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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 has a contingency plan for load shedding
2008-02-13


The University of the Free State (UFS) has put in place a contingency plan to ensure that there is minimal disruption to the normal academic operations of its Main Campus in Bloemfontein whenever load shedding occurs.

The plan includes alternative arrangements for certain lectures that fall within the load-shedding schedule provided by Centlec, the emergency power generation for certain lecture halls and buildings, as well as the functioning of the UFS Sasol Library. This is in addition to emergency power equipment that has already been ordered for the larger lecture-hall complexes.

Fortunately, the Qwaqwa Campus has adequate emergency power generation capacity. The situation on the Vista Campus in Bloemfontein is being monitored, but the same guidelines will apply as on the Main Campus.

On the Main Campus in Bloemfontein the following alternative arrangements regarding the timetable for evening classes will come into effect when load shedding occurs:

  • An alternative module and venue timetable has been compiled so that classes that cannot take place on weekdays as a result of load shedding can be accommodated on Fridays and Saturdays.
  • Classes that are presented in the timeslot 18:10 to 21:00 on Thursdays are alternatively accommodated in the same venues at the same times on a Friday.
  • Classes that take place in the timeslot 20:10 to 22:00 on Wednesdays are alternatively accommodated in the timeslot 08:10 to 12:00 on Saturdays, in a few cases in different venues from those scheduled initially.
  • After consultation with students, lecturers will decide whether the alternative timetable will apply when load shedding does indeed occur or whether the alternative timetable will be a permanent arrangement.

Some other steps that have been taken regarding the functioning of lecture halls include:

  • The design and installation of emergency power equipment in all the large lecture-hall complexes within the next few months. This includes the Examination Centre, Flippie Groenewoud Building, the Stabilis and Genmin lecture halls.
  • The ordering of a larger generator for the Agriculture Building to simultaneously provide essential research equipment such as refrigerators, ovens and glasshouses with emergency power.
  • An investigation into the optimal utilisation of present emergency power installations.
    The purchasing of loose standing equipment such as battery lights, uninterruptible power supplies, loose-standing generators, etc.

The UFS Sasol Library will continue as normal as far as possible though there may be some minor changes as a result of load shedding. The library has an emergency generator that will be used in the event of load shedding to allow students and other users to exit the library. If load shedding occurs during daylight hours, the library will remain open with limited services. If the load shedding occurs after 6 pm (18:00), all users will be allowed to exit and the library will remain closed until the next day.

A comprehensive investigation into the university’s preparedness for and management of long term power interruptions is also receiving attention.

More information on the contingency plan for load shedding can be obtained from the UFS website at www.ufs.ac.za/loadshedding.

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
13 February 2008


 

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