During the first lockdown, the pharmaceutical industry was paralyzed. Many GMP inspections by foreign authorities did not take place or were postponed indefinitely. However, pharmaceutical companies quickly resorted to technical solutions that made remote GMP inspections possible. As GMP translators, we report below on the technical aspects of remote inspections.

How is the technical implementation of remote GMP inspections carried out? Requests for interpreters to participate in remote GMP inspections have become the norm over the last year and a half. During numerous Russian and Belarusian GMP inspections, we interpreters and translators have noticed that most pharmaceutical companies are well-equipped in technical terms. In view of the COVID-19 situation, they were able to find technical solutions for carrying out remote GMP inspections quickly. Most companies decided on a video conferencing tool, be it Cisco WebEx or MS Teams, which is used uniformly by all employees. For the GMP inspections, which usually last several days, specific virtual rooms are usually set up with the selected video conferencing tool, which are entered by the Russian GMP inspectors and the employees involved at the scheduled time. In addition, most pharmaceutical companies have meeting rooms with special equipment for video conferencing where large screens or screens and mobile conference speakers with microphones can be found. This allows several employees to participate in the meeting simultaneously.

Document management in the context of audits and GMP inspections

One of the most important focuses of a GMP inspection is the review of documentation by GMP inspectors. Sharing confidential documents is a tricky area, as the security provided by many cloud file-sharing services is occasionally inadequate. Preparing for remote inspections therefore also involves choosing a sharing tool that is immune to attacks.

In the case of remote inspections, greater importance is also attached to document verification, as GMP inspectors have no opportunity to visually inspect the rooms, processes or facilities. Until now, photographs and video recordings have been the only means used to replace a personal tour of the respective pharmaceutical plant. A short video series is usually recorded for each area (production, storage and laboratory rooms, etc.), either with an audio track or with real-time commentary for the GMP inspectors during playback and translated into their respective language with the help of a professional pharmaceutical interpreter.

Virtual tours for remote GMP inspections in live mode

Recently, we have come across some pharmaceutical companies that have organized a live video tour where employees walk through the production or storage rooms with a camera. In fact, this is an excellent way to see the operation in live mode. The GMP inspectors can ask to be shown a part of the room or a larger section. They also have the opportunity to ask questions immediately. This ensures that the requests of the GMP inspectors are responded to and that no pre-prepared image material is presented by the employees. However, it is necessary that the site have a perfect internet connection in all rooms. During the walk-through of the rooms, rustling and other background noises from the employee filming can be heard, and it is often difficult to understand what is being said if the employee is wearing a protective mask. Another difficulty is the lack of a tripod during the recording. This can lead to decreased video quality.

Remote inspections even after the COVID-19 situation eases?

Even though the technical means of remote inspections are increasingly fulfilling their purpose, most Russian GMP inspectors would like GMP inspections to take place at the pharmaceutical manufacturer's site again as soon as possible. In principle, it is possible to demonstrate the production steps and the factory premises using video conferencing. In the meantime, remote GMP inspections have also become well-established in many places. However, the inspectors are unable to get an  overall impression or a full overview that can be gained directly on site at the pharmaceutical company. In addition, remote GMP inspections are directly influenced by the quality of the internet connection.

Support from professional interpreters is particularly important for remote GMP inspections, as they need to have additional skills and experience from previous GMP inspections in addition to the indispensable linguistic support when interpreting remotely in the pharmaceutical and GMP sector. In addition to a perfect command of the specialist terminology and flawless preparation, it is important, for example, that the interpreter be able to operate the video conferencing platform, know the entire remote setting and coordinate the discussions. It is usually recommended that the interpreters be in the same location as one of the parties.

Our interpreters have now successfully adapted to this mode of conducting foreign GMP inspections. In most cases, our interpreters travel to the location of the pharmaceutical company in question and are therefore in the same room as one of the parties, while the GMP inspectors join them online from abroad. However, completely virtual GMP inspections are becoming increasingly common, with each party joining in from their home or office. After several experiences with remote inspections, our pharmaceutical interpreters naturally find it easy to find their way around this mode. Even if the COVID-19 situation eases somewhat, it would be conceivable for our Russian interpreters to continue working remotely depending on the situation and customer requirements. Ultimately, however, the decision lies predominantly with the regulatory authorities and pharmaceutical companies who the best judges in terms of assessing how a site can be properly inspected for compliance with GMP guidelines best.

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