1.\u8981\u65e8<\/p>\n
1.1.\u4e16\u754c\u5e02\u5834\u306e\u5c55\u671b<\/p>\n
1.2.\u9700\u8981\u30b5\u30a4\u30c9\u306e\u52d5\u5411<\/p>\n
1.3.\u4f9b\u7d66\u30b5\u30a4\u30c9\u306e\u52d5\u5411<\/p>\n
1.4.\u6280\u8853\u30ed\u30fc\u30c9\u30de\u30c3\u30d7\u5206\u6790<\/p>\n
1.5.\u5206\u6790\u3068\u63d0\u8a00<\/p>\n
2.\u5e02\u5834\u6982\u8981<\/p>\n
2.1.\u5e02\u5834\u7bc4\u56f2\uff0f\u5206\u985e<\/p>\n
2.2.\u5e02\u5834\u306e\u5b9a\u7fa9\uff0f\u7bc4\u56f2\uff0f\u5236\u9650<\/p>\n
3.\u5e02\u5834\u306e\u80cc\u666f<\/p>\n
3.1.\u5e02\u5834\u30c0\u30a4\u30ca\u30df\u30af\u30b9<\/p>\n
3.1.1.\u30c9\u30e9\u30a4\u30d0\u30fc<\/p>\n
3.1.2.\u5236\u7d04\u4e8b\u9805<\/p>\n
3.1.3.\u6a5f\u4f1a<\/p>\n
3.1.4.\u30c8\u30ec\u30f3\u30c9<\/p>\n
3.2.\u30b7\u30ca\u30ea\u30aa\u4e88\u60f3<\/p>\n
3.2.1.\u697d\u89b3\u30b7\u30ca\u30ea\u30aa\u306b\u304a\u3051\u308b\u9700\u8981<\/p>\n
3.2.2.\u53ef\u80fd\u6027\u306e\u9ad8\u3044\u30b7\u30ca\u30ea\u30aa\u306b\u304a\u3051\u308b\u9700\u8981<\/p>\n
3.2.3.\u4fdd\u5b88\u7684\u30b7\u30ca\u30ea\u30aa\u306b\u304a\u3051\u308b\u9700\u8981<\/p>\n
3.3.\u6a5f\u4f1a\u30de\u30c3\u30d7\u5206\u6790<\/p>\n
3.4.\u6295\u8cc7\u53ef\u80fd\u6027\u30de\u30c8\u30ea\u30c3\u30af\u30b9<\/p>\n
3.5.PESTLE\u5206\u6790\u3068\u30dd\u30fc\u30bf\u30fc\u5206\u6790<\/p>\n
3.6.\u898f\u5236\u306e\u72b6\u6cc1<\/p>\n
3.6.1.\u4e3b\u8981\u5730\u57df\u5225<\/p>\n
3.6.2.\u4e3b\u8981\u56fd\u5225<\/p>\n
3.7.\u5730\u57df\u5225\u89aa\u4f1a\u793e\u5e02\u5834\u306e\u5c55\u671b<\/p>\n
4.GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306e\u4e16\u754c\u5e02\u5834\u5206\u67902017-2021\u5e74\u304a\u3088\u3073\u4e88\u6e2c\u30012022-2032\u5e74<\/p>\n
4.1.\u904e\u53bb\u306e\u5e02\u5834\u898f\u6a21\uff08US$ Mn\uff09\u5206\u6790\u30012017-2021\u5e74<\/p>\n
4.2.2022\uff5e2032\u5e74\u306e\u73fe\u5728\u3068\u5c06\u6765\u306e\u5e02\u5834\u898f\u6a21\u4e88\u6e2c\uff08US$ Mn\uff09<\/p>\n
4.2.1.\u524d\u5e74\u6bd4\u6210\u9577\u30c8\u30ec\u30f3\u30c9\u5206\u6790<\/p>\n
4.2.2.\u7d76\u5bfe\u4fa1\u683c\u6a5f\u4f1a\u5206\u6790<\/p>\n
5.GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306e\u4e16\u754c\u5e02\u5834\u5206\u67902017-2021\u5e74\u304a\u3088\u3073\u4e88\u6e2c2022-2032\u5e74\u3001\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
5.1.\u306f\u3058\u3081\u306b\uff0f\u4e3b\u306a\u8abf\u67fb\u7d50\u679c<\/p>\n
5.2.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225\u306e\u904e\u53bb\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u5206\u6790\u30012017\u5e74\uff5e2021\u5e74<\/p>\n
5.3.2022\u5e74\uff5e2032\u5e74\u306e\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u5206\u6790\u3068\u5c06\u6765\u4e88\u6e2c<\/p>\n
5.3.1.\u88fd\u54c1\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a66\u9a13<\/p>\n
5.3.2.\u30d0\u30a4\u30aa\u5206\u6790\u30b5\u30fc\u30d3\u30b9<\/p>\n
5.3.3.\u5305\u88c5\u3068\u8cde\u5473\u671f\u9650\u8a66\u9a13<\/p>\n
5.3.4.\u305d\u306e\u4ed6\u306e\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7<\/p>\n
5.4.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225\u524d\u5e74\u6bd4\u6210\u9577\u30c8\u30ec\u30f3\u30c9\u5206\u6790\uff082017\uff5e2021\u5e74<\/p>\n
5.5.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225\u7d76\u5bfe\u4fa1\u683c\u6a5f\u4f1a\u5206\u6790\u30012022-2032\u5e74<\/p>\n
6.GMP\u691c\u67fb\u30b5\u30fc\u30d3\u30b9\u306e\u4e16\u754c\u5e02\u5834\u5206\u67902017-2021\u5e74\u304a\u3088\u3073\u4e88\u6e2c2022-2032\u5e74\uff1a\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
6.1.\u306f\u3058\u3081\u306b\uff0f\u4e3b\u306a\u8abf\u67fb\u7d50\u679c<\/p>\n
6.2.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225\u306e\u904e\u53bb\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u5206\u6790\u30012017\u5e74\uff5e2021\u5e74<\/p>\n
6.3.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225\u5e02\u5834\u898f\u6a21\u306e\u73fe\u5728\u3068\u5c06\u6765\uff082022\uff5e2032\u5e74\uff09\u306e\u5206\u6790\u30fb\u4e88\u6e2c\uff08US$ Mn<\/p>\n
6.3.1.\u88fd\u85ac\u4f1a\u793e\u304a\u3088\u3073\u30d0\u30a4\u30aa\u88fd\u85ac\u4f1a\u793e<\/p>\n
6.3.2.\u533b\u7642\u6a5f\u5668\u4f01\u696d<\/p>\n
6.4.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225\u524d\u5e74\u6bd4\u6210\u9577\u30c8\u30ec\u30f3\u30c9\u5206\u6790\uff082017\uff5e2021\u5e74<\/p>\n
6.5.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225\u7d76\u5bfe\u4fa1\u683c\u6a5f\u4f1a\u5206\u6790\u30012022\uff5e2032\u5e74<\/p>\n
7.GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306e\u4e16\u754c\u5e02\u5834\u5206\u67902017-2021\u5e74\u304a\u3088\u3073\u4e88\u6e2c2022-2032\u5e74\u3001\u5730\u57df\u5225<\/p>\n
7.1.\u306f\u3058\u3081\u306b<\/p>\n
7.2.\u5730\u57df\u5225\u306e\u904e\u53bb\u306e\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u5206\u6790\u30012017-2021\u5e74<\/p>\n
7.3.\u5730\u57df\u5225\u306e\u73fe\u5728\u306e\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u5206\u6790\u3068\u4e88\u6e2c\u30012022-2032\u5e74<\/p>\n
7.3.1.\u5317\u7c73<\/p>\n
7.3.2.\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab<\/p>\n
7.3.3.\u30e8\u30fc\u30ed\u30c3\u30d1<\/p>\n
7.3.4.\u30a2\u30b8\u30a2\u592a\u5e73\u6d0b<\/p>\n
7.3.5.MEA<\/p>\n
7.4.\u5730\u57df\u5225\u5e02\u5834\u9b45\u529b\u5ea6\u5206\u6790<\/p>\n
8.\u5317\u7c73\u306eGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u5206\u67902017-2021\u5e74\u304a\u3088\u3073\u4e88\u6e2c2022-2032\u5e74\uff08\u56fd\u5225<\/p>\n
8.1.\u5e02\u5834\u5206\u985e\u5225\u904e\u53bb\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u52d5\u5411\u5206\u6790\uff082017-2021\u5e74<\/p>\n
8.2.\u5e02\u5834\u5206\u985e\u5225\u5e02\u5834\u898f\u6a21\uff08\u767e\u4e07\u7c73\u30c9\u30eb\uff09\u4e88\u6e2c\u30012022-2032\u5e74<\/p>\n
8.2.1.\u56fd\u5225<\/p>\n
8.2.1.1.\u7c73\u56fd<\/p>\n
8.2.1.2.\u30ab\u30ca\u30c0<\/p>\n
8.2.2.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
8.2.3.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
8.3.\u5e02\u5834\u9b45\u529b\u5ea6\u5206\u6790<\/p>\n
8.3.1.\u56fd\u5225<\/p>\n
8.3.2.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
8.3.3.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
8.4.\u30ad\u30fc\u30dd\u30a4\u30f3\u30c8<\/p>\n
9.\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab\u306eGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u5206\u67902017-2021\u5e74\u304a\u3088\u3073\u4e88\u6e2c2022-2032\u5e74\uff1a\u56fd\u5225<\/p>\n
9.1.\u5e02\u5834\u5206\u985e\u5225\u904e\u53bb\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u52d5\u5411\u5206\u6790\uff082017\uff5e2021\u5e74<\/p>\n
9.2.\u5e02\u5834\u5206\u985e\u5225\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u4e88\u6e2c\u30012022-2032\u5e74<\/p>\n
9.2.1.\u56fd\u5225<\/p>\n
9.2.1.1.\u30d6\u30e9\u30b8\u30eb<\/p>\n
9.2.1.2.\u30e1\u30ad\u30b7\u30b3<\/p>\n
9.2.1.3.\u305d\u306e\u4ed6\u306e\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab<\/p>\n
9.2.2.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
9.2.3.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
9.3.\u5e02\u5834\u9b45\u529b\u5ea6\u5206\u6790<\/p>\n
9.3.1.\u56fd\u5225<\/p>\n
9.3.2.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
9.3.3.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
9.4.\u8981\u70b9<\/p>\n
10.\u6b27\u5ddeGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u5206\u67902017-2021\u5e74\u304a\u3088\u3073\u4e88\u6e2c2022-2032\u5e74\uff08\u56fd\u5225<\/p>\n
10.1.\u5e02\u5834\u5206\u985e\u5225\u904e\u53bb\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u52d5\u5411\u5206\u6790\u30012017\u5e74\uff5e2021\u5e74<\/p>\n
10.2.\u5e02\u5834\u5206\u985e\u5225\u5e02\u5834\u898f\u6a21\uff08\u767e\u4e07\u7c73\u30c9\u30eb\uff09\u4e88\u6e2c\u30012022-2032\u5e74<\/p>\n
10.2.1.\u56fd\u5225<\/p>\n
10.2.1.1.\u30c9\u30a4\u30c4<\/p>\n
10.2.1.2.\u82f1\u56fd<\/p>\n
10.2.1.3.\u30d5\u30e9\u30f3\u30b9<\/p>\n
10.2.1.4.\u30b9\u30da\u30a4\u30f3<\/p>\n
10.2.1.5.\u30a4\u30bf\u30ea\u30a2<\/p>\n
10.2.1.6.\u305d\u306e\u4ed6\u306e\u30e8\u30fc\u30ed\u30c3\u30d1<\/p>\n
10.2.2.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
10.2.3.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
10.3.\u5e02\u5834\u9b45\u529b\u5ea6\u5206\u6790<\/p>\n
10.3.1.\u56fd\u5225<\/p>\n
10.3.2.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
10.3.3.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
10.4.\u30ad\u30fc\u30dd\u30a4\u30f3\u30c8<\/p>\n
11.\u30a2\u30b8\u30a2\u592a\u5e73\u6d0b\u5730\u57df\u306eGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u5206\u67902017-2021\u5e74\u304a\u3088\u3073\u4e88\u6e2c2022-2032\u5e74\uff08\u56fd\u5225<\/p>\n
11.1.\u5e02\u5834\u5206\u985e\u5225\u904e\u53bb\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u52d5\u5411\u5206\u6790\uff082017\uff5e2021\u5e74<\/p>\n
11.2.\u5e02\u5834\u5206\u985e\u5225\u5e02\u5834\u898f\u6a21\uff08\u767e\u4e07\u7c73\u30c9\u30eb\uff09\u4e88\u6e2c\u30012022-2032\u5e74<\/p>\n
11.2.1.\u56fd\u5225<\/p>\n
11.2.1.1.\u4e2d\u56fd<\/p>\n
11.2.1.2.\u65e5\u672c<\/p>\n
11.2.1.3.\u97d3\u56fd<\/p>\n
11.2.1.4.\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb<\/p>\n
11.2.1.5.\u30bf\u30a4<\/p>\n
11.2.1.6.\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2<\/p>\n
11.2.1.7.\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2<\/p>\n
11.2.1.8.\u30cb\u30e5\u30fc\u30b8\u30fc\u30e9\u30f3\u30c9<\/p>\n
11.2.1.9.\u305d\u306e\u4ed6\u306e\u30a2\u30b8\u30a2\u592a\u5e73\u6d0b\u5730\u57df<\/p>\n
11.2.2.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
11.2.3.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
11.3.\u5e02\u5834\u9b45\u529b\u5ea6\u5206\u6790<\/p>\n
11.3.1.\u56fd\u5225<\/p>\n
11.3.2.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
11.3.3.\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
11.4.\u4e3b\u8981\u9805\u76ee<\/p>\n
12.MEA\u306eGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u5206\u67902017-2021\u5e74\u304a\u3088\u3073\u4e88\u6e2c2022-2032\u5e74\uff1a\u56fd\u5225<\/p>\n
12.1.\u5e02\u5834\u5206\u985e\u5225\u904e\u53bb\u5e02\u5834\u898f\u6a21\u91d1\u984d\uff08US$ Mn\uff09\u52d5\u5411\u5206\u6790\u30012017\u5e74\uff5e2021\u5e74<\/p>\n
12.2.\u5e02\u5834\u5206\u985e\u5225\u5e02\u5834\u898f\u6a21\uff08\u767e\u4e07\u7c73\u30c9\u30eb\uff09\u4e88\u6e2c\u30012022-2032\u5e74<\/p>\n
12.2.1.\u56fd\u5225<\/p>\n
12.2.1.1.GCC\u8af8\u56fd<\/p>\n
12.2.1.2.\u5357\u30a2\u30d5\u30ea\u30ab<\/p>\n
12.2.1.3. \u30a4\u30b9\u30e9\u30a8\u30eb<\/p>\n
12.2.1.4. \u305d\u306e\u4ed6\u306eMEA\u8af8\u56fd<\/p>\n
12.2.2. \u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
12.2.3. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
12.3 \u5e02\u5834\u9b45\u529b\u5ea6\u5206\u6790<\/p>\n
12.3.1. \u56fd\u5225<\/p>\n
12.3.2. \u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
12.3.3. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
12.4 \u91cd\u8981\u306a\u30dd\u30a4\u30f3\u30c8<\/p>\n
13.\u4e3b\u8981\u56fd\u306eGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u5206\u6790<\/p>\n
13.1 \u7c73\u56fd<\/p>\n
13.1.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.1.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.1.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.1.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.2. \u30ab\u30ca\u30c0<\/p>\n
13.2.1.\u4fa1\u683c\u5206\u6790<\/p>\n
13.2.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.2.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.2.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.3. \u30d6\u30e9\u30b8\u30eb<\/p>\n
13.3.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.3.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.3.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.3.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.4. \u30e1\u30ad\u30b7\u30b3<\/p>\n
13.4.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.4.2.\u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.4.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.4.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.5.\u30c9\u30a4\u30c4<\/p>\n
13.5.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.5.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.5.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.5.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.6 \u30a4\u30ae\u30ea\u30b9<\/p>\n
13.6.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.6.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.6.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.6.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.7. \u30d5\u30e9\u30f3\u30b9<\/p>\n
13.7.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.7.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.7.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.7.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.8. \u30b9\u30da\u30a4\u30f3<\/p>\n
13.8.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.8.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.8.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.8.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.9. \u30a4\u30bf\u30ea\u30a2<\/p>\n
13.9.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.9.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.9.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.9.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.10.\u4e2d\u56fd<\/p>\n
13.10.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.10.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.10.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.10.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.11. \u65e5\u672c<\/p>\n
13.11.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.11.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.11.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.11.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.12.\u97d3\u56fd<\/p>\n
13.12.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.12.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.12.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.12.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.13.\u30b7\u30f3\u30ac\u30dd\u30fc\u30eb<\/p>\n
13.13.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.13.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.13.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.13.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.14.\u30bf\u30a4<\/p>\n
13.14.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.14.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.14.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.14.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.15.\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2<\/p>\n
13.15.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.15.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.15.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.15.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.16.\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2<\/p>\n
13.16.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.16.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.16.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.16.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.17.\u30cb\u30e5\u30fc\u30b8\u30fc\u30e9\u30f3\u30c9<\/p>\n
13.17.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.17.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.17.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.17.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.18. GCC\u8af8\u56fd<\/p>\n
13.18.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.18.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.18.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.18.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.19. \u5357\u30a2\u30d5\u30ea\u30ab<\/p>\n
13.19.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.19.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.19.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.19.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
13.20. \u30a4\u30b9\u30e9\u30a8\u30eb<\/p>\n
13.20.1. \u4fa1\u683c\u5206\u6790<\/p>\n
13.20.2. \u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790\uff082021\u5e74<\/p>\n
13.20.2.1.\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
13.20.2.2. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
14.\u5e02\u5834\u69cb\u9020\u5206\u6790<\/p>\n
14.1 \u30b3\u30f3\u30da\u30c6\u30a3\u30b7\u30e7\u30f3\u30fb\u30c0\u30c3\u30b7\u30e5\u30dc\u30fc\u30c9<\/p>\n
14.2 \u30b3\u30f3\u30da\u30c6\u30a3\u30b7\u30e7\u30f3\u306e\u30d9\u30f3\u30c1\u30de\u30fc\u30ad\u30f3\u30b0<\/p>\n
14.3 \u30c8\u30c3\u30d7\u30d7\u30ec\u30fc\u30e4\u30fc\u306e\u5e02\u5834\u30b7\u30a7\u30a2\u5206\u6790<\/p>\n
14.3.1. \u5730\u57df\u5225<\/p>\n
14.3.2. \u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225<\/p>\n
14.3.3. \u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u5225<\/p>\n
15.\u7af6\u5408\u5206\u6790<\/p>\n
15.1. \u30b3\u30f3\u30da\u30c6\u30a3\u30b7\u30e7\u30f3\u306e\u30c7\u30a3\u30fc\u30d7\u30fb\u30c0\u30a4\u30d6<\/p>\n
15.1.1.\u30e6\u30fc\u30ed\u30d5\u30a3\u30f3\u30ba\u30fb\u30b5\u30a4\u30a8\u30f3\u30c6\u30a3\u30d5\u30a3\u30c3\u30af<\/p>\n
15.1.1.1 \u6982\u8981<\/p>\n
15.1.1.2. \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/p>\n
\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u53ce\u76ca\u6027<\/p>\n
15.1.1.4. \u30bb\u30fc\u30eb\u30b9\u30fb\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8<\/p>\n
15.1.1.5 \u6226\u7565\u306e\u6982\u8981<\/p>\n
15.1.1.5.1 \u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565<\/p>\n
15.1.2. \u30a2\u30eb\u30de\u30c3\u30af\u30b0\u30eb\u30fc\u30d7<\/p>\n
15.1.2.1.\u6982\u8981<\/p>\n
15.1.2.2. \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/p>\n
\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u53ce\u76ca\u6027<\/p>\n
15.1.2.4.\u30bb\u30fc\u30eb\u30b9\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8<\/p>\n
15.1.2.5 \u6226\u7565\u306e\u6982\u8981<\/p>\n
15.1.2.5.1. \u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565<\/p>\n
15.1.3.\u30a4\u30f3\u30bf\u30fc\u30c6\u30c3\u30af\u30b0\u30eb\u30fc\u30d7 Plc<\/p>\n
15.1.3.1 \u6982\u8981<\/p>\n
15.1.3.2. \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/p>\n
\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u53ce\u76ca\u6027<\/p>\n
15.1.3.4. \u30bb\u30fc\u30eb\u30b9\u30fb\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8<\/p>\n
15.1.3.5 \u6226\u7565\u306e\u6982\u8981<\/p>\n
15.1.3.5.1. \u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565<\/p>\n
15.1.4. \u5449\u897fAppTec<\/p>\n
15.1.4.1 \u6982\u8981<\/p>\n
15.1.4.2. \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/p>\n
\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u53ce\u76ca\u6027<\/p>\n
15.1.4.4. \u30bb\u30fc\u30eb\u30b9\u30fb\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8<\/p>\n
15.1.4.5 \u6226\u7565\u306e\u6982\u8981<\/p>\n
15.1.4.5.1. \u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565<\/p>\n
15.1.5\u30b6\u30eb\u30c8\u30ea\u30a6\u30b9AG<\/p>\n
15.1.5.1 \u6982\u8981<\/p>\n
15.1.5.2. \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/p>\n
\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u53ce\u76ca\u6027<\/p>\n
15.1.5.4. \u30bb\u30fc\u30eb\u30b9\u30fb\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8<\/p>\n
15.1.5.5. \u6226\u7565\u306e\u6982\u8981<\/p>\n
15.1.5.5.1. \u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565<\/p>\n
15.1.6.\u5317\u7c73\u79d1\u5b66\u30a2\u30bd\u30b7\u30a8\u30fc\u30c4<\/p>\n
15.1.6.1 \u6982\u8981<\/p>\n
15.1.6.2. \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/p>\n
\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u53ce\u76ca\u6027<\/p>\n
15.1.6.4. \u30bb\u30fc\u30eb\u30b9\u30fb\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8<\/p>\n
15.1.6.5 \u6226\u7565\u306e\u6982\u8981<\/p>\n
15.1.6.5.1. \u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565<\/p>\n
15.1.7\u30cd\u30eb\u30bd\u30f3\u30fb\u30e9\u30dc\u30e9\u30c8\u30ea\u30fc\u30baLLC<\/p>\n
15.1.7.1 \u6982\u8981<\/p>\n
15.1.7.2. \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/p>\n
\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u53ce\u76ca\u6027<\/p>\n
15.1.7.4. \u30bb\u30fc\u30eb\u30b9\u30fb\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8<\/p>\n
15.1.7.5 \u6226\u7565\u306e\u6982\u8981<\/p>\n
15.1.7.5.1 \u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565<\/p>\n
15.1.8.\u30dc\u30b9\u30c8\u30f3\u30a2\u30ca\u30ea\u30c6\u30a3\u30ab\u30eb<\/p>\n
15.1.8.1 \u6982\u8981<\/p>\n
15.1.8.2. \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/p>\n
\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u53ce\u76ca\u6027<\/p>\n
15.1.8.4. \u30bb\u30fc\u30eb\u30b9\u30fb\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8<\/p>\n
15.1.8.5 \u6226\u7565\u306e\u6982\u8981<\/p>\n
15.1.8.5.1 \u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565<\/p>\n
15.1.9.\u30da\u30fc\u30b9\u5206\u6790\u30b5\u30fc\u30d3\u30b9<\/p>\n
15.1.9.1 \u6982\u8981<\/p>\n
15.1.9.2. \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/p>\n
\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u53ce\u76ca\u6027<\/p>\n
15.1.9.4. \u30bb\u30fc\u30eb\u30b9\u30fb\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8<\/p>\n
15.1.9.5 \u6226\u7565\u306e\u6982\u8981<\/p>\n
15.1.9.5.1. \u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565<\/p>\n
15.1.10.\u30b5\u30fc\u30e2\u30d5\u30a3\u30c3\u30b7\u30e3\u30fc\u30b5\u30a4\u30a8\u30f3\u30c6\u30a3\u30d5\u30a3\u30c3\u30af\u793e<\/p>\n
15.1.10.1 \u6982\u8981<\/p>\n
15.1.10.2. \u88fd\u54c1\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa<\/p>\n
\u5e02\u5834\u30bb\u30b0\u30e1\u30f3\u30c8\u5225\u53ce\u76ca\u6027<\/p>\n
15.1.10.4. \u30bb\u30fc\u30eb\u30b9\u30fb\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8<\/p>\n
15.1.10.5 \u6226\u7565\u306e\u6982\u8981<\/p>\n
15.1.10.5.1 \u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u6226\u7565<\/p>\n
16.\u524d\u63d0\u6761\u4ef6\u3068\u7565\u8a9e<\/p>\n
17.\u7814\u7a76\u65b9\u6cd5\u8ad6<\/p>\n","protected":false},"excerpt":{"rendered":"
\u4e16\u754c\u306eGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306f\u30012022\u5e74\u306b1\u51049,000\u4e07\u7c73\u30c9\u30eb\u3068\u8a55\u4fa1\u3055\u308c\u30012022\u5e74\u304b\u30892032\u5e74\u306b\u304b\u3051\u3066\u5e74\u5e73\u5747\u6210\u9577\u73875.4%\u3067\u62e1\u5927\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u308b\u3002\u88fd\u85ac\u5206\u91ce\u306e\u62e1\u5927\u3084\u533b\u85ac\u54c1\u30fb\u6a5f\u5668\u958b\u767a\u306e\u5897\u52a0\u306a\u3069\u306e\u8981\u56e0\u304c\u3001\u5e02\u5834\u62e1\u5927\u3092\u5f8c\u62bc\u3057\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u3066\u3044\u308b\u3002<\/p>\n
GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306e\u9700\u8981\u5206\u6790\uff082017-2021\u5e74\uff09\u3068\u5e02\u5834\u4e88\u6e2c\uff082022-2032\u5e74\uff09\u306e\u6bd4\u8f03
\nGMP\u691c\u67fb\u30b5\u30fc\u30d3\u30b9\u306e\u4e16\u754c\u5e02\u5834\u306f\u3001\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u52b9\u679c\u7684\u306a\u6587\u66f8\u5316\u57fa\u6e96\u3001\u9ad8\u54c1\u8cea\u306a\u88fd\u54c1\u3092\u751f\u307f\u51fa\u3059\u80fd\u529b\u306b\u5bfe\u3059\u308b\u8981\u6c42\u306e\u9ad8\u307e\u308a\u306b\u3088\u308a\u3001\u5927\u5e45\u306a\u5897\u52a0\u304c\u898b\u8fbc\u307e\u308c\u3066\u3044\u308b\u3002GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306f\u3001\u6700\u7d42\u9867\u5ba2\u306e\u30cb\u30fc\u30ba\u306b\u5fdc\u3058\u3066\u5e45\u5e83\u3044\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u3002<\/p>\n
\u9769\u65b0\u7684\u306a\u7279\u6b8a\u533b\u85ac\u54c1\u306f\u3001GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u3092\u5229\u7528\u3059\u308b\u3053\u3068\u3067\u8a8d\u8a3c\u3055\u308c\u308b\u54c1\u8cea\u57fa\u6e96\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u3001\u7d30\u5fc3\u306e\u6ce8\u610f\u3092\u6255\u3063\u3066\u88fd\u9020\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306f\u3001\u5e02\u5834\u304b\u3089\u306e\u88fd\u54c1\u56de\u53ce\u3092\u6e1b\u3089\u3059\u305f\u3081\u306b\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u4e0d\u53ef\u6b20\u306a\u30cb\u30fc\u30ba\u3067\u3059\u3002\u751f\u7269\u5206\u6790\u8a66\u9a13\u3001\u88fd\u54c1\u958b\u767a\u8a66\u9a13\u3001\u7121\u83cc\u8a66\u9a13\u3001\u8cde\u5473\u671f\u9650\u8a66\u9a13\u306f\u3059\u3079\u3066GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306e\u4e00\u4f8b\u3067\u3042\u308b\u3002\u3057\u305f\u304c\u3063\u3066\u3001GMP\u691c\u67fb\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306f\u4e88\u6e2c\u671f\u9593\u4e2d\u3001\u5e74\u5e73\u5747\u6210\u9577\u73875.4%\u3067\u6210\u9577\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u308b\u3002<\/p>\n
GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306e\u6210\u9577\u53ef\u80fd\u6027\u3092\u5f62\u6210\u3057\u3066\u3044\u308b\u3082\u306e\u306f\u4f55\u304b\uff1f
\n\u4e16\u754c\u5e02\u5834\u3092\u727d\u5f15\u3059\u308b\u533b\u7642\u6a5f\u5668\u9700\u8981\u306e\u9ad8\u307e\u308a<\/p>\n
\u533b\u7642\u6a5f\u5668\u90e8\u9580\u306f\u3001\u3055\u307e\u3056\u307e\u306a\u75be\u60a3\u306e\u8a3a\u65ad\u3084\u6cbb\u7642\u306b\u5f79\u7acb\u3064\u533b\u7642\u6280\u8853\u306e\u958b\u767a\u3092\u4fc3\u9032\u3059\u308b\u91cd\u8981\u306a\u5f79\u5272\u3092\u62c5\u3063\u3066\u3044\u308b\u3002\u3053\u306e\u4e8b\u696d\u3067\u306f\u3001\u624b\u8853\u7528\u30de\u30b9\u30af\u306e\u3088\u3046\u306a\u4e00\u822c\u7684\u306a\u3082\u306e\u304b\u3089\u30cf\u30a4\u30c6\u30af\u753b\u50cf\u6a5f\u5668\u307e\u3067\u3001\u3042\u3089\u3086\u308b\u3082\u306e\u3092\u88fd\u9020\u3057\u3066\u3044\u308b\u3002\u30a4\u30f3\u30b9\u30ea\u30f3\u30fb\u30c7\u30ea\u30d0\u30ea\u30fc\u30fb\u30b7\u30b9\u30c6\u30e0\u3001\u30b0\u30eb\u30b3\u30fc\u30b9\u30fb\u30e2\u30cb\u30bf\u30fc\u3001\u9178\u7d20\u6fc3\u7e2e\u5668\u3001\u30cd\u30d6\u30e9\u30a4\u30b6\u30fc\u306a\u3069\u306f\u3001\u3044\u304f\u3064\u304b\u306e\u533b\u7642\u554f\u984c\u306e\u8a3a\u65ad\u3068\u6cbb\u7642\u306e\u305f\u3081\u306b\u5bb6\u5ead\u3067\u5229\u7528\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u304d\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\u306e\u3072\u3068\u3064\u3067\u3042\u308b\u3002\u3053\u308c\u3089\u306e\u30ac\u30b8\u30a7\u30c3\u30c8\u306f\u3001\u60a3\u8005\u306eEMR\u3001\u30a6\u30a7\u30a2\u30e9\u30d6\u30eb\u3001\u96fb\u8a71\u3001\u9060\u9694\u533b\u7642\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3068\u30ea\u30f3\u30af\u3057\u3001\u3088\u308a\u826f\u3044\u81e8\u5e8a\u7684\u30fb\u696d\u52d9\u7684\u610f\u601d\u6c7a\u5b9a\u306e\u305f\u3081\u306b\u5fc5\u8981\u306a\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3059\u308b\u3002PRODSMART\u306e\u7d71\u8a08\u306b\u3088\u308b\u3068\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u4e8b\u696d\u306f2020\u5e74\u306b42\u5104\u30c9\u30eb\u3068\u8a55\u4fa1\u3055\u308c\u305f\u3002<\/p>\n
\u6162\u6027\u75be\u60a3\u306e\u983b\u5ea6\u5897\u52a0\u3084\u9ad8\u9f62\u8005\u4eba\u53e3\u306e\u5897\u52a0\u304c\u3001\u4eca\u5f8c\u6570\u5e74\u9593\u306e\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u9032\u6b69\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3068\u4e88\u6e2c\u3055\u308c\u308b\u4e3b\u306a\u5909\u6570\u3067\u3042\u308b\u3002\u30b9\u30de\u30fc\u30c8\u30ac\u30b8\u30a7\u30c3\u30c8\u3001\u30b9\u30de\u30fc\u30c8\u30bb\u30f3\u30b5\u30fc\u3001\u305d\u306e\u4ed6\u306e\u8efd\u91cf\u901a\u4fe1\u6a5f\u5668\u306f\u3001\u533b\u7642\u6a5f\u5668\u3068\u30e2\u30ce\u306e\u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\uff08IoMT\uff09\u30b7\u30b9\u30c6\u30e0\u306e\u7d71\u5408\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u308c\u3089\u306e\u9032\u6b69\u306f\u3001\u533b\u7642\u5f93\u4e8b\u8005\u304c\u30b3\u30b9\u30c8\u3092\u524a\u6e1b\u3057\u52b9\u7387\u3092\u9ad8\u3081\u306a\u304c\u3089\u60a3\u8005\u306e\u8ee2\u5e30\u3092\u6539\u5584\u3059\u308b\u306e\u306b\u5f79\u7acb\u3063\u3066\u3044\u308b\u3002<\/p>\n
GMP\u306f\u3001\u4e00\u822c\u306b\u6d41\u901a\u3059\u308b\u3042\u3089\u3086\u308b\u54c1\u76ee\u306e\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u7d14\u5ea6\u3001\u5f37\u5ea6\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u3001\u533b\u7642\u6a5f\u5668\u88fd\u9020\u306b\u304a\u3044\u3066\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u3002\u3053\u308c\u3089\u306e\u624b\u9806\u3092\u9075\u5b88\u3059\u308b\u3053\u3068\u3067\u3001\u751f\u7523\u8005\u306f\u3001\u5c06\u6765\u7684\u306b\u9ad8\u984d\u306a\u8ce0\u511f\u8cac\u4efb\u8a34\u8a1f\u306b\u767a\u5c55\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u5426\u5b9a\u7684\u306a\u7d50\u679c\u3001\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u3001\u6b20\u9665\u3092\u56de\u907f\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u751f\u7523\u30b5\u30a4\u30af\u30eb\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u3068\u5747\u4e00\u306a\u691c\u67fb\u8a2d\u5b9a\u304c\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u305f\u3081\u3001\u88fd\u54c1\u306e\u6c5a\u67d3\u3001\u4e0d\u826f\u3001\u54c1\u8cea\u306e\u3070\u3089\u3064\u304d\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u305f\u3081\u306b\u3001GMP\u304c\u91cd\u8996\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u304d\u3066\u3044\u308b\u3002<\/p>\n
\u5e02\u5834\u6210\u9577\u3092\u963b\u5bb3\u3059\u308b\u8981\u56e0\u306f\u4f55\u304b\uff1f
\n\u7d71\u4e00\u3055\u308c\u305f\u898f\u5236\u67a0\u7d44\u307f\u306e\u6b20\u5982\u304c \u5e02\u5834\u6210\u9577\u3092\u6291\u5236<\/p>\n
GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306b\u95a2\u3059\u308b\u7d71\u4e00\u7684\u306a\u898f\u5236\u67a0\u7d44\u307f\u304c\u306a\u3044\u3053\u3068\u304c\u3001GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u696d\u754c\u5168\u4f53\u306e\u6210\u9577\u3092\u963b\u5bb3\u3057\u3066\u3044\u308b\u3002GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306e\u898f\u5236\u9075\u5b88\u57fa\u6e96\u306f\u3001\u88fd\u85ac\u30fb\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u4f01\u696d\u306e\u6d41\u901a\u7db2\u306e\u5730\u7406\u7684\u7bc4\u56f2\u306b\u3088\u3063\u3066\u6c7a\u5b9a\u3055\u308c\u308b\u3002<\/p>\n
\u5317\u7c73\u3067\u306fFDA\u304cGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u696d\u754c\u3092\u76e3\u7763\u3057\u3001\u6b27\u5dde\u3067\u306f\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u304cGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u3092\u76e3\u7763\u3057\u3066\u3044\u308b\u3002GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u3092\u7ba1\u7406\u3059\u308b\u305d\u306e\u4ed6\u306e\u7d44\u7e54\u306b\u306f\u3001\u6771\u5357\u30a2\u30b8\u30a2\u8af8\u56fd\u9023\u5408\uff08ASEAN\uff09\u304a\u3088\u3073\u533b\u85ac\u54c1\u691c\u67fb\u6761\u7d04\u304c\u542b\u307e\u308c\u308b\u3002\u3053\u308c\u3089\u306e\u898f\u5236\u5f53\u5c40\u306f\u3001\u88fd\u85ac\u4f01\u696d\u304c\u3069\u3053\u3067\u88fd\u54c1\u3092\u88fd\u9020\u3001\u6d41\u901a\u3001\u5ba3\u4f1d\u3057\u3066\u3044\u308b\u304b\u306b\u57fa\u3065\u3044\u3066\u3001\u9069\u5207\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u4fdd\u8a3c\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n
\u533b\u85ac\u54c1\u306e\u88fd\u9020\u306b\u95a2\u308f\u308b\u3059\u3079\u3066\u306e\u5834\u6240\u306f\u3001\u898f\u5236\u5f53\u5c40\u306b\u3088\u3063\u3066\u8a55\u4fa1\u3055\u308c\u308b\u3002\u3053\u306e\u8a55\u4fa1\u306b\u306f\u3001\u539f\u6750\u6599\/API\u88fd\u9020\u304b\u3089\u6700\u7d42\u5305\u88c5\u65bd\u8a2d\u307e\u3067\u3001\u3059\u3079\u3066\u306e\u6bb5\u968e\u304c\u542b\u307e\u308c\u308b\u3002\u3055\u3089\u306b\u3001\u7279\u5b9a\u306e\u88fd\u9020\u5de5\u7a0b\u306b\u95a2\u308f\u308b\u30d7\u30ed\u30bb\u30b9\u306b\u3088\u3063\u3066\u898f\u5247\u304c\u7570\u306a\u308b\u5834\u5408\u3082\u3042\u308b\u3002\u4f01\u696d\u304c\u7279\u5b9a\u306e\u56fd\u3084\u5730\u57df\u306e\u898f\u5236\u6a5f\u95a2\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u304b\u3063\u305f\u5834\u5408\u3001\u305d\u306e\u88fd\u54c1\u306f\u6cd5\u5f8b\u306b\u3088\u308a\u7c97\u60aa\u54c1\u3068\u307f\u306a\u3055\u308c\u3001FDA\u306f\u60a3\u8005\u306b\u305d\u306e\u3088\u3046\u306a\u533b\u85ac\u54c1\u3092\u4f7f\u7528\u3057\u306a\u3044\u3088\u3046\u4fc3\u3057\u3001\u5065\u5eb7\u306b\u91cd\u5927\u306a\u5f71\u97ff\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002\u305d\u306e\u7d50\u679c\u3001\u591a\u304f\u306e\u5730\u57df\u3067GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306b\u5bfe\u3059\u308b\u898f\u5236\u306e\u67a0\u7d44\u307f\u304c\u53b3\u3057\u304f\u306a\u308a\u3001\u5e02\u5834\u306e\u6210\u9577\u3092\u59a8\u3052\u3066\u3044\u308b\u3002<\/p>\n
GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306e\u5730\u57df\u5225\u30dd\u30c6\u30f3\u30b7\u30e3\u30eb\u3092\u5b9a\u7fa9\u3059\u308b\u5c55\u671b\u3068\u306f\uff1f
\n\u78ba\u7acb\u3055\u308c\u305f\u30a4\u30f3\u30d5\u30e9\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u53d7\u5bb9\u304cGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9 \u5e02\u5834\u3092\u727d\u5f15<\/p>\n
WHO\u7248\u306eGMP\u306f\u4f4e\u958b\u767a\u56fd\u3067\u5e83\u304f\u5229\u7528\u3055\u308c\u3066\u3044\u308b\u304c\u3001\u5404\u56fd\u306f\u72ec\u81ea\u306e\u6700\u4f4eGMP\u57fa\u6e96\u3092\u6301\u3064\u3053\u3068\u304c\u3067\u304d\u308b\u3002GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306f7\u3064\u306e\u5730\u57df\u306b\u5206\u3051\u3089\u308c\u308b\uff1a\u5357\u30a2\u30b8\u30a2\u3001\u6771\u30a2\u30b8\u30a2\u3001\u6b27\u5dde\u3001\u4e2d\u5357\u7c73\u3001\u5317\u7c73\u3001\u30aa\u30bb\u30a2\u30cb\u30a2\u3001\u4e2d\u6771\u30fb\u30a2\u30d5\u30ea\u30ab\u3067\u3042\u308b\u3002<\/p>\n
\u5317\u7c73\u306f\u3001\u305d\u306e\u78ba\u7acb\u3055\u308c\u305f\u30a4\u30f3\u30d5\u30e9\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u53d7\u5bb9\u6027\u306b\u3088\u308a\u3001\u6700\u5927\u306e\u53ce\u76ca\u30b9\u30c6\u30fc\u30af\u30db\u30eb\u30c0\u30fc\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u9ad8\u3044\u3002\u30d8\u30eb\u30b9\u30b1\u30a2\u88fd\u54c1\u306e\u88fd\u9020\u65bd\u8a2d\u304c\u591a\u3044\u6b27\u5dde\u306f\u5317\u7c73\u306b\u7d9a\u304f\u3068\u4e88\u60f3\u3055\u308c\u308b\u3002<\/p>\n
\u56fd\u5225\u30a4\u30f3\u30b5\u30a4\u30c8
\n\u306a\u305cGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u7c73\u56fd\u306b\u6295\u8cc7\u3059\u308b\u306e\u304b\uff1f<\/p>\n
\u9769\u65b0\u7684\u306a\u533b\u85ac\u54c1\u3068\u6280\u8853\u306e\u5275\u51fa\u306b\u5bfe\u3059\u308b\u9700\u8981\u306e\u9ad8\u307e\u308a\u304c\u5e02\u5834\u6210\u9577\u3092\u727d\u5f15<\/p>\n
\u9769\u65b0\u7684\u306a\u533b\u85ac\u54c1\u3084\u6280\u8853\u306e\u5275\u51fa\u306b\u5bfe\u3059\u308b\u9700\u8981\u304c\u9ad8\u307e\u3063\u3066\u3044\u308b\u305f\u3081\u3001\u5317\u7c73\u306fGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u3067\u5727\u5012\u7684\u306a\u5730\u4f4d\u3092\u5360\u3081\u308b\u3068\u601d\u308f\u308c\u308b\u3002\u7c73\u56fd\u75be\u75c5\u4e88\u9632\u7ba1\u7406\u30bb\u30f3\u30bf\u30fc\u306e\u30c7\u30fc\u30bf\u306b\u3088\u308b\u3068\u30012022\u5e741\u670810\u65e5\u73fe\u5728\u30013,420\u4e07\u4eba\u4ee5\u4e0a\u306e\u30a2\u30e1\u30ea\u30ab\u4eba\u304c\u7cd6\u5c3f\u75c5\u3092\u60a3\u3063\u3066\u304a\u308a\u3001\u6bce\u5e7486\u4e078,000\u4eba\u4ee5\u4e0a\u304c\u5fc3\u81d3\u75c5\u3067\u6b7b\u4ea1\u3057\u3066\u3044\u308b\u3002<\/p>\n
\u6b7b\u4ea1\u7387\u306e\u5897\u52a0\u3084\u6162\u6027\u75be\u60a3\u306e\u8513\u5ef6\u306e\u7d50\u679c\u3001\u533b\u85ac\u54c1\u88fd\u9020\u5de5\u5834\u306e\u6570\u306f\u5897\u52a0\u3057\u3066\u3044\u308b\u3002\u524d\u8ff0\u306e\u8981\u56e0\u306b\u3088\u308a\u3001GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306e\u62e1\u5927\u304c\u898b\u8fbc\u307e\u308c\u3066\u3044\u308b\u3002\u3055\u3089\u306b\u30012020\u5e7411\u6708\u73fe\u5728\u3001\u56fd\u5185FDA\u767b\u9332\u306e\u533b\u7642\u6a5f\u5668\u88fd\u9020\u65bd\u8a2d\u306f13,010\u65bd\u8a2d\u3001\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u88fd\u9020\u65bd\u8a2d\u306f3,568\u65bd\u8a2d\u3001\u533b\u85ac\u54c1\u88fd\u9020\u65bd\u8a2d\u306f5,112\u65bd\u8a2d\u3067\u3042\u308b\u3002<\/p>\n
\u533b\u85ac\u54c1\u88fd\u9020\u65bd\u8a2d\u306e\u5897\u52a0\u306b\u4f34\u3044\u3001GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306e\u62e1\u5927\u304c\u898b\u8fbc\u307e\u308c\u3066\u3044\u308b\u3002\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u306b\u3088\u308b\u3068\u3001\u7c73\u56fd\u306b\u306f\u7d044676\u306e\u533b\u85ac\u54c1\u88fd\u9020\u65bd\u8a2d\u304c\u3042\u308b\uff08FDA\uff09\u3002\u7c73\u56fd\u7acb\u885b\u751f\u7814\u7a76\u6240\uff08National Institutes of Health\uff09\u3082\u3001\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u304a\u3088\u3073\u95a2\u9023\u4f01\u696d\u3078\u306e\u52a9\u6210\u3092\u62e1\u5927\u3057\u3066\u3044\u308b\uff08NIH\uff09\u3002\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u306f2020\u5e74\u306b\u7c73\u56fd\u30677,655\u767e\u4e07\u7c73\u30c9\u30eb\u306e\u8cc7\u91d1\u3092\u5f97\u308b\u3002<\/p>\n
\u3055\u3089\u306b\u3001\u56fd\u7acb\u885b\u751f\u7814\u7a76\u6240\uff08NIH\uff09\u306f\u8fd1\u5e74\u3001\u7cd6\u5c3f\u75c5\u3084\u304c\u3093\u306a\u3069\u3001\u6700\u5148\u7aef\u306e\u691c\u67fb\u6a5f\u5668\u3092\u5fc5\u8981\u3068\u3059\u308b\u3055\u307e\u3056\u307e\u306a\u75be\u60a3\u3078\u306e\u52a9\u6210\u3092\u5897\u3084\u3057\u3066\u3044\u308b\u30022020\u5e74\u306e\u7c73\u56fd\u306b\u304a\u3051\u308b\u7cd6\u5c3f\u75c5\u3078\u306e\u52a9\u6210\u91d1\u306f1,179\u767e\u4e07\u7c73\u30c9\u30eb\u3067\u3042\u3063\u305f\u3002TS\u88c5\u7f6e\u306e\u7cbe\u5ea6\u3092\u8a66\u9a13\u3059\u308b\u5927\u4f01\u696d\u306e\u5927\u90e8\u5206\u306f\u3001\u7814\u7a76\u8cc7\u91d1\u306e\u5897\u52a0\u306b\u5f15\u3063\u5f35\u3089\u308c\u3001\u696d\u754c\u306e\u6025\u6210\u9577\u306b\u62cd\u8eca\u3092\u304b\u3051\u308b\u3068\u4e88\u60f3\u3055\u308c\u308b\u3002GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306f\u3001\u65b0\u85ac\u3084\u6cbb\u7642\u6cd5\u306e\u30cb\u30fc\u30ba\u304c\u9ad8\u307e\u308b\u306b\u3064\u308c\u3066\u6210\u9577\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u308b\u3002<\/p>\n
\u4e2d\u56fd\u306eGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306f\u3069\u3046\u9032\u5316\u3059\u308b\u304b\uff1f<\/p>\n
\u88fd\u9020\u8acb\u8ca0\u696d\u8005\u6570\u306e\u5897\u52a0\u304c\u5730\u57df\u5e02\u5834\u306e\u6210\u9577\u3092\u62bc\u3057\u4e0a\u3052\u308b<\/p>\n
\u4e2d\u56fd\u306b\u304a\u3051\u308b\u53d7\u8a17\u88fd\u9020\u90e8\u9580\u306e\u5897\u52a0\u306b\u3088\u308a\u3001GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306e\u9700\u8981\u306f\u5897\u52a0\u3059\u308b\u3068\u601d\u308f\u308c\u308b\u3002GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u306f\u3001\u88fd\u9020\u59d4\u8a17\u5148\u3068\u88fd\u9020\u59d4\u8a17\u5148\u304c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u8981\u6c42\u4e8b\u9805\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3067\u3042\u308b\u3002<\/p>\n
\u30ab\u30c6\u30b4\u30ea\u30fc\u5225\u30a4\u30f3\u30b5\u30a4\u30c8
\n\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u5225\u3001\u5e02\u5834\u6210\u9577\u3092\u727d\u5f15\u3059\u308b\u30bb\u30b0\u30e1\u30f3\u30c8\u306f\uff1f<\/p>\n
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GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306f\u3001\u88fd\u54c1\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a66\u9a13\u3001\u751f\u7269\u5206\u6790\u30b5\u30fc\u30d3\u30b9\u3001\u5305\u88c5\u30fb\u8cde\u5473\u671f\u9650\u8a66\u9a13\u306a\u3069\u3001\u3044\u304f\u3064\u304b\u306e\u30b5\u30fc\u30d3\u30b9\u30bf\u30a4\u30d7\u306b\u5206\u3051\u3089\u308c\u308b\u30022021\u5e74\u306b\u306f\u3001\u88fd\u54c1\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u8a66\u9a13\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u304c\u5e02\u5834\u3092\u30ea\u30fc\u30c9\u3057\u3066\u3044\u305f\u3002\u4e88\u6e2c\u671f\u9593\u4e2d\u3001\u3053\u306e\u5206\u91ce\u306e\u5e02\u5834\u306f\u5e74\u5e73\u5747\u6210\u9577\u73875%\u3067\u767a\u5c55\u3059\u308b\u3068\u4e88\u6e2c\u3055\u308c\u308b\u3002<\/p>\n
GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u3067\u5c0e\u5165\u304c\u9032\u3080\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u306f\uff1f<\/p>\n
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\u30e6\u30fc\u30ed\u30d5\u30a3\u30f3\u30ba\u30fb\u30d0\u30a4\u30aa\u30d5\u30a1\u30fc\u30de\u30fb\u30d7\u30ed\u30c0\u30af\u30c8\u30fb\u30c6\u30b9\u30c6\u30a3\u30f3\u30b0\u30fb\u30a4\u30bf\u30ea\u30a2\u306f\u30012020\u5e7412\u6708\u306bCOVID-19\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u304c\u59cb\u307e\u3063\u305f\u969b\u306b\u3001\u6bba\u30a6\u30a4\u30eb\u30b9\u6027\u8a66\u9a13\u80fd\u529b\u3092\u5f37\u5316\u3057\u305f\u3002\u540c\u69d8\u306b\u3001\u4e16\u754c\u7684\u306b\u6709\u540d\u306a\u533b\u85ac\u54c1\u958b\u767a\u696d\u52d9\u53d7\u8a17\u4f1a\u793e\u3067\u3042\u308bPPD Inc.\u306f2021\u5e744\u6708\u3001\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u306e\u8a66\u9a13\u80fd\u529b\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u3001\u30a2\u30a4\u30eb\u30e9\u30f3\u30c9\u306b\u3042\u308b\u9069\u6b63\u88fd\u9020\u57fa\u6e96\uff08GMP\uff09\u65bd\u8a2d\u3092\u62e1\u5f35\u3059\u308b\u610f\u5411\u3092\u767a\u8868\u3057\u305f\u3002\u7d50\u679c\u3068\u3057\u3066\u3001\u88fd\u85ac\u30fb\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u4f01\u696d\u304c\u5e02\u5834\u62e1\u5927\u3092\u727d\u5f15\u3057\u3066\u304a\u308a\u3001\u4e88\u6e2c\u671f\u9593\u4e2d\u3001GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u5e02\u5834\u306e\u62e1\u5927\u306b\u30d7\u30e9\u30b9\u306e\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3068\u4e88\u60f3\u3055\u308c\u308b\u3002<\/p>\n
\u7af6\u4e89\u74b0\u5883
\nGMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u696d\u754c\u306b\u306f\u6570\u591a\u304f\u306e\u4e3b\u8981\u4f01\u696d\u304c\u5b58\u5728\u3059\u308b\u3002\u5e02\u5834\u30b7\u30a7\u30a2\u306e\u9762\u3067\u306f\u3001\u73fe\u5728\u3001\u5c11\u6570\u306e\u91cd\u8981\u306a\u4f01\u696d\u304c\u696d\u754c\u3092\u652f\u914d\u3057\u3066\u3044\u308b\u3002\u4f01\u696d\u306f\u533b\u85ac\u54c1\u3084\u533b\u7642\u6a5f\u5668\u306e\u9700\u8981\u5897\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u5bfe\u7b56\u3092\u8b1b\u3058\u3066\u3044\u308b\u3002<\/p>\n
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\u6700\u8fd1\u306e\u52d5\u5411<\/p>\n
2022\u5e746\u6708\u3001\u30a2\u30eb\u30de\u30c3\u30af\u30b0\u30eb\u30fc\u30d7\u306e\u5b50\u4f1a\u793e\u3067\u3042\u308b\u30a2\u30eb\u30de\u30c3\u30af\u30fb\u30c0\u30a4\u30a2\u30b0\u30ce\u30b9\u30c6\u30a3\u30c3\u30af\u30fb\u30b5\u30fc\u30d3\u30b7\u30ba\u306f\u3001\u30a2\u30b9\u30c8\u30e9\u30bc\u30cd\u30ab\u3068\u591a\u304f\u306e\u30b3\u30f3\u30d1\u30cb\u30aa\u30f3\u8a3a\u65ad\u85ac\uff08CDx\uff09\u88fd\u54c1\u3092\u958b\u767a\u30fb\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306e\u30de\u30b9\u30bf\u30fc\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u5951\u7d04\uff08MCA\uff09\u3092\u7de0\u7d50\u3057\u305f\u3002\u30a2\u30eb\u30de\u30c3\u30af\u306f\u30a2\u30b9\u30c8\u30e9\u30bc\u30cd\u30ab\u3068\u5354\u529b\u3057\u3001\u30a2\u30f3\u30e1\u30c3\u30c8\u30fb\u30e1\u30c7\u30a3\u30ab\u30eb\u30fb\u30cb\u30fc\u30ba\u304c\u9ad8\u3044\u5730\u57df\u306e\u60a3\u8005\u306b\u65b0\u305f\u306a\u6cbb\u7642\u6cd5\u3092\u63d0\u4f9b\u3059\u308b\u3002
\n2021\u5e7412\u6708\u3001\u30e6\u30fc\u30ed\u30d5\u30a3\u30f3\u30ba\u306f \u3001\u30a2\u30b9\u30c6\u30e9\u30b9\u30fb\u30a2\u30ca\u30ea\u30c6\u30a3\u30ab\u30eb\u30fb\u30b5\u30a4\u30a8\u30f3\u30b9\u30fb\u30e9\u30dc\u30e9\u30c8\u30ea\u30fc\u30ba\uff08ASL\uff09\u306e\u8cb7\u53ce\u306b\u3088\u308a\u3001\u30d0\u30a4\u30aa\u30d5\u30a1\u30fc\u30de\u88fd\u54c1\u8a66\u9a13\u30e9\u30dc\u306e\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u304cGMP\u8a66\u9a13\u30e9\u30dc\u306e\u30d5\u30c3\u30c8\u30d7\u30ea\u30f3\u30c8\u3092\u62e1\u5927\u3057\u305f\u3068\u767a\u8868\u3057\u305f\u3002ASL\u306f\u3053\u306e\u8cb7\u53ce\u306b\u3088\u308a\u3001\u30e6\u30fc\u30ed\u30d5\u30a3\u30f3\u30ba\u306e\u65e5\u672c\u521d\u306eGMP\uff08\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u53ca\u3073\u54c1\u8cea\u7ba1\u7406\u306b\u95a2\u3059\u308b\u57fa\u6e96\uff09\u8a66\u9a13\u65bd\u8a2d\u3092\u8a2d\u7acb\u3057\u305f\u3002<\/p>\n
GMP\u8a66\u9a13\u30b5\u30fc\u30d3\u30b9\u7523\u696d\u8abf\u67fb\u306e\u4e3b\u8981\u30bb\u30b0\u30e1\u30f3\u30c8
\n\u30bf\u30a4\u30d7\u5225<\/p>\n
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