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.

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.

Sustainable GMP production in the pharmaceutical industry

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.

Global differences in drug approvals and GMP inspections

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 - Digitalisation in pharmaceutical production

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 and drug production

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.

American customs agreement burdens Europe's pharmaceutical industry

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 EAEU/EAWU has adopted new guidelines for GLP inspections.

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.

History of the European Medicines Agency (EMA)

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.

History, grammar and use of the Russian language in the GMP and pharmaceutical world

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.

Exciting information & facts about the English language

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!

Evolution of pharmacy from ancient apothecaries to modern pharmaceutical industry

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.

Photo of a bottle of Hoxsey's ineffective "cure" for cancer, which the FDA took off the market in the 1950s. Find out more about the history of the FDA!

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.

Overview of the Johnson & Johnson product range. The US company is regularly subjected to GMP inspections by national and foreign authorities.

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.

Interview with GMP translator and pharmaceutical interpreter Alexander Podarewski

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.

Definition, meaning and explanation of the term consecutive interpreting. Pharmaceutical interpreters working in GMP inspections mainly use consecutive interpreting - often with a language combination of Russian, English and German

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.

For international pharmaceutical and medical technology congresses, specialised conference interpreters are booked who have a perfect command of this complex service. Conference interpreters for English, Russian, German present examples.

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.

The Spiral, the new headquarters of Pfizer Inc. in New York. The US pharmaceutical company must regularly undergo national and foreign GMP inspections.

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 interpreters at pharmaceutical inspections & audits

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.

Excellent liaison / conversational interpreting skills are part of the toolbox of trained pharmaceutical interpreters and translators. They are regularly employed for GMP inspections.

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.

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.

Bayer's pharmaceutical products undergo a strict quality assurance process. This includes regular GMP inspections, for which pharmaceutical interpreters and GMP translators (e.g. for Russian and English) are needed.

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.

Are qualified translators and interpreters absolutely necessary in the pharmaceutical sector? Specialised GMP translators and pharmaceutical interpreters ensure perfect communication during GMP inspections and GMP audits.

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.

10 tips on how to find pharmaceutical interpreters and experts for pharmaceutical translations of documents & SOPs into English and Russian and how to successfully process large volumes of documentation shortly before a remote GMP inspection

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.

Merck & Co. and Merck KGaA are two independent pharmaceutical manufacturers. Both companies frequently have to pass GMP inspections for the approval of their products – often with the help of pharmaceutical interpreters.

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.

Roche’s global operations rely on GMP inspection interpreters and pharmaceutical translators

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.

GMP inspections are carried out regularly at Novartis production sites - depending on the target market, pharmaceutical interpreters are used for Russian, English or other languages.

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!

The home of the company founder in Chicago, where he lived from 1891 until his death in 1921. Abbott Laboratories has to undergo regular national and foreign GMP inspections.

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.

Eli Lilly's first pharmacy in Indianapolis (USA) in 1885. Eli Lilly went on to become a global pharmaceutical giant. They must regularly undergo national and foreign GMP inspections.

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.

The Russian Institute for Medicines and Good Practice (SID&GP) is responsible, among other things, for the worldwide implementation of Russian GMP inspections

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.

Pharmaceutical interpreters at work during a GMP inspection by a foreign authority

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.

Flag of the Eurasian Economic Union; source: GMP-inspection.com (interpreters and translators for pharmaceuticals)

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 high-performance pharmaceutical industry is an important location factor in Switzerland, Germany and Austria.

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.

The first COVID-19 vaccine was approved in Russia. Pharmaceutical manufacturers from Germany, the USA, the UK and China followed suit. Drugs against COVID-19 have also already been approved. Contribution from our pharmaceutical interpreters and GMP transl

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.

Technical implementation and document management for remote GMP inspections taking Russia and Belarus as examples

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.

Translators and interpreters ensure that the Russian GMP inspection runs smoothly

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.

Portrait of a Russian GMP inspector who inspects German, Austrian and Swiss pharmaceutical companies as part of official GMP inspections

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?

Russia assures pharmaceutical companies of its support if they choose to relocate their production of medicinal products to Russia.

"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.

News from Moscow: New "Pharma 2030" strategy for the development of the Russian pharmaceutical industry including national security, import substitution, ...

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?

Meaning & definition: A GMP inspection is a regulatory/official measure to verify compliance with GMP guidelines at a pharmaceutical company.

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.