Pharmaceutical translations of GMP-relevant documents for English, Russian and German

As part of GMP inspections, we also provide legal and pharmaceutical translations in English, Russian and German. These are required in all phases of GMP inspections in Germany, Austria and Switzerland:

  • Preparation for the GMP inspection: Provision of documents from both parties in the respective languages (inspection plan and assignment to carry out GMP inspections are provided to the pharmaceutical company in Russian; in turn, the pharmaceutical company must ensure that several documents are professionally translated from German or English into Russian in advance. Some Russian GMP inspectors are also satisfied with English translations, provided they speak English.)

  • Active part of the GMP inspection: Individual documents, sections or sentences are translated into Russian / German on the spot as required during the GMP inspection. This has become particularly important with the introduction of remote audits via online mode. In addition, documents that have already been translated into Russian are uploaded to a server so that the GMP inspectors can peruse them independently.

  • Inspection results: If further documents are required for the final review of any outstanding issues after the final meeting with the German, Austrian or Swiss pharmaceutical company, , we are also happy to provide pharmaceutical translations into English or Russian. Our pharmaceutical translations are required during the GMP inspection follow-up, especially when implementing the CAPA plan, which must always be translated into Russian in accordance with the official requirements of the Russian authorities GILS i NP and VGNKI (for animal health). Pharmaceutical translations that have been produced by machines are generally rejected.

Expertise of GMP translators and interpreters

Working in the field of pharmacy requires a high degree of responsibility and sound specialized knowledge. This also applies to the demanding work of the English, Russian and German GMP translators and pharmaceutical interpreters who work in this field. Among others, pharmaceutical and GMP documents deal with base materials, excipients and active agents, their manufacture, composition, areas of application, chemical and microbiological analysis as part of quality control and their impact on the environment, health and quality of life of humans and animals. The specialist translator must therefore be familiar with the field of pharmacy (which is a very complex area in itself) as well as with technology, medicine and law in order to translate the documents for risk assessment and minimization of various technological processes as well as extensive qualification and validation documents relating to processes, devices, substances or service providers in a professional manner.

For pharmaceutical translations of documentation on occupational safety, personnel hygiene and equipment cleaning, sampling, carrying out tests and handling test and reserve samples, the language expert must also use highly specialized biological, microbiological, chemical and virological terminology in their translation. When discussing the topic of "computerized systems", the translator must in turn switch to an equally complex topic, namely information technology. In conclusion, pharmacy draws from a variety of disciplines.

A high level of responsibility is expected of a pharmaceutical and GMP translator, not only for the appropriate quality of their translation work, but also for meeting deadlines. Individual company documents such as batch documentation, operating instructions, process descriptions, qualification and validation documents as well as in-process controls and the Site Master File (SMF) can contain hundreds or even thousands of pages. Therefore, a realistic estimate of the delivery date is also one of the translator's tasks. If the pharmaceutical translation is urgent and a translator is not able to do it alone, it is common practice to form a project team. This also has the advantage that synergy effects are created by combining the expertise of several translators. To better understand the scheduling and technical challenges of such large and particularly urgent projects, we recommend reading our blog post Professional pharmaceutical translations of 1,500 pages of documents & SOPs 10 days before a remote GMP inspection.

GMP documentation as the basis for a functioning quality system

Documentation is an indispensable part of a pharmaceutical quality system and a key element in the organization of manufacturing and quality control in accordance with Good Manufacturing Practice (GMP). Document management can be carried out in paper form, electronically or as a combination of both. The main purpose of the document management system is to structure all processes at the pharmaceutical site that can influence certain aspects of medicinal product quality. And this in turn has an impact on the health of patients.

In addition to inspecting incoming goods, sampling, storage, production, laboratories and stability chambers, building control systems and ancillary areas, a lot of time is invested in checking documents and their pharmaceutical translations during GMP inspections. Precise and high-quality translations are a prerequisite for the correct interpretation of the processes at the production site by the GMP inspectors or auditors. Not every translator is suitable for this task. A GMP inspection by foreign inspection authorities regarding compliance with the requirements of Good Manufacturing Practice is of crucial importance for the pharmaceutical company. Everything has to be perfectly prepared. This is why only competent and experienced language experts are trusted with the translation of highly complex pharmaceutical texts.

Quality assurance of GMP-relevant pharmaceutical translations

Not only pharmaceutical companies, but also GMP translators and pharmaceutical interpreters must have a functioning quality system. A specialist translator is not only expected to have specialized training, broad knowledge and experience in the field of GMP, but also the ability to work under pressure, a strong ability to concentrate, a good memory and a high level of speed when using the appropriate specialist terminology. Researching specialized terminology can sometimes take a lot of time, especially when it comes to new technologies that the translator is not yet familiar with. For this reason, pharmaceutical translators are not only expected to be diligent but also to continuously further their education. To be able to translate documents correctly, they must also be inquisitive and thorough and not not simply be satisfied with his previous successes.

A GMP translator must realistically assess his skills and capacities. This applies not only to the turnaround time of a pharmaceutical translation, but also to its quality. Our German, Russian and English pharmaceutical translations undergo additional proofreading for semantic, linguistic and stylistic accuracy by an expert native speaker with GMP experience.

A technically flawless pharmaceutical translation is therefore an important prerequisite for a functioning quality system in pharmaceutical companies to be audited in Germany, Switzerland or Austria. Even seemingly unimportant details in the translation can have far-reaching consequences. To avoid errors and ensure the best possible quality of a pharmaceutical translation into German, English or Russian, we only use highly qualified linguists with many years of experience in the pharmaceutical industry and in GMP translations. With the above-mentioned quality assurance measures, our translation agency in Nuremberg minimizes any risks and offers our clients excellent translation services with the "Made in Germany" seal of quality.