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1 WEB 8 17 GMP GMP GMP GMP ISPE GMP GMP 16 GMP GMP PAT GMP WEB 9 ICH Q8 ICH Q9 17 4 3 GMP

2 14 3 GMP GMP GMP GMP ICH 2 2 C1 16 GMP GMP GMP GMP GMP GMP GMP 10 GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP GMP

3 GMP ICH Q7A GMP GMP GMP GMP GMP GMP GMP GMP GMP ICH Q7A 1 2 GMP GMP GMP GMP GMP GMP 14 GMP GMP GMP GMP GMP GMP 16 GMP 11 GMP C2 ICH ISPE GMP 17 9 AAPS 10 PAT(Process Analytical Technology)

4 9 5 GMP 7 GMP 11 PAT GMP ISPE GMP GMP ICH US-FDA ISPE 10 5 7 US-FDA EU A Pharmaceutical Development, PD PD B CMC CMC Regulatory Process C CMC CMC D Communication E Design Space.

5 DS F QbD Quality by Design Wyeth Research QbD Abbott G QOS Quality Overall Summary H I 12 J GMP CMC GMP K QbD CMC L QbD Schering-Plough Research Institute Glaxo Smith Kline PAT/QbD QOS Quality Overall Summary 12 ICHQ8 2 PAT(Process Analytical Technology) PAT GMP PAT(Process Analytical Technology)

6 PAT 10 4 Division of Product Quality Research, White Oak Life Science Building, Silver Spring, Maryland Division of Product Quality Research Chemistry team, Physical pharmacy team, Biopharmaceutics team Support, Policy, Safety, Industrization, Post market, Risk management Research Regulatory Policy Review and Regulation Research Critical Path Research GMP GMP GMP GMP 13

7 ICH 2005 6 Quality System Q10 GMP ICH Q 3 FDA FDA GMP GMP GMP GMP GMP PHARMA TECH JAPAN, 21, 1365-1376(2005) GMP 37(1) 42-56 (2006) Q9- 37(2) 131-139 (2006) 2005 4 Process Analytical Technology 2005 5 Process Analytical 14 Technology GMP 2005 7 GMP/ QA GCP GMP - - QA GCP GMP 17 10 17 10 17 11 15 2005 11 GMP 2005 11 ( )

8 17 12 14 GMP 18 2 126 18 3 Yukio Hiyama, Global GMP Harmonization- Japanese Perspective ISPE European GMP Conference, 2005 9 Yukio Hiyama, Japanese CMC Review System with Quality overall Summary AAPS/FDA/ISPE workshop on CMC Assessment, 2005 10 GMP Guideline for Drug Products 2004 version Guideline for Technology Transfer 2004 version ISPE . ISPE Prague September 19-21 2005 AAPS workshop on Pharm Quality Assessment AAPS Workshop Breakout Session G : QOS 1 GMP GMP GMP 1 2.

9 5 .. 5 .. 5 .. 5 .. 6 .. 7 .. 7 .. 8 .. 8 .. 9 .. 9 .. 9 .. 9 ..10 .. 10 .. 11 .. 11 .. 12 .. 12 .. 12 .. 13 .. 14 .. 14 .. 15 .. 15 .. 16 .. 16 .. 17 .. 17 .. 18 .. 18 .. 18 .. 19 .. 20 3 ..20 .. 21 .. 21 .. 21 .. 22 .. 22 .. 23 .. 23 .. 23 .. 23 .. 24 .. 24 .. 24 .. 25 .. 25 .. 25 .. 26.

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