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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

Guidelines for diminishing the possible impact of power interruptions on academic activities at the UFS
2008-01-31

The Executive Management of the UFS resolved to attempt to manage the possible impact of power interruptions on teaching and learning proactively. Our greatest challenge is to adapt to what we cannot control at present and, as far as possible, refrain from compromising the quality of teaching and learning at the UFS.

First the following realities are important:

  • There is no clarity regarding the period of disruption. It is possible that it may last for a few months to approximately five years.
  • At present Eskom (as well as Centlec) is not giving any guarantees that the scheduled interruptions will be adhered to. It comes down to this that the power supply may be interrupted without notice, but can also be switched back on in an unpredictable manner.
  • Certain scheduled teaching-learning activities/classes, etc. may (initially) be affected very negatively, as the UFS is working according to a scheduled weekly module timetable at present.
  • During the day certain venues with natural lighting and ventilation may remain suitable for contact sessions, while towards evening venues will no longer be suitable for the presentation of classes.
  • Lecturers will have to fall back on tried and tested presentation methods not linked to electricity, without neglecting innovative technology-linked presentation methods, or will have to schedule alternative teaching-learning activities for lost teaching-learning time.

Against the background of the above-mentioned realities, we secondly request you to comply with the following guidelines as far as possible:

  1.  In addition to your module work programme, develop an alternative programme (which can, for example, among others, consist of additional lectures or a more rapid work rate) in which provision is made for a loss of at least two weeks’ class/contact time during the semester. Consult Centlec’s schedule of foreseen power interruptions for this planning.
  2. Should it appear that your class(es) will probably be disrupted seriously by the scheduled power interruptions, you should contact your dean for possible rescheduling of your timeslot and a supplementary timetable. A prescheduled supplementary timetable for Friday afternoons and Saturdays and/or other suitable times will be compiled for this purpose in co-operation with faculties.
  3. The principle of equivalent educational treatment of day and evening lectures must be maintained at all times. Great sensitivity must be shown by, for instance, not only rescheduling the lectures of evening students - given specifically the sensitivity regarding language and the distribution of day and evening lectures.
  4. In the case of full-time undergraduate courses, no lectures should be cancelled beforehand, even when a power interruption is announced, as power interruptions sometimes do not take place or are of shorter duration than announced. If the power supply is interrupted, it should not be accepted that it will remain off and that subsequent lectures will not take place. Should a power interruption occur in a venue, lecturers and students must wait for at least ten minutes before the lecture is cancelled. Should natural lighting and ventilation make it possible to continue with the lecture, it should be done.
  5. Our point of departure is that no student must be able to use the power interruptions and non-presentation/cancellation of lectures as an argument for having failed modules, for poor academic performance or to negotiate for a change of examination scheduling.

Thirdly we wish to make suggestions regarding teaching and learning strategies (which can be especially useful in case of a power interruption).

  • Emphasise a greater measure of self-activity (self-initiative) on the part of students in this unpredictable environment right from the start.
  • Also emphasise the completion of assessment assignments in good time, so that students cannot use power interruptions as an excuse for late submission. Flexibility will, however, have to be maintained.
  • Place your PowerPoint presentations and any other supplementary learning materials on the web.
  • Use the opportunity to stimulate buzz groups, group work, panel discussions and peer evaluation.

Please also feel free to consult Dr Saretha Brussow, Head: Teaching, Learning and Assessment Division at the Centre for Higher Education Studies and Development, about alternative teaching, learning and assessment strategies. Phone extension x2448 or send an email to sbrussow.rd@ufs.ac.za .

Thank you for your friendly co-operation!

Prof. D. Hay
 

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