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.
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.
As professional GMP translators and pharmaceutical interpreters, we explain below how a bundle of documents requested shortly before a GMP inspection can be translated in a manner that is prompt, in compliance with the specialist terminology, and cost-effective.
One name, two pharmaceutical manufacturers: both the US pharmaceutical group Merck & Co. and the German pharmaceutical company Merck KGaA have their origins in Darmstadt. Strict GMP guidelines apply to the manufacture of pharmaceutical products on both sides of the Atlantic.
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.
The Swiss pharmaceutical manufacturer Novartis is one of the biggest names in the pharmaceutical industry. As one of the top-selling pharmaceutical companies in the world, the Basel-based company is active in every area of pharmaceutical production. Accordingly, GMP inspections are carried out frequently at Novartis sites. Read more to learn about the history of Novartis!
When he founded the Abbott Alkaloidal Company in 1888, the young doctor and pharmacy owner Wallace C. Abbott had no idea that it would become one of the world's leading pharmaceutical companies for diagnostics and medical devices.
Founded in 1876 as a small pharmacy with four employees, Eli Lilly grew into a true pharmaceutical giant over the 100 years that followed. One of the first medicinal products manufactured was the antimalarial drug quinine.
Since 2016, the Russian State Institute of Drugs and Good Practices (SID&GP) has been responsible for the global implementation of Russian GMP inspections, among other things. Even at the beginning of the first GMP inspection, the institute could look back on decades of history.
When opening up new markets, there is no way around GMP inspections in the pharmaceutical sector. Passing foreign GMP inspections requires thorough preparation. This also includes the selection of a specialized interpreter. Read more to find out how the qualifications of a pharmaceutical interpreter can be verified.
Starting in 2022, pharmaceutical manufacturers will only be issued GMP certificates if their manufacturing practices are in accordance with the uniform regulations of the Eurasian Economic Union (EAEU). But what exactly is the EAEU and what does the implementation of these new regulations mean?
The manufacture of medicinal products is one of the most important branches of industry in Germany, Switzerland and Austria. The pharmaceutical industry is growing in all three countries. When tapping into new markets such as Russia, manufacturers have to overcome a number of approval hurdles.
After the COVID-19 outbreak and during the subsequent race for the fastest possible approval of vaccines and medicines, the pharmaceutical industry was the focus of global public attention. Groundbreaking developments in Russia and Germany, among others, led to the rapid approval of vaccines.
During the first lockdown, the pharmaceutical industry was paralyzed. Many GMP inspections by foreign authorities did not take place or were postponed indefinitely. However, pharmaceutical companies quickly resorted to technical solutions that made remote GMP inspections possible. As GMP translators, we report below on the technical aspects of remote inspections.
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.
It is the GMP inspector whom the pharmaceutical manufacturer must convince of compliance with all GMP guidelines in its pharmaceutical plant and of the safety of its products. But what character traits do Russian GMP inspectors need?
"The expansion of pharmaceutical production in Russia must become attractive for investors and foreign manufacturers. It is especially important that pharmaceutical manufacturers who have ventured into Russia be supported." - Various options were weighed in a panel discussion at the Russian Chamber of Commerce and Industry.
Expanding national production, promoting innovative research and increasing the export of medicinal products fivefold - the new development strategy for the Russian pharmaceutical industry leading up to 2030 has set ambitious goals. According to the authors of the draft strategy, Russia needs to become independent from the import of medications and ensure national security despite sanctions and possible conflicts. How can these goals be achieved and who could benefit from them?
Definition: A GMP inspection is a monitoring measure that aims to verify compliance with GMP guidelines (also known as Good Manufacturing Practice guidelines) at a specific pharmaceutical company. Read the blog post by our pharmaceutical interpreters and GMP translators on this topic.