Blog of our interpreters and translators for GMP and pharmaceutics

Our blog offers much more than just information about interpreting and translating between Russian, English, and German. Here, we share our insights from GMP inspections by foreign authorities and provide valuable recommendations on how to successfully pass your GMP inspection or audit. You will also periodically receive useful information about the Russian and Belarusian pharmaceutical markets and the market of the Eurasian Economic Union (EAEU). As enthusiastic pharmaceutical interpreters and GMP translators, we are excited to share valuable information about the history of the world's largest pharmaceutical manufacturers and their secrets to success.

Boehringer Ingelheim - family-owned pharmaceutical company

In Germany and Austria, Boehringer Ingelheim produces pharmaceuticals for the global market, including the field of animal health. Compliance with GMP guidelines is checked during GMP inspections.

Boehringer Ingelheim occupies a leading position among pharmaceutical companies in Germany, Austria and Switzerland. GMP translators and pharmaceutical interpreters are regularly deployed during GMP inspections at the production sites.

The beginning and rise of a traditional German pharmaceutical company

The pharmaceutical company Boehringer Ingelheim was founded in 1885 in the small town of Nieder-Ingelheim, today part of Ingelheim am Rhein. Albert Boehringer, who gave the company its name, started with 28 employees - by the time he died in 1939, there were already 1,500. The company was continued by his two sons and his son-in-law and is still family-owned to this day. The scientific department was founded in 1917. The continuing importance of pharmaceutical research and development is part of Boehringer Ingelheim's DNA.

During the Second World War, the pharmaceutical company is instructed to decentralise production and establish a new site. This is being built in Biberach an der Riß, where the research and development centre has been located since the 1990s. By contrast, almost all domestic pharmaceutical production now takes place at the headquarters in Ingelheim - with the exception of biopharmaceuticals. Soon after the end of the Second World War, the first foreign company is founded in Vienna. This makes Boehringer Ingelheim a major player in the pharmaceutical industry in Germany, Austria and Switzerland. The following decades were characterised by international expansion, particularly within Europe and on the American continent. In 1955, Boehringer Ingelheim enters the field of animal health, which is still an important cornerstone of the German pharmaceutical company today. Most recently, this sub-division was significantly strengthened in 2017 with the acquisition of the animal health division of the French pharmaceutical company Sanofi. This was followed in 2020 by the acquisition of the Swiss biotech company NBE Therapeutics. Even after almost 140 years of company history, Boehringer Ingelheim is still family-owned, making it the 14th largest family-run company in Germany. Among German pharmaceutical companies, Boehringer Ingelheim ranks second after Bayer and ahead of Merck.

The pharmaceutical company Boehringer Ingelheim today - figures and current developments

Today Boehringer Ingelheim employs more than 53,000 people worldwide, more than 17,000 of them in Germany. In 2022, annual sales totalled over 24 billion euros. This makes the Ingelheim-based pharmaceutical company one of the 20 largest pharmaceutical companies in the world. The lion's share is generated in the Human Pharmaceuticals division (with a focus on diabetes medication); the company portfolio also includes the Animal Health and Biopharmaceutical Contract Manufacturing divisions. The German pharmaceutical company opened a new site for the production of biopharmaceuticals in Austria in 2021. Boehringer Ingelheim also has research sites in Switzerland and other countries. The company has recently invested heavily in its headquarters in Ingelheim, including investments in a new factory for the production of solid pharmaceuticals in tablet form during the market launch phase.

GMP translators and interpreters are indispensable for global pharmaceutical companies

The pharmaceuticals manufactured by Boehringer Ingelheim in Germany and Austria must first be approved by the pharmaceutical authority of the respective target market before they can be sold to customers. For this purpose, the pharmaceutical production sites are inspected for compliance with the applicable GMP guidelines as part of a GMP inspection. These regulate the conditions under which the production of pharmaceuticals must take place and under which quality is controlled and assured. In practice, this can look like this, for example: Boehringer Ingelheim intends to launch a successful diabetes drug manufactured in Ingelheim on the Russian market. The competent authority is the Russian institute GILS i NPwhen it comes to medicinal products for human use. In the case of veterinary medicinal products, the Russian authority VGNKI is responsible for carrying out GMP inspections. If Boehringer Ingelheim has requested a GMP inspection of the German production site, the SID&GP sends Russian GMP inspectors to Ingelheim with the task of checking the production conditions there for conformity with the GMP regulations applicable in the EAEU. As a rule, the Russian GMP inspectors only speak Russian, while German and possibly English are spoken at the site to be inspected. The task of the GMP translators is now to carry out all the necessary written pharmaceutical translations before and during the GMP inspection and to facilitate the dialogue between site employees and Russian GMP inspectors through expert pharmaceutical interpreting. As a rule, only qualified translators and interpreters are used for this sensitive task - a not insignificant factor for passing the GMP inspection. Following a positive result, the drug can then be approved for Russia or the countries of the Eurasian Economic Union (EAEU).

This blog post concludes our series of articles on the Big Five in the pharmaceutical industry in Germany, Austria and Switzerland. We hope you have had an enjoyable reading experience and will of course continue to provide you with exciting insights into the pharmaceutical industry and interesting facts relating to GMP inspections and challenges for GMP translators and pharmaceutical interpreters.

 

Image: National Cancer Institute, unsplash.com

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