Pharmaceutical interpreting for English & Russian at GMP inspections and GMP audits in Germany, Switzerland & Austria

Professional pharmaceutical interpreters from Nuremberg on assignment in Ulm for the pharmaceutical manufacturer Teva-ratiopharm. Members of the GMP audit team take care of coordinating everything.

GLP, GCP and GMP inspections of pharmaceutical companies themselves as well as contract manufacturers and laboratories are gaining increasing relevance. The GMP inspection of production sites that manufacture active agents, excipients and finished medicinal products postulates a thorough inspection for compliance with the requirements of Good Manufacturing Practice. A dialogue takes place between GMP inspectors and representatives of the pharmaceutical company to be inspected during a GMP audit by a foreign regulatory authority (be it the FBU "GILS and NP" of the Ministry of Industry and Trade of the Russian Federation or the regulatory authority of the Republic of Belarus or the American Food and Drug Administration).. Professional interpreters specializing in pharmaceutical translation are utilized to support GMP inspections by foreign regulatory authorities.

Pharmaceutical interpreting during GMP audits and GMP inspections is one of the most demanding forms of verbal communication

It is of the utmost importance to engage an experienced, diligent and stress-resistant pharmaceutical interpreter for these interpreting assignments. A GMP specialist interpreter not only translates the content extremely accurately into the target language, but is also very familiar with the respective pharmaceutical context.

The language experts at GMP-inspection.com are characterized by:

  • Specialized higher education
  • Specialization in the pharmaceutical industry
  • Perfect proficiency in German, Russian and English
  • Many years of professional experience
  • Expertise in pharmaceutical terminology and understanding of complex connections
  • Numerous excellent letters of recommendation

Our pharmaceutical interpreters are aware that accurate interpreting is very important during GMP inspections and that the outcome of the inspection depends heavily on the quality of their work.

Criteria for the selection of professional pharmaceutical interpreters to accompany GMP inspections in Russian or English

In addition to the general requirements for the interpreter, such as an excellent proficiency in the working languages, the ability to concentrate and precise interpreting, expertise in the specific specialist terminology and a deep understanding of the respective processes are prerequisites for successful communication throughout the entire GMP audit or GMP inspection. This in turn facilitates the successful completion of the inspection and helps our clients obtain a GLP, GCP or GMP certificate. Our experienced team of pharmaceutical interpreters knows from many years of experience in supporting GMP inspections and GMP audits, how much the quality of their work influences the outcome of these monitoring measures. This is why our experienced language experts approach every GMP audit or GMP inspection with the utmost diligence.

Pharmaceutical translation services include the fields of medicine, technology, biology, microbiology and chemistry. In addition, a pharmaceutical interpreter must be familiar with research and developments in this field, with the operating principles of various plants and laboratories as well as production processes, quality control methods, building control technology, storage and logistics. If contract negotiations are considered during GMP audits and GMP inspections, the interpreter must also have an understanding of legal issues and the law.

The quality management system of a language service provider specialized in pharmaceutical interpreting

During the first GMP inspections, our team of certified pharmaceutical interpreters developed an in-house database that currently contains over 5,000 specialized pharmaceutical terms in Russian, German and English. This glossary is updated regularly and new specialist terms are added, ensuring a high level of expertise.

We are highly specialized simultaneous and consecutive interpreters. For GMP inspections and GMP audits in Germany, Switzerland and Austria, 90% of the communication between the production site and the foreign GMP inspectors takes place in the respective native language of both parties (i.e. German and Russian). However, we often have to deal with English documents (standard operating procedures, presentations, certificates, specifications, qualification and validation documents, etc.) as well as with English-speaking colleagues from company branches in other countries. Naturally, we also have in-depth knowledge of specialised English terminology and speak fluent English, which is essential for discussions and impromptu translations.

Only the best are tasked with complex interpreting assignments in the pharmaceutical sector

To successfully pass a GCP, GLP or GMP inspection by a foreign inspectorate, you should not leave things to chance. In such cases, it is customary to hire only interpreters who have proven their expertise and reliability time and time again. This is the key to the success of a GMP inspection or GMP audit of your pharmaceutical company or laboratory.

In addition to German and Russian, our pharmaceutical interpreters also speak English. This ensures an authentic rendering of what is said in the respective language. In addition, our experienced language experts are proficient in all interpreting techniques:

We can see the results of our professional work. The success of our work as well as written references, positive feedback and letters of thanks from our pharmaceutical customers motivate us to continuously develop in the area of GMP. Contact us and allow us to convince you of the high quality of our services. The competent and friendly staff at GMP-inspection.com will be happy to advise you and answer all your questions.

When you turn to GMP-inspection.com, you can count on our expertise, reliability and experience. Choose the best!