The International Council for Harmonisation (ICH) recently published the long-awaited draft guideline on continuous manufacturing. This new ICH Q13 guideline aims to establish harmonized scientific and technical requirements needed to fulfill regulatory expectations for development, implementation and lifecycle management during CM.
Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.
ICH Q13 consists of a main guideline and five annexes; the guideline discusses different models of continuous manufacturing and reviews control strategy and regulatory considerations.
In summary, Q13 covers similar topics as the FDA's drafted Quality Considerations for Continuous Manufacturing, Guidance for Industry, specifically:
- Definition of Batch/Lot
- Control Strategy (Process Dynamics, Material Characterization, Equipment Design, Process Monitoring and Control, Material Diversion, and Process Modeling)
- Changes in Production Output (Scale-up Considerations)
- Process Validation
- Pharmaceutical Quality Systems
- Location of Continuous Manufacturing Specific Information in the eCTD
Public comments are now being collected and will be reviewed at a face-to-face meeting in November 2021, where steps will then be taken to sign off on the document in November 2022.