Q13（ステップ5）
- 原薬及び製剤の連続生産に関するガイドライン [973.88KB]（2023年5月31日）
- （原文）Continuous Manufacturing of Drug Substances and Drug Products [1.04MB]
トレーニングマテリアル
Q13
- 「原薬及び製剤の連続生産に関するガイドライン」に関するトレーニングマテリアル
- Q13 Training Material Module 1 - Introduction and Training Overview
- Q13 Training Material Module 2 - Batch Definition and Batch Size
- Q13 Training Material Module 3 - State of Control and Steady State
- Q13 Training Material Module 4 - Principles of Process Dynamics and Residence Time Distribution
- Q13 Training Material Module 5 - Case-Studies on Process Development, Material Traceability and Sampling Frequency
- Q13 Training Material Module 6 - Case studies on RTD Model Development and Setting Alarm Limits
- Q13 Training Material Module 7 - General Pharmaceutical Quality System (PQS) Considerations for Continuous Manufacturing (CM)
- Q13 Training Material Module 8 - Demonstration of Material Diversion
- Q13 Training Material Module 9 - Process Monitoring and Control
- Q13 Training Material Module 10 - Process Models
- Q13 Training Material Module 11 - Drug Substance and Drug Product Stability
- Q13 Training Material Module 12 - Batch to CM Conversion for Small Molecule Oral Solid Dosage Forms