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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

Academic and security arrangements on the Bloemfontein and South Campuses for the coming week
2016-02-28

All academic and administrative services on the Bloemfontein and South Campuses of the University of the Free State (UFS) will resume on Monday 29 February 2016.

The following academic and security arrangements have been put in place:

1.    Academic arrangements:
It is important to remember that losing an academic week has major implications for all students, particularly for first-year students, and for purposes of academic planning. The university will therefore resume its normal work on Monday 29 February 2016. Losing any additional time will severely disadvantage students, especially those who desperately need the time to catch up with lectures ahead of the coming tests and examinations. Many more students will struggle to complete the academic year if any further time is lost.

In order to ensure that the academic work of the university is not undermined, the UFS will extend this academic term by one week. This will allow the completion of the work scheduled for last week. Given the impact that disruptions had on the emotions and concentration of many of our students, academics are requested to manage the setting and re-setting of all tests and assignments scheduled for last week with sensitivity, and to be supportive of students as they re-start their academic work.  No student should be disadvantaged in terms of tests or assignments as a result of last week’s closure. We know you would do this anyway, but this is a reminder to all staff of what we expect to be a common approach and understanding on the part of lecturers.

We rely on the leadership of the deans in the seven faculties to support staff and students in dealing with the lost time in the most appropriate manner and in supporting all efforts to refocus energies on the academic project.

As the senior leadership and management of the university, we will continue to do everything in our power to make sure that the academic programme continues uninterrupted.

2.    Security arrangements:
The Bloemfontein Campus is secure and we have more than doubled the security arrangements, with the interdict firmly in place.

The university management condemns in the strongest possible terms the violence that took place at Xerox Shimla Park on the night of Monday 22 February 2016. It also condemns the disruptions of the university that followed Monday’s event, which resulted in the suspension of academic and administrative activities on the Bloemfontein Campus. In line with the terms of the interdict - and now that we are at full capacity to secure this very large and spread-out campus - the university will act swiftly and firmly if any protests or disruption recur.

The following security arrangements are in place:
2.1  Staff and students must have their staff and student cards with them when entering the campus. Passengers in motor vehicles will have to present their cards to security personnel before access could be granted. Security personnel will check this physically by verifying that each person has a valid staff or student card.

2.2  Buses will not be allowed to enter the campus and passengers will have to be dropped off outside the gates - passengers will enter through the turnstiles with their valid access cards. Anyone without a valid access card will have to go to the Visitors Centre and present positive proof of ID (SA ID, passport or driver’s licence).

2.3  Pedestrians will have to swipe their cards at the turnstiles at the gates. Those without cards will have to enter through the Visitors Centre by presenting positive proof of ID (SA ID, passport or driver’s licence).

2.4  Visitors must report to the Visitors Centre (at Gate 5 in DF Malherbe Drive) and present positive proof of ID (SA ID, passport or driver’s licence).

2.5  Due to anticipated delays, it is advised that people allow some additional time when planning their routes to campus and to also make use of the less busy gates, such as Gate 4 (Furstenburg Road) and Gate 2 (Roosmaryn Residence).

2.6  It is advised that walkways be used, especially at night, and that pedestrians should keep to areas that are well lit.

Security helpline: +27(0)51 401 2911 | +27(0)51 401 2634.
 

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