{"id":17310,"date":"2026-08-09T01:32:48","date_gmt":"2026-08-09T01:32:48","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=17310"},"modified":"2026-05-08T02:45:22","modified_gmt":"2026-05-08T02:45:22","slug":"sop-for-contract-manufacturing-in-pharmaceutical","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/sop-for-contract-manufacturing-in-pharmaceutical\/","title":{"rendered":"\u533b\u85ac\u54c1\u53d7\u8a17\u88fd\u9020\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"17310\" class=\"elementor elementor-17310\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-656075b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"656075b4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-78348194\" data-id=\"78348194\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2b902b66 product-data-tab elementor-widget elementor-widget-text-editor\" data-id=\"2b902b66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u53d7\u8a17\u88fd\u9020\u306e\u6a19\u6e96\u696d\u52d9\u624b\u9806\u3002.<\/p><figure id=\"attachment_17315\" aria-describedby=\"caption-attachment-17315\" style=\"width: 1000px\" class=\"wp-caption aligncenter\"><img fetchpriority=\"high\" decoding=\"async\" class=\"size-full wp-image-17315\" src=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Contract-Manufacturing-in-Pharmaceutical.jpg\" alt=\"\u533b\u85ac\u54c1\u53d7\u8a17\u88fd\u9020\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\" width=\"1000\" height=\"668\" title=\"\" srcset=\"https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Contract-Manufacturing-in-Pharmaceutical.jpg 1000w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Contract-Manufacturing-in-Pharmaceutical-500x334.jpg 500w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Contract-Manufacturing-in-Pharmaceutical-300x200.jpg 300w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Contract-Manufacturing-in-Pharmaceutical-768x513.jpg 768w, https:\/\/pharmamachinecn.com\/wp-content\/uploads\/2026\/08\/SOP-for-Contract-Manufacturing-in-Pharmaceutical-18x12.jpg 18w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><figcaption id=\"caption-attachment-17315\" class=\"wp-caption-text\"><em><strong>\u533b\u85ac\u54c1\u53d7\u8a17\u88fd\u9020\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u3002.<\/strong><\/em><\/figcaption><\/figure><h2><strong>1.0 \u76ee\u7684:<\/strong><\/h2><p>\u5f53\u65bd\u8a2d\u306b\u304a\u3051\u308b\u53d7\u8a17\u88fd\u9020\u696d\u52d9\u306e\u53d6\u308a\u6271\u3044\u65b9\u91dd\u3092\u5b9a\u3081\u308b\u3002\u3053\u308c\u306b\u306f\u3001\u7b2c\u4e09\u8005\u5411\u3051\u306b\u88fd\u9020\u3055\u308c\u308b\u88fd\u54c1\u306b\u52a0\u3048\u3001\u5f53\u65bd\u8a2d\u304c\u81ea\u3089\u306e\u305f\u3081\u306b\u7b2c\u4e09\u8005\u306b\u88fd\u9020\u3092\u59d4\u8a17\u3057\u305f\u88fd\u54c1\u3082\u542b\u307e\u308c\u308b\u3002\u305d\u306e\u76ee\u7684\u306f\u3001\u5951\u7d04\u671f\u9593\u3092\u901a\u3058\u3066\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3001\u60a3\u8005\u306e\u5b89\u5168\u3001\u304a\u3088\u3073GMP\u306e\u9075\u5b88\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u306b\u3042\u308b\u3002.<\/p><h2><strong>2.0 \u7bc4\u56f2:<\/strong><\/h2><p>\u672c\u624b\u9806\u66f8\u306f\u3001\u5f53\u8a72\u62e0\u70b9\u304c\u5f53\u4e8b\u8005\u3068\u306a\u308b\u3059\u3079\u3066\u306e\u53d7\u8a17\u88fd\u9020\u5951\u7d04\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u5f53\u8a72\u62e0\u70b9\u304c\u59d4\u8a17\u8005\u3067\u3042\u308b\u304b\u53d7\u8a17\u8005\u3067\u3042\u308b\u304b\u3092\u554f\u308f\u305a\u3001\u672c\u624b\u9806\u66f8\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u7528\u30d0\u30c3\u30c1\u3001\u5e02\u8ca9\u88fd\u54c1\u3001\u304a\u3088\u3073\u8f38\u51fa\u7528\u88fd\u54c1\u306f\u3059\u3079\u3066\u3001\u672c\u624b\u9806\u66f8\u306e\u9069\u7528\u7bc4\u56f2\u306b\u542b\u307e\u308c\u307e\u3059\u3002.<\/p><h2><strong>3.0 \u8cac\u4efb:<\/strong><\/h2><p>\u53d7\u8a17\u88fd\u9020\u62c5\u5f53\u8005\u3001\u54c1\u8cea\u4fdd\u8a3c\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3001\u304a\u3088\u3073\u85ac\u4e8b\u62c5\u5f53\u5b98<\/p><h2><strong>4.0 \u8aac\u660e\u8cac\u4efb:<\/strong><\/h2><p>\u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005\u304a\u3088\u3073\u6709\u8cc7\u683c\u8005\uff08QP\uff09\u3002.<\/p><h2><strong>5.0 \u624b\u9806:<\/strong><\/h2><p>5.1 \u3042\u3089\u3086\u308b\u53d7\u8a17\u88fd\u9020\u5951\u7d04\u306b\u304a\u3044\u3066\u30012\u3064\u306e\u5f79\u5272\u304c\u4e2d\u6838\u3092\u306a\u3057\u3066\u3044\u307e\u3059\u3002\u300c\u59d4\u8a17\u8005\u300d\u3068\u306f\u3001\u88fd\u54c1\u304a\u3088\u3073\u8ca9\u58f2\u627f\u8a8d\u3092\u6240\u6709\u3059\u308b\u5f53\u4e8b\u8005\u3092\u6307\u3057\u307e\u3059\u3002\u300c\u53d7\u8a17\u8005\u300d\u3068\u306f\u3001\u81ea\u793e\u306e\u65bd\u8a2d\u3067\u5b9f\u969b\u306b\u88fd\u54c1\u3092\u88fd\u9020\u3059\u308b\u5f53\u4e8b\u8005\u3092\u6307\u3057\u307e\u3059\u3002.<\/p><p>5.2 \u3069\u3061\u3089\u306e\u5f79\u5272\u306b\u3082\u3001GMP\u306b\u57fa\u3065\u304f\u660e\u78ba\u306a\u7fa9\u52d9\u304c\u8ab2\u305b\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u59d4\u8a17\u8005\u306f\u3001\u305f\u3068\u3048\u88fd\u9020\u304c\u7b2c\u4e09\u8005\u306b\u3088\u3063\u3066\u884c\u308f\u308c\u305f\u5834\u5408\u3067\u3082\u3001\u8ca9\u58f2\u3055\u308c\u305f\u88fd\u54c1\u306b\u5bfe\u3059\u308b\u8cac\u4efb\u3092\u8ca0\u3044\u7d9a\u3051\u307e\u3059\u3002\u53d7\u8a17\u8005\u306f\u3001\u5951\u7d04\u306b\u660e\u8a18\u3055\u308c\u305f\u57fa\u6e96\u306b\u5f93\u3063\u3066\u305d\u306e\u88fd\u54c1\u3092\u88fd\u9020\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p><p>5.3 \u5f53\u30b5\u30a4\u30c8\u306b\u304a\u3051\u308b\u3059\u3079\u3066\u306e\u53d7\u8a17\u88fd\u9020\u5951\u7d04\u306f\u30012\u3064\u306e\u5225\u500b\u306e\u6587\u66f8\u306b\u3088\u3063\u3066\u88cf\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u5546\u696d\u5951\u7d04\u306b\u306f\u3001\u4fa1\u683c\u3001\u6570\u91cf\u3001\u304a\u3088\u3073\u7d0d\u671f\u304c\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u54c1\u8cea\u5951\u7d04\u306b\u306f\u3001\u5404\u5f53\u4e8b\u8005\u306e\u54c1\u8cea\u306b\u95a2\u3059\u308b\u3059\u3079\u3066\u306e\u7fa9\u52d9\u304c\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p><p>5.4 \u53cc\u65b9\u306eQP\u304c\u4e21\u65b9\u306e\u66f8\u985e\u306b\u7f72\u540d\u3059\u308b\u307e\u3067\u306f\u3001\u3044\u304b\u306a\u308b\u88fd\u54c1\u3082\u3001\u5951\u7d04\u306b\u57fa\u3065\u304d\u88fd\u9020\u3001\u51fa\u8377\u3001\u307e\u305f\u306f\u51fa\u8377\u8a31\u53ef\u3092\u884c\u3063\u3066\u306f\u306a\u3089\u306a\u3044\u3002.<\/p><h3><strong>5.5 \u65b0\u898f\u5951\u7d04\u5148\u306e\u5be9\u67fb\uff1a<\/strong><\/h3><p>5.5.1 \u65b0\u898f\u30d1\u30fc\u30c8\u30ca\u30fc\u306f\u3001\u5951\u7d04\u7de0\u7d50\u524d\u306b\u5fc5\u305a\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u3092\u7d4c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u3001\u30b5\u30a4\u30c8\u5074\u304c\u4ed5\u4e8b\u3092\u59d4\u8a17\u3059\u308b\u5834\u5408\u3082\u3001\u5f15\u304d\u53d7\u3051\u308b\u5834\u5408\u3082\u3001\u53cc\u65b9\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002.<\/p><h4><strong>5.5.2 \u5be9\u67fb\u306e\u5bfe\u8c61\u3068\u306a\u308b\u5206\u91ce\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\uff1a<\/strong><\/h4><p>5.5.2.1 GMP\u306e\u9069\u5408\u72b6\u6cc1\uff1a\u6709\u52b9\u306a\u88fd\u9020\u8a31\u53ef\u8a3c\u3001\u304a\u3088\u3073\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u3001\u6240\u7ba1\u5f53\u5c40\u304c\u767a\u884c\u3057\u305f\u6709\u52b9\u306aGMP\u8a3c\u660e\u66f8\u3002.<\/p><p>5.5.2.2 \u76e3\u67fb\u5c65\u6b74\uff1a\u672a\u89e3\u6c7a\u306e\u898f\u5236\u4e0a\u306e\u6307\u6458\u4e8b\u9805\u3001\u30ea\u30b3\u30fc\u30eb\u306e\u5c65\u6b74\u3001\u304a\u3088\u3073\u904e\u53bb3\u5e74\u9593\u306e\u691c\u67fb\u7d50\u679c\u3002.<\/p><p>5.5.2.3 \u6280\u8853\u7684\u80fd\u529b\uff1a\u9069\u5207\u306a\u8a2d\u5099\u3001\u9069\u5207\u306a\u8a13\u7df4\u3092\u53d7\u3051\u305f\u30b9\u30bf\u30c3\u30d5\u3001\u304a\u3088\u3073\u8a08\u753b\u3055\u308c\u305f\u51e6\u7406\u91cf\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u5341\u5206\u306a\u51e6\u7406\u80fd\u529b\u3002.<\/p><p>5.5.2.4 \u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\uff1a\u5909\u66f4\u7ba1\u7406\u3001\u9038\u8131\u3001\u304a\u3088\u3073\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u304c\u3059\u3079\u3066\u6574\u5099\u3055\u308c\u305f\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3002.<\/p><p>5.5.2.5 \u8ca1\u52d9\u72b6\u6cc1\uff1a\u5951\u7d04\u671f\u9593\u4e2d\u306b\u7d4c\u55b6\u7834\u7dbb\u306e\u30ea\u30b9\u30af\u304c\u3042\u308b\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u6392\u9664\u3059\u308b\u305f\u3081\u306e\u57fa\u672c\u7684\u306a\u8ca1\u52d9\u30c1\u30a7\u30c3\u30af\u3002.<\/p><p>5.5.3 \u5951\u7d04\u7de0\u7d50\u306b\u5148\u7acb\u3061\u3001\u73fe\u5730\u76e3\u67fb\u304c\u5b9f\u65bd\u3055\u308c\u308b\u3002\u3053\u306e\u76e3\u67fb\u3067\u306f\u3001\u76f4\u63a5\u89b3\u5bdf\u3001\u66f8\u985e\u5be9\u67fb\u3001\u304a\u3088\u3073\u30b9\u30bf\u30c3\u30d5\u3078\u306e\u805e\u304d\u53d6\u308a\u3092\u901a\u3058\u3066\u3001\u4e0a\u8a18\u306b\u6319\u3052\u305f\u3059\u3079\u3066\u306e\u9805\u76ee\u306b\u3064\u3044\u3066\u78ba\u8a8d\u304c\u884c\u308f\u308c\u308b\u3002.<\/p><p>5.5.4 \u30d9\u30f3\u30c0\u30fc\u76e3\u67fb\u5831\u544a\u66f8\u306f\u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005\u306b\u63d0\u51fa\u3055\u308c\u308b\u3002\u300c\u91cd\u5927\u300d\u307e\u305f\u306f\u300c\u91cd\u5927\u306a\u554f\u984c\u300d\u3068\u8a55\u4fa1\u3055\u308c\u305f\u6307\u6458\u4e8b\u9805\u306f\u3001\u5951\u7d04\u7de0\u7d50\u524d\u306b\u3059\u3079\u3066\u662f\u6b63\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>5.5.5 \u5be9\u67fb\u6bb5\u968e\u3067\u4e0d\u5408\u683c\u3068\u306a\u3063\u305f\u30d1\u30fc\u30c8\u30ca\u30fc\u306f\u3001\u4e0d\u63a1\u7528\u3068\u306a\u308a\u307e\u3059\u3002\u30d9\u30f3\u30c0\u30fc\u76e3\u67fb\u5831\u544a\u66f8\u304a\u3088\u3073\u4e0d\u63a1\u7528\u306e\u7406\u7531\u306f\u3001\u4eca\u5f8c\u306e\u53c2\u8003\u306e\u305f\u3081\u306b\u8a18\u9332\u3068\u3057\u3066\u4fdd\u7ba1\u3055\u308c\u307e\u3059\u3002.<\/p><h3><strong>5.6 \u54c1\u8cea\u5408\u610f\u66f8\uff1a<\/strong><\/h3><p>5.6.1 \u54c1\u8cea\u5354\u5b9a\u66f8\u306f\u30012\u3064\u306e\u62e0\u70b9\u306b\u304a\u3051\u308b\u54c1\u8cea\u7ba1\u7406\u306e\u65b9\u6cd5\u3092\u5b9a\u3081\u305f\u4e2d\u6838\u3068\u306a\u308b\u6587\u66f8\u3067\u3042\u308b\u3002\u3053\u308c\u306f\u5546\u696d\u5951\u7d04\u3068\u4e26\u884c\u3057\u3066\u5b58\u5728\u3059\u308b\u304c\u3001\u305d\u308c\u81ea\u4f53\u304c\u72ec\u7acb\u3057\u305f\u6587\u66f8\u3067\u3042\u308b\u3002.<\/p><p>5.6.2 \u5404\u54c1\u8cea\u5408\u610f\u66f8\u306b\u306f\u3001\u5c11\u306a\u304f\u3068\u3082\u4ee5\u4e0b\u306e\u4e8b\u9805\u3092\u76db\u308a\u8fbc\u3080\u5fc5\u8981\u304c\u3042\u308b\uff1a<\/p><p>5.6.2.1 \u4e21\u5f53\u4e8b\u8005\u9593\u306e\u8077\u52d9\u5206\u62c5\u3092\u3001\u8868\u307e\u305f\u306f\u8cac\u4efb\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u306e\u5f62\u5f0f\u3067\u660e\u78ba\u306b\u533a\u5206\u3059\u308b\u3053\u3068\u3002.<\/p><p>5.6.2.2 \u672c\u5951\u7d04\u306e\u5bfe\u8c61\u3068\u306a\u308b\u88fd\u54c1\u30ea\u30b9\u30c8\uff08\u52b9\u529b\u3001\u5305\u88c5\u30b5\u30a4\u30ba\u3001\u8ca9\u58f2\u5e02\u5834\u3092\u542b\u3080\uff09\u3002.<\/p><p>5.6.2.3 \u88fd\u54c1\u3001\u5de5\u7a0b\u3001\u62e0\u70b9\u3001\u307e\u305f\u306f\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u5909\u66f4\u306b\u95a2\u3059\u308b\u898f\u5247\u3002.<\/p><p>5.6.2.4 \u9038\u8131\u3001\u82e6\u60c5\u3001\u6709\u5bb3\u4e8b\u8c61\u3001\u304a\u3088\u3073\u30ea\u30b3\u30fc\u30eb\u306b\u3064\u3044\u3066\u3001\u5404\u5f53\u4e8b\u8005\u304c\u3069\u306e\u3088\u3046\u306b\u5bfe\u5fdc\u3059\u308b\u304b\u3002.<\/p><p>5.6.2.5 \u30d0\u30c3\u30c1\u51fa\u8377\u57fa\u6e96\u3001\u304a\u3088\u3073\u6700\u7d42\u51fa\u8377\u306e\u627f\u8a8d\u306b\u7f72\u540d\u3059\u308b\u6709\u8cc7\u683c\u8005\u306e\u6c0f\u540d\u3002.<\/p><p>5.6.2.6 \u76e3\u67fb\u6a29\u9650\u3002\u3053\u308c\u306b\u306f\u3001\u5951\u7d04\u767a\u6ce8\u8005\u304c\u3001\u5408\u7406\u7684\u306a\u4e8b\u524d\u901a\u77e5\u3092\u3082\u3063\u3066\u5951\u7d04\u53d7\u6ce8\u8005\u306e\u4e8b\u696d\u6240\u3092\u76e3\u67fb\u3059\u308b\u6a29\u5229\u304c\u542b\u307e\u308c\u308b\u3002.<\/p><p>5.6.2.7 \u8a66\u6599\u306e\u4fdd\u5b58\u306b\u95a2\u3059\u308b\u898f\u5247\uff1a\u8a66\u6599\u306e\u6570\u3001\u4fdd\u5b58\u6761\u4ef6\u3001\u4fdd\u5b58\u671f\u9593\u3001\u304a\u3088\u3073\u4fdd\u7ba1\u62c5\u5f53\u8005\u3002.<\/p><p>5.6.2.8 \u6587\u66f8\u306e\u4fdd\u5b58\u898f\u5247\uff1a\u8ab0\u304c\u3069\u306e\u8a18\u9332\u3092\u3001\u3069\u306e\u304f\u3089\u3044\u306e\u671f\u9593\u4fdd\u5b58\u3059\u308b\u304b\u3002.<\/p><p>5.6.3 \u54c1\u8cea\u5408\u610f\u66f8\u306f\u3001\u5c11\u306a\u304f\u3068\u30822\u5e74\u3054\u3068\u306b\u53cc\u65b9\u306e\u54c1\u8cea\u4fdd\u8a3c\u90e8\u9580\u306b\u3088\u3063\u3066\u898b\u76f4\u3055\u308c\u308b\u3002\u307e\u305f\u3001\u91cd\u5927\u306a\u5909\u66f4\u3084\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u63aa\u7f6e\u304c\u3042\u3063\u305f\u5834\u5408\u306b\u3082\u3001\u898b\u76f4\u3057\u304c\u5b9f\u65bd\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308b\u3002.<\/p><p>5.6.4 \u54c1\u8cea\u5951\u7d04\u66f8\u306b\u5bfe\u3059\u308b\u3059\u3079\u3066\u306e\u5909\u66f4\u306f\u3001\u5909\u66f4\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u884c\u308f\u308c\u308b\u3002\u5909\u66f4\u304c\u6709\u52b9\u306b\u306a\u308b\u306b\u306f\u3001\u4e21\u5f53\u4e8b\u8005\u306e\u627f\u8a8d\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002.<\/p><h3><strong>5.7 \u6280\u8853\u79fb\u8ee2\uff1a<\/strong><\/h3><p>5.7.1 \u30d0\u30c3\u30c1\u306e\u88fd\u9020\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001\u88fd\u54c1\u3092\u767a\u6ce8\u8005\u304b\u3089\u53d7\u6ce8\u8005\u3078\u5f15\u304d\u6e21\u3059\u5fc5\u8981\u304c\u3042\u308b\u3002\u3053\u308c\u3092\u6280\u8853\u79fb\u8ee2\u3068\u3044\u3046\u3002.<\/p><p>5.7.2 \u5951\u7d04\u8005\u306f\u3001\u8b72\u6e21\u306e\u4e00\u74b0\u3068\u3057\u3066\u3001\u4ee5\u4e0b\u306e\u66f8\u985e\u3092\u5f15\u304d\u6e21\u3059\u3082\u306e\u3068\u3059\u308b\uff1a<\/p><p>5.7.2.1 \u30de\u30b9\u30bf\u30fc\u30d0\u30c3\u30c1\u88fd\u9020\u8a18\u9332\u3002.<\/p><p>5.7.2.2 \u30de\u30b9\u30bf\u30fc\u30d0\u30c3\u30c1\u5145\u586b\u8a18\u9332\u3002.<\/p><p>5.7.2.3 \u88fd\u54c1\u4ed5\u69d8\u304a\u3088\u3073\u5206\u6790\u8a66\u9a13\u65b9\u6cd5\u3002.<\/p><p>5.7.2.4 \u5f53\u8a72\u88fd\u54c1\u306e\u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u3002.<\/p><p>5.7.2.5 \u539f\u88fd\u9020\u62e0\u70b9\u304b\u3089\u306e\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u5831\u544a\u66f8\u3002.<\/p><p>5.7.2.6 \u88fd\u54c1\u304c\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u5e02\u5834\u306b\u304a\u3051\u308b\u898f\u5236\u5f53\u5c40\u3078\u306e\u5c4a\u51fa\u3002.<\/p><p>5.7.3 \u5951\u7d04\u53d7\u8afe\u8005\u306f\u3001\u73fe\u5730\u306b\u304a\u3051\u308b\u6280\u8853\u79fb\u8ee2\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u7b56\u5b9a\u3059\u308b\u3002\u3053\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u306f\u3001\u65b0\u62e0\u70b9\u3067\u88fd\u54c1\u3092\u7a3c\u50cd\u3055\u305b\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u3059\u3079\u3066\u306e\u624b\u9806\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002.<\/p><p>5.7.4 \u307e\u305a\u3001\u4e00\u9023\u306e\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30d0\u30c3\u30c1\u304c\u4f5c\u6210\u3055\u308c\u308b\u3002\u3053\u308c\u3089\u306e\u30d0\u30c3\u30c1\u306f\u3001\u5951\u7d04\u53d7\u8afe\u8005\u306e\u8a2d\u5099\u306b\u304a\u3044\u3066\u30d7\u30ed\u30bb\u30b9\u304c\u554f\u984c\u306a\u304f\u52d5\u4f5c\u3059\u308b\u3053\u3068\u3092\u5b9f\u8a3c\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u3002.<\/p><p>5.7.5 \u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30d0\u30c3\u30c1\u306e\u88fd\u9020\u5f8c\u3001\u5546\u696d\u751f\u7523\u898f\u6a21\u30673\u3064\u306e\u9023\u7d9a\u3057\u305f\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u30d0\u30c3\u30c1\u3092\u88fd\u9020\u3059\u308b\u3002\u5404\u30d0\u30c3\u30c1\u306b\u3064\u3044\u3066\u3001\u539f\u85ac\u306e\u540c\u5b9a\u3001\u5b9a\u91cf\u3001\u6eb6\u51fa\u8a66\u9a13\u3001\u304a\u3088\u3073\u95a2\u9023\u7269\u8cea\u306b\u95a2\u3059\u308b\u4e00\u9023\u306e\u8a66\u9a13\u3092\u3059\u3079\u3066\u5b9f\u65bd\u3059\u308b\u3002.<\/p><p>5.7.6 \u6280\u8853\u79fb\u8ee2\u5831\u544a\u66f8\u306b\u3088\u308a\u3001\u6280\u8853\u79fb\u8ee2\u304c\u5b8c\u4e86\u3059\u308b\u3002\u540c\u5831\u544a\u66f8\u306b\u306f\u3001\u5f53\u8a72\u88fd\u54c1\u304c\u65b0\u62e0\u70b9\u306b\u304a\u3044\u3066\u3059\u3079\u3066\u306e\u4ed5\u69d8\u3092\u6e80\u305f\u3057\u3066\u304a\u308a\u3001\u91cf\u7523\u958b\u59cb\u306e\u6e96\u5099\u304c\u6574\u3063\u3066\u3044\u308b\u3053\u3068\u304c\u8a18\u8f09\u3055\u308c\u308b\u3002.<\/p><h3><strong>5.8 \u8cc7\u6750\u306e\u4f9b\u7d66\uff1a<\/strong><\/h3><p>5.8.1 \u54c1\u8cea\u5354\u5b9a\u66f8\u306b\u306f\u3001\u5404\u539f\u6750\u6599\u3001\u5305\u88c5\u8cc7\u6750\u3001\u304a\u3088\u3073\u6709\u52b9\u6210\u5206\u306e\u4f9b\u7d66\u5143\u304c\u660e\u8a18\u3055\u308c\u3066\u3044\u308b\u3002\u591a\u304f\u306e\u5834\u5408\u3001\u5951\u7d04\u767a\u6ce8\u8005\u304c\u6709\u52b9\u6210\u5206\u3092\u4f9b\u7d66\u3057\u3001\u5951\u7d04\u53d7\u6ce8\u8005\u304c\u305d\u308c\u4ee5\u5916\u306e\u3082\u306e\u3092\u8abf\u9054\u3059\u308b\u3002.<\/p><p>5.8.2 \u6709\u52b9\u6210\u5206\u306e\u4f9b\u7d66\u696d\u8005\u306f\u3001\u3059\u3079\u3066\u767a\u6ce8\u8005\u306e\u627f\u8a8d\u3092\u5f97\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u53d7\u6ce8\u8005\u306f\u3001\u6b63\u5f0f\u306a\u5909\u66f4\u4f9d\u983c\u304c\u306a\u3044\u9650\u308a\u3001\u6709\u52b9\u6210\u5206\u306e\u4f9b\u7d66\u696d\u8005\u3092\u5909\u66f4\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002.<\/p><p>5.8.3 \u767a\u6ce8\u8005\u304c\u4f9b\u7d66\u3059\u308b\u6750\u6599\u306b\u306f\u3001\u30ed\u30c3\u30c8\u3054\u3068\u306b\u5206\u6790\u8a3c\u660e\u66f8\u304c\u6dfb\u4ed8\u3055\u308c\u3066\u3044\u308b\u3002\u53d7\u6ce8\u8005\u306f\u53d7\u9818\u6642\u306b\u540c\u5b9a\u8a66\u9a13\u3092\u884c\u3046\u304c\u3001\u51fa\u8377\u524d\u8a66\u9a13\u306e\u5168\u9805\u76ee\u3092\u518d\u5ea6\u5b9f\u65bd\u3059\u308b\u3053\u3068\u306f\u306a\u3044\u3002.<\/p><p>5.8.4 \u5951\u7d04\u53d7\u8afe\u8005\u304c\u8abf\u9054\u3057\u305f\u8cc7\u6750\u306b\u3064\u3044\u3066\u306f\u3001\u5165\u8377\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u3092\u5b8c\u5168\u306b\u9075\u5b88\u3059\u308b\u3002\u5404\u30ed\u30c3\u30c8\u306b\u3064\u3044\u3066\u3001\u5206\u6790\u8a3c\u660e\u66f8\u3092\u63d0\u51fa\u3059\u308b\u3002.<\/p><p>5.8.5 \u8cc7\u6750\u306e\u4e0d\u8db3\u304c\u751f\u3058\u305f\u5834\u5408\u306f\u300124\u6642\u9593\u4ee5\u5185\u306b\u4e21\u5f53\u4e8b\u8005\u9593\u3067\u305d\u306e\u65e8\u304c\u901a\u77e5\u3055\u308c\u308b\u3002\u5b8c\u6210\u306b\u5fc5\u8981\u306a\u8cc7\u6750\u304c\u4e0d\u8db3\u3057\u3066\u3044\u308b\u30d0\u30c3\u30c1\u306e\u751f\u7523\u306f\u958b\u59cb\u3055\u308c\u306a\u3044\u3002.<\/p><h3><strong>5.9 \u30d0\u30c3\u30c1\u88fd\u9020\u304a\u3088\u3073\u76e3\u7763\uff1a<\/strong><\/h3><p>5.9.1 \u5404\u30d0\u30c3\u30c1\u306f\u3001\u6280\u8853\u79fb\u8ee2\u306e\u969b\u306b\u5f15\u304d\u7d99\u304c\u308c\u305f\u300c\u30de\u30b9\u30bf\u30fc\u30d0\u30c3\u30c1\u88fd\u9020\u8a18\u9332\u300d\u306b\u5f93\u3063\u3066\u88fd\u9020\u3055\u308c\u308b\u3002\u53d7\u8a17\u8005\u306f\u3001\u59d4\u8a17\u8005\u304b\u3089\u306e\u66f8\u9762\u306b\u3088\u308b\u627f\u8a8d\u304c\u306a\u3044\u9650\u308a\u3001\u5f53\u8a72\u8a18\u9332\u3092\u5909\u66f4\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002.<\/p><p>5.9.2 \u751f\u7523\u4e2d\u3001\u767a\u6ce8\u8005\u306b\u3088\u308a\u300c\u30d7\u30e9\u30f3\u30c8\u5e38\u99d0\u62c5\u5f53\u8005\uff08PIP\uff09\u300d\u304c\u914d\u7f6e\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308b\u3002PIP\u306f\u88fd\u9020\u4e2d\u306e\u30d0\u30c3\u30c1\u3092\u76e3\u8996\u3057\u3001\u91cd\u8981\u306a\u5de5\u7a0b\u306b\u3064\u3044\u3066\u627f\u8a8d\u3092\u884c\u3046\u3002.<\/p><p>5.9.3 \u5de5\u7a0b\u5185\u54c1\u8cea\u691c\u67fb\u306f\u3001\u30de\u30b9\u30bf\u30fc\u30ec\u30b3\u30fc\u30c9\u306b\u8a18\u8f09\u3055\u308c\u305f\u901a\u308a\u5b9f\u65bd\u3055\u308c\u308b\u3002\u898f\u683c\u5916\u306e\u7d50\u679c\u304c\u51fa\u305f\u5834\u5408\u306f\u3001\u9038\u8131\u3068\u3057\u3066\u8a18\u9332\u3055\u308c\u30011\u55b6\u696d\u65e5\u4ee5\u5185\u306b\u767a\u6ce8\u8005\u306b\u5831\u544a\u3055\u308c\u308b\u3002.<\/p><p>5.9.4 \u30d0\u30c3\u30c1\u6587\u66f8\u306f\u3001\u307e\u305a\u53d7\u8a17\u5074\u306e\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u90e8\u9580\u306b\u3088\u3063\u3066\u5be9\u67fb\u3055\u308c\u308b\u3002\u305d\u306e\u5f8c\u3001\u7f72\u540d\u6e08\u307f\u306e\u30d0\u30c3\u30c1\u8a18\u9332\u306e\u5b8c\u5168\u306a\u5199\u3057\u304c\u3001\u59d4\u8a17\u5074\u306e\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u90e8\u9580\u306b\u9001\u4ed8\u3055\u308c\u308b\u3002.<\/p><p>5.9.5 \u54c1\u8cea\u7ba1\u7406\u8a66\u9a13\u304a\u3088\u3073\u4fdd\u5b58\u7528\u3068\u3057\u3066\u3001\u3059\u3079\u3066\u306e\u30ed\u30c3\u30c8\u304b\u3089\u8a66\u6599\u304c\u63a1\u53d6\u3055\u308c\u308b\u3002\u8a66\u6599\u63a1\u53d6\u8a08\u753b\u306f\u54c1\u8cea\u5354\u5b9a\u66f8\u306b\u5b9a\u3081\u3089\u308c\u3066\u3044\u308b\u3002.<\/p><h3><strong>5.10 \u30d0\u30c3\u30c1\u30ea\u30ea\u30fc\u30b9\uff1a<\/strong><\/h3><p>5.10.1 \u30d0\u30c3\u30c1\u30ea\u30ea\u30fc\u30b9\u306b\u306f\u3001\u5e02\u5834\u306b\u3088\u3063\u3066\u30011\u6bb5\u968e\u306e\u30d7\u30ed\u30bb\u30b9\u30682\u6bb5\u968e\u306e\u30d7\u30ed\u30bb\u30b9\u306e2\u7a2e\u985e\u304c\u3042\u308a\u307e\u3059\u3002.<\/p><p>5.10.2 \u5358\u4e00\u30b9\u30c6\u30c3\u30d7\u306e\u30ea\u30ea\u30fc\u30b9\u306b\u3064\u3044\u3066\u306f\u3001\u53d7\u8a17\u88fd\u9020\u696d\u8005\u306e\u6709\u8cc7\u683c\u8005\u304c\u3001\u7f72\u540d\u6e08\u307f\u306e\u30d0\u30c3\u30c1\u8a18\u9332\u304a\u3088\u3073\u3059\u3079\u3066\u306e\u8a66\u9a13\u7d50\u679c\u306b\u57fa\u3065\u304d\u3001\u5f53\u8a72\u30d0\u30c3\u30c1\u3092\u30ea\u30ea\u30fc\u30b9\u3059\u308b\u3002\u3053\u306e\u30e2\u30c7\u30eb\u306f\u3001\u5358\u7d14\u306a\u53d7\u8a17\u88fd\u9020\u306b\u304a\u3044\u3066\u4e00\u822c\u7684\u3067\u3042\u308b\u3002.<\/p><p>5.10.3 2\u6bb5\u968e\u306e\u30ea\u30ea\u30fc\u30b9\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3044\u3066\u306f\u3001\u5951\u7d04\u53d7\u8afe\u8005\u304c\u6280\u8853\u7684\u306a\u30ea\u30ea\u30fc\u30b9\u3092\u884c\u3044\u3001\u5951\u7d04\u4ed8\u4e0e\u8005\u304c\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u4e0a\u306e\u30ea\u30ea\u30fc\u30b9\u3092\u884c\u3046\u3002\u88fd\u54c1\u3092\u3044\u304b\u306a\u308b\u5e02\u5834\u306b\u3082\u51fa\u8377\u3059\u308b\u306b\u306f\u3001\u53cc\u65b9\u306e\u7f72\u540d\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002.<\/p><p>5.10.4 \u3044\u305a\u308c\u304b\u306e\u8a66\u9a13\u7d50\u679c\u304c\u627f\u8a8d\u3055\u308c\u305f\u4ed5\u69d8\u7bc4\u56f2\u5916\u3068\u306a\u3063\u305f\u5834\u5408\u3001\u305d\u306e\u30ed\u30c3\u30c8\u306f\u51fa\u8377\u3055\u308c\u306a\u3044\u3002\u4ed5\u69d8\u5916\u306e\u7d50\u679c\u304c\u51fa\u305f\u5834\u5408\u306f\u3001\u73fe\u5834\u306e\u9038\u8131\u5bfe\u5fdc\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u306b\u5f93\u3063\u3066\u8abf\u67fb\u304c\u884c\u308f\u308c\u308b\u3002.<\/p><p>5.10.5 \u6709\u8cc7\u683c\u8005\u306f\u3001\u7f72\u540d\u5165\u308a\u306e\u300c\u30ea\u30ea\u30fc\u30b9\u6c7a\u5b9a\u8a18\u9332\u300d\u3092\u4fdd\u7ba1\u3059\u308b\u3002\u3059\u3079\u3066\u306e\u30ed\u30c3\u30c8\u306e\u30ea\u30ea\u30fc\u30b9\u3001\u4fdd\u7559\u3001\u304a\u3088\u3073\u4e0d\u9069\u5408\u306e\u6c7a\u5b9a\u306f\u3001\u65e5\u4ed8\u3068\u7406\u7531\u3068\u3068\u3082\u306b\u3053\u306e\u8a18\u9332\u306b\u8a18\u8f09\u3055\u308c\u308b\u3002.<\/p><h3><strong>5.11 \u5909\u66f4\u7ba1\u7406\uff1a<\/strong><\/h3><p>5.11.1 \u3044\u305a\u308c\u304b\u306e\u62e0\u70b9\u306b\u304a\u3051\u308b\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u5909\u66f4\u306f\u3001\u3059\u3079\u3066\u5909\u66f4\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u884c\u308f\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u308c\u306b\u306f\u3001\u914d\u5408\u3001\u5de5\u7a0b\u3001\u8a2d\u5099\u3001\u65bd\u8a2d\u3001\u4ed5\u69d8\u3001\u304a\u3088\u3073\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u95a2\u3059\u308b\u5909\u66f4\u304c\u542b\u307e\u308c\u308b\u3002.<\/p><p>5.11.2 \u5909\u66f4\u3092\u63d0\u6848\u3059\u308b\u5f53\u4e8b\u8005\u306f\u3001\u5909\u66f4\u7ba1\u7406\u4f9d\u983c\u66f8\u3092\u4f5c\u6210\u3057\u3001\u3053\u308c\u3092\u76f8\u624b\u65b9\u306b\u9001\u4ed8\u3057\u3066\u5be9\u67fb\u3092\u6c42\u3081\u308b\u3002\u76f8\u624b\u65b9\u306f\u300130\u65e5\u4ee5\u5185\u306b\u627f\u8a8d\u3001\u5374\u4e0b\u3001\u307e\u305f\u306f\u8ffd\u52a0\u60c5\u5831\u306e\u63d0\u4f9b\u3092\u6c42\u3081\u308b\u65e8\u306e\u56de\u7b54\u3092\u884c\u308f\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p><p>5.11.3 \u5909\u66f4\u306f\u3001\u4e21\u5f53\u4e8b\u8005\u304c\u627f\u8a8d\u3059\u308b\u307e\u3067\u5b9f\u65bd\u3055\u308c\u306a\u3044\u3002\u9ed9\u793a\u306e\u627f\u8a8d\u306f\u3001\u53d7\u8a17\u88fd\u9020\u696d\u52d9\u306b\u306f\u9069\u7528\u3055\u308c\u306a\u3044\u3002.<\/p><p>5.11.4 \u5909\u66f4\u306b\u95a2\u3059\u308b\u898f\u5236\u5f53\u5c40\u3078\u306e\u5c4a\u51fa\u306f\u3001\u54c1\u8cea\u5408\u610f\u66f8\u306b\u8a18\u8f09\u3055\u308c\u305f\u5f53\u4e8b\u8005\u304c\u62c5\u5f53\u3059\u308b\u3002\u307b\u3068\u3093\u3069\u306e\u5834\u5408\u3001\u3053\u308c\u306f\u8ca9\u58f2\u627f\u8a8d\u4fdd\u6301\u8005\u3067\u3042\u308b\u5951\u7d04\u767a\u6ce8\u8005\u3068\u306a\u308b\u3002.<\/p><p>5.11.5 \u7dca\u6025\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u306f\u3001\u66f8\u9762\u306b\u3088\u308b\u627f\u8a8d\u304c\u5f97\u3089\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u3067\u3082\u3001\u76f8\u624b\u5148\u306e\u54c1\u8cea\u4fdd\u8a3c\u62c5\u5f53\u8005\u306e\u53e3\u982d\u306b\u3088\u308b\u627f\u8a8d\u304c\u3042\u308c\u3070\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u305f\u3060\u3057\u3001\u53e3\u982d\u306b\u3088\u308b\u627f\u8a8d\u5f8c\u300148\u6642\u9593\u4ee5\u5185\u306b\u66f8\u9762\u306b\u3088\u308b\u78ba\u8a8d\u3092\u884c\u3046\u3082\u306e\u3068\u3059\u308b\u3002.<\/p><h3><strong>5.12 \u9038\u8131\u304a\u3088\u3073\u82e6\u60c5\uff1a<\/strong><\/h3><p>5.12.1 \u5951\u7d04\u53d7\u8afe\u8005\u306e\u73fe\u5834\u3067\u4e0d\u5099\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u306f\u30011\u55b6\u696d\u65e5\u4ee5\u5185\u306b\u5951\u7d04\u767a\u6ce8\u8005\u306b\u5831\u544a\u3059\u308b\u3002\u5831\u544a\u5185\u5bb9\u306b\u306f\u3001\u767a\u751f\u3057\u305f\u4e8b\u8c61\u3001\u5f71\u97ff\u3092\u53d7\u3051\u305f\u88fd\u54c1\u3001\u304a\u3088\u3073\u8b1b\u3058\u305f\u63aa\u7f6e\u3092\u542b\u3081\u308b\u3082\u306e\u3068\u3059\u308b\u3002.<\/p><p>5.12.2 \u4e0d\u9069\u5408\u8abf\u67fb\u306f\u5171\u540c\u3067\u5b9f\u65bd\u3055\u308c\u308b\u3002\u5951\u7d04\u53d7\u9818\u8005\u304c\u6280\u8853\u7684\u306a\u8abf\u67fb\u3092\u4e3b\u5c0e\u3059\u308b\u3002\u5951\u7d04\u767a\u6ce8\u8005\u306f\u3001\u8abf\u67fb\u7d50\u679c\u304a\u3088\u3073\u662f\u6b63\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u8a08\u753b\u3092\u5be9\u67fb\u3057\u3001\u627f\u8a8d\u3059\u308b\u3002.<\/p><p>5.12.3 \u53d7\u8a17\u88fd\u9020\u88fd\u54c1\u306b\u95a2\u3057\u3066\u3044\u305a\u308c\u304b\u306e\u5f53\u4e8b\u8005\u304c\u53d7\u9818\u3057\u305f\u82e6\u60c5\u306f\u300124\u6642\u9593\u4ee5\u5185\u306b\u76f8\u624b\u65b9\u306b\u901a\u77e5\u3055\u308c\u308b\u3002\u82e6\u60c5\u306e\u8abf\u67fb\u306f\u3001\u901a\u5e38\u306e\u82e6\u60c5\u51e6\u7406\u624b\u9806\uff08SOP\uff09\u306b\u5f93\u3063\u3066\u5b9f\u65bd\u3055\u308c\u308b\u3002.<\/p><p>5.12.4 \u88fd\u54c1\u306e\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u554f\u984c\u3092\u6307\u6458\u3059\u308b\u82e6\u60c5\u304c\u5bc4\u305b\u3089\u308c\u305f\u5834\u5408\u3001\u5f53\u8a72\u88fd\u54c1\u306e\u56de\u53ce\u624b\u7d9a\u304d\u304c\u958b\u59cb\u3055\u308c\u308b\u3002\u8ca9\u58f2\u627f\u8a8d\u3092\u4fdd\u6709\u3057\u3066\u3044\u308b\u306e\u306f\u767a\u6ce8\u8005\u3067\u3042\u308b\u305f\u3081\u3001\u5e02\u5834\u306b\u304a\u3051\u308b\u63aa\u7f6e\u306b\u3064\u3044\u3066\u306f\u767a\u6ce8\u8005\u304c\u4e3b\u5c0e\u3059\u308b\u3002.<\/p><p>5.12.5 \u5404\u5f53\u4e8b\u8005\u306f\u3001\u3059\u3079\u3066\u306e\u9038\u8131\u304a\u3088\u3073\u82e6\u60c5\u306e\u7d50\u679c\u306b\u3064\u3044\u3066\u3001\u76f8\u624b\u65b9\u306b\u5831\u544a\u3092\u884c\u3046\u3002\u5f53\u8a72\u5831\u544a\u66f8\u306f\u3001\u5404\u88fd\u54c1\u3054\u3068\u306e\u300c\u5951\u7d04\u54c1\u8cea\u30d5\u30a1\u30a4\u30eb\u300d\u306b\u4fdd\u7ba1\u3055\u308c\u308b\u3002.<\/p><h3><strong>5.13 \u5b9a\u671f\u7684\u306a\u898b\u76f4\u3057\u304a\u3088\u3073\u76e3\u67fb\uff1a<\/strong><\/h3><p>5.13.1 \u5951\u7d04\u767a\u6ce8\u8005\u306f\u3001\u5951\u7d04\u53d7\u6ce8\u8005\u306e\u4e8b\u696d\u6240\u306b\u5bfe\u3057\u3001\u5c11\u306a\u304f\u3068\u30822\u5e74\u306b1\u56de\u3001\u76e3\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u3002\u91cd\u5927\u306a\u9038\u8131\u3084\u898f\u5236\u4e0a\u306e\u6307\u6458\u304c\u3042\u3063\u305f\u5834\u5408\u306f\u3001\u3088\u308a\u77ed\u3044\u901a\u77e5\u671f\u9593\u3067\u91cd\u70b9\u76e3\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u3042\u308b\u3002.<\/p><p>5.13.2 \u76e3\u67fb\u7d50\u679c\u306b\u3064\u3044\u3066\u306f\u3001\u300c\u91cd\u5927\u300d\u3001\u300c\u91cd\u8981\u300d\u3001\u300c\u8efd\u5fae\u300d\u306e3\u6bb5\u968e\u306b\u5206\u985e\u3055\u308c\u308b\u3002\u5951\u7d04\u53d7\u8afe\u8005\u306f\u3001\u76e3\u67fb\u5831\u544a\u66f8\u306e\u53d7\u9818\u304b\u308930\u65e5\u4ee5\u5185\u306bCAPA\u8a08\u753b\u3092\u63d0\u51fa\u3059\u308b\u3002.<\/p><p>5.13.3 \u5951\u7d04\u88fd\u54c1\u3054\u3068\u306b\u300112\u304b\u6708\u3054\u3068\u306b\u88fd\u54c1\u54c1\u8cea\u30ec\u30d3\u30e5\u30fc\u304c\u4f5c\u6210\u3055\u308c\u308b\u3002\u3053\u306e\u30ec\u30d3\u30e5\u30fc\u3067\u306f\u3001\u30ed\u30c3\u30c8\u53ce\u7387\u3001\u9038\u8131\u3001\u82e6\u60c5\u3001\u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u3001\u304a\u3088\u3073\u5909\u66f4\u5c65\u6b74\u306b\u3064\u3044\u3066\u691c\u8a0e\u3092\u884c\u3046\u3002.<\/p><p>5.13.4 \u88fd\u54c1\u54c1\u8cea\u30ec\u30d3\u30e5\u30fc\u306f\u4e21\u5f53\u4e8b\u8005\u9593\u3067\u5171\u6709\u3055\u308c\u3001\u5404\u5f53\u4e8b\u8005\u306e\u54c1\u8cea\u8cac\u4efb\u8005\uff08QP\uff09\u304c\u7f72\u540d\u3059\u308b\u3002\u4e0d\u90fd\u5408\u306a\u50be\u5411\u304c\u898b\u3089\u308c\u305f\u5834\u5408\u306f\u3001\u6b21\u56de\u306e\u5408\u540c\u54c1\u8cea\u4f1a\u8b70\u306e\u8b70\u984c\u306b\u76db\u308a\u8fbc\u307e\u308c\u308b\u3002.<\/p><p>5.13.5 \u4e21\u5f53\u4e8b\u8005\u9593\u3067\u306f\u3001\u5c11\u306a\u304f\u3068\u3082\u56db\u534a\u671f\u306b1\u56de\u3001\u5408\u540c\u54c1\u8cea\u4f1a\u8b70\u304c\u958b\u50ac\u3055\u308c\u308b\u3002\u5951\u7d04\u88fd\u9020\u62c5\u5f53\u8005\u304c\u4f1a\u8b70\u3092\u62db\u96c6\u3057\u3001\u8b70\u4e8b\u9332\u3092\u4f5c\u6210\u3059\u308b\u3002\u4f1a\u8b70\u3067\u306f\u3001\u672a\u89e3\u6c7a\u306e\u9038\u8131\u4e8b\u9805\u3001\u672a\u5b8c\u4e86\u306e\u662f\u6b63\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u3001\u304a\u3088\u3073\u4eca\u5f8c\u306e\u5909\u66f4\u4e8b\u9805\u306b\u3064\u3044\u3066\u691c\u8a0e\u3092\u884c\u3046\u3002.<\/p><h3><strong>5.14 \u5951\u7d04\u306e\u89e3\u9664\uff1a<\/strong><\/h3><p>5.14.1 \u53d7\u8a17\u88fd\u9020\u5951\u7d04\u306f\u3001\u3044\u304f\u3064\u304b\u306e\u7406\u7531\u306e\u3044\u305a\u308c\u304b\u306b\u3088\u308a\u7d42\u4e86\u3059\u308b\u3002\u901a\u5e38\u306e\u5951\u7d04\u6e80\u4e86\u3001\u53cc\u65b9\u306e\u5408\u610f\u3001\u88fd\u54c1\u306e\u88fd\u9020\u4e2d\u6b62\u3001GMP\u8a8d\u5b9a\u306e\u55aa\u5931\u3001\u307e\u305f\u306f\u54c1\u8cea\u5408\u610f\u66f8\u306e\u91cd\u5927\u306a\u9055\u53cd\u306a\u3069\u304c\u3001\u5178\u578b\u7684\u306a\u7d42\u4e86\u4e8b\u7531\u3067\u3042\u308b\u3002.<\/p><p>5.14.2 \u7d42\u4e86\u8a08\u753b\u306f\u3001\u53ef\u80fd\u306a\u9650\u308a\u3001\u5b9f\u969b\u306e\u7d42\u4e86\u65e5\u306e\u5c11\u306a\u304f\u3068\u3082180\u65e5\u524d\u307e\u3067\u306b\u7b56\u5b9a\u3055\u308c\u308b\u3002\u3053\u306e\u8a08\u753b\u306b\u306f\u3001\u6700\u7d42\u30d0\u30c3\u30c1\u306e\u5b9f\u884c\u3001\u30b5\u30f3\u30d7\u30eb\u306e\u4fdd\u5b58\u3001\u6587\u66f8\u306e\u30a2\u30fc\u30ab\u30a4\u30d6\u3001\u304a\u3088\u3073\u8cc7\u6750\u306e\u51e6\u5206\u304c\u542b\u307e\u308c\u308b\u3002.<\/p><p>5.14.3 \u5951\u7d04\u767a\u6ce8\u8005\u306b\u5e30\u5c5e\u3059\u308b\u8cc7\u6750\u306f\u3001\u7d42\u4e86\u8a08\u753b\u66f8\u306e\u6307\u793a\u306b\u5f93\u3063\u3066\u8fd4\u5374\u307e\u305f\u306f\u5ec3\u68c4\u3055\u308c\u308b\u3002\u8fd4\u9001\u3055\u308c\u308b\u5404\u51fa\u8377\u5206\u306b\u3064\u3044\u3066\u3001\u300c\u8cc7\u6750\u8fd4\u5374\u8a18\u9332\u300d\u304c\u4f5c\u6210\u3055\u308c\u308b\u3002.<\/p><p>5.14.4 \u4fdd\u5b58\u30b5\u30f3\u30d7\u30eb\u304a\u3088\u3073\u30d0\u30c3\u30c1\u6587\u66f8\u306f\u3001\u5951\u7d04\u7d42\u4e86\u5f8c\u3082\u3001\u4fdd\u5b58\u671f\u9593\u5168\u4f53\u3092\u901a\u3058\u3066\u5951\u7d04\u53d7\u8afe\u8005\u304c\u4fdd\u7ba1\u3059\u308b\u3002\u3053\u308c\u306f\u3001\u53d6\u5f15\u95a2\u4fc2\u306b\u304b\u304b\u308f\u3089\u305a\u3001GMP\u3067\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3002.<\/p><p>5.14.5 \u4e21\u5074\u306e\u54c1\u8cea\u8cac\u4efb\u8005\uff08QP\uff09\u304c\u6700\u7d42\u627f\u8a8d\u3092\u884c\u3044\u3001\u672a\u89e3\u6c7a\u4e8b\u9805\u304c\u3059\u3079\u3066\u89e3\u6c7a\u3055\u308c\u3001\u5f53\u8a72\u30d5\u30a1\u30a4\u30eb\u304c\u9577\u671f\u4fdd\u5b58\u306e\u6e96\u5099\u304c\u6574\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u3053\u306e\u627f\u8a8d\u66f8\u306f\u3001\u5951\u7d04\u54c1\u8cea\u30d5\u30a1\u30a4\u30eb\u306b\u4fdd\u7ba1\u3055\u308c\u308b\u3002.<\/p><h3><strong>5.15 \u8a18\u9332\uff1a<\/strong><\/h3><p>5.15.1 \u54c1\u8cea\u5408\u610f\u66f8\u3002.<\/p><p>5.15.2 \u30d9\u30f3\u30c0\u30fc\u76e3\u67fb\u5831\u544a\u66f8\u3002.<\/p><p>5.15.3 \u6280\u8853\u79fb\u8ee2\u306b\u95a2\u3059\u308b\u5354\u5b9a\u3002.<\/p><p>5.15.4 \u6280\u8853\u79fb\u8ee2\u5831\u544a\u66f8\u3002.<\/p><p>5.15.5 \u30ea\u30ea\u30fc\u30b9\u6c7a\u5b9a\u30ed\u30b0\u3002.<\/p><p>5.15.6 \u5909\u66f4\u7ba1\u7406\u4f9d\u983c\u3002.<\/p><p>5.15.7 \u5951\u7d04\u54c1\u8cea\u30d5\u30a1\u30a4\u30eb\u3002.<\/p><p>5.15.8 \u88fd\u54c1\u54c1\u8cea\u30ec\u30d3\u30e5\u30fc\u3002.<\/p><p>5.15.9 \u8cc7\u6750\u8fd4\u5374\u8a18\u9332\u3002.<\/p><h2><strong>6.0 \u7565\u8a9e:<\/strong><\/h2><p><strong>6.1 \u6a19\u6e96\u64cd\u4f5c\u624b\u9806:<\/strong> \u6a19\u6e96\u64cd\u4f5c\u624b\u9806\u3002.<\/p><p><strong>6.2 \u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\uff1a<\/strong> \u54c1\u8cea\u4fdd\u8a3c\u3002.<\/p><p><strong>6.3 QP\uff1a<\/strong> \u6709\u8cc7\u683c\u8005\u3002.<\/p><p><strong>6.4 GMP\uff1a<\/strong> \u9069\u6b63\u88fd\u9020\u898f\u7bc4\u3002.<\/p><p><strong>6.5 CAPA\uff1a<\/strong> \u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u3002.<\/p><p><strong>6.6 PIP\uff1a<\/strong> \u5de5\u5834\u5185\u306e\u8005\u3002.<\/p>\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":"<p>Standard operating procedure of Contract Manufacturing in the Pharmaceutical Industry. 1.0 OBJECTIVE: To set out how contract manufacturing work is [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":17315,"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 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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-17310","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\/17310","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=17310"}],"version-history":[{"count":0,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/17310\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/17315"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=17310"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=17310"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=17310"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}