Introduction. The article discusses significant changes in the procedure for pharmaceutical inspection of drug manufacturers for compliance with the requirements of the rules of good manufacturing practice (GMP) of the Eurasian Economic Union (EAEU), related to restrictions due to the COVID-19 pandemic.Text. The article presents the main international guidelines describing the remote conduct of pharmaceutical inspections, which is the basis for further updating the relevant procedures in the law of the EAEU. An overview of the foreign practice of pharmaceutical inspection during the pandemic is given. In addition, the changes in the Russian regulatory approaches to control and supervision in the Russian legislation are presented.Conclusion. These data give an idea that, with considering the above, there is a need for further convergence of the requirements, the practice of conducting pharmaceutical inspections for compliance with the requirements of GMP Rules in order to harmonize the norms between Russian regulatory documents, the norms of the EAEU law and international standards. This requires the development of a dialogue with the participation of stakeholders.
Introduction. The article is focused on differences in quality assurance-related obligations and responsibilities between Marketing Authorisation Holders (MAHs) and manufacturing authorisation holder (manufacturers) in pharmaceutical industry. In case of outsourcing and technical agreements there is a need to differentiate responsibilities related to quality assurance between the above mentioned categories.Text. The guidelines for the pharmaceutical sector of the European Union (EU) provide guidance on the responsibilities of the MAHs in relation to the GMP rules, which are scattered throughout the various chapters of the GMP and its appendices. In addition, certain provisions on this topic are contained in the EU directives. With this in mind the European Medicines Agency (EMA) issued in January 2020 a draft Reflection paper on Good manufacturing practice and Marketing Authorisation Holders. The draft clarifies that while certain activities of an MAH may be delegated to the manufacturer, MAH retains ultimate responsibility for the performance of a medicinal product, its safety, quality and efficacy. The important obligation of MAH in this context is to facilitate GMP compliance by establishing a robust two-way communication system with national competent authorities, manufacturing sites, Qualified Persons (QPs) certifying batches before release, and other interested parties. The MAH ought to communicate to manufacturing personnel, normally through QPs, production processes and related quality control procedures, including subsequent variations, described in registration dossiers.Conclusion. A general one conclusion: in view of rapid developments in the EU GMP Guide, the Eurasian Economic Union GMP requirements ought to be updated. In respect of specific responsibilities of MAH pertaining to GMP compliance the EMA draft Reflection paper merits attention as a guidance regarding separation of obligations and responsibilities between MAH and personnel of manufacturing sights.
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