The client is a pharmaceutical manufacturing company, producing drug products like antibiotic powder for injections, various injection products and tablets. They have a full manufacturing license from the Mongolian government and want to apply for a WHO licence.
Solving some technical problems and explaining the requirements that come with preparing for a WHO audit. A major challenge is the limited experience of the staff in writing reports in English.
Most technical problems could be resolved, and the WHO guidelines for Good Manufacturing Practice were explained in detail. It is quite clear which work has to be done before they can apply for a WHO audit.