FSI «SID & GP»
The Ministry of industry and trade of the Russian Federation
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Leading world regulatory agencies discussed the future of remote GMP inspections at ISPE Global Pharmaceutical Regulatory Summit

On April 28 a global ISPE summit on pharmaceutical regulation was held. In the summit’s work representatives of the world’s leading regulatory agencies took part, including deputy head of the Russian GMP inspectorate, director of Federal State Institution “State Institute of Drugs and Good Practices” of the Russian Ministry of Industry and Trade Vladislav Shestakov. The summit focused on remote GMP inspections and changes within the system at a time of the coronavirus pandemic.

In the ISPE summit regulatory agency representatives from around the world participated: FDA (USA), EMA (European Union), MHRA (United Kingdom), AEMPS (Spain), AIFA (Italy), FSI “SID&GP” (Russia) and others. The regulators shared their perspectives on distant inspections during the period of closed borders and spoke extensively about the system’s changes that had been implemented in different countries in the era of the COVID-19 pandemic.

All the participants of the summit agreed that remote inspections are no substitute for on-site inspections; the length of distant inspections is twice as much routine inspections, and in the future, they could be deployed for training purposes or for inspecting low-risk manufacturing sites, with the mandatory use of risk-based approach when conducting an inspection.

The highest number of non-conformities in the course of remote inspections were related to manufacturing sites’ operational procedures. At the same time, inspectors found it very difficult to receive necessary information swiftly in the real time, which in turn increased the time required to conduct an inspection.

Participants of the summit placed a special emphasis on the technological security in the process of remote inspections, particularly with regard to assurance of protected communication channels and reliable video-call lines, so as on the availability of the appropriate technological infrastructure to ensure the efficacy of inspections. What’s more, the summit’s participants agreed that preparatory works play a crucial role when conducting distant inspections. The inspected site carries an additional burden, and here the task of regulatory agencies is to provide support, have opening meetings, daily meetings in the course of an inspection period, whereas it is also incumbent upon the side to prepare the documentation in advance and facilitate interpretation, if required.

Director of FSI “SID&GP” Vladislav Shestakov noted in particular that it is imperative to distinguish the concepts of “Mutual Recognition Agreement” and “Sharing of information”.

“In order to increase the effectiveness of harmonization of terms and practices on remote GMP inspections, regulatory authorities from different countries could enter into confidential agreements relating to exchange of information on conducting distant inspections”, – proposed Vladislav Shestakov in his remarks.

During the pandemic, the Russian GMP inspectorate has not reduced the number of conducted inspections in order not to allow the drug shortages. Since 2020, the Russian GMP Inspectorate has conducted approximately 430 remote inspections.