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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

During 2011: Sport
2011-12-01

Our sports stars set their gaols high and with hard work, dedication a good measure of determination they show that they will not give up until these goals are met. A place in the national team or a medal or award in hand is enough proof that our Kovsie sportsmen and women are serious about their successes on the sports field.

 Description: 2011 Sport_Cricket Tags: 2011 Sport_Cricket  Description: 2011 Sport_Karate Tags: 2011 Sport_Karate  Description: 2011 Sport_Hockey Tags: 2011 Sport_Hockey  Description: 2011 Sport_Netball Tags: 2011 Sport_Netball  Description: 2011 Sport_Rugby Tags: 2011 Sport_Rugby

Some of our stars this year were:

Athletics:

Thuso Mpuang, our Kovsie Sportsman of the year, represented South Africa during the World Athletic Championships in Deague, Korea. He obtained the silver medal in the 200m during the World Student Games in Shenzhen, China and a gold medal as a member of the 4 x 100m relay team.

Janette Siebert represented South Africa during the Southern Africa Championships in Maputo, Mozambique.

Boy Soke represented South Africa during the Africa Cross Country Championships in Cape Town. He also represented South Africa during the World Cross Country Championships in China.

Cricket:

The 21-year-old former Kovsie, Obus Pienaar, who was still playing cricket for our university club until the end of the season (end of March), has been playing abroad for the Irish cricket club Waringstown from the end of April 2011.
We are proud of Obus’ achievements, in particular his contribution to the match against the CIYMS. During this game, Obus hit the highest score ever in the Northern Cricket Unions when he scored 244 runs in only 114 balls. This included 22 sixes and 13 fours. During his innings in this match, Obus also broke the July 2004 record of his compatriot, AB de Villiers of the Proteas.

Hockey:

Lesley Ann George represented the Protea Women’s Hockey Team during the series against China, Belgium and Azerbaijan. She was also a member of the Protea Women’s Hockey Team during the Champs Challenge in Ireland. The team finished fifth.

Nicole de Vries represented the Protea Women’s Hockey Team during the series against China, Belgium and Azerbaijan. She was also a member of the Protea Women’s Hockey Team during the Africa Cup in Bulawayo. The team obtained a gold medal.

Hettie Oosthuizen represented the Protea Women’s Hockey Team during the series against China, Belgium and Azerbaijan.

Izelle Lategan represented the Protea Women’s Hockey Team during the series against China, Belgium and Azerbaijan.

Nicole Kemp was a member of the Protea Women’s Hockey Team during the Africa Cup in Bulawayo. The team obtained a gold medal.

Karate:

Elsabe le Roux was a member of the Protea JKA Shotokan Karate Team that participated in the Africa Zone 6 Championships in Maputo where she obtained a gold and silver medal.

Bruno Schwalbach was a member of the Protea JKA Shotokan Karate Team that participated in the Africa Zone 6 Championships in Maputo where he obtained two gold medals. He was also a member of the Protea JKA Shotokan Karate Team that participated in the Common Wealth Karate Championship in Australia where he obtained one silver and two bronze medals. He was a member of the Protea JKA Shotokan Karate Team that participated in the All Africa Games in Maputo Mozambique where he obtained a bronze medal.

Balungile Nchofe was a member of the Protea JKA Shotokan Karate Team that participated in the Africa Zone 6 Championship in Maputo, where he obtained a gold medal.

Netball:

Kovsies’ netball team has performed well over the past year with, amongst others, the inclusion of players in the SA Universities World-cup Group.

Karla Mostert and Maryka Holtzhausen participated during the World Cup in Singapore in the SPAR SA Protea team.

We are also proud of the eight players who have been included in the SA team. They are Zimari Smit, Sheri Duimpies, Ane Botha, Danique du Toit, Nieke Loubser, Karla Mostert, Fikile Mkhuzangwe and Lauren-lee Christians.

At the SA tournament, Ane Botha was named as the centre-court player of the tournament, whilst Karla Mostert was named as the best defending player. Karla has also been included in the SPAR SA Protea team to the All African Games, which start in Mozambique at the end of August.

Rugby:

Boom Prinsloo and Robert Ebershohn are representing the Springboks in the HSBC Sevens World Series.

Soccer:

Gabisile Hlumbane, our Kovsie Sportswomanof the year, is a member of the Banyana Banyana National Soccer Team. The team obtained a bronze medal at the African Women’s Championships during October 2010, a gold medal at the Unity Cup Hosted during December 2010, a silver medal at the COSAFA Women’s Championship hosted during July 2011 and qualified for the London Olympics in 2012.

Squash:

Paul Rodrigues represented the South African U/ 23 team at the All Africa Squash Championships in Johannesburg.

Triathlon:

Nelmaré Loubser represented the SA Elite Team during the World Championships in Spain.

 

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