{"id":375001,"date":"2025-01-03T13:49:46","date_gmt":"2025-01-03T18:49:46","guid":{"rendered":"https:\/\/caiready.com\/life-sciences\/blog\/%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9pic-s%e3%81%a8eu-gmp%e3%82%92%e6%b4%bb%e7%94%a8%e3%81%97%e3%81%9f%e6%88%90%e5%8a%9f%e3%81%ae%e6%9e%a0%e7%b5%84%e3%81%bf\/"},"modified":"2025-01-03T13:49:46","modified_gmt":"2025-01-03T18:49:46","slug":"%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9pic-s%e3%81%a8eu-gmp%e3%82%92%e6%b4%bb%e7%94%a8%e3%81%97%e3%81%9f%e6%88%90%e5%8a%9f%e3%81%ae%e6%9e%a0%e7%b5%84%e3%81%bf","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/ja\/blog\/%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9pic-s%e3%81%a8eu-gmp%e3%82%92%e6%b4%bb%e7%94%a8%e3%81%97%e3%81%9f%e6%88%90%e5%8a%9f%e3%81%ae%e6%9e%a0%e7%b5%84%e3%81%bf\/","title":{"rendered":"\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9PIC\/S\u3068EU GMP\u3092\u6d3b\u7528\u3057\u305f\u6210\u529f\u306e\u67a0\u7d44\u307f"},"content":{"rendered":"\n

\u306f\u3058\u3081\u306b<\/h3>\n\n\n\n

PIC\/S\u306fPIC\uff08\u533b\u85ac\u54c1\u67fb\u5bdf\u6761\u7d04\uff09\u306e\u5ef6\u9577\u3068\u3057\u30661995\u5e74\u306b\u8a2d\u7acb\u3055\u308c\u305f\u3002PIC\/S\u306f\u300156\u306e\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u62d8\u675f\u529b\u306e\u306a\u3044\u5354\u529b\u4f53\u5236\u3067\u3059\u300256\u3068\u3044\u3046\u6570\u5b57\u3092\u898b\u305f\u3060\u3051\u3067\u306f\u3001\u4e0b\u306e\u5730\u56f3\u3092\u898b\u3066PIC\/S\u306e\u771f\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u5e83\u304c\u308a\u3092\u7406\u89e3\u3059\u308b\u307b\u3069\u306e\u30a4\u30f3\u30d1\u30af\u30c8\u306f\u3042\u308a\u307e\u305b\u3093\u3002PIC\/S\u306e\u4f7f\u547d\u306f\u533b\u85ac\u54c1\u5206\u91ce\u306b\u304a\u3051\u308b\u8abf\u548c\u3055\u308c\u305fGMP\u57fa\u6e96\u304a\u3088\u3073\u67fb\u5bdf\u6a5f\u95a2\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u56fd\u969b\u7684\u306a\u958b\u767a\u3001\u5b9f\u65bd\u3001\u7dad\u6301\u3092\u4e3b\u5c0e\u3059\u308b\u3053\u3068” \u3067\u3042\u308b\u3002 <\/strong><\/em>PIC\/S\u306f\u8ab0\u3067\u3082\u53c2\u52a0\u3067\u304d\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001 <\/em>\u52a0\u76df\u306f\u898f\u5236\u5f53\u5c40\u306e\u307f\u306b\u9650\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u500b\u4eba\u3084\u4f01\u696d\u304c\u52a0\u76df\u3057\u305f\u308a\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u4f5c\u6210\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u306a\u3044\u3002 <\/p>\n

<\/p>\n\n\n\n

\"\"<\/a><\/figure><\/div>\n\n\n\n

\u9644\u5c5e\u66f81\u306e\u66f4\u65b0\u306b\u7d9a\u304d\u3001PIC\/S\u306f\u9644\u5c5e\u66f81\u306e\u767a\u52b9\u3068\u540c\u30582023\u5e748\u670825\u65e5\u306b<\/i>\u65b0\u3057\u3044\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u300c\u533b\u85ac\u54c1\u306e\u9069\u6b63\u88fd\u9020\u898f\u7bc4\u306e\u624b\u5f15\u304d \u9644\u5c5e\u66f8<\/i>\u300d\u3092\u516c\u8868\u3057\u305f\u3002\u3053\u308c\u306f\u5076\u7136\u306e\u4e00\u81f4\u3068\u601d\u308f\u308c\u308b\u3002 <\/p>\n\n\n\n

\u533b\u85ac\u54c1\u306e\u9069\u6b63\u88fd\u9020\u898f\u7bc4\u306b\u95a2\u3059\u308bPIC\/S\u30ac\u30a4\u30c9 \u9644\u5c5e\u66f8<\/h3>\n\n\n\n

PIC\/S GMP\u30ac\u30a4\u30c9\u306f2000\u5e7412\u6708\u306b\u767a\u884c\u3055\u308c\u300119\u56de\u306e\u6539\u8a02\u3092\u7d4c\u3066\u3044\u308b\u3002\u672c\u66f8\u306f\u30014\u3064\u306e\u4e3b\u8981\u51fa\u7248\u7269\u30012\u3064\u306e\u4e3b\u8981\u30bb\u30af\u30b7\u30e7\u30f3\u3001\u304a\u3088\u3073\u8907\u6570\u306e\u9644\u5c5e\u66f8\u306b\u5206\u304b\u308c\u3066\u3044\u308b\u3002\u30d1\u30fc\u30c81\u306f\u533b\u85ac\u54c1\u88fd\u9020\u306e\u305f\u3081\u306eGMP\u539f\u5247\u306b\u7126\u70b9\u3092\u5f53\u3066\u3001EU\u306eGMP9\u7ae0\u3092\u542b\u3080\u3002\u7b2c2\u90e8\u306f\u533b\u85ac\u54c1\u539f\u85ac\u306b\u7126\u70b9\u3092\u5f53\u3066\u300120\u306e\u7570\u306a\u308b\u30bb\u30af\u30b7\u30e7\u30f3\u304b\u3089\u69cb\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n\n\n

2023\u5e748\u6708\u306ePIC\/S GMP\u30ac\u30a4\u30c9\u306e\u6700\u65b0\u6539\u8a02\u7248\u3067\u306f\u3001\u6539\u8a02\u3055\u308c\u305f\u9644\u5c5e\u66f81\u3068\u6574\u5408\u3057\u3066\u3044\u308b\u3002 <\/p>\n\n\n\n

PIC\/S GMP\u30ac\u30a4\u30c9\u3068EU GMP\u30ac\u30a4\u30c9\u306e\u9055\u3044\u306f\u305d\u308c\u307b\u3069\u591a\u304f\u306a\u3044\u304c\u3001\u305d\u306e\u3044\u304f\u3064\u304b\u3092\u4ee5\u4e0b\u306b\u7d39\u4ecb\u3059\u308b\uff1a<\/p>\n\n\n\n

    \n
  • \u533b\u85ac\u54c1\u306f\u3001PIC\/S GMP\u30ac\u30a4\u30c9\u3067\u306fMedicinal Product\u3068\u547c\u3070\u308c\u308b\u3002<\/li>\n\n\n\n
  • PIC\/S GMP\u30ac\u30a4\u30c9\u306fEU\u6307\u4ee4\u3084MRA\u306b\u8a00\u53ca\u3057\u3066\u3044\u306a\u3044\u3002<\/li>\n\n\n\n
  • PIC\/S GMP\u30ac\u30a4\u30c9\u3067\u306f\u3001Qualified Person\u306fAuthorized Person\u3068\u547c\u3070\u308c\u3066\u3044\u308b\u3002<\/li>\n\n\n\n
  • PIC\u30b9\u30ad\u30fc\u30e0\u306e\u3059\u3079\u3066\u306e\u53c2\u52a0\u6a5f\u95a2\u304c\u6b27\u5dde\u85ac\u5c40\u65b9\u6761\u7d04\u306b\u52a0\u76df\u3057\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u306e\u3067\u3001PIC\/S\u30ac\u30a4\u30c9\u306f\u5358\u306b\u6b27\u5dde\u85ac\u5c40\u65b9\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u95a2\u9023\u3059\u308b\u85ac\u5c40\u65b9\u3092\u8a18\u8f09\u3057\u3066\u3044\u308b\u3060\u3051\u3067\u3042\u308b\u3002<\/li>\n<\/ul>\n\n\n\n

    \u9644\u5c5e\u66f81 \u6539\u8a02\u306e\u7dcf\u62ec<\/h3>\n\n\n\n

    \u9644\u5c5e\u66f81\u306f\u3053\u306e\u30d6\u30ed\u30b0\u306e\u7126\u70b9\u3067\u306f\u306a\u3044\u304c\u3001\u3053\u3053\u3067\u306f\u3001PIC\/S GMP\u30ac\u30a4\u30c9\u3092\u4f5c\u6210\u3059\u308b\u305f\u3081\u306e\u30a4\u30e1\u30fc\u30b8\u3092\u63cf\u304f\u305f\u3081\u306b\u3001\u9644\u5c5e\u66f81\u306e\u5927\u6539\u8a02\u306b\u3064\u3044\u3066\u7c21\u5358\u306b\u601d\u3044\u51fa\u3059\u3002 <\/p>\n\n\n\n

    \u9644\u5c5e\u66f81\u306f\u5f53\u521d1971\u5e74\u306b\u767a\u8868\u3055\u308c\u3001\u305d\u306e\u5f8c\u4f55\u5ea6\u3082\u5909\u66f4\u304c\u52a0\u3048\u3089\u308c\u30012017\u5e74\u672b\u306b\u5927\u6539\u8a02\u306e\u7b2c\u4e00\u7a3f\u304c\u767a\u8868\u3055\u308c\u305f\u3002  2017\u5e74\u304b\u30892023\u5e74\u306b\u304b\u3051\u3066\u88fd\u85ac\u696d\u754c\u306e\u5909\u5316\u306f\u975e\u5e38\u306b\u5927\u304d\u304f\u3001GMP\/GDP\u67fb\u5bdf\u5b98\u4f5c\u696d\u90e8\u4f1a\u3068PIC\/S\u59d4\u54e1\u4f1a\u306f\u5171\u540c\u3067\u9644\u5c5e\u66f81\u306e\u6539\u8a02\u3092\u52e7\u544a\u3057\u305f\u3002  \u6539\u8a02\u3055\u308c\u305f\u9644\u5c5e\u66f81\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001\u65b0\u305f\u306a\u500b\u5225\u5316\u533b\u85ac\u54c1\u3084\u5148\u9032\u6cbb\u7642\u3068\u3068\u3082\u306b\u3001\u533b\u85ac\u54c1\u3084\u6cbb\u7642\u88fd\u54c1\u306e\u5909\u5316\u306b\u9069\u5fdc\u3057\u3066\u3044\u308b\u3002  \u3064\u307e\u308a\u3001\u9644\u5c5e\u66f81\u306f\u308f\u305a\u304b16\u30da\u30fc\u30b8\u304b\u308956\u30da\u30fc\u30b8\u306b\u306a\u3063\u305f\u3002\u3053\u308c\u306f\u696d\u754c\u306e\u5909\u5316\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u5927\u6539\u9769\u3060\u3063\u305f\u3002  <\/p>\n\n\n\n

    FDA\u3001MHRA\u3001PIC\/S – \u6700\u9ad8\u306e\u30c1\u30fc\u30e0\u30ef\u30fc\u30af<\/h3>\n\n\n\n

    FDA\u306f\u65b0\u3057\u3044\u9644\u5c5e\u66f81\u306e\u6539\u8a02\u3092\u5b9f\u65bd\u3067\u304d\u308b\u306e\u304b\uff1f  FDA\u306f\u9023\u90a6\u898f\u5247\u96c6\uff08CFR\uff09\u3092\u898b\u76f4\u3057\u3001\u305d\u3053\u304b\u3089\u629c\u7c8b\u3057\u3066\u3044\u308b\u3060\u3051\u306a\u306e\u3060\u3002  \u3082\u3063\u3068\u9577\u3044\u7b54\u3048\u306f\u3001\u300e\u9055\u53cd\u3042\u308b\u3068\u3053\u308d\u306b\u9053\u3042\u308a\u300f\u3060\u3002  PIC\/S\u304c56\u306e\u7570\u306a\u308b\u898f\u5236\u5f53\u5c40\u306e\u5171\u901a\u57fa\u76e4\u3092\u4f5c\u308a\u3001\u76f8\u4e92\u306e\u4fe1\u983c\u3092\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u6211\u3005\u306f\u3059\u3079\u3066\u306e\u5f53\u5c40\u9593\u306e\u5354\u529b\u3092\u671f\u5f85\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002 <\/p>\n\n\n\n

    FDA\u3068MHRA\u306f\u3068\u3082\u306b\u3001\u88fd\u85ac\u65bd\u8a2d\u306e\u8a8d\u8a3c\u3001\u691c\u67fb\u3001\u53d6\u308a\u7de0\u307e\u308a\u3092\u884c\u3063\u3066\u3044\u308b\u3002PIC\/S\u306f\u3053\u308c\u3089\u306e\u6a5f\u80fd\u3092\u4e00\u5207\u679c\u305f\u3057\u3066\u3044\u306a\u3044\u3002MHRA\u3068FDA\u306e\u5354\u529b\u95a2\u4fc2\u306f\u3001\u3053\u3053\u6570\u5e74\u3067\u7dca\u5bc6\u5316\u3057\u3001\u3088\u308a\u660e\u78ba\u306b\u306a\u3063\u3066\u304d\u3066\u3044\u308b\u3002\u6700\u8fd1\u306e\u591a\u304f\u306e\u4f1a\u8b70\u3067\u306f\u3001\u3053\u306e\u5354\u529b\u95a2\u4fc2\u306f\u307e\u3059\u307e\u3059\u5f37\u304f\u306a\u3063\u3066\u3044\u308b\u3068\u6307\u6458\u3055\u308c\u3066\u3044\u308b\u3002\u3067\u306f\u3001PIC\/S\u306f\u3053\u306e\u3069\u3053\u306b\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u308b\u306e\u3060\u308d\u3046\u304b\uff1f\u3055\u3066\u3001PIC\/S\u306f\u975e\u5e38\u306b\u591a\u304f\u306e\u898f\u5236\u5f53\u5c40\u9593\u306e\u5171\u901a\u9805\u3067\u3042\u308b\u3002PIC\/S\u306f\u3001\u307e\u3055\u306b\u30b3\u30e9\u30dc\u30ec\u30fc\u30b7\u30e7\u30f3\u3068\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u30c1\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u305f\u3081\u306e\u3082\u3046\u4e00\u3064\u306e\u3064\u306a\u304c\u308a\u306a\u306e\u3067\u3059\u3002 <\/p>\n\n\n\n

    \u672a\u6765<\/h3>\n\n\n\n

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