The interpreters of the Nuremberg-based company GMP-inspection.com take part in pharmaceutical GMP inspections across Germany, Austria and Switzerland. Since our first audit at a medical-technical department of Siemens in Erlangen (Bavaria), where we participated as interpreters, we have supported numerous audits and GMP inspections with our professional performance long before the first Russian GMP inspection was conducted by the Russian regulatory authority GILS i NP. Ever since, we have been active as interpreters at GMP inspections on a regular basis. We have comprehensive experience in cooperating with Russian and Belarusian authorities and we look back on dozens of successfully completed inspections as well as thousands of pages of translated pharmaceutical documents.

Due to the Corona pandemic, the Belarusian and Russian GMP inspections have become a lot more challenging. As a subsidiary company of AP Fachübersetzungen, we have already written several articles, e.g. GMP interpreters speak about online / remote inspections (topics: new GMP inspection format, organizational changes in GMP inspections, technical equipment in video conferences with the Russian authorities, software recommendations, audio quality in regard to the work of the interpreters), New format for providing information at GMP inspections (topics: GMP remote interpreting, possible imponderables, cloud / servers for confidential documents, express translations of GMP documents prior to the start of the GMP inspection, scope of the inspection, remote GMP inspections as a makeshift, role of the interpreters in Russian GMP inspections) and Russian GMP remote inspections: preparation and action (topics: importance of the timely preparation for the Russian GMP inspections, tips for preparation, skills of the qualified interpreters, expectancies of the pharmacy companies, confidentiality in regard to data contained in pharmaceutical documents and their translations into English, German and Russian, confidentiality agreement of the Russian GMP inspectors). Caution: These are not evaluations of market research data regarding the Russian pharmaceutical market, but experiences and observations by English translators of pharmaceutical documents and Russian interpreters at Belarusian and Russian GMP inspections conducted by the relevant regulatory authorities. That is why these articles are intended for pharmaceutical manufacturers from Germany, Austria and Switzerland facing an inspection by the authorities. We will write about the particularities of the Russian pharmaceutical market at a later date in our blog. Take a look!