The Q13 Training Modules 1-12 aim to facilitate an aligned interpretation and a harmonised implementation of the ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products Guideline in ICH and non-ICH regions by:
- Illustrating the general concept of Continuous Manufacturing (CM) process operation;
- Providing detailed clarification of novel scientific concepts and regulatory expectations pertinent to CM;
- Expanding discussion of Annex I-V in Q13 to address some specific CM implementation aspects relevant for different modalities.
Further information can be found in the Q13 IWG Concept Paper and Video Training Modules 1-12:
- Module 1: Introduction and Training Overview
- Module 2: Batch Definition and Batch Size
- Module 3: State of Control and Steady State
- Module 4: Principles of Process Dynamics and Residence Time Distribution
- Module 5: Case-studies on Process Dynamics, Material Traceability, and Sampling Frequency
- Module 6: Case-studies on RTD Model Development and Setting Alarm Limits
- Module 7: General Pharmaceutical Quality System (PQS) Considerations for Continuous Manufacturing (CM)
- Module 8: Demonstration of Material Diversion
- Module 9: Process Monitoring and Control
- Module 10: Process Models
- Module 11: Drug Substance and Drug Product Stability
- Module 12: Batch to CM Conversion for Small Molecule Oral Solid
