{"id":7401,"date":"2025-10-10T00:47:15","date_gmt":"2025-10-10T00:47:15","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=7401"},"modified":"2025-09-24T03:14:34","modified_gmt":"2025-09-24T03:14:34","slug":"sop-in-pharmaceutical-industry","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/sop-in-pharmaceutical-industry\/","title":{"rendered":"\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bSOP\uff1a\u30b3\u30a2\u8981\u7d20\u3001\u7a2e\u985e\u3001\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9"},"content":{"rendered":"
\n\t\t\t\t\t\t
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\u88fd\u85ac\u696d\u754c\u3067\u306f\u3001\u5c0f\u3055\u306a\u30df\u30b9\u3067\u3082\u5927\u304d\u306a\u30ea\u30b9\u30af\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u4f01\u696d\u306f\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\uff08SOP\uff09\u306b\u983c\u3063\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n

\"\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\"
\u88fd\u85ac\u696d\u754c\u306eSOP<\/strong><\/figcaption><\/figure>\n

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bSOP\u306f\u5358\u306a\u308b\u66f8\u985e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u8cab\u6027\u3001\u5b89\u5168\u6027\u3001\u305d\u3057\u3066\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306e\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002\u660e\u78ba\u306aSOP\u304c\u306a\u3051\u308c\u3070\u3001\u5f93\u696d\u54e1\u304c\u540c\u3058\u30bf\u30b9\u30af\u3092\u7570\u306a\u308b\u65b9\u6cd5\u3067\u5b9f\u884c\u3057\u3001\u30df\u30b9\u3084\u898f\u5236\u4e0a\u306e\u554f\u984c\u304c\u767a\u751f\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n

\u305d\u308c\u304c\u4f55\u3067\u3042\u308b\u304b\u3001\u307e\u305f\u306f\u4f1a\u793e\u3067\u305d\u308c\u3092\u3069\u306e\u3088\u3046\u306b\u69cb\u7bc9\u3059\u308b\u304b\u304c\u308f\u304b\u3089\u306a\u3044\u5834\u5408\u306f\u3001\u8aad\u307f\u9032\u3081\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b SOP \u3068\u306f\u4f55\u3067\u3059\u304b?<\/b><\/h2>\n

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bSOP\uff08\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09\u306f\u3001\u7279\u5b9a\u306e\u4f5c\u696d\u3092\u4e00\u8cab\u6027\u3068\u7ba1\u7406\u6027\u3092\u3082\u3063\u3066\u5b9f\u65bd\u3059\u308b\u65b9\u6cd5\u3092\u6bb5\u968e\u7684\u306b\u8aac\u660e\u3057\u305f\u6587\u66f8\u3067\u3059\u3002\u5358\u306a\u308b\u6587\u66f8\u3067\u306f\u306a\u304f\u3001\u65e5\u3005\u306e\u696d\u52d9\u306e\u6839\u5e79\u3092\u6210\u3059\u3082\u306e\u3067\u3059\u3002<\/span><\/p>\n

\"FDA\u306f2023\u5e74\u306b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\u306e\u4e0d\u5099\u306738\u4ef6\u306e\u9055\u53cd\u5207\u7b26\u3092\u767a\u884c\u3057\u305f\u3002\"
FDA\u306f2023\u5e74\u306b\u4e0d\u5408\u683c\u3068\u306a\u3063\u305fSOP\u306b\u5bfe\u3057\u306638\u4ef6\u306e\u544a\u767a\u72b6\u3092\u767a\u884c\u3057\u305f\u3002<\/strong> \u30bd\u30fc\u30b9\uff1a <\/i><\/b>\u5c02\u9580\u5bb6\u30d6\u30ea\u30fc\u30d5\u30a3\u30f3\u30b0<\/span><\/i><\/a><\/figcaption><\/figure>\n

\u6a5f\u5668\u306e\u6d17\u6d44\u304b\u3089\u30b5\u30f3\u30d7\u30eb\u306e\u691c\u67fb\u307e\u3067\u3001\u3059\u3079\u3066\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u6bce\u56de\u4e00\u8cab\u3057\u3066\u6b63\u78ba\u306b\u5b9f\u884c\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002SOP\u306f\u305d\u308c\u3092\u5b9f\u73fe\u3059\u308b\u3082\u306e\u3067\u3059\u3002SOP\u306f\u3001\u533b\u85ac\u54c1\u304c\u53b3\u683c\u306a\u57fa\u6e96\u306b\u5f93\u3063\u3066\u88fd\u9020\u30fb\u691c\u67fb\u3055\u308c\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3053\u3068\u3067\u3001\u30df\u30b9\u3092\u6e1b\u3089\u3057\u3001\u52b9\u7387\u3092\u5411\u4e0a\u3055\u305b\u3001\u60a3\u8005\u306e\u5b89\u5168\u3092\u5b88\u308a\u307e\u3059\u3002<\/span><\/p>\n

\u3060\u304b\u3089\u3053\u305d\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u306f\u91cd\u8981\u306a\u306e\u3067\u3059\u30022023\u5e74\u3060\u3051\u3067\u3082\u3001 <\/span>FDA\u306f180\u901a\u306e\u8b66\u544a\u66f8\u3092\u767a\u884c\u3057\u305f<\/span><\/a> \u88fd\u9020\u696d\u8005\u3078\u306e\u5831\u544a\u3067\u3059\u3002\u305d\u306e\u3046\u306138\u4ef6\u306f\u9069\u5207\u306a\u6a19\u6e96\u4f5c\u696d\u624b\u9806\uff08SOP\uff09\u306e\u7b56\u5b9a\u306b\u5931\u6557\u3057\u305f\u3053\u3068\u304c\u539f\u56e0\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u4e00\u8cab\u6027\u3092\u4fdd\u3064\u305f\u3081\u306e\u9069\u5207\u306a\u6a19\u6e96\u4f5c\u696d\u624b\u9806\uff08SOP\uff09\u3092\u6574\u5099\u3057\u3066\u3044\u306a\u3044\u4f01\u696d\u304c\u3044\u304b\u306b\u591a\u3044\u304b\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bSOP\u306e\u91cd\u8981\u6027<\/b><\/h2>\n

SOP \u306f\u3001\u30d7\u30ed\u30bb\u30b9\u306e\u4e00\u8cab\u6027\u3001\u5b89\u5168\u6027\u3001\u304a\u3088\u3073 FDA\u3001EMA\u3001WHO \u306a\u3069\u306e\u4e16\u754c\u7684\u306a\u898f\u5236\u3078\u306e\u6e96\u62e0\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u30c4\u30fc\u30eb\u3067\u3059\u3002<\/span><\/p>\n

SOP\u304c\u91cd\u8981\u306a\u6700\u5927\u306e\u7406\u7531\u306e\u4e00\u3064\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u305f\u3081\u3067\u3059\u3002\u898f\u5236\u5f53\u5c40\u306f\u3001\u88fd\u85ac\u4f1a\u793e\u306b\u5bfe\u3057\u3001\u88fd\u9020\u5de5\u7a0b\u306e\u3042\u3089\u3086\u308b\u6bb5\u968e\u3067\u3001 <\/span>\u533b\u85ac\u54c1\u88fd\u9020<\/span><\/a>\u88fd\u9020\u3001\u30c6\u30b9\u30c8\u3001\u305d\u3057\u3066\u914d\u9001\u306f\u3001\u66f8\u9762\u306b\u3088\u308b\u6307\u793a\u306b\u5f93\u3063\u3066\u884c\u308f\u308c\u307e\u3059\u3002SOP\u304c\u6b20\u843d\u3057\u3066\u3044\u308b\u3068\u3001\u76e3\u67fb\u306e\u4e0d\u5408\u683c\u3001\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u3001\u3055\u3089\u306b\u306f\u64cd\u696d\u505c\u6b62\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n

\u3053\u308c\u3089\u306e\u6a19\u6e96\u306f\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306b\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002\u65b0\u5165\u793e\u54e1\u304c\u5165\u793e\u3059\u308b\u969b\u3001SOP\u306f\u660e\u78ba\u306a\u30ac\u30a4\u30c9\u3068\u3057\u3066\u6a5f\u80fd\u3057\u3001\u5b66\u7fd2\u66f2\u7dda\u3092\u77ed\u7e2e\u3057\u3001\u7d4c\u9a13\u8c4a\u5bcc\u306a\u30b9\u30bf\u30c3\u30d5\u3068\u540c\u3058\u9ad8\u3044\u57fa\u6e96\u3092\u9075\u5b88\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u6642\u9593\u3092\u7bc0\u7d04\u3057\u3001\u30b3\u30b9\u30c8\u306e\u304b\u304b\u308b\u30df\u30b9\u3092\u524a\u6e1b\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\uff08SOP\uff09\u306e\u4e2d\u6838\u8981\u7d20<\/b><\/h2>\n

SOP\u3092\u4f5c\u6210\u3059\u308b\u524d\u306b\u3001\u4fe1\u983c\u6027\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u660e\u78ba\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u8981\u7d20\u3092\u660e\u78ba\u306b\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u5f37\u529b\u306aSOP\u306f\u3001\u63a8\u6e2c\u306b\u3088\u308b\u4f5c\u696d\u3092\u6e1b\u3089\u3057\u3001\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3057\u3001\u88fd\u54c1\u3068\u4f01\u696d\u306e\u8a55\u5224\u306e\u4e21\u65b9\u3092\u5b88\u308a\u307e\u3059\u3002<\/span><\/p>\n

1. \u660e\u78ba\u306a\u76ee\u7684\u3068\u7bc4\u56f2<\/b><\/h3>\n

\u3059\u3079\u3066\u306eSOP\u306f\u3001\u305d\u306e\u624b\u9806\u306e\u76ee\u7684\u3068\u91cd\u8981\u6027\u3092\u660e\u8a18\u3059\u308b\u3053\u3068\u304b\u3089\u59cb\u3081\u308b\u3079\u304d\u3067\u3059\u3002\u3053\u306e\u7c21\u6f54\u306a\u5c0e\u5165\u306b\u3088\u308a\u3001\u5f93\u696d\u54e1\u306fSOP\u3092\u3044\u3064\u3001\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3059\u3079\u304d\u304b\u3092\u3059\u3050\u306b\u7406\u89e3\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002\u307e\u305f\u3001\u76e3\u67fb\u62c5\u5f53\u8005\u304cSOP\u306e\u610f\u56f3\u3092\u3059\u3050\u306b\u7406\u89e3\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u76e3\u67fb\u306e\u52b9\u7387\u5316\u306b\u3082\u3064\u306a\u304c\u308a\u307e\u3059\u3002<\/span><\/p>\n

2. \u308f\u304b\u308a\u3084\u3059\u3044\u8a00\u8449\u3067\u6bb5\u968e\u7684\u306b\u8aac\u660e\u3059\u308b<\/b><\/h3>\n

SOP\u306e\u6838\u5fc3\u306f\u3001\u660e\u78ba\u3067\u9806\u5e8f\u7acb\u3063\u305f\u624b\u9806\u3067\u3059\u3002\u30e6\u30fc\u30b6\u30fc\u3092\u30bf\u30b9\u30af\u306b\u5c0e\u304f\u305f\u3081\u306b\u3001\u30b7\u30f3\u30d7\u30eb\u306a\u8a00\u8449\u3068\u52d5\u8a5e\u3092\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u5c02\u9580\u7528\u8a9e\u306f\u63a7\u3048\u3081\u306b\u3001\u307e\u305f\u306f\u660e\u78ba\u306b\u5b9a\u7fa9\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n

3. \u5f79\u5272\u3068\u8cac\u4efb\u306e\u5b9a\u7fa9<\/b><\/h3>\n

\u305d\u308c\u305e\u308c\u306e\u30a2\u30af\u30b7\u30e7\u30f3\u306b\u306f\u30aa\u30fc\u30ca\u30fc\u304c\u5fc5\u8981\u3067\u3059\u3002\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u3001\u30bf\u30b9\u30af\u306e\u5b9f\u884c\u304b\u3089\u7d50\u679c\u306e\u627f\u8a8d\u307e\u3067\u3001\u8ab0\u304c\u4f55\u3092\u884c\u3046\u304b\u3092\u660e\u78ba\u306b\u898f\u5b9a\u3057\u307e\u3059\u3002\u8cac\u4efb\u304c\u660e\u78ba\u3067\u3042\u308c\u3070\u3001 <\/span>GMP\u6e96\u62e0<\/span><\/a> \u304c\u5f37\u5316\u3055\u308c\u3001\u691c\u67fb\u4e2d\u306e\u8aac\u660e\u8cac\u4efb\u306e\u7ba1\u7406\u304c\u5bb9\u6613\u306b\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n

4. \u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3068\u76e3\u67fb\u306e\u53c2\u7167\u304c\u7d44\u307f\u8fbc\u307e\u308c\u3066\u3044\u308b<\/b><\/h3>\n

\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u624b\u9806\u3084\u53c2\u8003\u8cc7\u6599\u3092\u542b\u3080SOP\u306f\u3001\u30c1\u30fc\u30e0\u5168\u4f53\u306b\u77e5\u8b58\u3092\u6d78\u900f\u3055\u305b\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u3053\u308c\u3089\u306f\u696d\u52d9\u30ac\u30a4\u30c9\u3068\u3057\u3066\u3060\u3051\u3067\u306a\u304f\u3001\u76e3\u67fb\u8a3c\u62e0\u3068\u3057\u3066\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002\u307e\u305f\u3001\u8abf\u67fb\u306b\u3088\u308b\u3068\u3001\u4eba\u70ba\u7684\u30df\u30b9\u306f\u5168\u4f53\u306e100%\u4ee5\u4e0a\u3092\u5360\u3081\u3066\u3044\u307e\u3059\u3002 <\/span>80%\u306e\u30d7\u30ed\u30bb\u30b9\u9038\u8131<\/span><\/a> \u533b\u85ac\u54c1\u88fd\u9020\u696d\u306b\u304a\u3044\u3066\u3002<\/span><\/p>\n

\"\u30d7\u30ed\u30bb\u30b9\u9038\u8131\u306e80%\u306f\u4eba\u70ba\u7684\u30df\u30b9\u306b\u3088\u308a\u767a\u751f\"
\u30d7\u30ed\u30bb\u30b9\u9038\u8131\u306e 80 \u30d1\u30fc\u30bb\u30f3\u30c8\u306f\u4eba\u70ba\u7684\u30a8\u30e9\u30fc\u306b\u3088\u308a\u767a\u751f\u3057\u307e\u3059\u3002 \u30bd\u30fc\u30b9\uff1a <\/i><\/b>\u56fd\u7acb\u79d1\u5b66\u56f3\u66f8\u9928<\/span><\/i><\/a><\/figcaption><\/figure>\n

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b5\u7a2e\u985e\u306eSOP<\/b><\/h2>\n

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b 5 \u7a2e\u985e\u306e SOP \u306e\u6982\u8981\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/span><\/p>\n

\n\n\n\n\n\n\n\n\n
\n

SOP\u306e\u7a2e\u985e<\/i><\/b><\/p>\n<\/td>\n

\n

\u76ee\u7684<\/i><\/b><\/p>\n<\/td>\n

\n

\u306a\u305c\u305d\u308c\u304c\u91cd\u8981\u306a\u306e\u304b<\/i><\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\u88fd\u9020SOP<\/span><\/p>\n<\/td>\n

\n

\u533b\u85ac\u54c1\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u306e\u30ac\u30a4\u30c9<\/span><\/p>\n<\/td>\n

\n

GMP\u9055\u53cd\u3092\u9632\u6b62\u3057\u3001\u88fd\u54c1\u306e\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3057\u307e\u3059<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u54c1\u8cea\u7ba1\u7406SOP<\/span><\/p>\n<\/td>\n

\n

\u30c6\u30b9\u30c8\u3068\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u3092\u901a\u3058\u3066\u30d0\u30c3\u30c1\u54c1\u8cea\u3092\u78ba\u4fdd\u3059\u308b<\/span><\/p>\n<\/td>\n

\n

FDA\u306e\u67fb\u5bdf\u306b\u304a\u3051\u308b\u4e3b\u306a\u91cd\u70b9\u5206\u91ce<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6e05\u6383\u3068\u885b\u751f\u306eSOP<\/span><\/p>\n<\/td>\n

\n

\u7121\u83cc\u74b0\u5883\u3092\u7dad\u6301\u3059\u308b<\/span><\/p>\n<\/td>\n

\n

\u6c5a\u67d3\u3068\u9ad8\u984d\u306a\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u3092\u9632\u6b62<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8SOP<\/span><\/p>\n<\/td>\n

\n

\u8a18\u9332\u4fdd\u7ba1\u65b9\u6cd5\u3092\u6a19\u6e96\u5316\u3059\u308b<\/span><\/p>\n<\/td>\n

\n

\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8a3c\u660e\u3092\u78ba\u4fdd<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5b89\u5168\u304a\u3088\u3073\u7dca\u6025\u6642\u306eSOP<\/span><\/p>\n<\/td>\n

\n

\u7dca\u6025\u6642\u306b\u30b9\u30bf\u30c3\u30d5\u3068\u65bd\u8a2d\u3092\u4fdd\u8b77\u3059\u308b<\/span><\/p>\n<\/td>\n

\n

\u8077\u5834\u306e\u4e8b\u6545\u3084\u5065\u5eb7\u30ea\u30b9\u30af\u3092\u8efd\u6e1b<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

SOP\u306e\u898f\u5236\u8981\u4ef6<\/b><\/h2>\n

\u88fd\u85ac\u696d\u754c\u3067\u306f\u3001\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\u306f\u5358\u306a\u308b\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3067\u306f\u306a\u304f\u3001\u898f\u5236\u4e0a\u306e\u8981\u4ef6\u3067\u3059\u3002 <\/span>FDA\u3001EMA\u3001ICH<\/span><\/a> \u4f01\u696d\u306b\u306f\u660e\u78ba\u3067\u3001\u7ba1\u7406\u3055\u308c\u3001\u4e00\u8cab\u3057\u3066\u9075\u5b88\u3055\u308c\u308b\u624b\u9806\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u305d\u3053\u3067\u3001\u6ce8\u610f\u3059\u3079\u304d\u70b9\u306b\u3064\u3044\u3066\u304a\u8a71\u3057\u3057\u307e\u3057\u3087\u3046\u3002<\/span><\/p>\n

1. FDA\u3001EMA\u3001\u304a\u3088\u3073 ICH \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/b><\/h3>\n

\u7c73\u56fdFDA\uff08<\/span>21 CFR\u30d1\u30fc\u30c8211<\/span><\/a>\uff09\u3001\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u3001\u56fd\u969b\u533b\u85ac\u54c1\u898f\u5236\u8abf\u548c\u4f1a\u8b70\uff08ICH Q10\uff09\u306f\u3059\u3079\u3066\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3068\u4e00\u8cab\u6027\u3092\u7dad\u6301\u3059\u308b\u4e0a\u3067\u306e SOP \u306e\u5f79\u5272\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n

\u3053\u308c\u306f\u3001\u898f\u5236\u5f53\u5c40\u304cSOP\u306e\u9075\u5b88\u3092\u975e\u5e38\u306b\u91cd\u8996\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3092\u5ff5\u982d\u306b\u7f6e\u304d\u3001\u5f93\u696d\u54e1\u5411\u3051\u306b\u4e00\u8cab\u6027\u306e\u3042\u308bSOP\u3092\u4f5c\u6210\u3059\u308b\u3088\u3046\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u00a0<\/span><\/p>\n

2. GxP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ea\u30f3\u30af<\/b><\/h3>\n

SOP\u306fGxP\uff08\u9069\u6b63\u88fd\u9020\u57fa\u6e96\u3001\u8a66\u9a13\u5b9f\u65bd\u57fa\u6e96\u3001\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u57fa\u6e96\uff09\u306e\u6839\u5e79\u3092\u6210\u3059\u3082\u306e\u3067\u3059\u3002\u6587\u66f8\u5316\u3055\u308c\u305f\u624b\u9806\u304c\u306a\u3051\u308c\u3070\u3001\u4f01\u696d\u306f\u30d7\u30ed\u30bb\u30b9\u304c\u4e00\u8cab\u3057\u3066\u304a\u308a\u3001\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3067\u304d\u307e\u305b\u3093\u3002\u00a0<\/span><\/p>\n

\u4f8b\u3048\u3070\u3001\u6587\u66f8\u5316\u306e\u5f31\u70b9\u306f\u3001 <\/span>\u4e16\u754c\u4e2d\u306724%\u306e\u30ea\u30b3\u30fc\u30eb<\/span><\/a>\u3053\u308c\u306f\u3001\u9069\u5207\u306b\u7ba1\u7406\u3055\u308c\u305f SOP \u304c\u4ea4\u6e09\u306e\u4f59\u5730\u304c\u306a\u3044\u7406\u7531\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n

3. \u898f\u5236\u5f53\u5c40\u306b\u3088\u308bSOP\u76e3\u67fb\u306e\u65b9\u6cd5<\/b><\/h3>\n

\u691c\u67fb\u5b98\u306fSOP\u3092\u78ba\u8a8d\u3059\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u30c1\u30fc\u30e0\u304c\u5b9f\u969b\u306bSOP\u306b\u5f93\u3063\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3082\u78ba\u8a8d\u3057\u307e\u3059\u3002\u898f\u5236\u5f53\u5c40\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u691c\u8a3c\u3059\u308b\u305f\u3081\u306b\u3001\u5b9f\u5730\u691c\u67fb\u3084\u5b9f\u5730\u4f5c\u696d\u306e\u8ffd\u8de1\u8abf\u67fb\u3092\u884c\u3046\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n

\u6587\u66f8\u5316\u3055\u308c\u305f\u624b\u9806\u3068\u5b9f\u969b\u306e\u6163\u884c\u306e\u9593\u306b\u77db\u76fe\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u6587\u66f8\u304c\u6574\u3063\u3066\u3044\u3066\u3082\u8b66\u544a\u66f8\u304c\u767a\u884c\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u52b9\u679c\u7684\u306aSOP\u4f5c\u6210\u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9<\/b><\/h2>\n

SOP\u306f\u3001\u4eba\u3005\u304c\u7406\u89e3\u3057\u3001\u5f93\u3046\u3053\u3068\u304c\u3067\u304d\u306a\u3051\u308c\u3070\u5f79\u306b\u7acb\u3061\u307e\u305b\u3093\u3002\u591a\u304f\u306e\u88fd\u85ac\u4f1a\u793e\u306f\u3001\u624b\u9806\u3092\u904e\u5ea6\u306b\u8907\u96d1\u306b\u3057\u3001\u660e\u78ba\u3055\u3092\u6b20\u304f\u3068\u3044\u3046\u904e\u3061\u3092\u72af\u3057\u3066\u3044\u307e\u3059\u3002\u512a\u308c\u305fSOP\u306f\u5b9f\u7528\u7684\u3067\u3001\u6bce\u65e5\u4f7f\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u5fd8\u308c\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u00a0<\/span><\/p>\n

1. \u660e\u78ba\u304b\u3064\u30b7\u30f3\u30d7\u30eb\u306b<\/b><\/h3>\n

SOP\u306f\u6559\u79d1\u66f8\u306e\u3088\u3046\u306a\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u5f93\u696d\u54e1\u304c\u8aad\u307f\u3084\u3059\u304f\u3001\u5b9f\u8df5\u3057\u3084\u3059\u3044\u65b9\u6cd5\u3067\u3001\u30b9\u30c6\u30c3\u30d7\u30d0\u30a4\u30b9\u30c6\u30c3\u30d7\u3067\u624b\u9806\u3092\u6848\u5185\u3059\u308b\u3079\u304d\u3067\u3059\u3002\u77ed\u3044\u6587\u7ae0\u3001\u660e\u78ba\u306a\u6307\u793a\u3001\u305d\u3057\u3066\u5206\u304b\u308a\u3084\u3059\u3044\u66f8\u5f0f\u3092\u7528\u3044\u308b\u3053\u3068\u3067\u3001\u5f93\u696d\u54e1\u306f\u6df7\u4e71\u3059\u308b\u3053\u3068\u306a\u304f\u624b\u9806\u306b\u5f93\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><\/p>\n

2. \u5f93\u696d\u54e1\u3092\u5b9a\u671f\u7684\u306b\u7814\u4fee\u3059\u308b<\/b><\/h3>\n

\u5f93\u696d\u54e1\u304cSOP\uff08\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff09\u3092\u3088\u304f\u7406\u89e3\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u3001\u3069\u3093\u306a\u306b\u826f\u304f\u66f8\u304b\u308c\u305f\u3082\u306e\u3067\u3082\u5f79\u306b\u7acb\u3061\u307e\u305b\u3093\u3002\u5b9a\u671f\u7684\u306a\u7814\u4fee\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u3067\u3001\u5f93\u696d\u54e1\u306f\u81ea\u5206\u306b\u4f55\u304c\u671f\u5f85\u3055\u308c\u3066\u3044\u308b\u304b\u3092\u7406\u89e3\u3057\u3001\u65e5\u3005\u306e\u696d\u52d9\u3067\u6b63\u3057\u304f\u9069\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002\u7814\u4fee\u306f\u826f\u3044\u7fd2\u6163\u3092\u5b9a\u7740\u3055\u305b\u3001\u65b0\u3057\u3044\u30c1\u30fc\u30e0\u30e1\u30f3\u30d0\u30fc\u304c\u3059\u3050\u306b\u696d\u52d9\u306b\u6163\u308c\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u00a0<\/span><\/p>\n

3. \u6587\u66f8\u7ba1\u7406\u306b\u30c7\u30b8\u30bf\u30eb\u30c4\u30fc\u30eb\u3092\u6d3b\u7528\u3059\u308b<\/b><\/h3>\n

SOP\u3092\u624b\u4f5c\u696d\u3067\u7ba1\u7406\u3059\u308b\u3068\u3001\u6df7\u4e71\u3084\u53e4\u3044\u6307\u793a\u66f8\u306e\u6d41\u7528\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u30c7\u30b8\u30bf\u30eb\u30c4\u30fc\u30eb\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u6587\u66f8\u306e\u66f4\u65b0\u3001\u5909\u66f4\u5c65\u6b74\u306e\u8ffd\u8de1\u304c\u5bb9\u6613\u306b\u306a\u308a\u3001\u5f93\u696d\u54e1\u306f\u6700\u65b0\u30d0\u30fc\u30b8\u30e7\u30f3\u306b\u8fc5\u901f\u306b\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u5168\u54e1\u306e\u610f\u8b58\u304c\u7d71\u4e00\u3055\u308c\u3001\u53e4\u3044\u60c5\u5831\u306b\u3088\u308b\u30df\u30b9\u306e\u767a\u751f\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n

\u5f37\u529b\u306aSOP\u306b\u306f\u5f37\u529b\u306a\u30b5\u30dd\u30fc\u30c8\u30b7\u30b9\u30c6\u30e0\u304c\u5fc5\u8981<\/b><\/h2>\n

\u88fd\u85ac\u696d\u754c\u3067\u6700\u3082\u512a\u308c\u305f SOP \u3067\u3042\u3063\u3066\u3082\u3001\u6a5f\u5668\u304c\u6642\u4ee3\u9045\u308c\u3067\u3042\u3063\u305f\u308a\u975e\u52b9\u7387\u3067\u3042\u3063\u305f\u308a\u3059\u308b\u3068\u3001\u3042\u307e\u308a\u5f79\u306b\u7acb\u3061\u307e\u305b\u3093\u3002<\/span><\/p>\n

\u305d\u3053\u3067 <\/span>\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af<\/i><\/b><\/a> \u5165\u3063\u3066\u6765\u307e\u3059\u3002<\/span><\/p>\n

30\u5e74\u4ee5\u4e0a\u306e\u7d4c\u9a13\u306b\u57fa\u3065\u304d\u3001\u5f53\u793e\u306f\u304a\u5ba2\u69d8\u306eSOP\uff08\u6a19\u6e96\u696d\u52d9\u624b\u9806\uff09\u306e\u5c0e\u5165\u3092\u5bb9\u6613\u306b\u3059\u308b\u3001\u5148\u9032\u7684\u3067\u74b0\u5883\u306b\u512a\u3057\u3044\u533b\u85ac\u54c1\u88fd\u9020\u6a5f\u68b0\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u30ab\u30d7\u30bb\u30eb\u5145\u586b\u304b\u3089\u30d6\u30ea\u30b9\u30bf\u30fc\u5305\u88c5\u307e\u3067\u3001\u5f53\u793e\u306e\u6a5f\u5668\u306f\u30a8\u30e9\u30fc\u3092\u524a\u6e1b\u3057\u307e\u3059\u3002<\/span><\/p>\n

\u4eca\u3059\u3050\u30d5\u30a1\u30a4\u30f3\u30c6\u30c3\u30af\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/span><\/i><\/a> \u6700\u9069\u306a\u533b\u85ac\u54c1\u6a5f\u5668\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u898b\u3064\u3051\u307e\u3057\u3087\u3046\uff01\u00a0<\/span><\/i><\/p>\n

\u3088\u304f\u3042\u308b\u8cea\u554f<\/b><\/h2>\n

1. \u88fd\u85ac\u4f1a\u793e\u3067\u306f\u8ab0\u304c SOP \u3092\u4f5c\u6210\u3059\u308b\u8cac\u4efb\u304c\u3042\u308a\u307e\u3059\u304b?<\/b><\/h3>\n

\u901a\u5e38\u3001SOP\u306f\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u307e\u305f\u306f\u54c1\u8cea\u4fdd\u8a3c\u30c1\u30fc\u30e0\u304c\u4f5c\u6210\u3057\u307e\u3059\u3002\u5f7c\u3089\u306f\u30d7\u30ed\u30bb\u30b9\u3092\u8a73\u7d30\u306b\u628a\u63e1\u3057\u3001\u6307\u793a\u304c\u660e\u78ba\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u5b9f\u969b\u306b\u30bf\u30b9\u30af\u3092\u5b9f\u884c\u3059\u308b\u30b9\u30bf\u30c3\u30d5\u304b\u3089\u306e\u610f\u898b\u3082\u91cd\u8981\u3067\u3059\u3002\u5f7c\u3089\u306f\u3001\u4f55\u304c\u6700\u3082\u52b9\u679c\u7684\u304b\u306b\u3064\u3044\u3066\u5b9f\u8df5\u7684\u306a\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u63d0\u4f9b\u3057\u3066\u304f\u308c\u308b\u304b\u3089\u3067\u3059\u3002<\/span><\/p>\n

2. \u5f93\u696d\u54e1\u304c SOP \u306b\u5f93\u308f\u306a\u3044\u5834\u5408\u306f\u3069\u3046\u306a\u308a\u307e\u3059\u304b?<\/b><\/h3>\n

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3. SOP \u306f\u3069\u306e\u88fd\u85ac\u4f1a\u793e\u3067\u3082\u540c\u3058\u3067\u3059\u304b?<\/b><\/h3>\n

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<\/h1>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

In the pharmaceutical industry, even a small mistake can lead to huge risks. That\u2019s why companies rely on Standard Operating […]<\/p>\n","protected":false},"author":1,"featured_media":7403,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[61],"tags":[],"class_list":["post-7401","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-technology"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/7401","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/comments?post=7401"}],"version-history":[{"count":8,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/7401\/revisions"}],"predecessor-version":[{"id":7430,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/7401\/revisions\/7430"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/7403"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=7401"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=7401"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=7401"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}