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.
Sustainability has long been more than just an image factor. In pharmaceutical production, it is becoming a strategic success factor - also in the context of GMP inspections. Energy efficiency, resource-saving processes and compliance are interlinked and influence quality, authorisation and inspection reliability.
A drug approved in Europe is not automatically available worldwide. Different regulatory requirements, national approval procedures and varying GMP inspections lead to global differences. The article explains the background and the role of international authorities.
Pharma 4.0 refers to the integration of digital technologies into pharmaceutical production, for example through networked machines, data analyses and intelligent processes. GMP inspections must take these digital approaches into account to ensure quality and compliance.
Errors in pharmaceutical manufacturing can have serious regulatory consequences. GMP inspections can effectively counteract this. Good preparation, a functioning quality system and professional handling of deviations are crucial.
Trump's trade agreement with the EU brings tariffs on pharmaceuticals. A setback for Europe's pharmaceutical industry - and for global healthcare. How will the European pharmaceutical industry and politicians react to this?
The Council of the Eurasian Economic Commission has adopted new rules for conducting GLP inspections in research institutions. The aim is to ensure consistent good laboratory practice (GLP) in the development of medicines.
In this article by our pharmaceutical interpreters and GMP translators, you will learn interesting facts about the history of the EMA, the European Medicines Agency. What are the advantages of the EU authority for the member states? Find out in the following blog post.
Learn previously unknown facts and information about the Russian language, which is spoken by more than 260 million people worldwide, about its historical development, grammatical peculiarities and use in the GMP and pharmaceutical world.
English belongs to the Germanic languages of the Indo-European language family. Around 350 million people worldwide are native English speakers. Around 250 million of them live in the United States. 61 million native English speakers can be found in the UK. Find out more interesting facts!
Drugs were already used in prehistoric times. Find out more about the origins of pharmacy, its historical development and the nature of pharmacy in modern times! In our blog post, we also report on the importance of GMP in pharmaceutical manufacturing.
In this article by our pharmaceutical interpreters and GMP translators, you will learn exciting details about the history of the FDA, the Food and Drug Administration in the USA. How did the authority come about and what have been some of the milestones in its history since then? Read more in the following blog post.
When three brothers founded Johnson & Johnson in 1886, they wanted to offer a very specific product - sterile surgical bandages. A good 150 years later, the globally operating company's product range includes not only medical products but also pharmaceuticals and various consumer goods.
The December 2023 issue of PHARMPROM, one of the leading Russian trade journals for the pharmaceutical industry, featured an interview with Mr Alexander Podarewski, Managing Director of GMP-inspection.com. It was a special honour for us to be the exclusive partner of this edition.
Professional consecutive interpreting takes place with a time delay and can be used unilaterally (in one language direction) or bilaterally (in two language directions). In addition to many other skills, a trained consecutive interpreter must master a special note-taking technique.
Conference interpreting is required for a wide variety of occasions. Organisers in the pharmaceutical and medical industry rely on experienced conference interpreters with specialist knowledge for congresses, international GMP conferences and pharmaceutical and medical conferences with foreign participants.
In 1849, Karl Pfizer and Karl Erhart moved from Ludwigsburg to New York, where they bought a small production building for borrowed money and founded Charles Pfizer & Company. Today, the former two-person company is considered the world's highest-grossing pharmaceutical group.
Simultaneous interpreting at GMP inspections, medical technology audits and other events such as trade fairs and pharmaceutical congresses is a particular challenge for professional pharmaceutical interpreters. Verbal transmission in real time requires maximum concentration.
Specialised GMP translators and pharmaceutical interpreters are used for GMP inspections by foreign regulatory authorities. During the GMP inspection, conversational / liaison interpreting skills are required to ensure perfect communication between GMP inspectors and site staff.
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.
Bayer is Germany's best-known and largest pharmaceutical manufacturer. Other than the crisis-ridden Agriculture division, the Pharmaceuticals and Consumer Health divisions (non-prescription pharmaceuticals) record stable sales. Find out more about Bayer's company history and development.
There is a widespread assumption that it is enough to be proficient in two languages in order to work as a qualified translator or interpreter. However, there is also the opposite view: without a professional qualification, it is not possible to interpret in the respective field. We explore this question in the GMP interpreter blog.
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.