel Marais’s successful conversion kick. Yet, the men from the North-West retaliated full force for the greater part of the first half and, two tries later, had a 18-8 lead over the UFS team. 

Shortly after the first strategy break, Shimlas No.8, Niell Jordaan, crossed the try line following a driving maul, but the visitors received another penalty and succeeded with the kick at goal. The last ten minutes before half time saw Shimlas taking advantage, with the Pukke skipper being sent to the sin bin. Wing Maphutha Dolo hit a gap in NWU’s defense, and scored the try that put Shimlas in the lead again. Not long after, Marais sparked in making a play, offloading to flank Daniel Maartens to score a final try before half time, securing a 26-20 lead.

The second half had not been in play too long when the home side crossed the try line again, scoring their fifth try. Marais was again central in creating the play that saw Shimlas outside centre, Nico Lee, putting the points on the board.

NWU fought back again, scoring a pushover try from a scrum. But Shimlas would not give up the lead again, and a well-timed pass from Marais had Lee crossing the line for his second try.

More Shimlas tries piled up from Marais, Dolo, and Maartens, leaving the Potchefstroom side behind 63-25, giving them little opportunity to score again. One desperate consolation try by Pukke in the final seconds did manage to close the gap on the scoreboard, but it was not nearly enough to snatch the title from the hungry and undefeated Shimlas.

FNB Player that Rocks: Niel Marais
Shimlas point scorers:
Tries: Johan van der Hoogt, Niell Jordaan, Maphutha Dolo (2), Daniel Maartens (2), Nico Lee (2), Niel Marais
Conversions: Niel Marais (6)

 

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