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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

UV vestig hom afgelope eeu as leier op verskeie terreine
2004-05-11

Michelle O'Connor - Volksblad - 11 Mei 2004

Ondank terugslae nou 'n 'gesonde volwassene'

HOEWEL die Universiteit van die Vrystaat (UV) vanjaar sy eeufees vier en met 23 000 studente die grootste universiteit in die sentrale deel van die land is, was dié instelling se geboorte glad nie maklik nie. MICHELÉ O'CONNOR het met prof. Frederick Fourie, rektor, oor die nederige begin van dié instelling gesels.

DIE behoefte aan 'n eie universiteit in die Vrystaat het reeds in 1855, kort ná die stigting van Grey-kollege, kop uitgesteek.

Grey se manne het hulleself teen 1890 begin voorberei om die intermediêre B.A.-eksamens af te lê. Dié eksamen het hulle toegang gegee tot die tweede jaar van 'n B.A.-graad aan die destydse University of the Cape Good Hope, nou die Universiteit van Kaapstad.

"Presidente F.W. Reitz en M.T. Steyn het destyds albei die stigting van 'n universiteit hier bepleit. Die grootste rede was sodat die seuns van die Vrystaat nie weggestuur word nie.

"Dié twee se droom is op 28 Januarie 1904 bewaarheid toe ses studente hulle onder dr. Johannes Bril, as hoof/rektor van Grey-kollege, vir die graad B.A. ingeskryf het. Dié graad is aanvanklik deur die Kaapse universiteit toegeken.

"Net die klassieke tale soos Latyns en Grieks, die moderne tale, Nederlands, Duits en Engels, filosofie, geskiedenis, wiskunde, fisika, chemie, plant- en dierkunde is aanvanklik aangebied.

"Die UV se geboue het gegroei van 'n klein tweevertrek-geboutjie wat nou naby Huis Abraham Fischer staan, en verblyf in die Grey-kollege se seunskoshuis," sê Fourie.

Volgens hom is die universiteit se eerste raad en senaat tussen 1904 en 1920 saamgestel. Die eerste dosente is aangestel en die eerste geboue opgerig. "Dié tyd was egter baie moeilik.

"Die instelling het teen 1920 net 100 studente gehad en was geldelik in die knyp. Daar was geen vaste rektor nie en geen vooruitgang nie. Vrystaatse kinders is steeds na ander universiteite gestuur.

"Ds. J.D. Kestell, rektor van 1920 tot 1927, het egter dié instelling finaal gevestig.

"Hy het self studente van oor die hele Vrystaat gewerf en geld by onder meer kerke en banke ingesamel. Kestell het selfs Engelse ouers oortuig om hul kinders na die Greyuniversiteitskollege (GUK) te stuur en teen 1927 het dié instelling met 400 studente gespog.

"In die tydperk tussen 1927 en 1950 het die GUK weer verskeie terugslae beleef.

"In dié tyd was dit onder meer die Groot Depressie en die Tweede Wêreldoorlog. Die armblanke-vraagstuk het regstreeks op studente en dosente ingewerk en die politieke onderstrominge van dié tyd het die instelling ontwrig.

"Die GUK het egter oorleef en die Universiteitskollege van die Oranje-Vrystaat (UKOVS) is in 1935 gebore," sê Fourie.

Hy sê in dié tyd is verskeie fakulteite gevestig en teen 1950 het die UKOVS met 1 000 studente gespog.

Teen 1950 het dit 'n onafhanklike universiteit geword en die naam is verander na die Universiteit van die OranjeVrystaat (UOVS).

Dié tydperk is gekenmerk deur Afrikaner- en blanke selfvertroue en heerskappy. Studentegetalle het tot 7 000 in 1975 gegroei en heelwat vooruitgang het in dié tyd plaasgevind.

"Tussen 1976 en 1989 sukkel dieuniversiteit weer met onder meer ekonomiese krisisse, die land se politieke onstabiliteit en word die UOVS geï soleer.

"Een ligpunt in dié tyd is die toelating van die eerste swart studente, die nuwe Sasol-biblioteek en die fakulteit teologie wat die lig sien.

"Tussen 1990 en vanjaar het die UOVS verskeie op- en afdraandes beleef. Die universiteit doen nie net die eerste stappe van transformasie nie, maar begin ook aan 'n beleid van multikulturaliteit werk.

"Die UOVS se naam verander in 1996 na die Universiteit van die Vrystaat/University of the Free State en in 2001 word die Sotho-vertaling bygevoeg.

"Geldelike druk en probleme neem drasties toe en personeel word gerasionaliseer.

"Teen 2000 begin die UV met 'n draaistrategie en studentegetalle neem tot meer as 23 000 toe," sê Fourie.

Hy sê die UV het die afgelope eeu nie net verskeie terugslae oorleef nie, maar homself ook op verskeie gebiede as 'n leier gevestig.

Die universiteit behaal sy eie geldelike mikpunte, neem 'n nuwe taalbeleid van veeltaligheid aan en herbelê in personeel.

Die instelling inkorporeer die kampusse van die Vista- en Qwaqwa-universiteit en groei internasionaal.

Die UV vestig ook fondamente van 'n institusionele kultuur van verdraagsaamheid, geregtigheid en diversiteit.

"Die baba het in die afgelope eeu 'n gesonde volwassene geword."

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