NWU researcher offers new considerations for Pharmaceutical Quality Control Labs

The impact of the international Covid-19 pandemic is severe and it remains the responsibility of all to prevent the spread of this virus.

This impact has clearly been detected in the workplace – with specific reference to the Pharmaceutical Quality Control Laboratory (PQCL) – where increased rates of worker absenteeism, downsizing in operations and service delivery and interrupted supply chains have been identified.

That is why Dr Marius Brits, director of the World Health Organisation (WHO) Collaboration Centre at the North-West University (NWU), sprang into action and got involved in combating the Covid-19 pandemic and its impact. He wrote an article on how to support quality-control laboratories during the Covid-19 pandemic that was published in The Journal of Medical Laboratory Science & Technology South Africa 2020. Dr Brits was invited by the WHO to present a podium session on this article at the 7th WHO Global Quality Control Laboratories Webinar 2020 in November.

Dr Brits says that since a PQCL is one of the critical pillars in the quality assurance of medicines to ensure the availability of safe and effective medicine, it is of critical importance that the PQCL should be able to continue delivering its service to the greater public.

The aim of his article was to provide practical guidance and easy access to information sources for PQCL managers in an attempt to ensure safer working environments for the analytical and administrative staff of PQCLs, and to support the continued availability of quality-assured medicines worldwide during this pandemic.

Dr Marius Brits’s study found that to ensure the safety and continuity of PQCLs, management in these institutions needs to perform and document risk-based assessments. “This should focus on critical activities such as organisation and management, the quality management system, control of documentation and records, personnel, premises, equipment, instruments and other devices, materials and reagents, incoming samples for testing in the laboratory, analytical reports, certificates of analysis and general safety practices.”

He says once all the associated risks have been identified, the necessary mitigation steps (by means of policies and procedures) should be developed and implemented. “The outcome of the risk assessment and its action plans to mitigate the identified risks should be shared with all PQCL staff and continuously reviewed to ensure the efficacy thereof in order to reduce the impact of Covid-19 on the safety and continuity of the PQCL activities,” Dr Brits concludes.

Dr Marius Brits

Submitted on Mon, 11/02/2020 - 08:58