E-DRUG: WHO Guidelines on Conduct of Surveys of Quality of Medicines
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WHO has now formally published (after having drafts for public comments in
2015) the Guidelines on the Conduct of Surveys of the Quality of Medicines.
In WHO Technical Report Series, No. 996, 2016, Annex 7 (2016; 36 pages)
http://apps.who.int/medicinedocs/en/m/abstract/Js22404en/
Abstract
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.
"Wilbert Bannenberg" <wjb@wxs.nl>
E-drug@healthnet.org