A new information provision format for GMP inspections
Second interview of the Russian pharmaceutical portal Pharmprom.ru with the Russian pharmaceutical interpreter Alexander Podarewski about remote GMP inspections
The first interview focused on the specifics of interpreter support during the conduct of remote inspections in Germany. Alexander Podarewski, a specialist translator and simultaneous interpreter as well as managing director of the translation agency AP Fachübersetzungen in the Bavarian city of Nuremberg, was the interpreter for the very first GMP remote inspection conducted by the Russian regulatory authority at a German pharmaceutical company in late May 2020. In the interview, he spoke about the new inspection format, the changes to interpreting work during the Covid-19 crisis and the preferences of pharmaceutical companies when selecting technical communication tools. We are delighted to be working with this master of interpreting in the field of pharmacy to talk about the intricacies of GMP inspections under difficult conditions.
Mr Podarewski, how did you interpret during the conference calls between the pharmaceutical companies and the Russian supervisory authorities - by joining virtually or in person?
- It all began with virtual presence during the remote inspection of the company Madaus in Troisdorf because in May 2020 the world was still in a certain "state of shock" due to the rampant infectious disease COVID-19. For this reason, the number of employees and individuals involved at the production sites was restricted as far as possible. Of course, the latter also includes interpreters, although no foreign audit can be conducted without them.
In recent months, pharmaceutical companies, particularly in Germany and Switzerland, have started to use interpreters on site. Of course, there is a strict access control at the factory entrance area, and the minimum distances and hygiene rules are observed during work. The challenge with remote work is that nobody can predict when exactly the interpreter will be needed. While the inspectors do their best to strictly adhere to the provided schedule of online meetings with the inspected companies, imponderables (unforeseen circumstances) may arise that require a change of plan. This includes, above all, questions that arise during the review of the company's documents. In addition, various changes on the part of the pharmaceutical manufacturer are possible. As a result, booking an interpreter only for certain hours severely restricts the flexibility of both parties during a GMP inspection.
Can you tell us how much the GMP inspection procedure has changed?
- The Russian supervisory authority provides the inspected company with a plan containing the list of the documents to be inspected 10 days prior to the GMP inspection. The foreign pharmaceutical manufacturer then submits the requested documents via its official representative or uploads them directly to the cloud before the inspection begins. If the provision of paper copies of the documents is possible under current conditions, they will be delivered to the authorities by the company's Russian representative.
It is worth noting that the documentation of Swiss companies is often only prepared in English. In Germany and Austria, the documents are often bilingual, i.e. German-English, which would generally be sufficient for the inspectors. However, there are numerous companies, including some big pharma corporations, whose documentation is predominantly in German. This often concerns the documents in the area of qualification and validation. A considerable number of documents are reviewed during each audit. Translating them all and in full only 10 working days before the GMP inspection is nearly impossible, as some dossiers can contain hundreds or even thousands of pages. In addition, the inspectors are not physically capable of thoroughly reviewing such extensive documents within the short inspection period. For this reason, the inspection of documents by the inspectors is done more on a random sampling or excerpt basis, which somewhat calls into question the necessity of translating all documents in full. An additional challenge in addressing this issue is that the inspectors must have the ability to access all parts of a document relating to the quality of the products submitted for a foreign GMP inspection. And if the interpreter is present on-site throughout the GMP inspection interpreting is possible at any given time.
Although the inspectors and the inspected companies require much more time for the online audits compared to the on-site inspections, many aspects remain unchanged. The task of each GMP inspector is to verify compliance with the applicable GMP guidelines of their country by inspecting the production of the respective company, whose products may also be imported into the inspector's home country. The Good Manufacturing Practice (GMP) guidelines, in turn, represent a system of requirements for production organization and quality control in the manufacture of pharmaceuticals. In this regard, the Covid-19 pandemic, humanity's response in the form of social distancing measures and the worldwide travel restrictions changed nothing at all. Only the format of presenting information about the site and numerous production specifics, as well as the format for receiving and analysing this information, have changed. In the past, inspectors, accompanied by interpreters, had personal access to all company premises and were able to communicate personally with each employee and discuss issues relating to their area of responsibility. Today, this is no longer possible.
Does this mean that all companies that were due for an on-site GMP inspection must undergo a remote inspection?
- As far as I know, only pharmaceutical manufacturers undergoing inspection for at least the second time have a remote or virtual GMP inspection, and this is intended as an emergency measure. On-site audits will resume only after the COVID-19 pandemic.
I would like to add here that the inspectors bear an enormous responsibility for putting a pharmaceutical company through its paces. Remote document review increases the time required to conduct a GMP inspection by 2 to 3 times and comes with a number of other technical limitations. This puts pharmaceutical companies and their Russian representatives, regulatory authorities and interpreters in a difficult position, which they must first adapt to so that the companies are then able to supply foreign markets with safe products.
How would you assess the role of the representative of the inspected foreign company from an interpreter’s perspective?
- The Russian or EAEU representatives of the inspected companies are in direct contact with the inspectors even before the GMP inspection and play an important role in every GMP inspection. They have many years of experience in working with the relevant supervisory and authorisation authorities. However, during my professional experience in this field, it happened several times that the representative did not provide any support after the start of the inspection other than forwarding the original emails from Russian inspectors to the German company - sometimes there was not even an attempt to translate the emails into English. In most cases, the representatives are quite proficient in English. In such situations, when I was either still on-site until the end of the workday or already at the hotel, I often had to urgently translate the inspectors’ observations and their requests for explanations or additional documents. This enabled the quality assurance manager, who in most cases is also the inspection coordinator at the inspected site, to organise the provision of any additional information requested before my arrival at the facility and until the next inspection day.
During one GMP inspection, the Russian representative promised to take care of the translation of the necessary documentation in Russia, as I was already occupied as an interpreter during the audit and had no time for translation. The required translation was for the annual Product Quality Reviews for several products, including the PQR for a finished product, the overview of complaints, changes and OOX. Obviously, the Russian representative forgot in the heat of the moment. We had to help ourselves "out of a jam", so I spontaneously interpreted the Excerpts from these documents after the inspectors had selected them during the video transmission.
Work in the pharmaceutical field is very responsible and extremely demanding for all participants. And we interpreters help as much as we can.
In the next interview in this series of articles, Mr Alexander Podarewski will talk to us about the importance of preparing for a remote inspection as well as the execution of the active part of the GMP inspection.
Image: AP Fachübersetzungen
