Russian Inspectorate Weighs in on Remote Audits and International Harmonization

At the 2020 ISPE Europe Annual Conference held virtually in September, Vladislav Shestakov, Director and Deputy Head of the Russian State GMP Inspectorate—the State Institute of Drugs and Good Practices (SID&GP)— weighed in on the following:

• Remote or so-called distance audits
• How his inspectorate conducts such audits
• His agency’s views on international cooperation and harmonization

Question (paraphrased): Are remote/distance audits temporary or do you think they will continue after the pandemic?

“I think that online inspections are temporary measures to get us through a time when it is impossible to accurately assess the areas, premises, and production processes as a whole, even with the help of special means of communication.

“It is very difficult for both sides—for the manufacturer and for the inspector—to make conclusions about the GMP compliance of a site without a physical presence at the manufacturing site, without the face-to-face personal experience of monitoring technological operations in real time.

“I would like to support previous speakers in that I believe it can be a hybrid model in the future. Russian inspectors have already conducted 111 online inspections since May, including 51 GMP inspections at sites being inspected for the first time and 53 follow up inspections (Table 1).

“Regarding the inspection framework mentioned previously, in Russia by a May decree of the government, number 683, we have a legal basis for conducting online inspections of Russian facilities.”

Question (paraphrased): What do you expect from the sites being inspected and how are you conducting virtual inspections?

“In the Russian GMP inspectorate, we are taking the following support measures. First of all, we are sending information requests 20 days in advance. Usually onsite inspections require ten days’ notice before the start of the inspection. But taking into account the online format of these inspections, we take 20 days before.

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“Also, we communicate to the company the complete list of documents that are required for the inspection. These documents are put in a special secure space belonging to the company and the access is restricted to only company members and the inspectors. In addition, we have agreements with the sites that the documents are available for us to access during the inspection period and until our report is complete.

“We hold regular meetings with the company and representatives of the site being inspected at the end of each day during the inspection period. Moreover, we have developed a method using an information security system.

“We also want to develop new technological solutions with international authorities.”

Question (paraphrased): How does your agency deal with completely new technologies being used by companies? Can they approach you to get feedback?

“We are open for dialogue and we are open to new technologies and ready to use any tools you offer us in a way that works with our tools. This complements the initiative for harmonization procedures that could be a tool for a more harmonized and common approach.

“I would like to add that I am sure all of us, the regulators, and professional communities, will develop principles that minimize variations in the inspection of pharmaceutical products and the pharmaceutical industry in general. I believe that today’s threats may not be the last.

“One important aspect in this regard is the level of mutual trust between regulators and the quality management system regulatory agencies, which should be transparent and harmonized. In the framework of relying on assessments, the Russian state agency inspectorate invites national regulatory authorities to join our inspections.

“The initiative to create a harmonized standard for remote GMP inspections may lead us to develop a working structure that includes three bases of mutual trust for regulatory agencies: the regulation itself, the quality management system, and the qualification of GMP inspectors.

“Our inspectorate is always ready for dialogue and cooperation.”