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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

Access to the Bloemfontein Campus
2015-04-02

Access Control Made Easy

The first phase of access control at the University of the Free State (UFS) was implemented in August 2014. The aim of this initiative is to tighten security measures on the Bloemfontein Campus.
 
Since November 2014, access control has been implemented at all five gates on the Bloemfontein Campus. These are:

  • The Main gate in Nelson Mandela Drive (Gate 1)
  • The gate in DF Malherbe Drive (Gate 5)
  • The gate in Wynand Mouton Drive (Gate 3) 
  • The gate in Furstenburg Street (Gate 4)
  • The gate in Badenhorst Street (Gate 2)

Here is some useful information about the access control system:

1. Remember your access card when you enter the campus

Dual-function cards (with distance reader compatibility) will make your movement through the gates more convenient. The university’s access system works automatically with remote or swipe action. Please make sure that you drive close to the reader or, better still, get the dual-frequency card to manage the distance between your vehicle and the remote card reader.

As of 23 March 2015, the extra security staff, who have been assisting at the gates since the implementation of access control on the Bloemfontein Campus, are no longer manning the card readers at the gates. Therefore, persons without cards will be able to enter the campus only at the one gate in DF Malherbe Drive where the Visitors Centre is situated. They will be referred to the Visitors Centre, where a day visitor’s card will be issued to them. You will need to produce a formal identification document (e.g. ID book, driver's licence).

Security will continue their normal duties at the guardhouses for the various gates on the campus.

2. Where do I get an access card?

You can apply at the university’s Visitors Centre front desk by producing your positive identification (ID book/passport/driver’s licence) and proof of payment for your access card.

You will then be directed to the Thakaneng Bridge where you will be able to collect your access card.

  • Go to the Cashier on the Thakaneng Bridge and pay your R65 for the dual-frequency card
  • Take your receipt, together with your existing card (if you have one), to the Card Division on the Thakaneng Bridge (next to Mellins Optometrists)
  • A new photo will be taken of you at the Card Office for your new card. Your new card will then be issued immediately.

Currently, there is a sufficient stock of the dual-frequency cards available at the Card Division on the Thakaneng Bridge.
 
Alternatively, you can apply online for your access card: http://apps.ufs.ac.za/cardapplication/application.aspx

Make sure you have the following documents ready to attach when completing the online form:

  • Copy of positive identification: ID/Driver's Licence/Passport
  • Signed declaration (http://supportservices.ufs.ac.za/dl/Userfiles/Documents/00007/4668_eng.pdf) by your service provider/employer (if you are a service provider) or a letter of confirmation from your spouse/partner/relative/coach/relevant UFS staff member or student in cases where you have to visit, pick-up or drop off your spouse/partner/relative frequently on the UFS Bloemfontein Campus.

Cost: R65 for a long-term card and free of charge for short-term visits and conference delegates. Pay at the Cashier on the Thakaneng Bridge or at Absa Bank, Account Number: 1 570 8500 71, Ref: 1 413 07670 0198.

3. Cutoff Date: 7 April 2015

After 7 April 2015, no pedestrian or motorist will be able to enter the campus without a valid access card. Persons without access cards will have to enter the campus at the gate in DF Malherbe Drive where the Visitors Centre is situated. You will then be referred to the Visitors Centre where you will have to apply for a day visitor’s card. It is important to note that no one will be able to enter the campus at the Visitors Centre without a formal identification document (e.g. ID book, driver's licence).

4. Dual-frequency card simplifies access to the campus

It is important to have your card ready on entering the campus.

This card will simplify access to the campus considerably, as the card reader will read the card when it is held in a vertical position at the driver’s side window in the direction of the distance reader. Please do not place the card on the dashboard. There is an antenna wire in the card. If the card is placed on the dashboard, you are not exposing the card surface to the reader, and that might influence the antenna’s response to the reader.

Remember, the distance between the reader and the boom is only a few metres.  If you approach the reader at a ’high’ speed, you are not allowing the system to identify your card, match it to the entry in the database, check if you are ‘legal’, and then send a signal to open the boom. 

All five gates are equipped with distance readers. Within the next three weeks, two extra distance readers will also be installed at the Main Gate in Nelson Mandela Drive.
 
Please note that the dual-frequency card is needed only when you enter the campus with a vehicle and you want to activate the distance reader. All the older cards will continue to work at the tag readers. 

5. Use alternative gates

At times, some of the gates carry more traffic than others, especially with the peak morning and afternoon traffic. Gates with less traffic include:

  • The gate in Badenhorst Street
  • The gate in DF Malherbe Drive
  • The gate in Nelson Mandela Drive

You are welcome to make use of one of these alternative gates.

6. Pedestrians

No pedestrian will be able to enter the Bloemfontein Campus without a valid access card. If you have left your card at home or have lost it, you should enter the campus at the gate in DF Malherbe Drive where the Visitors Centre is situated. You will be referred to the Visitors Centre where you can apply for a day visitor’s card. You will still need to produce a formal identification document (e.g. ID book, driver's licence).

7. More information

Email: visitorscentre@ufs.ac.za
Visitors Centre front desk: Tel: +27 51 401 7766 (Mondays-Fridays 07:45-16:30)
Card Division: Tel: +27 51 401 2799 (Mondays-Fridays 07:45-16:30)
Protection Services duty room: +27 51 401 2634 (24 hours)

 

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