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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

UFS presents unique rally
2005-06-07

On Friday 10 June 2005, the University of the Free State (UFS) will present the Kovsie version of the Amazing Race in Bloemfontein.

The Amazing Rainbow Rally will be held in aid of children and babies with serious diseases in the Department of Pediatrics and Child Health in the Faculty of Health Sciences.

By raising the necessary funds, equipment can be acquired to meet the unique health care needs of these special patients.  It will also enable the UFS to maintain the high standards of education, training and research in this field.

 The Amazing Rainbow Rally will give some residents of Bloemfontein an opportunity to test their knowledge of the city, as well as their time management skills, communication skills, team work and even their relationships! 

About 12 corporate teams from among others Vodacom, Eskom, Medi-Clinic, Mimosa Mall and Nedbank and four university teams must follow a specific route with various checkpoints by car.  Here they will have to complete activities or solve clues before receiving their clue to the next checkpoint.  Teams will be traveling with cars branded with the logo of the company they represent.

The rally will start at 09:00 at the Rooiplein of the UFS and will again end on the campus where they will complete the last task.  The first team to complete this task is the winner of Bloemfontein’s first Amazing Rainbow Rally.

OFM’s breakfast team will do live crossings on the day to reveal how teams are doing.

The Department of Pediatrics and Child Health at the UFS serves children with special needs, in other words children who need intensive care, or who suffer from cancer, heart disease, neurological diseases and conditions, endocrinological diseases or gastro-enterological conditions.

The Department provides secondary health care to more than 250 000 children in the southern parts of the Free State, but is responsible for the tertiary care of about a million children in the Free State and Northern Cape, as well as some parts of the North-West province, the Eastern Cape and Lesotho.  The intensive care units at Universitas and Pelonomi Hospitals serve approximately 1 300 neonatal and 350 intensive care patients annually.  The pediatric cardiology unit admits almost 300 high care heart patients per year.  Approximately 13 000 out-patients visit these two hospitals every year.

MEDIA RELEASE

Issued by:  Lacea Loader
   Media Representative
   Tel:  (051) 401-2584
   Cell:  083 645 2454
   E-mail:  loaderl.stg@mail.uovs.ac.za

7 June 2005
 

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