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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

Research project gives insight into the world of the deaf
2005-11-30

Mr Akach in conversation (using sign language) with his assistant Ms Emily Matabane. Photo: Lacea Loader

UFS research project gives insight into the world of the deaf

The Sign Language Division of the University of the Free State’s (UFS) Department of Afro-Asiatic Studies and Language Practice and Sign Language has signed a bilateral research project with the universities of Ghent and Brussels to write a book on sign language. 

“We want to compare the Belgium and South African sign languages with each other.  The book will be about the deaf telling us about themselves and how they live.  It will also focus on the use of story telling techniques and the grammar used by deaf people.  We want to see if the hand forms and the grammatical markers and other linguistic features that deaf people from these two countries use are the same or not,” said Mr Philemon Akach, lecturer at the UFS Sign Language Division and coordinator of the research.  

According to Mr Akach, the sign language community in South Africa, with about 600 000 deaf people who use South African Sign Language (SASL) as first language, is quite big.  “Over and above the deaf people in South Africa, there are also the non-deaf who use SASL, like the children of deaf parents etc.  This book can therefore be used to teach people about the deaf culture,” he added.

Another of Mr Akach’s achievements is his election as Vice-President of the newly established World Association of Sign Language Interpreters (WASLI).  The association was established earlier this month during a conference in Worcester.

Mr Akach has been actively involved with sign language interpretation since 1986 and has been interpreting at the World Congress of the World Federation of the Deaf (WFD) since 1987.  “My appointment as Vice-President of the WASLI is an emotional one.  I have been involved with deaf people for so long and have been trying to create awareness and obtain recognition for sign language, especially in Africa,” said Mr Akach.  WASLI is affiliated to the WFD.

According to Mr Akach there was no formal structure in the world to support sign language and sign language interpreters.   “Now we have the backup of WASLI and we can convince governments in other African countries and across the world to support deaf people by supporting WASLI and therefore narrow the communication gap between the deaf and the hearing.  My main aim as Vice-President is to endeavour for the recognition of sign language and spoken language interpreters as a profession by governments,” he said. 

According to Mr Akach the formal training of interpreters is of vital importance.  “Anybody who has a deaf person in his/her family and can communicate in sign language can claim that they are an interpreter.  This is not true.  It is tantamount to think that all mother tongue or first language speakers are interpreters.  Likewise students who learn sign language up to whatever level and are fluent in signing, should still join an interpreter’s programme,” he said.

“Sign language interpreting is a profession and should be presented as an academic course alongside other spoken languages.  The UFS has been taking the lead with sign language and spoken language interpretation and was the first university on the African continent to introduce sign language as an academic course,” he said.

“Although sign language has always been an unknown language to young people it has become quite popular in recent years.  This year we had a total of 160 students at the Sign Language Section of the UFS and the numbers seem to increase steadily every year,” he said.

Mr Akach’s assistant, Ms Emily Matabane, is deaf and they communicate in sign language.  Ms Matabane also handles the tutorials with students to give them hands-on experience on how to use sign language.  


Media release
Issued by: Lacea Loader
Media Representative
Tel:   (051) 401-2584
Cell:  083 645 2454
E-mail:  loaderl.stg@mail.uovs.ac.za
30 November 2005

 

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