Oligonucleotide Manufacturing Process Development
Analytical Methods
& Stability Study
Manufacturing for Clinical Phases
Manufacturing for Commercial Phases
Preparation, aseptic filling or
Validation & Quality

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.

Our quality management system includes but not limited to:

●  Personnel and Training Management
●  Material Supplier and Release Management
●  Process Control
●  Validation of Facility and Equipment Confirmation
●  Lab Quality Control
●  Product Release Management System
●  Deviation, Modification, CAPA, Internal Audit, etc

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.

Guangzhou RiboBio Co., Ltd.
Address:13-14/F, Innovation Building C3, 182 Kexue Avenue, Science Park
Guangzhou 510663, China
Service hotline:400-686-0075

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