OCT provides GMP inspection support to ensure that clinical development follows all international standards
Even though the standards for production and quality control are mostly unified at a global level, international inspections contribute to a more effective and open collaboration, experience exchange and a unified system of quality, cgiven that there are a variety of approaches and a lack of trust among the regulators from different countries. Following the trend, OCT offers its assistance by accompanying GMP inspection and certification for foreign sponsors.
Besides the strengthening of mutual trust and international interaction at the level of regulatory entities, accompanying GMP inspection increases export potential, since the next steps for any potential sponsor after successfully gaining certification are the registration of the drug and its launch into the local market. Obtaining the Russian GMP-Certificate is also necessary for foreign manufacturers whose drug products are already registered and circulate in Russia, when essential amendments are introduced into the Dossier of Registered Drug Products.
Our in-house experts possess broad expertise in assisting and accompanying comprehensive audits of manufacturing lines, quality control laboratories and storage facilities, as well as of workflow and the pharmaceutical quality system in manufacturing, in order to help our clients to be fully prepared for future inspection. We offer our services for collection and preparation of the application documents, perform any types of submissions to the Regulatory authorities and provide exhaustive support to our clients from the start of the project until receiving the GMP Certificate issued by Russian authorities.
Given the growth and relevance of globalization in the production of medicines and pharmaceutical substances, this practice contributes to the convergence of national approaches, deepening cooperation among regulators, and mutual recognition of results, as well as raising pharmaceutical quality standards.
OCT provides this service to our foreign sponsors both as part of a package and as a stand-alone option.
We assist our clients in:
• Preparation of the manufacturing site and manufacturing documentation for Russian GMP Inspection;
• Collection, writing and submission of application documents for conducting the Russian GMP Inspection;
• Communication with Russian authorities responsible for the conducting of inspection and preparation of answers to authorities` questions and requests;
• Comprehensive support of manufacturers during preparation and initiation of GMP inspection by Russian authorities (including support at the manufacturing site) until the Russian GMP Certificate is obtained.
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