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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

#Women’sMonth: Men should help change narrative on violence against women – Prof Solomon
2017-08-23

 Description: Issues affecting women Tags: Prof Hussein Solomon, Department of Political Studies, violence against women, Gender and Sexual Equity Office, Women’s Month, Embrace a Sister, Boko Haram 

The panellists at a discussion on Issues
Affecting Women
at the UFS Sasol library were
Zane Thela, Head of the Gender and Sexual
Equity Office Programme, Pumla Mgobhozi, founding
member of Embrace a Sister, and
Prof Prof Hussein Solomon, Senior Professor in the
Department of Political Studies.
From the left, are: Thela, Mgobhozi, Prof Solomon,
and Betsy Eister, Director: Library and
Information Services.
Photo: Jóhann Thormählen

The fight to eradicate violence against women is one which men should be involved in. According to Prof Hussein Solomon, Senior Professor in the Department of Political Studies at the University of the Free State (UFS), men have to help change the narrative of physical abuse and sexual violence which they perpetrate against women and children.
“Let them (men who might be offended by the #men are trash) reject violent masculinities, and in the process let them redefine what being a man is about. Let fathers teach their sons that no means no.”

Panel discussion on Issues Affecting Women
Prof Solomon was part of a panel discussion on Issues Affecting Women, organised by the UFS library, in collaboration with the Gender and Sexual Equity Office and Embrace a Sister, as part of Women’s Month in the UFS Sasol library on 3 August 2017.
The other panellists were Zane Thela, Head of the Gender and Sexual Equity Office Programme at the UFS, and Pumla Mgobhozi, founding member of Embrace a Sister. Prof Solomon’s book Understanding Boko Haram, focusing on the kidnapping of 200 young women in Nigeria was also launched.

Don’t accept things as they are
Prof Solomon says that responses by the SA government have no credibility and a lot more could be done. “What is clear is that outrage alone will not end this violence.”
Even at SA universities there are many examples of how women are mistreated. “We need to ask: What more can we do as a university to assist these (female) students.”

According to Thela, it is sad that these issues are only talked about seasonally (like during Women’s Month).
Thela says people should raise their children differently in order to change the narrative. “Then men won’t think they have to prove themselves to women.”
And we shouldn’t accept things as they are: “The most dangerous statement in society is to say: ‘It has always been done this way."

Role of women in their fate
Mgobhozi emphasised that women have a hand in the way they are being seen and treated in society. She therefore asked: “What is the role of women in making sure that we dismantle patriarchy”.
According to her women, especially black women, should dismantle the status quo. She added that cultures and parents often influence the way women are seen.
“Women should fight these social problems together,” Mgobhozi says.

 

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