cGMP Quality Management System

Based on the cGMP requirements of Chinese CMP (2010), ICH Q7, 21 CFR Part 210 & 211 and Part 11, EudraLex – Volume 4, etc, RiboBio has utilized risk management tool while combining with nucleic acid drug production process for clinical research to establish the complete cGMP quality management system. It also ensures that all production meet the cGMP and registration requirements to fulfill the quality requirements for treatment or diagnostic oligonucleotide-based API manufacturing.

In 2016, RiboBio obtained China’s first CFDA-approved cGMP oligonucleotide API production license, and has passed over 30 times of GMP audit from global customers.