{"id":4892,"date":"2019-09-26T15:48:51","date_gmt":"2019-09-26T13:48:51","guid":{"rendered":"https:\/\/mkobro.de\/ihr-gmp-audit\/"},"modified":"2019-10-05T14:33:15","modified_gmt":"2019-10-05T12:33:15","slug":"your-gmp-audit","status":"publish","type":"page","link":"https:\/\/mkobro.de\/en\/your-gmp-audit\/","title":{"rendered":"Ihr GMP-Audit"},"content":{"rendered":"

Kobro<\/strong> Kommunikation unterst\u00fctzt Pharmaproduzenten und Lohnhersteller bei GMP-Inspektionen<\/h3>\n

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\"Consulting\"\/<\/div>

Consulting<\/h3>

Specifics of the Russian GMP guideline, expectations of the Russian supervisory body<\/p><\/div><\/div><\/div>

\"GMP<\/div>

GMP interpreting<\/h3>

Professional interpreting during your GMP inspection. German-Russian-English<\/p><\/div><\/div><\/div>

\"Translations\"\/<\/div>

Translations<\/h3>

Russian GMP guideline in German and English. Translation of your correspondence with the supervisory body.<\/p><\/div><\/div><\/div>

\"GMP<\/div>

GMP terminology<\/h3>

Creating and updating glossaries and your GMP terminology lists German-Russian-English<\/p><\/div><\/div><\/div>

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Sichern Sie sich rechtzeitig professionelle GMP-Dolmetscher f\u00fcr Ihre n\u00e4chste Inspektion.<\/h2>Request<\/a><\/div>\n
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In Russia, pharmaceuticals can only be approved with a GMP certificate<\/h4>\n

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.<\/p>\n<\/div>\n

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Indispensable: qualified interpreters for GMP audits<\/h4>\n

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\u2019s clients, 30% of the success of a GMP certification is due to the interpreter\u2019s performance. Don\u2019t leave those 30% to chance. Leave it to Kobro Kommunikation.<\/p>\n

As an interpreter and translator, Kobro Kommunikation has already participated in public audits from Russia, Belarus and Kazakhstan. This is where Kobro\u2019s 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.<\/p>\n

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.<\/p>\n<\/div>\n

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The Kobro recommendation for a successful GMP audit<\/h4>\n

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.<\/p>\n<\/div>\n<\/div>\n

Nutzen Sie unsere Expertise in der Zusammenarbeit mit GMP-Inspektoren aus Russland.<\/h2>\n

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Kobro Kommunikation unterst\u00fctzt Pharmaproduzenten und Lohnhersteller bei GMP-Inspektionen  <\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-full-custom.php","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/mkobro.de\/en\/wp-json\/wp\/v2\/pages\/4892\/"}],"collection":[{"href":"https:\/\/mkobro.de\/en\/wp-json\/wp\/v2\/pages\/"}],"about":[{"href":"https:\/\/mkobro.de\/en\/wp-json\/wp\/v2\/types\/page\/"}],"author":[{"embeddable":true,"href":"https:\/\/mkobro.de\/en\/wp-json\/wp\/v2\/users\/3\/"}],"replies":[{"embeddable":true,"href":"https:\/\/mkobro.de\/en\/wp-json\/wp\/v2\/comments\/?post=4892"}],"version-history":[{"count":2,"href":"https:\/\/mkobro.de\/en\/wp-json\/wp\/v2\/pages\/4892\/revisions\/"}],"predecessor-version":[{"id":4974,"href":"https:\/\/mkobro.de\/en\/wp-json\/wp\/v2\/pages\/4892\/revisions\/4974\/"}],"wp:attachment":[{"href":"https:\/\/mkobro.de\/en\/wp-json\/wp\/v2\/media\/?parent=4892"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}