Transcription of 平成 28 年度 医薬品の連続生産に ... - nihs.go.jp
1 28 Points to Consider 1 Points to Consider Continuous Manufacturing
2 2 QbD Real Time Release Testing RTRT PAT RTRT 3 I Control Strategy 22 2 19 0219 1 0219 1 ICH Q10 22 6 28 0628 1 2
3 ICH Q8(R2) CQA 1. PAR PAT Performance based Approach
4 P2 CMA 4 Fitness for Purpose 2. State of Control PAT State of Control PAT RTD State of Control
5 State of Control State of Control PAT 5 3. QbD ICH Q8(R2) RTRT / ICH Q8(R2) CQA ICH Q8(R2) PAR ICH Q8(R2) PAT / ICH Q8(R2)
6 Action Limits ICH Q6B State of Control ICH Q10 Performance based Approach PAT Fitness for Purpose P2 ICH Q8 Q9 Q10 Quality by Design CTD 6 II 1. GMP 13 11 2 1200 ICH Q7 State of Control 2 1 2 3 PAT State of Control
7 7 III PV (1) (2) 1. 2. State of Control 1 3.
8 3 3 NDA 8 4. 1 5.
9 Continuous Process Verification 3 GMP GMP13-53 3 6. 7. ICH Q8(R2) 9 IV 1 State of Control 2
