OCT’s Sponsor Successfully Passes Regulatory Inspection and Receives a GMP Certificate

A major Chinese Sponsor, client of OCT, has successfully passed the Good Manufacturing Practice (GMP) test in China. The procedure was carried out by the State Institute of Medicines and Good Practices of the Ministry of Industry and Trade of the Russian Federation.

The inspection, which took place in January 2024, involved a comprehensive checkup of the Sponsor's production site for compliance with GMP standards. OCT played a key role in supporting the Sponsor at all stages of the inspection with our representative providing the Chinese Sponsor with all necessary assistance, including answering questions from Russian inspectors regarding theoretical aspects of submitted documentation. Successful completion of the inspection allowed the Sponsor to obtain the GMP certificate required for registration of medicines in the Russian Federation on June 5, 2024.

OCT has extensive experience in assisting in the preparation of GMP dossiers and achieving positive results during regulatory inspections. In recent years, OCT registration specialists have helped other companies from Asia, namely South Korea and Japan, to obtain GMP certificates.