GMP interpreters report on remote inspections
Interview by Pharmprom.ru with the pharmaceutical and GMP interpreter for Russian Alexander Podarewski
Due to the Covid-19 pandemic, a number of regulatory authorities, including PIC/S, FDA and the Russian State Institute for Medicines and GxP (FBU "GILS i NP"), have halted GMP inspections of foreign pharmaceutical companies or postponed them indefinitely. Following media reports on the shortage of (in some cases life-saving) drugs in Russia and the introduction of various mechanisms by the Russian government to improve this situation, other media outlets also fuelled Russians’ fears of an impending shortage of many drugs in the months that followed. In order to avoid drug shortages, the Russian supervisory authority quickly found an alternative approach and developed a method for virtual GMP remote inspection using video transmission. However, the GMP remote inspection is structured differently in many ways compared to the "classic" GMP inspection on site.
The Russian pharmaceutical information portal Pharmprom.ru spoke with Alexander Podarewski, a specialist translator, pharmaceutical and GMP interpreter, as well as managing director of AP Fachübersetzungen in Nuremberg, about this and his experience with so-called GMP remote inspections in Germany.
You were the first interpreter to accompany a Russian GMP remote inspection in Germany by the Russian supervisory authority GILS i NP. How would you describe the new format?
- Our company specialises in interpreting at GMP inspections in Europe as well as written German, English and Russian translations of pharmaceutical documentation. A number of companies supplying various pharmaceuticals to the Russian and EAEU markets were subject to numerous official GMP inspections prior to the outbreak of the Covid-19 pandemic, most of which involved the use of interpreters. However, most GMP inspections have been cancelled or postponed since the end of March 2020, not only in Germany but also worldwide. Albeit, thanks to the development of an alternative approach, many of the temporarily cancelled GMP inspections could be carried out online or remotely.
The first GMP remote inspection (or simply called "remote inspection") for compliance with Good Manufacturing Practice (GMP) requirements was carried out under COVID conditions by the Russian inspectorate in Basel, Switzerland. The Roche company was inspected. In Germany, the site of Madaus, a subsidiary of Mylan, was the first to be inspected in the same week of May 2020. I was invited as a Russian interpreter for this GMP inspection. Since then, many more GMP inspections of pharmaceutical manufacturers in German-speaking countries have been carried out with the support of our interpreters.
A remote GMP inspection requires a detailed review of documents, videos and other information (on various data carriers) of the site to be inspected as well as a thorough assessment of all possible risks. In the past, the inspectors, accompanied by interpreters, visited the incoming goods area, the storage rooms for active ingredients, for other components and finished products, the weighing areas, the production areas, the laboratories for in-process control and microbiological purity control, the building technology and the ancillary areas, including inspections of water and air treatment facilities and many other areas. Current bans on GMP inspectors travelling abroad, a range of "social distancing" measures and other restrictions are severely impacting pharmaceutical manufacturers' opportunities. For an audit to be successful, however, it is crucial to demonstrate all the mentioned areas and steps in the production processes so that the GMP inspectors can properly verify that everything at that site is indeed in order or otherwise make appropriate observations.
A GMP remote inspection, like an on-site inspection, is conducted by two inspectors The inspectors communicate with the site to be inspected via video conference. What the participants could experience previously in person, they now try to recreate through video recordings and pictures of the company premises and production. Otherwise, to put it very briefly, it boils down to the examination of documents with regard to the structure of the processes within the pharmaceutical company to be inspected. However, the inspectors emphasise that the remote or document inspection will not completely replace the usual on-site inspection. Therefore, once travel restrictions are lifted, GMP inspectors will return to the standard inspection process.
Mr Podarewski, to what extent has the work of an GMP interpreter changed in light of the pandemic and online audits?
- The shift to GMP remote inspections has significantly changed the manner of communication, particularly how the interpreter interacts with the conversation partner for whom they are interpreting. Until now, the interpreter always worked "in person", meaning the participants were physically present and communicated in different languages. For most of us, the use of modern communication tools is neither new nor particularly challenging.
Nevertheless, informal discourse, such as conversations about the weather or other trivial topics, is fundamentally different from conveying information upon which not only the fate of a global pharmaceutical company depends but also the drug supply for an entire nation. Interpreting, in general, is one of the most demanding intellectual activities. And pharmaceutical interpreting ranks among the most complex fields of interpreting. It requires not only specialised training and impeccable linguistic skills, but also the ability to easily comprehend the source information and swiftly convey it into another language. Furthermore, interpreters not only communicate information, but also operate on a non-verbal level: they transmit human emotions. This includes not only facial expressions and gestures but also the intonation of what is said. This in turn requires that you can see and hear each other without any disturbance.
How is this achieved technically?
- It is not only the quality of the telecommunications connection that plays a crucial role. This includes a high-quality microphone, a loudspeaker, noise-cancelling headphones, a microphone shock mount, broadband internet, a stable connection or a flawless Wi-Fi, optimal soundproofing of the room while maintaining an appropriate operating volume, as well as the option of screen sharing and the availability of rapid technical support in case of any disruptions. A range of additional features is also important. While there are numerous programmes designed solely for communicating with multiple participants, the ability to exchange files, quickly upload documents, and store them securely is particularly important. After all, this involves confidential pharmaceutical information.
It's no secret that Slack is one of the most successful tools for this type of communication. The use of the Cisco Webex Meetings app has become very popular. However, Microsoft has managed to surpass its competitors by launching a product called Microsoft Teams. In addition to the unlimited number of chat messages and search functions, Teams offers integrated audio and video calls for one-on-one, group and team meetings. Shared storage is also important: 10 GB plus an additional 2 GB per user, which can be utilized by teams of up to 300 people — even in the free version of the program. The ability to communicate and interact with people outside your company's team, such as GMP inspectors, is also a compelling feature. All the mentioned software solutions, which to my knowledge are also the most common, offer integration with other products and apps and have many other useful functions, even if they are only of secondary importance for GMP inspections. For pharmaceutical companies and regulatory authorities, one of the most critical aspects is the ironclad security these systems provide. And for me, as a language mediator, these programmes offer remarkably clear voice transmission with no audio or video interference. Zoom adds another layer for particularly demanding projects: separate interpreter channels for simultaneous interpreting.
Are the GMP interpreters present during the entire remote inspection?
- It’s important to note upfront that a GMP remote inspection involves two main steps: the self-review of the requested facility documents by the GMP inspectors, and addressing any questions that come up during the documentation review (this relates to the document inspection). During the GMP document inspection, the parties arrange teleconferences where relevant employees of the pharmaceutical company address the inspectors' questions. The interpreter can either be physically present at the site or join these teleconferences virtually.
For the vast majority of GMP inspections to verify compliance with Good Manufacturing Practice, freelance interpreters are hired. These are typically independent professionals with no affiliation to the pharmaceutical company being inspected. The teleconferences scheduled as part of the GMP inspection plan sometimes occur only once or twice during the entire inspection, while in other cases, they may happen multiple times a day and quite spontaneously. However, since freelancers typically provide translation services to a large number of clients and often have a rather full schedule, participating via on-line connection with planned hourly interpretation can lead to significant availability issues if there are changes in the inspection schedule. Therefore, most pharmaceutical companies prefer to have an interpreter on-site, allowing for communication at any unforeseen moment. In addition, between the online meetings with GMP inspectors, it is often necessary to translate certain documents and address the inspectors' questions via email in preparation for upcoming meetings. As a result, we interpreters always have plenty to do.
In the next interview on the pharmaceutical online portal Pharmprom.ru, Alexander Podarewski will discuss the specifics of online and remote interpreting in the field of GMP, interpreting with physical presence at the remotely inspected site, changes in the mode of GMP inspections themselves, the expectations of pharmaceutical companies whose on-site inspections were cancelled, as well as the role of a representative of the inspected foreign pharmaceutical manufacturer. And in the third interview in this series of Pharmprom.ru articles, Alexander Podarewski will inform readers about the importance of preparing for the remote GMP inspection and the specifics of the inspection process.
Image: AP Fachübersetzungen
