OCT Clinical accompanied its first remote inspection for the Korean innovation-driven pharmaceutical company Handok Inc. in order for it to obtain the Russian GMP certificate. The decision to launch a new, remote format of inspections was made due to the absence of regular flights between the countries and the implementation of COVID-19 social distancing measures that limit the number of staff at a manufacturing site.
Therefore, all documentation was provided by Handok Inc. team and was prepared in accordance with Russian requirements and submitted to Russian Regulatory Authorities by OCT Clinical team. The inspection itself was carried out via videoconference. Throughout the inspection the manufacturer demonstrated production facilities, areas of storage of pharmaceutical substances, completed medicinal products, a laboratory of internal manufacturing control, areas of engineering systems, and support areas.
The manufacturing site has successfully completed a GMP inspection with zero deficiencies cited. Handok Inc company received a certificate which confirms the company's full compliance with quality and production requirements, and specifications of the Russian pharmaceuticals market.
Quote from the Sponsor: We are very happy with the result of this initiative. We appreciate OCT Clinical’s role in securing our GMP certificate for the Russian market. Considering the current global situation, it is quite outstanding that they were able to carry out all required services and provide comprehensive support for the remote inspection.
Tatyana Goryushkina, Registration Manager at OCT Сlinical, said: The implementation of such a remote approach to conduct an inspection using advanced technologies turned out to be an appropriate temporary solution in consideration of the pandemic.