Quality System
Extensive certification through all stages
Chime Biologics’ Quality System is based on regulatory expectation and we follow the laws, regulations and rules for CMC activities, including:
- Requirements of US 21 CFR Part 210, 211, and 600 governing Good Manufacturing Practices (“cGMP”)
- Requirements of US 21 CFR Part 11 governing computerized systems used in the processing of drugs
- Rules Governing Medicinal Product in the EU (EudraLex)
- Requirements of China NMPA Good Manufacturing Practices
- Applicable ICH Guidelines
We foster a culture and process for continuous improvement of Compliance, Science and Risk-Based. The components of quality system is shown below. Our system is ready to meet the high expectations of our clients with commercial drug products but yet is flexible and adaptable to meet the cGMP compliance expectations for clinical phrase drug development.
