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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 policies want to help all students
2005-03-09

The death of Hannes van Rensburg, a first-year student from the JBM Hertzog residence, this past weekend, placed various aspects of student life in the spotlight.  Dr Natie Luyt, Dean:  Student Affairs at the University of the Free State (UFS), and the Student Representative Council (SRC) of the UFS explain which policies are in place to counter these practices.

At all tertiary institutions there are rules and policies to guide students and provide direction for certain behaviour and practices.  The same applies to the University of the Free State (UFS).

“At the beginning of the year the UFS provides every residence committee with a manual to establish a framework for meaningful and orderly relations within and among residences on the campus,” said Dr Natie Luyt.

However, it is one thing to set rules, but it is an impossible task to enforce all aspects thereof.  Policies currently in place include an alcohol policy, a policy on the induction of first years and a policy on banned practices in residence orientation. 

“The alcohol policy was compiled in cooperation with students and their input was constantly asked,” said Dr Luyt.  We also liaise on a continuous basis with residences and senior students to encourage the responsible use of alcohol, especially around activities like intervarsities and Rag. 

In the policy, recognition is given to the right and voluntary and informed choice of every individual to use alcohol on the UFS campus in a responsible way. 

Guidelines for the use of alcohol on campus include among others the following: 

Only authorised points of sale will be permitted on campus.  In this case it is the various league halls in most of the male residences on campus.

Alcohol will only be made available during fixed times and is not permitted in residence rooms.    

All alcohol-related functions are regulated and an application for a temporary alcohol license must be obtained from the Dean:  Student Affairs.     

The UFS obtained a liquor license in March 2004 which must be administered by senior leagues in various residences on campus.   Normal liquor license conditions and the county’s liquor laws apply.  Liquor can only be sold to members of the senior league (or special guests) and also to persons over the age of 18 years.  Liquor may not be used in public (outside the senior league) or on campus.    

The senior leagues may only be open three nights per week and within prescribed times.  No liquor could be used in any other place than the senior league halls.  Senior leagues could buy liquor from club monies generated by themselves. 

The right of senior leagues to serve liquor was suspended by the Rector and Vice-Chancellor the UFS, Prof Frederick Fourie, on Monday 7 March 2005 – pending an investigation of the recent events on campus. 

The policy on banned practices include among others that no swearing and shouting at first-years may take place, no first-year student may be targeted individually, no senior may enter the room of a first-year student without an invitation or permission from that first-year student and no senior under the influence of alcohol may have contact with first-year students. 

The induction of first-year students takes place by means of three functions, namely an information function (the introduction to the various facets and possibilities of the university system), an induction function (the first-year student becomes involved in various campus and residence activities) and a development function (the first-year student is motivated to take charge of his development potential). 

No first-year induction activity may commence before the residence committee’s contracting with the senior students is not completed.  This meeting is attended by the residence head and all senior students.  The induction policy, residence induction policy of first-year students and first-year rules are discussed.

The senior students sign an attendance list to show that he/she was informed about the policies.  A senior who does not sign, may not be involved with any induction session with first-year students.  

No physical contact is allowed during the conclusion of the first-year students’ official induction period.  The induction of first-year students as full members of the residence is a prestige event, presented by the residence committee.  No physical or degrading activities may take place. 

The Dean:  Student Affairs also has a daily meeting with the primarii of all the residences during the induction period.  This helps to monitor the situation and counter any problem behaviour or tendencies.

“Enforced behaviour – where a senior student forces a first-year student to do something against his/her own free wil – is not allowed.  Where there is any sign of this, it is met wortel en tak uitgeroei,” said Dr Luyt.

“In any group of people – whether it is a group of students or people at a workplace – there will always be those who will break the rules or those who would like to see how far they could push it.

The SRC, the UFS management and myself are and will stay committed to make each student’s life on this campus a school of learning and an experience which would be remembered for ever,” said Dr Luyt.

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