OCT specialists have great expertise in providing for a comprehensive audit of production lines, quality control laboratories and warehouses, as well as document management and pharmaceutical quality systems in production facilities. Our services are provided for the collection and preparation of a complete package of documents for submitting various kinds of applications to regulatory authorities and fully-fledged customer support is provided from the start of the project until the ultimate goal obtaining a Russian GMP certificate.
Given the growth and relevance of globalization in the production of medicines and pharmaceutical substances, such inspection practices contribute to the convergence of national approaches, by deepening cooperation between regulatory authorities, promoting mutual recognition of results and improving pharmaceutical quality standards.
GMP inspection support for international Sponsors is carried out both within the framework of turnkey projects and standalone services.
We assist our clients in the following areas:
- Preparation of production lines and documentation for the Russian\EAEU GMP inspection;
- Collection, writing and submission of documents for the Russian\EAEU GMP inspection;
- Interaction with local authorities responsible for inspection and preparation of responses to requests sent by these authorities;
- Full-fledged support of the manufacturer during the preparation and start of the GMP inspection by local regulatory bodies (including support at the production site) up to the moment when the Sponsor obtains the respective GMP certification.
