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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

Tanya takes over netball reins from big sister
2016-07-04

Description: Tanya Mostert USSA SASPA Tags: Tanya Mostert USSA

Tanya Mostert will lead the University of
the Free State Netball team at the USSA
tournament in Cape Town.

Photo: SASPA

Last year, big sister led the Kovsie team, and now it is the turn of her little sister. Tanya Mostert will be filling the shoes of her big sister, Karla Mostert, when she leads the University of the Free State (UFS) team in the USSA tournament in Cape Town from Monday 4 July 2016.

Karla now helping as defence coach

Karla was captain in Johannesburg in 2015 when the UFS lost against Tuks in the USSA final by 39-48. The star of the Proteas is too old to play for the UFS again, and is now helping out as defence coach. Karla and Lauren-Lee Christians, who won’t be playing in the USSA tournament, were included in the South African Universities Netball team that will compete in the World Student Games in Miami, America, from 13 to 17 July 2016.

The Kovsie Netball team is one of seven UFS sports teams competing in USSA tournaments. The others are hockey (men and women), rugby, badminton, basketball, squash, and volleyball.

Mostert sisters are both natural leaders

Like Karla, Tanya is a natural leader. She was captain of the Zwartkop High School team, as well as the Free State U19 and U21 teams. “It is amazing that two children from the same home are both leaders, even if there is naturally a difference in their leadership style,” says Burta de Kock, the Kovsie coach.
“For me as coach, it is also wonderful to know that they (Karla and Maryka Holtzhausen, Protea captain and Kovsie assistant coach) are prepared to plough back at this young age. They are also role models for the other players.”
According to De Kock, she has a strong USSA group and wants the UFS to perform better than in 2015.

The UFS teams taking part in the USSA tournaments from Monday 4 July 2016 are:

  • Netball (Cape Town)
  • Hockey (men and women, Johannesburg)
  • Rugby (East London)
  • Badminton (Stellenbosch)
  • Basketball (Johannesburg)
  • Squash (Stellenbosch)
  • Volleyball (Pretoria)

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