Transcription of 医薬品医療機器等法におけ ... - tokyo-eiken.go.jp
1 1 QMS GVP 2- 51 - QMS GVP 3 4- 52 - QMS pmda 5 QMS GQP 2 ISO13485 3 4 QMS QMS GVP GVP 5 QMS 6- 53 - QMS QMS 83 QMS GQP QMS GVP 114 60 2 3 7 QMS 8- 54 - QMS 1 3 1 4 2 5 9 3 10 20 4 21 25 5 26 53 6 54 64 4 64 65 72 73 79 80 81 82 849 QMS
2 ISO GQP 10- 55 -QMS / ISO 11 QMS 2 3 26 8 6 316 4 5 6 82 83 12- 56 -QMS QMS 13 QMS 4 30 31 32 33 4 23 2 5 1 23 2 23 1 30 36 34 35 36 14- 57 -QMS
3 20 2 20 3 20 1 2 15 QMS 6 2 12 13 18 23 24 38 1 2 63 64 6 2 23 1 2 4 5 24 1 38 1 2 63 16- 58 -QMS 83 83 1 2 5 49 2 3 69 72 3 83 2 69 72 3 6 2 24 17 QMS 82 82 2 3 49 2 3 65 69 72 3 18- 59 - QMS GQP 10 1 2 6 16 3 24 16 3 24 GVP 19 QMS GQP 3 4 8 9 10 3 4 11 12 7
4 21 22 23 20- 60 - 72 1 17 2 29 43 3 48 4 49 5 55 6 60 7 8 9 10 11 70 12 71 13 72 14 72 21 11 QMS GQP 22- 61 -QMS 23 QMS 24- 62 -QMS QMS QMS 25 QMS pmda
5 QMS QMS 69 QMS pmda QMS 69 QMS QMS QMS 26- 63 - 27 QMS QMS QMS QMS 28- 64 - 3 4 3 4 1 4 2 29 26 9 11 0911 1 30- 65 - 31 QMS 32- 66 - 3 1 NoQMS 1 5 5 6 6 1 7 6 2 9 7 1 8
6 9 33 3 1 NoQMS 10 7 2 8 1 3 12 8 2 14 8 4 67 15 9 1 16 9 2 17 9 3 68 No29 36 34- 67 - 3 2 NoQMS 18 2 16 19 10 20 16 1 21 16 2 16 2 35 3 2 NoQMS 22 23 2 14 1 23 23 2 14 2 24 71 1 71 1 25 28 72 1 4 GQP 4 3 9 12 No37 43 36- 68 - GVP 37 GVP 98 2 3 4 114 60 2 3 137 60 2 3 26 10 24 1024 2 1024 1 1024 9 1024 15 114 61 26 9 1 17 2 10 24 49 1 38- 69 -GVP GVP 2
7 39 GVP 40- 70 - 41 GVP QMS 26 7 30 87 9 GVP 3 29 11 24 10 2 10 1 QMS QMS 30 36 42- 71 - ISO13485:2003 Control of d o c um e n t s 15 2 4 2 5 2 5 2 5 2 6 2 8 3 0 38 4 0 4 0 41 4 2 4 3 5 2 52 6 0 6 0 1 0 6 2
8 25 30 37 4 0 4 3 4 5 46 47 47 4 8 52 5 2 5 3 5 5 5 6 6 0 61 62 6 2 63 64 - 72 - ISO13485:2003 Control of records 18 2 3 2 4 26 28 3 1
