Remote GMP inspections by Russian authorities
Experiences and guidance
GMP inspections of production facilities of foreign manufacturers by Russian authorities were introduced in 2016 by Federal Law
N 61-FZ dated 12.04.2010 (as amended). A valid GMP certificate is a prerequisite for new registrations of medicinal products as well as for the maintenance of existing registrations (renewals, variations) in Russian Federation. Without GMP certification of the manufacturing site, the regular import of medicinal products into the Russian Federation is not permitted. Due to the COVID-19 pandemic and the travel ban on Russian inspectors, the continuation of GMP inspections was endangered, as on-site visits to the manufacturing sites were simply not feasible.
In order to avoid a shortage of medicinal products, the Russian government issued several anti-crisis laws in Apr/May 2020, including Decrees #789 and #440, which directly influence the timing and mode of GMP inspections.
This article presents the current Russian legislation regarding GMP remote inspections, describes the process of remote inspections, which is officially implemented by Russia’s State Institute of Drugs and Good Practices (SID&GP), and outlines first experiences in this field. Although GMP remote inspections are to be prepared as meticulously as regular on-site inspections that have been carried out in the past, they require prior clarification of a number of additional questions, e.g. which means of communication and online systems are to be used, how the translation is to be organised and how confidentiality is to be ensured. The most important pitfalls are described here by the authors, who were both part of a manufacturing plant team.
https://www.ecv.de/beitrag/pharmind/Remote_GMP_inspections_by_Russian_authorities