For pharmaceutical companies from Germany, Austria and Switzerland that want to establish themselves on the Russian market, passing a GMP inspection is a requirement. In order to do so, it is essential that trained pharmaceutical interpreters and translators for Russian and English do a great job.

The importance of pharmaceutical translations for Russian GMP inspections

Pharmaceutical manufacturers must meet strict quality requirements in order for their products to be approved. This includes inspections of production sites with regard to compliance with Good Manufacturing Practice (GMP) guidelines, which are carried out by the responsible health or regulatory authority. In Russia, this is the SID&GP when it comes to GMP inspections of manufacturers of medicinal products for human use. Translated into English, the abbreviation SID&GP means "State Institute for Medicinal Products and Good Manufacturing Practice". This is directly subordinate to the Russian Ministry of Industry and Trade (Minpromtorg). The German, Austrian or Swiss pharmaceutical company must submit an application for a GMP inspection to the Minpromtorg in order to obtain approval for the distribution of for medicines produced at the respective manufacturing siteon the Russian market. If the pharmaceutical manufacturer succeeds in passing its Russian GMP inspection, the Minpromtorg issues it with a GMP certificate valid for three years.

After reviewing the documents from the pharmaceutical manufacturer's application, the Russian institute SID&GP sends the pharmaceutical company a GMP inspection plan. The GMP inspection plan is always written in Russian and must be translated into English by the inspected site itself. The preparation phase for the GMP inspection then begins for the pharmaceutical manufacturer. This requires the assistance of trained and qualified pharmaceutical translators. Even before the GMP inspection begins, numerous relevant documents are usually uploaded to a file server accessible to the Russian GMP inspectors. These documents are often only available on site in German, which makes a professional pharmaceutical translation into Russian or alternatively into English necessary. Optimal preparation (and thus the first step towards passing the GMP inspection) can only be guaranteed with flawless pharmaceutical translations of the documents provided.

Challenges with pharmaceutical translations

Documents that are relevant for a GMP inspection are complex texts with many specialized pharmaceutical terms. When translating into Russian or English, it is of the utmost importance that the texts are translated completely, accurately and unambiguously. For this reason, it is not sufficient to be proficient in the respective foreign language. Specially trained, technically and linguistically qualified translators are needed for the specialist translation of pharmaceutical documents. Not only must they have a perfect command of both working languages, they must also have significant specialist knowledge. This is not limited to the pharmaceutical field, but must also includes in-depth knowledge of medicine, biology, production processes, logistics and law. To make matters worse, GMP inspections often require hundreds of pages to be translated at very short notice. As a rule, the pharmaceutical translations should then be checked according to the dual control principle. In technical terms, this quality assurance step is called proofreading. Manufacturers should therefore rely on experienced pharmaceutical translators who are very familiar with the complicated subject matter.

Examples of translations of pharmaceutical documents

Depending on the requirements of the Russian GMP inspectors, English or Russian pharmaceutical translations of various documents must be provided for review in advance of the GMP inspection. This includes among other things documentation from areas such as incoming goods, storage, sampling, production, quality control and quality assurance, packaging and logistics as well as SOPs, batch documentation, qualification and validation documents, job descriptions and delimitation agreements. Depending on the type of document, these can be a running text, tables, flowcharts or lists. Technical pharmaceutical vocabulary is used in all documents. To avoid misunderstandings, it is advisable to use consistent terminology. For example, "dosage form" in English can be translated into German as either Darreichungsform or Arzneiform. However, only one term should be used within a pharmaceutical translation project. Of course, this applies all the more to pharmaceutical terminology - imprecise or unclear translations can have severe consequences or result in an undesirable loss of time needed for clarification. Mastery of pharmaceutical vocabulary is therefore one of the basic requirements for qualified pharmaceutical translators. They must also be very familiar with the relevant processes and, for example, understand the processes of air purification and water treatment, production, (micro)biological testing procedures, tableting, filling, packaging, storage and transportation of medicines, excipients or active ingredients and be able to describe them in several languages.

Professional interpreters and translators significantly increase the chances of success during GMP inspections

During the actual GMP inspection, the communication between the Russian GMP inspectors and the on-site team is facilitated by trained Russian interpreters. It is of course advantageous for the inspected manufacturer to use pharmaceutical translation and interpreting services from a single source to ensure that the preparation and execution of the GMP inspection run smoothly. Pharmaceutical manufacturers should not underestimate the importance of highly qualified pharmaceutical translators and interpreters for successful GMP inspections. Only through mutual understanding can the requirements for a successful GMP inspection be met.

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