Guidelines on the Conduct of Surveys of the Quality of Medicines. WHO Technical Report Series, No. 996, 2016, Annex 7
(2016; 36 pages)

Resumen

Good quality medicines are essential for efficient disease management. To ensure that good quality medicines are available to patients in their countries, national medicines regulatory authorities (NMRAs) can apply various regulatory instruments. These are:

  • authorization/registration for marketing following the assessment of product documentation, inspection to ascertain manufacturers’ compliance with the principles of good manufacturing practices (GMP) and approval of product information;
  • post-marketing surveillance activities, including maintenance of products’ authorization and/or registration through variations or renewals, regular inspections of manufacturers, wholesalers, distributors and retailers, quality control testing and pharmacovigilance;
  • implementation of regulatory actions in the event of any quality problem being found.

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. However, it has to be borne in mind that quality surveys that rely only on laboratory testing cannot offer complete assurance that medicines are safe and effective as formulated. Quality surveys can be organized by NMRAs, international organizations, procurement agents, nongovernmental organizations (NGOs) or academic and research groups.

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.

 
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