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 the global level, international inspections contribute to a more effective and open collaboration, experience exchange and a unified system of quality, considering a variety of approaches and lack of trust among the regulators from different countries. Following the trend, OCT offers its assistance in accompanying GMP inspection and certification to the foreign sponsors.
Besides strengthening of mutual trust and international interaction at the level of regulatory entities, accompanying GMP inspection increases the export potential, since the next steps for any potential sponsor after successfully passing the certification are 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 in case of making any essential variations into the Dossier of registered drug product.
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 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 start of the project until receiving 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, mutual recognition of results, as well as raising pharmaceutical quality standards.
OCT provides this service to our foreign sponsors both in 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 conducting of inspection, preparation of answers to authorities` questions and requests;
• Comprehensive support of a manufacturer 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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