A significant shift towards continuous manufacturing (CM) is currently underway in the pharmaceutical industry. Unlike the more commonly used batch processing, CM operates continuously. This method potentially offers increased efficiency, agility, and flexibility in the manufacturing of drug substances and products, potentially leading to superior product quality and expedited market access. In July 2023, the ICH Q13 guideline from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) was implemented in Europe. This guideline outlines a comprehensive approach for the development, implementation, operation, and lifecycle management of continuous manufacturing, integrating concepts from other ICH guidelines (e.g., ICH Q1, Q5, Q7, Q8, Q9, Q10, Q11, and Q12) specifically tailored to continuous manufacturing.

• QbD Group

• Process Control
• Regulatory

1. Material traceability
2. Other
3. process control
4. Process dynamics
5. process models
6. Process Validation
7. regulatory
8. system integration