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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

Accreditation status of the UFS School of Medicine
2016-06-14

This communication is a factual correction of the misinformation and accompanying hysteria that appeared in a local newspaper this past week on the accreditation status of programmes in the Faculty of Health Sciences’ School of Medicine. Here are the facts:
 
1. The flagship programme of the School of Medicine, the MB ChB, was fully accredited by the Health Professions Council of South Africa (HPCSA) through the year 2020. This is the maximum accreditation status that any programme can achieve, and the UFS leadership is extremely pleased with this outcome, as it expresses confidence in the work done by our academics in the School of Medicine. Not only was the basic medical training for new doctors fully accredited, the HPSCA approved an increase in the number of trainee doctors from 140 to 160, and also approved additional training sites in Trompsburg and Kimberley.
 
2. The honours programmes of the School of Medicine received full accreditation as well.
 
3. All the master’s degree programmes in the School of Medicine also received accreditation. The UFS is especially pleased with the significant improvements in the Department of Cardiology, which now has a full complement of staff under the leadership of the highly regarded cardiologist, Prof Makoali Makotoko.
 
4. Four master’s programmes received provisional accreditation, which means that (a) these programmes continue to be taught and (b) outstanding issues, such as inadequate staffing, must be fixed. It does not mean that these programmes will be or are likely to be discontinued.
 
5. It is a fact that staff retire or resign in all schools and departments of any university. It is also true that these departures offer opportunities to bring new academic and professional staff into the UFS. In fact, for the first time virtually every department in the School of Medicine now has a full-time Head of Department and 46 new staff were appointed since January 2015.
 
6. The main employer of academic staff in the School of Medicine is the provincial Department of Health (DoH), and the UFS works very closely and persistently with the Free State DoH to ensure that vacant posts are filled.
 
7. The attacks on the integrity of the outgoing Head of the School of Medicine were malicious. Prof Alan St Clair Gibson did not resign ‘overnight’; his departure has nothing to do with the accreditation status of the School – in fact, he can be proud of this achievement; and he effectively takes up a promotion post in New Zealand as academic Dean at the University of Waikato. Prof St Clair Gibson will be remembered for his leadership in transformation, especially regarding staff and student equity in the School of Medicine, and for securing our programme accreditation. For this, the university is deeply grateful.

Released by:
Lacea Loader (Director: Communication and Brand Management)
Telephone: +27(0)51 401 2584 | +27(0)83 645 2454
Email: news@ufs.ac.za | loaderl@ufs.ac.za
Fax: +27(0)51 444 6393

 

 



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