BfArM - Federal Institute for Drugs and Medical Devices

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On June 12, 2023, the first DQALab training started as part of the GHPP LabTrain project, which is carried out by the Federal Institute for Drugs and Medical Devices (BfArM) and the Institute for Pharmaceutical and Applied Analytics (InphA).

The DQALab training series is a practical supplement to the virtual DQA (Drug Quality Assurance) training during the COVID-19 pandemic. The DQA training program was developed in collaboration with the World Health Organization (WHO) to strengthen the performance of national control laboratories and improve the monitoring of drug quality according to international standards.

The LabTrain project continues this work and aims, among other things, to train specialist staff from African pharmaceutical authorities in the field of pharmaceutical analysis and quality assurance.

A joint kick-off meeting with fellows from the GHPP PharmTrain project marked the start of the first DQALab training course. Three trainees from Malawi, Rwanda and Tanzania were welcomed at the BfArM:

  • Chikondi Gama, Medicine Analyst, Pharmacy and Medicines Regulatory Authority, Malawi
  • Chantal Marie Umuhoza, Medicines Testing Specialist, Rwanda Food and Drugs Authority
  • Bugusu Nyamweru, Head of Laboratory, Tanzania Medicines and Medical Devices Authority
Trainees des DQALab1 Trainings mit GHPP LabTrain Team
Trainees des DQALab1 Trainings mit GHPP LabTrain Team Source: BfArM/LabTrain

One focus of the DQALab training courses is on imparting practical knowledge for carrying out various analytical techniques, such as spectroscopic, chromatographic and microbiological tests. In addition, the four-week training course covered topics such as the qualification of various analytical instruments and the management of reference substances and documents. The aim is to enable participating institutions to better align their quality assurance system with good practice guidelines for pharmaceutical quality control laboratories.

A major challenge of the DQALab training courses is to link the practical training with the content already taught virtually.

The DQALab1 training was able to link the practical training with the content that had already been taught virtually. Both the main areas of work of the supervising institutes, as approval authorities and quality control laboratories, and the content of DQA were taught in a practical and realistic way. To this end, particular emphasis was placed on giving the trainees sufficient space and opportunity during the training course to develop their own ideas.

Two further training courses are planned for 2023 as part of the DQALab training series.