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.

Swiss pharmaceutical company Roche – figures, history, present

Roche is a globally present company. Specialized interpreters for GMP inspections and pharmaceutical translators ensure smooth communication.

Switzerland is home to some of the world's largest pharmaceutical companies. Roche, based in Basel, has long been an established global player. The Basel-based pharmaceutical manufacturer also has sites  outside of Germany and Austria. Specialist pharmaceutical translators and GMP interpreters are essential for its global success.

Pharmaceutical company of superlatives: Swiss manufacturer Roche in figures

One name should certainly not be missing from our series of articles on the Big Five European pharmaceutical companies. With annual sales of 68.7 billion USD (2021), Roche Holding AG from Basel, Switzerland, ranks second among the world's top-selling pharmaceutical companies. Only the world's largest pharmaceutical company, the US manufacturer Pfizer, has higher figures. Roche employs more than 101,000 people around the world. Over 14,000 of those employees are based in Germany. The largest German site is located in Mannheim with around 8,000 employees. In the neighboring country of Austria, however, this figure is relatively small at around 400. Important milestones in the history of the Swiss pharmaceutical company are its founding in 1894, its transformation into an AG (German public limited company) in 1919 and its most significant expansion: in 1997, Roche took over the German pharmaceutical manufacturer Boehringer Mannheim – for a purchase price of 18.7 billion German marks. Today, the company structure is divided into two divisions: Pharmaceuticals and Diagnostics. At the beginning of February 2023, it was announced that the head of the Pharmaceuticals Division, Bill Anderson, would work for the company’s competitor Bayer.

From pharmacy in Basel to the global market – the history of the Roche pharmaceutical company

Switzerland is one of the most important countries in the world when it comes to pharmaceutical production. The small city of Basel in particular is an important center of the pharmaceutical industry in Germany, Austria and Switzerland. Not only Novartis has its headquarters here. Fritz Hoffmann and a pharmacist also founded the company "Hoffmann, Traub & Co" in Basel in 1894. Hoffmann's wife Adèle La Roche was also the pharmaceutical company’s later namesake. Initially specializing in the manufacture of pharmaceutical and chemical products, the pharmaceutical manufacturer, which had then become a joint-stock company, became the market leader in the production of synthetic vitamins in the 1930s. In the following decades, more and more successful pharmaceuticals were launched on the market. The famous Bepanthen cream (now manufactured by Bayer), for example, has been available since the 1950s. In 1968, the Diagnostics Division was founded and in the 1970s, a successful medication for Parkinson's disease and several medical devices for diabetes patients were launched on the market. Another milestone was the world's first HIV test. With the takeover of Boehringer Mannheim, Roche secured its the German pharmaceutical production site. During the coronavirus pandemic, Roche played an important role in the development of rapid antigen tests.

Roche sites receive regular visits from GMP inspectors

As a leading global pharmaceutical company, Roche is naturally interested in selling its products in as many countries as possible. The manufacture of pharmaceutical products at the German-speaking sites in Switzerland and Germany is subject to strict GMP guidelines, compliance with which is monitored by the relevant authorities in each country. If Roche wants to sell a product manufactured in Germany in Russia, for example, the Russian institute SID & GP is responsible for approval. A team of Russian GMP inspectors then travels to the site in question on the behalf of the Russian regulatory authority and verifies compliance with the GMP guidelines applicable in the EAEU. Under no circumstances should there be any misunderstandings between those responsible for the site and the GMP inspectors during the GMP inspection, as the consequences can be disastrous and lead to the GMP inspection not being passed. For this reason, pharmaceutical companies rely on specialized pharmaceutical interpreters to support foreign GMP inspections, who translate the complex pharmaceutical content into Russian or German with a high level of expertise. Written translations of GMP-relevant documents such as SOPs, job descriptions for Qualified Persons (QPs), PQRs, SMFs, qualification documents and other documents are often required in advance. A precise verbal and written translation by the pharmaceutical translators is essential for a successful GMP inspection. Large pharmaceutical companies such as Roche therefore assign particular importance to highly qualified interpreters for GMP inspections.

As highly specialized pharmaceutical translators and GMP interpreters, we hope to have given you an exciting insight into one of the world's largest pharmaceutical companies. Naturally, everything that moves the pharmaceutical world is of great interest to us. We are happy to share our knowledge on relevant topics, personalities and manufacturers in the pharmaceutical industry in our blog. If you would like to make use of our expertise to facilitate your GMP inspection, our interpreters are available for you throughout Europe.

 

Image: Ricardo Gomez Angel, unsplash.com

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