Lab shines in testing

2019-05-22 06:01
Marlena Visagie (quality assurance ma­nager) and Dr Quinton Meyer (deputy director) of the National Control Laboratory (NCL) for Biological Products at the University of the Free State.Photo: Supplied

Marlena Visagie (quality assurance ma­nager) and Dr Quinton Meyer (deputy director) of the National Control Laboratory (NCL) for Biological Products at the University of the Free State.Photo: Supplied

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The National Control Laboratory for Biological Products (NCL) at the University of the Free State (UFS) remains highly rated internationally for retaining a high standard as a pharmaceutical testing laboratory.

The South African Accreditation System (Sanas) has endorsed the institute quality management systems as of high standard in line with the International Standards Organisation’s requirements.

The NCL has also received a certificate of Good Manufacturing Compliance (GMP) from the South African Health Products Regulatory Authority (Sahpra).

This was announced on Tuesday, 14 May.

Prof. Derek Litthauer, director of the NCL, said their laboratory – which is also approved by the World Health Organisation (WHO) – has again achieved international testing standards.

“The certification provides Sahpra, the WHO, and other national control laboratories around the world, with the confidence that the test results from the NCL can be trusted,” said Litthauer.

The institution is one of the 12 laboratories worldwide to perform vaccine testing for the WHO. Furthermore, 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.

The NCL was one of the first full members of the WHO NCL Network for Biologicals, which consists of associate members of regulatory authorities from more than 30 countries.

Litthauer said the NCL has a staff 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.

“Our biggest problem is to get enough suit­able space to expand our testing,” he said.

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, adding that this process was followed for all human vaccines used in South Africa.

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 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.

“What makes this special, is that the NCL also complies with the additional GMP standards required by a pharmaceutical manufacturer,” said Marlena Visagie, the NCL quality assu­rance manager.

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