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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 application figures show a good upward trend
2008-10-23

Applications for admission to the University of the Free State (UFS) are showing an upward trend. In comparison with the same time last year, the total application figure has increased from 6 273 to 7 507 – a growth of 19,7%.

So far, applications for postgraduate studies are showing the biggest growth with 1 342 applications received. During the same time last year, 594 applications for postgraduate studies were received – an increase of 126%.

Prospective students have until 30 November 2008 to apply for admission. “This applies to first-time entering first-year students and senior students who have interrupted their studies for at least one year,” said Mr Vernon Collett, Registrar: Student Academic Services, at the UFS.

According to Mr Collett students whose applications for admission are received after 30 November 2008 and until 13 January 2009 will be accepted subject to the availability of place on the programme they applied for.

Applications from prospective students who wrote the Senior Certificate (prior to 2008) and who are in the possession of a conditional exemption will only be accepted until 5 January 2009.

Prospective students who want to apply must pay a non-refundable fee of R140.
The signed application form must be accompanied by a certified copy of the prospective student’s identity document or passport, a proof of payment of the application fee as well as a certified copy of their Statement of Results of their Senior Certificate.

Prospective students who are in Grade 12 this year will receive a National Senior Certificate. A certified copy of their Statement of Results must be faxed to the UFS not later than 7 January 2009.

The application form of a minor must be signed by his/her parent or guardian and the field of study should be clearly indicated.

First-time entering first-year students from the Faculties of Economic and Management Sciences and the Humanities (including Education) will be welcomed by the Acting Rector, Prof. Teuns Verschoor, on Friday, 9 January 2009 at 09:00 in the Callie Human Centre on the Main Campus.

The welcoming of students from the Faculties of Health Sciences, Natural and Agricultural Sciences, Law and Theology will take place on Saturday, 10 January 2009 at 09:00 in the Callie Human Centre.

The registration of first-time entering first-year students will commence on 13 January 2009 and that of senior students on 19 January 2009 at the Callie Human Centre according to a programme.

Students who applied for admission after 30 November 2008 and are accepted can register from 4 February 2009.

Lectures will commence on 2 February 2009 and the registration process will end on 10 February 2009. This is applicable to all students – undergraduate as well as postgraduates

Prospective students who want to apply for admission or who have any enquiries can call 051 401 3000 or visit the UFS web site at www.ufs.ac.za.

 

Media Release:
Issued by: Lacea Loader
Assistant Director: Media Liaison
Tel: 051 401 2584
Cell: 083 645 2454
E-mail: loaderl.stg@ufs.ac.za  
22 October 2008

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