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* World Health Organisation LEFT TO RIGHT: Deus Mubangizi*, Stephanie Croft*, Dr. André van Zyl*, Prof. Banie Boneschans, Dr. Erna Swanepoel & Prof. Marlene Viljoen.
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The WHO Collaborating Centre for the Quality Assurance of Medicines (North-West University) in collaboration with the Research Institute for Industrial Pharmacy® incorporating CENQAM®, presented a Quality Control Laboratory Training session to a selection of national and international inspectors of the World Health Organisation (WHO) and South African Medicines Control Council (MCC). The training session was presented from the 19th to the 22nd of April 2010 at the North West University – Potchefstroom campus.
A request for training, with special emphasis on practical aspects of Quality Control laboratory inspections, was forwarded to the Collaborating Centre by the inspectorate of the WHO HQ in Geneva. The Collaborating Centre responded to this request, in line with its terms of reference, and compiled a suitable training module to address not only the training needs of the WHO inspectorate but also those of the inspectors of the MCC.
The purpose of the training session was to provide a comprehensive overview of the basic theory/principals, applications, qualification, preventative maintenance and quality assurance of the results generated by various analytical techniques in a quality control laboratory. The training session was an interactive event which included numerous hands-on training sessions on the various equipment. Training topics included:
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High Pressure Liquid Chromatography (HPLC) |
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Validation of analytical methods |
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Preventative maintenance programmes for analytical instruments |
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X-ray powder diffraction (XRPD) |
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Diffuse Reflectance Infrared Fourier Transform spectroscopy (DRIFT-IR) |
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Ultraviolet spectroscopy (UV) |
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Disintegration testing |
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Dissolution testing |
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Comparative dissolution testing |
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Introduction to microbiological testing |
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General overview of Good Manufacturing Procedures guideline (GMP) |
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Gas Chromatography (GC) |
Dr. Marius Brits
Deputy director - WHO Collaboration Centre for the Quality Assurance of Medicines |
