Kobro Kommunikation unterstützt Pharmaproduzenten und Lohnhersteller bei GMP-Inspektionen
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In Russia, pharmaceuticals can only be approved with a GMP certificate
Since 2016, new pharmaceuticals produced by foreign manufacturers can only be approved in Russia upon presenting a GMP certificate, which is issued by the Ministry of Industry and Trade of the Russian Federation. As of 2019, a GMP certification will also be required when changing the registration of pharmaceuticals. A GMP assessment is issued after the required documentation, in particular the site master files, have been reviewed and an on-site inspection of the respective foreign pharmaceutical manufacturer has evaluated their compliance with the good manufacturing practice (GMP) guideline.
Indispensable: qualified interpreters for GMP audits
Having qualified interpreters present during GMP inspections is absolutely essential. By choosing Kobro Kommunikation, you will be working with a partner who has the relevant expertise regarding GMP audits. After all, according to Kobro’s clients, 30% of the success of a GMP certification is due to the interpreter’s performance. Don’t leave those 30% to chance. Leave it to Kobro Kommunikation.
As an interpreter and translator, Kobro Kommunikation has already participated in public audits from Russia, Belarus and Kazakhstan. This is where Kobro’s working language triad really pays off: Russian-speaking inspectors auditing a German company using English SOPs. Specific GMP terminology in three languages as well as normative documents, including Order No. 916 by the Russian Ministry of Industry and Trade, are all part of the Kobro knowledge base, as is experience in the fields of pharmaceutical manufacturing, medicine, quality assurance, quality control, microbiology, biotechnology and chemistry.
Kobro Kommunikation is personally acquainted with several of the inspectors of the Russian State Institute for Drugs and Good Practices (GILSINP) and has good work relations with them.
The Kobro recommendation for a successful GMP audit
In order to be prepared for a successful GMP audit to the fullest possible extent, Kobro Kommunikation recommends conducting a training session or mock audit. During this two- to three-day-long advanced training, the expectations of the Russian inspectors, especially their interpretation of the Russian GMP guidelines, are explained in detail. Being knowledgeable about the differences between the Russian and the EU GMP guidelines and the reasons behind certain critical questions can make all the difference during an inspection, because it allows you to potentially mitigate any deviations.