元素不純物のリスクアセスメント - jpma.or.jp

1 ICH . ich q3d IWG . ICH Q3 Q3D training module 5. Risk Assessment 5.. ich q3d .. EU .. Module .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 2. Q3D training module 5. Risk Assessment . ICH .. ICH ICH.. ICH .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 3. Q3D training module 5. Risk Assessment . ich q3d .. o .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 4. Q3D training module 5. Risk Assessment .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 5.

2 Q3D training module 5. Risk Assessment . ich q3d .. PDE .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 6. Q3D training module 5. Risk Assessment .. * . * .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 7. Q3D training module 5. Risk Assessment .. o .. o . o .. o . o . o . 5-1 .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 8. Q3D training module 5. Risk Assessment Q3D 5-1 .. Cd 1 . Pb 1 . As 1 . Hg 1 . Co 2A . V 2A . Ni 2A.

3 TI 2B . Au 2B . Pd 2B . lr 2B . Os 2B . Rh 2B . Ru 2B . Se 2B . Ag 2B . Pt 2B . Li 3 . Sb 3 . Ba 3 . Mo 3 . Cu 3 . Sn 3 . Cr 3 .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 9. Q3D training module 5. Risk Assessment .. 1 2a . 3 . 2b .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 10. Q3D training module 5. Risk Assessment .. Q3D .. PDE. 30%.. PDE . PDE . PDE .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 11. Q3D training module 5.

4 Risk Assessment .. Q3D . 2B .. 3 . Li Sb Ba Mo Cu Sn Cr Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 12. Q3D training module 5. Risk Assessment .. GMP .. Pb TiO2 1 g TiO2 10 mg 1%. TiO2 TiO2 Pb 1 10 g/g Pb . g/day Pb g/g . Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 13. Q3D training module 5. Risk Assessment .. PDE .. Pb K2CO3 1 g K2CO3 500 mg . K2CO3 Pb 1 8 g/g Pb . 4 ppm PDE 5 g/g . Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 14.

5 Q3D training module 5. Risk Assessment . PDE .. PDE . 2 .. Cd CaHPO4 750 mg CaHPO4 500 mg . Ca2 HPO4 Cd 8 9 g/g Cd . 6 g Cd PDE 5 g/day . Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 15. Q3D training module 5. Risk Assessment .. GMP .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 16. Q3D training module 5. Risk Assessment .. o .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 17. Q3D training module 5. Risk Assessment .. GMP.

6 Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 18. Q3D training module 5. Risk Assessment .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 19. Q3D training module 5. Risk Assessment .. 1 .. 1 .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 20. Q3D training module 5. Risk Assessment . Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 21. Q3D training module 5. Risk Assessment.

7 * .. * .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 22. Q3D training module 5. Risk Assessment .. o .. o .. 3 6 .. o .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 23. Q3D training module 5. Risk Assessment .. o . - .. - . o . - .. - .. - 1 .. o . o . Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 24. Q3D training module 5. Risk Assessment 1 .. As .. As .. pH .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 25.

8 Q3D training module 5. Risk Assessment . 3 6 .. = ( ( g)/g) ( g/day). PDE 1 . o . o .. 1 ICH. Q3D AL AL . 1 . Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 26. Q3D training module 5. Risk Assessment PDE . PDE 30% .. PDE PDE .. PDE . PDE . PDE .. - Q3D 2 .. AL . AL 1 . Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 27. Q3D training module 5. Risk Assessment . Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 28. Q3D training module 5.

9 Risk Assessment .. * .. ^ . 3 .. ^ . ^ .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 29. Q3D training module 5. Risk Assessment .. GMP .. o . o . GMP .. o . o . o .. o .. o . Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 30. Q3D training module 5. Risk Assessment .. GMP .. o . o . o .. o . o Cr Mn Mo V Ni .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 31. Q3D training module 5. Risk Assessment .. o Jenke, D. , A Compilation of Metals and Trace Elements Extracted from Materials Relevant to Pharmaceutical Applications Such as Packaging Systems and Devices , PDA J.

10 Pharm. Sci. Technol., 67(4):354-75, 2013.. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 32. Q3D training module 5. Risk Assessment .. As .. As .. pH .. Prepared by the Q3D Implementation Working Group for example only; not an official policy/guidance ICH 2015 33. Q3D training module 5. Risk Assessment .. o 1,2.. As Pb .. o . o . 1 Morman SA, Plumlee GS, Smith DB (2009) Application of in vitro extraction studies to evaluate element bioaccessibility in soils from a transect across the United States and Canada, Applied Geochemistry 24, 1454 1463. 2 Oomen AG, Hack A, Minekus M, Zeijdner E, Cornelis C, Schoeters G, Verstraete W,Van de Wiele T, Wragg J, Rompelberg CJM, Sips A, Van Wijnen JH, (2002) Comparison of five in vitro digestion models to study the bioaccessibility of soil contaminants.