WHO Expert Committee on Specifications for Pharmaceutical Preparations (Fiftieth report), 2016
Good quality medicines are essential for efficient disease management. Quality surveys may serve as a source of information about the quality of medicines available to patients and are an important part of regulatory systems in all countries, whether they are strong or weak. These guidelines outline the steps to consider when preparing and conducting a survey of medicines quality. They provide recommendations and examples of various methodological approaches with a discussion of their advantages and disadvantages, and suggestions on preparation of reports on the results obtained from such surveys.