Guidelines on the conduct of surveys of the quality of medicines
1. Introduction:
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.
If properly collected, interpreted and used relevant data are vital for the planning of effective interventions to improve the quality of medicines. Surveys give snapshots of the medicine quality situation; however, the accuracy, reliability and interpretation of the data obtained depend on the survey design, organization of sample collection and available resources. Medicine quality surveys are costly and limitations on resources may restrict the number of samples collected, parameters tested, techniques to be used for analysis or number of staff available to conduct the survey and analysis. Therefore it is important to optimize use of resources by focusing on those medicines and parameters that pose a higher risk to patients and apply risk analysis during planning of the survey. Also cooperation with partners, joint organization of surveys in several countries, and sharing testing capacities, experience and information can enhance the effectiveness of quality surveys.
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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Table of Contents
3. Objectives of the
survey and initial planning
4. Survey management and
time frame
6. Data management and
publication
Appendix 1 Example of a
sample collection form
Appendix 2 Content of
the analytical test report/certificate of analysis
WHO TRS (Technical Report Series) 996, 2016 Annex 7:
