Remote Russian GMP inspections: preparation and active part

In our second article on the new format of GMP inspections under covid conditions, Alexander Podarewski, simultaneous interpreter for German and Russian in Germany with a focus on pharmacy, reported on the specifics of interpreting online and in person on site, the changes in the conduct of the remote GMP inspections themselves, the expectations of the companies whose inspections were cancelled and on the role of the representative of the German, Swiss or Austrian pharmaceutical company to be inspected. In this article, Mr Podarewski talks about the importance of preparing for remote Russian GMP inspections and the specifics of the active part of the audit.

Mr Podarewski, what happens immediately before the start of a remote GMP inspection?

- A representative of the foreign site to be inspected is usually very actively involved in the initiation of a remote GMP inspection, but less so in the active part. There is also a very close relationship between the site, the interpreters and the GMP inspectors. The provision of documents rests on the shoulders of the manufacturer, while the urgent specialised translation of the documents into Russian or English is the responsibility of the specialist translators. Sometimes Russian or Belarusian GMP inspectors have quite a good command of the English language. However, this is not always the case. And the documentation from European pharmaceutical manufacturers is not always bilingual or in English. When switching to online or remote GMP inspections, the pharmaceutical interpreters were at first invited to participate virtually by joining the negotiations via the Internet from their place of residence or work. However, this turned out to be unfavourable for many reasons, as I explained in detail in the first article of this series. It is easiest and most practical if the German-Russian interpreters are personally present on site and can support communication at any time. It is of course important not only to show the document, but also to explain to the GMP inspector the purpose for which the document was created, what role it plays in the pharmaceutical quality system and how it is implemented in practice. As a rule, the necessary documents created in a foreign language as part of a virtual audit must be professionally translated in advance, usually into Russian. Naturally, the site is prepared for this process. However, in the course of the document review, the GMP inspectors might have to inspect some related documents. It may therefore be necessary to have certain passages of the document professionally interpreted. When planning, it should be borne in mind that this essential part of the remote GMP inspection can slow down the entire inspection process.

I would like to point out that many representatives of the foreign pharmaceutical companies or laboratories to be inspected are often already in possession of specialised translations of their documents into Russian or English. Manufacturers may not even be aware of the existence of such specialised translations. In the past, the representative could translate the relevant documents themselves or commission a pharmaceutical translation agency. Since one of the decisive criteria in a GMP inspection is the rapid submission of documents, a proactive representative can be an extremely useful asset during an audit. Incidentally, this applies to both formats of inspections - on-site GMP inspections and remote inspections.

As a specialised interpreter, what advice could you give pharmaceutical companies on how to prepare for a remote GMP inspection?

- If the foreign company to be inspected is not represented by a pharmaceutical registration, certification and authorisation consultancy service, but by a department of the pharmaceutical company itself in the country of the regulatory authority, such a representative will know, based on years of experience in the company, which documents the GMP inspectors will have to check in addition to the Site Master File and the important documents from the inspection plan. It is recommended to upload these documents to a server in advance, as the Belarusian or Russian GMP inspectors usually start checking the documents before the first official day of the inspection. In our experience, many pharmaceutical companies start uploading documents to the cloud 2-3 weeks before a remote GMP inspection or immediately after its confirmation and give the Russian inspectors access rights shortly after receiving the inspection plan (usually 10 calendar days before the inspection).

In my view, the previous GMP inspections by the supervisory authorities of the country to be inspected, the supervisory authorities of other countries and customer audits of the pharmaceutical site to be inspected are highly underestimated. Firstly, legislation in pharmaceuticals and GMP does not change as much as the trends that inspectors pay attention to. It is therefore very important to look at the protocols and results of GMP inspections from previous years and check where various inspectors have focussed their attention. Secondly, it is worth checking which issues the GMP inspectors have paid little attention to, but where new problems or "weak points" may have arisen in the company. This means being prepared for surprises if such details are checked after all. Thirdly, it must be confirmed whether all deficiencies from previous GMP inspections have been rectified and all comments from GMP inspectors have been taken into account.

How do the parties communicate immediately after the start of the remote GMP inspection? Are there any differences to the usual on-site inspection?

- It is customary to start the GMP inspection with the introduction of the parties (including position, education and professional experience), the formulation of the inspection objectives by the GMP inspectors and an introductory presentation of the pharmaceutical company to be inspected. An on-site inspection usually involves a tour that begins with the receipt of materials, goods, products or packaging materials at the company (or samples or test specimens for the laboratory) and continues following the flow of goods. For remote GMP inspections, it is practical if the pharmaceutical manufacturer to be inspected shows a pre-recorded video of the flow of goods from the meeting room.

This has several advantages: The video can be shot under pleasant conditions, without a hectic pace and, for example, in the evening so as not to disturb other employees of the pharmaceutical company at work. It is important to create such a video in the appropriate quality and resolution. When the video is reviewed and paused, the image also remains in focus, giving GMP inspectors the opportunity to write down room and equipment numbers and pay attention to important details such as labels with appropriate qualification status and identification tags on products. If this is not possible due to insufficient video resolution, re-shooting a video in the company can take a lot of time, which often happens to be the case at the most inopportune time when there is no extra time available.

After viewing and discussing the introductory presentation and the video recordings, we slowly move on to discussing the documents and information specified in the GMP inspection plan.

In your experience as a pharmaceutical interpreter, what else is important?

- It should not be forgotten that the documents uploaded to the server should be available for the period of time that the GMP inspectors allow for the preparation of an inspection report (30 calendar days).

While the inspected pharmaceutical companies were already quite concerned about the confidential data in the controlled copies issued before the coronavirus pandemic, these concerns have increased significantly with remote GMP inspections. After all, the companies provide their "holy of holies", namely the documentation of all necessary processes and working steps. Some companies expressed their concerns with the following words: "In terms of documentation, we laid ourselves completely bare in front of the Russian GMP inspectors". However, in order to certify compliance with good manufacturing practice, GMP inspectors must ensure that all manufacturing processes and quality control are organised in such a way that only safe medicinal products can enter the country of the inspectors.

To this end, the Russian GMP inspectors sign a written assurance of confidentiality with regard to all verbal and written information received and also give this assurance verbally during the online or remote GMP inspection.

An atmosphere of openness is very important, not only on the part of the pharmaceutical company to be inspected, but also on the part of the GMP inspectors. In the past, it was customary to inform the company about the observations made by the inspectors and their classification, but later the classification of the observations was no longer publicised. No matter how wonderful and experienced the English or Russian specialist translator or pharmaceutical interpreter is, part of what is said is always lost when interpreting. That is in the nature of the expression of human thoughts. In fact, no one can express exactly what he means, but only very approximately. And if it is communicated in another language, even for pharmaceutical specialists, the interpreters still don't know the company as well as its own employees. It is also not uncommon for GMP inspectors to have different interpretations of the same phenomenon due to their experience and training. No matter how experienced they are, they might not immediately understand some of the technological features of the pharmaceutical company under review. This is why feedback and detailed clarifications are very important, especially during GMP inspections. It is the open communication that makes it possible to avoid possible misinterpretations and misunderstandings when the GMP inspectors report their observations and the deficiencies found. This gives the employees of the company being audited the opportunity to ensure that they have actually been heard.

Last but not least, it is important to engage interpreters who are experienced in accompanying GMP inspections and who are familiar with the highly specialised pharmaceutical terminology. We are proud to have a large number of extremely satisfied customers who have successfully passed GMP inspections due to our specialisation in pharmaceuticals and our many years of experience in the field of good manufacturing practice. We have therefore placed several letters of recommendation on our website so that clients can not only form an independent opinion about the standard of our work, but can also read what pharmaceutical companies emphasise in their letters of recommendation and what is particularly important to them in such complex assignments. The task of a pharmaceutical interpreters is not only to translate highly complex information into a foreign language. Among other things, they also assume the role of a mediator on a non-verbal level and convey human emotions. We are therefore particularly pleased to receive such high praise for our work as "We are surprised at how fluent the communication is with your interpretation!" from Mr Björn Kümer, Managing Director of the A&M Stabtest site (specialising in pharmaceutical analysis of small molecules) in Mainz, during the very first GMP remote inspection in Germany by the Belarusian inspectorate from 8 to 11 February 2021.

Image: AP Fachübersetzungen