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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

It takes a village to raise a child
2016-06-13

Description: Valentino_Student Bursary Fund Campaign Tags: Valentino_Student Bursary Fund Campaign

Valentino Ndaba
Photo: Sonia Small

(Click on CC for subtitles)

Video
Student Bursary Fund Campaign booklet (pdf)
Donate
Student Bursary Fund Campaign launched: #FundAFuture and make a difference
Motho ke motho ka batho. A person is a person through others

Want to make a difference in the world? Here is how

South Africa has one of the most spectacular coastlines in the world. Take the ribbon of golden beaches sweeping along the shores of KwaZulu-Natal, for instance. But just beyond the kiteboards dappling the ocean and fields of swaying sugarcane lies one of the largest informal settlements in the province: Amaoti. A place where barefoot children are skipping alongside poverty, and violent crime incinerates hope.

Nonetheless, that place could not keep Valentino Ndaba from graduating at the University of the Free State (UFS), and setting her sails for post-graduate studies.

A village
It takes a village to raise a child. This African proverb ripples across Valentino’s life story. “My gran always used to say education is your eternal bread. She still says it to this day. She has always instilled in me the importance of education,” Valentino smiles. Her grandmother has been but one of several champions in Valentino’s life.

Maalthee Dayaram – a teacher at Brookdale Secondary School that Valentino attended – noticed a budding talent in the young girl’s writing. With dedicated attention and ceaseless encouragement, Mrs Dayaram helped pave the way for this young writer. “You might be talented and have potential, but having someone actually believe in you and tell you that you have potential makes such a difference,” Valentino says. “I fell in love with writing, and had an idea that writing might be my future.” Dire economic circumstances threatened to snuff out any sparks of hope from that fragile future, though.

Aided by Lungisani Indlela (a non-profit organisation that provides children in the Amaoti area with school fees, uniforms, shoes, etc), Valentino clung to faith in the power of education. With unwavering single-mindedness, she consistently earned top grades.

Description: Valentino Ndaba 2 Tags: Valentino Ndaba 2

Photo: Sonia Small

Not if, but when
“Dreaming of my future, my gran would always say to me, ‘when you go to university’ or ‘when you have graduated’, this and that will follow.” Her gran’s words proved to be prophetic. As the final matric results were published in early January 2012, Valentino received a phone call that would change her life irrevocably.

That call came from the well-known South African humanitarian, Tich Smith. “Would you be willing to go to university in another province?” Smith asked. Never having travelled beyond her immediate surroundings, Valentino’s brave answer was: “Yes.”

A few days later, she walked onto the Bloemfontein Campus of the UFS.

Changing futures

Valentino proceeded to obtain a BA degree in Media Studies and Journalism in 2014. She has now set her sights on an honours degree, and envisions pursuing a Master’s degree in creative writing overseas.

“Without the support I received, I would have been stuck without a future,” she says. “University has shaped me into a better version of myself. I’ve grown intellectually, spiritually, and emotionally.”

You can bring about the same change for other students in need. By contributing to the UFS Student Bursary Fund Campaign, you can change the future not only of individuals, but of communities and of our country as well.

The impact of your financial support reaches far beyond its monetary value. It pulls families from poverty. It sends forth experts and visionaries into the world. It sets in motion a culture of giving.

Visit our Giving page for ways to contribute.

 

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