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id=\"\u624b\u9593\u3068\u54c1\u8cea\u3078\u306e\u3053\u3060\u308f\u308a\u304c\u751f\u3080\u5e0c\u5c11\u306a\u56fd\u7523\u30de\u30ab\u306e\u4fa1\u5024\">\u624b\u9593\u3068\u54c1\u8cea\u3078\u306e\u3053\u3060\u308f\u308a\u304c\u751f\u3080\u3001\u5e0c\u5c11\u306a\u56fd\u7523\u30de\u30ab\u306e\u4fa1\u5024<\/h3>\n<p>\u65e5\u672c\u56fd\u5185\u3067\u683d\u57f9\u3055\u308c\u308b\u30de\u30ab\u306f\u3001\u305f\u3060\u3067\u3055\u3048\u6c17\u5019\u6761\u4ef6\u3068\u306e\u95d8\u3044\u304c\u3042\u308b\u306e\u3067\u3059\u304c\u3001\u305d\u306e\u5e0c\u5c11\u6027\u3092\u3055\u3089\u306b\u9ad8\u3081\u3066\u3044\u308b\u306e\u304c\u3001\u53ce\u7a6b\u5f8c\u306e\u624b\u9593\u3068\u54c1\u8cea\u3078\u306e\u5fb9\u5e95\u3057\u305f\u3053\u3060\u308f\u308a\u306a\u3093\u3067\u3059\u3002\u5358\u306b\u300c\u56fd\u7523\u3060\u304b\u3089\u826f\u3044\u300d\u3068\u3044\u3046\u3060\u3051\u3067\u306a\u304f\u3001\u305d\u3053\u306b\u306f\u76ee\u306b\u898b\u3048\u306a\u3044\u591a\u304f\u306e\u52aa\u529b\u304c\u8a70\u307e\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u307e\u305a\u3001\u53ce\u7a6b\u3055\u308c\u305f\u30de\u30ab\u306f\u3001\u54c1\u8cea\u3092\u4fdd\u3064\u305f\u3081\u306b\u975e\u5e38\u306b\u4e01\u5be7\u306a\u4f5c\u696d\u3092\u7d4c\u3066\u4e7e\u71e5\u30fb\u9078\u5225\u3055\u308c\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u592a\u967d\u5149\u3067\u81ea\u7136\u4e7e\u71e5\u3055\u305b\u308b\u5834\u5408\u3067\u3082\u3001\u5929\u5019\u3092\u898b\u306a\u304c\u3089\u7d30\u5fc3\u306e\u6ce8\u610f\u3092\u6255\u3063\u3066\u914d\u7f6e\u3092\u5909\u3048\u305f\u308a\u3001\u96e8\u304c\u964d\u308c\u3070\u3059\u3050\u306b\u5c4b\u5185\u306b\u79fb\u52d5\u3055\u305b\u305f\u308a\u3002\u6a5f\u68b0\u4e7e\u71e5\u306e\u5834\u5408\u3067\u3082\u3001\u6e29\u5ea6\u3084\u6642\u9593\u3092\u53b3\u5bc6\u306b\u7ba1\u7406\u3057\u3001\u30de\u30ab\u672c\u6765\u306e\u6804\u990a\u3084\u98a8\u5473\u3092\u640d\u306a\u308f\u306a\u3044\u3088\u3046\u306b\u5de5\u592b\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u305d\u3057\u3066\u3001\u4e00\u3064\u4e00\u3064\u4e01\u5be7\u306b\u5f62\u72b6\u3084\u8272\u306a\u3069\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3001\u57fa\u6e96\u3092\u6e80\u305f\u3057\u305f\u3082\u306e\u3060\u3051\u304c\u9078\u3070\u308c\u308b\u306e\u3067\u3059\u3002\u3053\u306e\u9078\u5225\u4f5c\u696d\u306f\u3001\u4eba\u306e\u624b\u3067\u4e00\u3064\u4e00\u3064\u884c\u308f\u308c\u308b\u3053\u3068\u304c\u307b\u3068\u3093\u3069\u3067\u3001\u6642\u9593\u3082\u52b4\u529b\u3082\u304b\u304b\u308a\u307e\u3059\u3002<\/p>\n<p>\u307e\u305f\u3001<strong>\u5fb9\u5e95\u3057\u305f\u54c1\u8cea\u7ba1\u7406\u4f53\u5236<\/strong>\u3082\u3001\u5e0c\u5c11\u306a\u56fd\u7523\u30de\u30ab\u306e\u4fa1\u5024\u3092\u652f\u3048\u3066\u3044\u307e\u3059\u3002\u539f\u6599\u304c\u3069\u3053\u3067\u3001\u3044\u3064\u3001\u3069\u306e\u3088\u3046\u306b\u683d\u57f9\u3055\u308c\u305f\u306e\u304b\u3001\u3068\u3044\u3063\u305f\u60c5\u5831\u304c\u3057\u3063\u304b\u308a\u3068\u8a18\u9332\u3055\u308c\u3001\u8ffd\u8de1\u3067\u304d\u308b\u300c\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u78ba\u4fdd\u300d\u304c\u91cd\u8981\u8996\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u5b89\u5fc3\u30fb\u5b89\u5168\u306a\u88fd\u54c1\u3092\u6d88\u8cbb\u8005\u306b\u5c4a\u3051\u308b\u305f\u3081\u306e\u57fa\u672c\u4e2d\u306e\u57fa\u672c\u3067\u3059\u304c\u3001\u5c0f\u898f\u6a21\u3067\u683d\u57f9\u3055\u308c\u308b\u3053\u3068\u304c\u591a\u3044\u56fd\u7523\u30de\u30ab\u306b\u304a\u3044\u3066\u306f\u3001\u305d\u306e\u7ba1\u7406\u4f53\u5236\u3092\u7bc9\u304f\u3053\u3068\u81ea\u4f53\u304c\u5927\u304d\u306a\u624b\u9593\u3068\u306a\u308a\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u8fb2\u5bb6\u3055\u3093\u304c\u683d\u57f9\u8a18\u9332\u3092\u7d30\u304b\u304f\u3064\u3051\u3001\u305d\u308c\u3092\u52a0\u5de5\u696d\u8005\u3084\u8ca9\u58f2\u8005\u304c\u5171\u6709\u3059\u308b\u4ed5\u7d44\u307f\u306a\u3069\u3001\u95a2\u4fc2\u8005\u5168\u54e1\u3067\u54c1\u8cea\u3092\u5b88\u308d\u3046\u3068\u3044\u3046\u610f\u8b58\u304c\u5171\u6709\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u304c\u5927\u5207\u306a\u3093\u3067\u3059\u3002<\/p>\n<p>\u305d\u3057\u3066\u3001\u4f55\u3088\u308a\u3082\u300c\u5c11\u91cf\u751f\u7523\u3060\u304b\u3089\u3053\u305d\u306e\u3001\u539f\u6599\u3078\u306e\u304d\u3081\u7d30\u3084\u304b\u306a\u914d\u616e\u300d\u304c\u3001\u56fd\u7523\u30de\u30ab\u306e\u4fa1\u5024\u3092\u969b\u7acb\u305f\u305b\u3066\u3044\u307e\u3059\u3002\u5927\u898f\u6a21\u751f\u7523\u306e\u3088\u3046\u306b\u3001\u52b9\u7387\u3060\u3051\u3092\u8ffd\u6c42\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u4e00\u682a\u4e00\u682a\u306e\u30de\u30ab\u306e\u72b6\u614b\u306b\u5408\u308f\u305b\u305f\u683d\u57f9\u3084\u7ba1\u7406\u304c\u884c\u308f\u308c\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u307e\u308b\u3067\u6211\u304c\u5b50\u306e\u3088\u3046\u306b\u30de\u30ab\u3092\u80b2\u3066\u308b\u3088\u3046\u306a\u611f\u899a\u306b\u8fd1\u3044\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u4f8b\u3048\u3070\u3001\u3042\u308b\u683d\u57f9\u8fb2\u5bb6\u3055\u3093\u3067\u306f\u3001\u571f\u58cc\u306e\u72b6\u614b\u3092\u5e38\u306b\u30c1\u30a7\u30c3\u30af\u3057\u3001\u30de\u30ab\u306e\u751f\u80b2\u306b\u6700\u9069\u306a\u6804\u990a\u30d0\u30e9\u30f3\u30b9\u306b\u306a\u308b\u3088\u3046\u3001\u305d\u306e\u90fd\u5ea6\u571f\u58cc\u6539\u826f\u6750\u3092\u8abf\u6574\u3057\u3066\u3044\u308b\u3001\u3068\u3044\u3046\u8a71\u3092\u805e\u3044\u305f\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u3046\u3057\u305f\u624b\u9593\u6687\u3092\u304b\u3051\u308b\u3053\u3068\u3067\u3001\u3088\u308a\u8cea\u306e\u9ad8\u3044\u30de\u30ab\u304c\u751f\u307e\u308c\u308b\u306e\u3067\u3059\u3002\u3053\u306e\u3001\u539f\u6599\u305d\u306e\u3082\u306e\u3078\u306e\u6df1\u3044\u611b\u60c5\u3068\u914d\u616e\u304c\u3001\u5e0c\u5c11\u306a\u56fd\u7523\u30de\u30ab\u306e\u8c4a\u304b\u306a\u98a8\u5473\u3084\u6804\u990a\u4fa1\u306b\u3064\u306a\u304c\u3063\u3066\u3044\u308b\u306e\u3060\u3068\u611f\u3058\u3066\u3044\u307e\u3059\u3002<\/p>\n<h2 id=\"GMP\u8a8d\u5b9a\u5de5\u5834\u88fd\u9020\u304c\u7d04\u675f\u3059\u308b\u63fa\u308b\u304e\u306a\u3044\u54c1\u8cea\u3068\u5b89\u5168\u6027\">GMP\u8a8d\u5b9a\u5de5\u5834\u88fd\u9020\u304c\u7d04\u675f\u3059\u308b\u3001\u63fa\u308b\u304e\u306a\u3044\u54c1\u8cea\u3068\u5b89\u5168\u6027<\/h2>\n<h3 id=\"GMP\u8a8d\u5b9a\u5de5\u5834\u88fd\u54c1\u306e\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u56fd\u969b\u57fa\u6e96\">GMP\u8a8d\u5b9a\u5de5\u5834\uff1a\u88fd\u54c1\u306e\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u56fd\u969b\u57fa\u6e96<\/h3>\n<p>\u56fd\u7523\u30de\u30ab\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3092\u9078\u3076\u4e0a\u3067\u3001<strong>GMP\u8a8d\u5b9a\u5de5\u5834<\/strong>\u3067\u306e\u88fd\u9020\u304b\u3069\u3046\u304b\u306f\u3001\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u4e0a\u3067\u975e\u5e38\u306b\u5927\u5207\u306a\u30dd\u30a4\u30f3\u30c8\u3060\u3068\u611f\u3058\u3066\u3044\u307e\u3059\u3002\u521d\u3081\u3066\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306b\u8208\u5473\u3092\u6301\u3063\u305f\u9803\u306f\u3001\u300cGMP\u3063\u3066\u4f55\u3060\u308d\u3046\uff1f\u300d\u3068\u3001\u6b63\u76f4\u3088\u304f\u5206\u304b\u3063\u3066\u3044\u307e\u305b\u3093\u3067\u3057\u305f\u3002<\/p>\n<p>GMP\u3068\u306f\u3001\u300cGood Manufacturing Practice\u300d\u306e\u7565\u3067\u3001\u65e5\u672c\u8a9e\u3067\u306f\u300c\u9069\u6b63\u88fd\u9020\u898f\u7bc4\u300d\u3068\u547c\u3070\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u533b\u85ac\u54c1\u3092\u4f5c\u308b\u969b\u306b\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3092\u4e00\u5b9a\u306b\u4fdd\u3061\u3001\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u56fd\u969b\u7684\u306a\u57fa\u6e96\u306a\u3093\u3067\u3059\u3002\u539f\u6599\u306e\u53d7\u3051\u5165\u308c\u304b\u3089\u88fd\u9020\u3001\u51fa\u8377\u307e\u3067\u306e\u5168\u3066\u306e\u5de5\u7a0b\u3067\u3001\u4eba\u306e\u5065\u5eb7\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u69d8\u3005\u306a\u8981\u56e0\u3092\u7ba1\u7406\u3057\u3001\u5e38\u306b\u4e00\u5b9a\u306e\u54c1\u8cea\u3092\u4fdd\u3064\u3053\u3068\u3092\u76ee\u6307\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u4f8b\u3048\u3070\u3001\u533b\u85ac\u54c1\u306e\u88fd\u9020\u73fe\u5834\u3067\u306f\u3001\u88fd\u9020\u3059\u308b\u5834\u6240\u306e\u6e05\u6d44\u5ea6\u3092\u4fdd\u3064\u3053\u3068\u306f\u3082\u3061\u308d\u3093\u3001\u4f5c\u696d\u54e1\u304c\u7740\u7528\u3059\u308b\u670d\u88c5\u3001\u4f7f\u7528\u3059\u308b\u5668\u5177\u306e\u6d88\u6bd2\u3001\u88fd\u9020\u8a18\u9332\u306e\u7ba1\u7406\u307e\u3067\u3001\u7d30\u304b\u304f\u6c7a\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3082\u3057\u3001\u88fd\u9020\u904e\u7a0b\u3067\u7570\u7269\u304c\u6df7\u5165\u3057\u305f\u308a\u3001\u6210\u5206\u306e\u914d\u5408\u91cf\u304c\u9593\u9055\u3063\u305f\u308a\u3059\u308b\u3068\u3001\u4eba\u306e\u547d\u306b\u95a2\u308f\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u304b\u3089\u3001\u305d\u308c\u3060\u3051\u53b3\u683c\u306a\u7ba1\u7406\u304c\u6c42\u3081\u3089\u308c\u308b\u308f\u3051\u3067\u3059\u3002<\/p>\n<p>\u3053\u306eGMP\u306e\u8003\u3048\u65b9\u306f\u3001\u8fd1\u5e74\u3001\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306e\u88fd\u9020\u306b\u304a\u3044\u3066\u3082\u975e\u5e38\u306b\u91cd\u8981\u8996\u3055\u308c\u308b\u3088\u3046\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306f\u3001\u85ac\u306e\u3088\u3046\u306b\u75c5\u6c17\u3092\u6cbb\u7642\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u79c1\u305f\u3061\u306e\u4f53\u306b\u5165\u308c\u308b\u3082\u306e\u3067\u3059\u304b\u3089\u3001\u3084\u306f\u308a\u54c1\u8cea\u3084\u5b89\u5168\u6027\u306f\u3057\u3063\u304b\u308a\u3068\u78ba\u8a8d\u3057\u305f\u3044\u3067\u3059\u3088\u306d\u3002\u7279\u306b\u3001<strong>\u54c1\u8cea\u7ba1\u7406 GMP<\/strong>\u3068\u3044\u3046\u8a00\u8449\u3092\u8033\u306b\u3059\u308b\u6a5f\u4f1a\u304c\u5897\u3048\u305f\u306e\u306f\u3001\u305d\u308c\u3060\u3051\u6d88\u8cbb\u8005\u306e\u5b89\u5168\u306b\u5bfe\u3059\u308b\u610f\u8b58\u304c\u9ad8\u307e\u3063\u3066\u3044\u308b\u8a3c\u62e0\u3060\u3068\u601d\u3044\u307e\u3059\u3002<\/p>\n<p>\u4f8b\u3048\u3070\u3001\u79c1\u304c\u4ee5\u524d\u3001\u3042\u308b\u56fd\u7523\u30de\u30ab\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3092\u9078\u3076\u969b\u306b\u3001\u305d\u306e\u88fd\u9020\u5143\u304cGMP\u8a8d\u5b9a\u5de5\u5834\u3067\u3042\u308b\u3068\u3044\u3046\u8868\u793a\u3092\u898b\u3066\u3001\u5b89\u5fc3\u611f\u3092\u5f97\u3089\u308c\u305f\u7d4c\u9a13\u304c\u3042\u308a\u307e\u3059\u3002\u5177\u4f53\u7684\u306b\u306f\u3001\u305d\u306e\u5de5\u5834\u3067\u306f\u3001\u539f\u6599\u3068\u306a\u308b\u30de\u30ab\u304c\u3069\u306e\u3088\u3046\u306b\u683d\u57f9\u3055\u308c\u3001\u3069\u306e\u3088\u3046\u306b\u52a0\u5de5\u3055\u308c\u3066\u3044\u308b\u306e\u304b\u3001\u305d\u306e\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\uff08\u8ffd\u8de1\u53ef\u80fd\u6027\uff09\u304c\u3057\u3063\u304b\u308a\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u5506\u3057\u3066\u3044\u307e\u3057\u305f\u3002\u5358\u306b\u300c\u56fd\u7523\u300d\u3068\u3044\u3046\u3060\u3051\u3067\u306a\u304f\u3001\u3069\u3053\u3067\u3001\u8ab0\u304c\u3001\u3069\u306e\u3088\u3046\u306b\u4f5c\u3063\u305f\u306e\u304b\u304c\u660e\u78ba\u3067\u3042\u308b\u3053\u3068\u306f\u3001\u4fe1\u983c\u3067\u304d\u308b\u88fd\u54c1\u3092\u9078\u3076\u4e0a\u3067\u5927\u304d\u306a\u5b89\u5fc3\u6750\u6599\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u3082\u3046\u4e00\u3064\u3001GMP\u8a8d\u5b9a\u5de5\u5834\u3067\u88fd\u9020\u3055\u308c\u3066\u3044\u308b\u3068\u3044\u3046\u3053\u3068\u306f\u3001\u54c1\u8cea\u306e\u3070\u3089\u3064\u304d\u304c\u5c11\u306a\u3044\u3068\u3044\u3046\u70b9\u3067\u3082\u91cd\u8981\u3067\u3059\u3002\u4f8b\u3048\u3070\u3001\u540c\u3058\u30de\u30ab\u3068\u3044\u3046\u539f\u6599\u3092\u4f7f\u3063\u3066\u3082\u3001\u53ce\u7a6b\u6642\u671f\u3084\u4e7e\u71e5\u65b9\u6cd5\u3001\u52a0\u5de5\u306e\u4ed5\u65b9\u306b\u3088\u3063\u3066\u3001\u542b\u307e\u308c\u308b\u6804\u990a\u6210\u5206\u306e\u91cf\u306a\u3069\u304c\u5fae\u5999\u306b\u5909\u308f\u3063\u3066\u304f\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002GMP\u306b\u6e96\u62e0\u3057\u305f\u5de5\u5834\u3067\u306f\u3001\u3053\u308c\u3089\u306e\u5de5\u7a0b\u304c\u6a19\u6e96\u5316\u3055\u308c\u3066\u304a\u308a\u3001\u3044\u3064\u8cfc\u5165\u3057\u3066\u3082\u3001\u3067\u304d\u308b\u3060\u3051\u540c\u3058\u54c1\u8cea\u306e\u88fd\u54c1\u304c\u624b\u306b\u5165\u308b\u3088\u3046\u306b\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u3093\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u6bce\u65e5\u7d99\u7d9a\u3057\u3066\u6442\u53d6\u3059\u308b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3060\u304b\u3089\u3053\u305d\u3001\u5b09\u3057\u3044\u30dd\u30a4\u30f3\u30c8\u3060\u3068\u611f\u3058\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u300c<strong>GMP\u8a8d\u5b9a\u5de5\u5834 \u30de\u30ab<\/strong>\u300d\u3068\u3044\u3063\u305f\u30ad\u30fc\u30ef\u30fc\u30c9\u3067\u691c\u7d22\u3059\u308b\u3068\u3001\u591a\u304f\u306e\u88fd\u54c1\u304c\u51fa\u3066\u304d\u307e\u3059\u304c\u3001\u305d\u306e\u4e2d\u3067\u3082\u3001\u88fd\u9020\u904e\u7a0b\u306e\u900f\u660e\u6027\u3084\u3001\u54c1\u8cea\u3078\u306e\u3053\u3060\u308f\u308a\u304c\u611f\u3058\u3089\u308c\u308b\u88fd\u54c1\u3092\u9078\u3076\u3053\u3068\u304c\u3001\u81ea\u5206\u81ea\u8eab\u306e\u5065\u5eb7\u3092\u5b88\u308b\u305f\u3081\u306b\u3082\u5927\u5207\u3060\u3068\u8003\u3048\u3066\u3044\u307e\u3059\u3002<\/p>\n<h3 id=\"GMP\u8a8d\u5b9a\u5de5\u5834\u88fd\u9020\u3067\u5f97\u3089\u308c\u308b\u78ba\u304b\u306a\u5b89\u5fc3\u611f\">GMP\u8a8d\u5b9a\u5de5\u5834\u88fd\u9020\u3067\u5f97\u3089\u308c\u308b\u3001\u78ba\u304b\u306a\u5b89\u5fc3\u611f<\/h3>\n<p>\u56fd\u7523\u30de\u30ab\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3092\u9078\u3076\u4e0a\u3067\u3001<strong>GMP\u8a8d\u5b9a\u5de5\u5834<\/strong>\u3067\u306e\u88fd\u9020\u304b\u3069\u3046\u304b\u306f\u3001\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u4e0a\u3067\u975e\u5e38\u306b\u5927\u5207\u306a\u30dd\u30a4\u30f3\u30c8\u3060\u3068\u611f\u3058\u3066\u3044\u307e\u3059\u3002\u521d\u3081\u3066\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306b\u8208\u5473\u3092\u6301\u3063\u305f\u9803\u306f\u3001\u300cGMP\u3063\u3066\u4f55\u3060\u308d\u3046\uff1f\u300d\u3068\u3001\u6b63\u76f4\u3088\u304f\u5206\u304b\u3063\u3066\u3044\u307e\u305b\u3093\u3067\u3057\u305f\u3002<\/p>\n<p>GMP\u3068\u306f\u3001\u300cGood Manufacturing Practice\u300d\u306e\u7565\u3067\u3001\u65e5\u672c\u8a9e\u3067\u306f\u300c\u9069\u6b63\u88fd\u9020\u898f\u7bc4\u300d\u3068\u547c\u3070\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u304c\u4e00\u5b9a\u306b\u4fdd\u305f\u308c\u308b\u3088\u3046\u306b\u3001\u539f\u6599\u306e\u53d7\u3051\u5165\u308c\u304b\u3089\u88fd\u9020\u3001\u51fa\u8377\u307e\u3067\u306e\u5168\u3066\u306e\u904e\u7a0b\u3067\u3001\u4eba\u70ba\u7684\u306a\u8aa4\u308a\u3092\u306a\u304f\u3057\u3001\u6c5a\u67d3\u3084\u54c1\u8cea\u4f4e\u4e0b\u3092\u9632\u304e\u3001\u9ad8\u3044\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u56fd\u969b\u7684\u306a\u57fa\u6e96\u306a\u3093\u3067\u3059\u3002\u3064\u307e\u308a\u3001\u3053\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u5de5\u5834\u3067\u4f5c\u3089\u308c\u3066\u3044\u308b\u3068\u3044\u3046\u3053\u3068\u306f\u3001\u305d\u308c\u3060\u3051\u3067\u300c\u3061\u3083\u3093\u3068\u4f5c\u3089\u308c\u3066\u3044\u307e\u3059\u3088\u300d\u3068\u3044\u3046\u8a3c\u660e\u306b\u306a\u308b\u308f\u3051\u3067\u3059\u3002<\/p>\n<p>\u79c1\u304c\u5b9f\u969b\u306bGMP\u8a8d\u5b9a\u5de5\u5834\u3067\u88fd\u9020\u3055\u308c\u3066\u3044\u308b\u88fd\u54c1\u3092\u9078\u3093\u3067\u826f\u304b\u3063\u305f\u3068\u611f\u3058\u305f\u306e\u306f\u3001\u307e\u305a\u7570\u7269\u6df7\u5165\u3084\u54c1\u8cea\u4f4e\u4e0b\u306e\u5fc3\u914d\u304c\u683c\u6bb5\u306b\u6e1b\u3063\u305f\u3053\u3068\u3067\u3059\u3002\u4f8b\u3048\u3070\u3001\u5de5\u5834\u5185\u306f\u5e38\u306b\u6e05\u6f54\u306b\u4fdd\u305f\u308c\u3066\u3044\u3066\u3001\u7a7a\u6c17\u6e05\u6d44\u30b7\u30b9\u30c6\u30e0\u306f\u3082\u3061\u308d\u3093\u3001\u4f5c\u696d\u54e1\u306e\u65b9\u3005\u3082\u885b\u751f\u7ba1\u7406\u304c\u5fb9\u5e95\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u79c1\u304c\u4ee5\u524d\u3001\u5225\u306e\u88fd\u54c1\u3067\u5c0f\u3055\u306a\u7570\u7269\u304c\u5165\u3063\u3066\u3044\u305f\u7d4c\u9a13\u304c\u3042\u3063\u305f\u3053\u3068\u304b\u3089\u3001\u7279\u306b\u91cd\u8996\u3059\u308b\u3088\u3046\u306b\u306a\u3063\u305f\u70b9\u3067\u3059\u3002GMP\u8a8d\u5b9a\u5de5\u5834\u3067\u306f\u3001\u88fd\u9020\u30e9\u30a4\u30f3\u3054\u3068\u306b\u53b3\u683c\u306a\u7ba1\u7406\u304c\u884c\u308f\u308c\u3001\u539f\u6750\u6599\u306e\u53d7\u3051\u5165\u308c\u304b\u3089\u6700\u7d42\u88fd\u54c1\u306b\u306a\u308b\u307e\u3067\u3001\u7d30\u304b\u304f\u30c1\u30a7\u30c3\u30af\u3055\u308c\u3066\u3044\u308b\u306e\u3067\u3001\u5b89\u5fc3\u3057\u3066\u53e3\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u307e\u305f\u3001\u30ed\u30c3\u30c8\u3054\u3068\u306e\u54c1\u8cea\u306e\u5747\u4e00\u6027\u3068\u5b89\u5b9a\u6027\u3082\u3001GMP\u8a8d\u5b9a\u5de5\u5834\u306e\u5927\u304d\u306a\u30e1\u30ea\u30c3\u30c8\u3060\u3068\u611f\u3058\u3066\u3044\u307e\u3059\u3002\u30de\u30ab\u306e\u683d\u57f9\u81ea\u4f53\u304c\u81ea\u7136\u76f8\u624b\u3067\u5927\u5909\u306a\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u304c\u3001\u53ce\u7a6b\u3055\u308c\u305f\u539f\u6599\u3092\u52a0\u5de5\u3057\u3066\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306b\u3059\u308b\u904e\u7a0b\u3067\u3082\u3001\u54c1\u8cea\u306b\u3070\u3089\u3064\u304d\u304c\u51fa\u3084\u3059\u3044\u3093\u3067\u3059\u3002GMP\u8a8d\u5b9a\u5de5\u5834\u3067\u306f\u3001\u4e00\u5b9a\u306e\u88fd\u9020\u65b9\u6cd5\u304c\u78ba\u7acb\u3055\u308c\u3066\u304a\u308a\u3001\u6e29\u5ea6\u3084\u6e7f\u5ea6\u3001\u6df7\u5408\u6642\u9593\u306a\u3069\u304c\u7d30\u304b\u304f\u7ba1\u7406\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u3044\u3064\u8cfc\u5165\u3057\u3066\u3082\u540c\u3058\u54c1\u8cea\u306e\u88fd\u54c1\u304c\u624b\u306b\u5165\u308b\u3068\u3044\u3046\u5b89\u5fc3\u611f\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u7d99\u7d9a\u3057\u3066\u5065\u5eb7\u306e\u305f\u3081\u306b\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3092\u6442\u308a\u305f\u3044\u3068\u8003\u3048\u3066\u3044\u308b\u8005\u3068\u3057\u3066\u306f\u3001\u975e\u5e38\u306b\u3042\u308a\u304c\u305f\u3044\u30dd\u30a4\u30f3\u30c8\u3067\u3059\u3002<\/p>\n<p>\u5177\u4f53\u4f8b\u3092\u6319\u3052\u308b\u3068\u3001\u3042\u308b\u56fd\u7523\u30de\u30ab\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3067\u306f\u3001GMP\u8a8d\u5b9a\u5de5\u5834\u3067\u306e\u88fd\u9020\u306b\u52a0\u3048\u3001\u539f\u6750\u6599\u306e\u53d7\u3051\u5165\u308c\u6642\u306b\u83cc\u691c\u67fb\u3084\u6210\u5206\u5206\u6790\u3092\u5fb9\u5e95\u3057\u3066\u3044\u308b\u305d\u3046\u3067\u3059\u3002\u3055\u3089\u306b\u3001\u88fd\u9020\u5de5\u7a0b\u3067\u306f\u3001\u7c89\u672b\u304c\u5747\u4e00\u306b\u6df7\u3056\u308b\u3088\u3046\u306b\u7279\u6b8a\u306a\u30df\u30ad\u30b5\u30fc\u3092\u4f7f\u7528\u3057\u3001\u305d\u306e\u90fd\u5ea6\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u3057\u3066\u6210\u5206\u306e\u504f\u308a\u304c\u306a\u3044\u304b\u3092\u78ba\u8a8d\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306b\u3001\u76ee\u306b\u898b\u3048\u306a\u3044\u90e8\u5206\u3067\u306e\u78ba\u304b\u306a\u54c1\u8cea\u7ba1\u7406\u304c\u3042\u308b\u304b\u3089\u3053\u305d\u3001\u79c1\u305f\u3061\u306f\u300c\u3053\u306e\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306a\u3089\u5927\u4e08\u592b\u300d\u3068\u4fe1\u983c\u3057\u3066\u9078\u3076\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u3060\u3068\u601d\u3044\u307e\u3059\u3002\u30de\u30ab \u30b5\u30d7\u30ea \u54c1\u8cea\u4fdd\u8a3c\u3092\u6c42\u3081\u308b\u306a\u3089\u3001\u3053\u3046\u3057\u305f\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3078\u306e\u3053\u3060\u308f\u308a\u306f\u6b20\u304b\u305b\u306a\u3044\u8981\u7d20\u3060\u3068\u611f\u3058\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u3055\u3089\u306b\u3001\u88fd\u9020\u74b0\u5883\u306e\u885b\u751f\u7ba1\u7406\u3060\u3051\u3067\u306a\u304f\u3001\u4f5c\u696d\u54e1\u306e\u6559\u80b2\u4f53\u5236\u3082GMP\u306e\u91cd\u8981\u306a\u8981\u7d20\u3067\u3059\u3002\u4f5c\u696d\u54e1\u4e00\u4eba\u3072\u3068\u308a\u304c\u3001\u885b\u751f\u7ba1\u7406\u306e\u91cd\u8981\u6027\u3084\u6b63\u3057\u3044\u88fd\u9020\u624b\u9806\u3092\u7406\u89e3\u3057\u3001\u5b9f\u8df5\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30d2\u30e5\u30fc\u30de\u30f3\u30a8\u30e9\u30fc\u306b\u3088\u308b\u54c1\u8cea\u4f4e\u4e0b\u306e\u30ea\u30b9\u30af\u3082\u6700\u5c0f\u9650\u306b\u6291\u3048\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u5b89\u5168 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