平成23年度厚生労働科学研究費補助金 ― Quality by Designの …

1 1 23 Quality by Design EU (ICH) Quality by Design ( ) CTD 2 ( ) ICH Q11 PMDA ( ) ( )

2 ( )HS ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) 2 ( ) ( ) ( ) ( ) ( ) PMDA PMDA PMDA PMDA PMDA PMDA PMDA A. EU (ICH) Q (Q8 Q9 Q10) ICH ICH Q11 2008 6 2012 4 4 Q11 Q

3 3 ICH 21 22 21 ( ) CTD 2 ICH Q11 4 Q11 22 (QbD) QbD ICH Q8(R2) B.

4 PMDA QbD Torcetrapib HP 6 9 5 2011 6 29 9 27 12 6 2012 1 19 3 27 2 2012 1 13 3 15 ICH 1) Q8(R2) , 2) Q9 , 3) Q10 4) (Q&A) 5 ICH Quality IMPLEMENTATION WORKING GROUP POINTS TO CONSIDER (R2) ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation 6 17 2 10 0210001 EU C.

5 I CQA Q11 CQA QTPP CQA QTPP CQA ICH Q8 CQA CQA QTPP CQA Q11 Q11 Q11 5 22 II 2 QbD CTD CTD Q11

6 ICH M4Q The description of the drug substance manufacturing process represents the applicant s commitment for the manufacture of the drug substance. Information should be provided to adequately describe the manufacturing process and process controls (see ICH M4Q ( ).) CTD 6 SOP

7 SOP GMP QbD ICH Q-IWG Points to Consider.

8 Relationship between risk and criticality criticality severity probability detectability QA criticality 7 PP criticality CQA CQA QbD No impact CQA CQA Q8 CPP CPP CQA CQA CQA CPP No impact 3 CPP CPP CPP

9 No impact CPP 8 CQA ICH Q8(R2) QTPP ICH Q8(R2) 30 17 2 10 0210001 CPP ICH Q8(R2)

10 ICH Q8(R2) D. 9 QbD PA