CDMO may request certifications of up to 9 currently defined Systems per manufacturing site, as described on the Systems and Certification Criteria page.
- For a Capability to be certified, CDMO must demonstrate compliance with all associated Criteria.
- If a CDMO demonstrates all Capabilities for a given System, the System will be “Fully Certified”.
- If most, but not all Capabilities are demonstrated, the System will be “Conditionally Certified”, at Inspector’s discretion.
- A given System can only be “Conditionally Certified” once and will subsequently need to meet the requirements of “Fully Certified” in order to be certified.
- If most or all Capabilities are not demonstrated, or the certification of the System is not requested by the CDMO, the System will be “Not Certified”.
- Certification of Commercial Readiness requires all 9 currently defined Systems to be “Fully Certified”.
