{"id":10803,"date":"2026-02-20T02:04:26","date_gmt":"2026-02-20T02:04:26","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=10803"},"modified":"2025-12-25T02:20:21","modified_gmt":"2025-12-25T02:20:21","slug":"sop-for-tube-filling-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/sop-for-tube-filling-machine\/","title":{"rendered":"\u30c1\u30e5\u30fc\u30d6\u5145\u586b\u6a5f\u306eSOP"},"content":{"rendered":"
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

\u30c1\u30e5\u30fc\u30d6\u5145\u586b\u6a5f\u306e\u6a19\u6e96\u64cd\u4f5c\u624b\u9806<\/i><\/em><\/strong><\/p>

\"\u30c1\u30e5\u30fc\u30d6\u5145\u586b\u6a5f\u306e\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\"
\u30c1\u30e5\u30fc\u30d6\u5145\u586b\u6a5f\u306e\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\u3002.<\/strong><\/em><\/figcaption><\/figure>

1.0 \u76ee\u7684:<\/b><\/strong><\/h2>

\u3053\u306eSOP\u306f\u3001\u30c1\u30e5\u30fc\u30d6\u5145\u586b\u6a5f\u3092\u6b63\u3057\u304f\u64cd\u4f5c\u3059\u308b\u65b9\u6cd5\u3092\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u79c1\u305f\u3061\u306f\u3001\u5747\u4e00\u306a\u5145\u586b\u3001\u6c5a\u67d3\u306e\u306a\u3044\u5145\u586b\u3001\u305d\u3057\u3066\u30e9\u30a4\u30f3\u304b\u3089\u51fa\u3066\u304d\u305f\u30c1\u30e5\u30fc\u30d6\u306e\u5916\u89b3\u304c\u7f8e\u3057\u3044\u3053\u3068\u3092\u76ee\u6307\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6a5f\u68b0\u306f\u3001\u30af\u30ea\u30fc\u30e0\u3001\u30b8\u30a7\u30eb\u3001\u6b6f\u78e8\u304d\u7c89\u3001\u63a5\u7740\u5264\u306a\u3069\u3001\u6298\u308a\u305f\u305f\u307f\u5f0f\u30c1\u30e5\u30fc\u30d6\u306b\u5145\u586b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u307b\u307c\u3042\u3089\u3086\u308b\u3082\u306e\u3092\u6271\u3044\u307e\u3059\u3002cGMP\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u306e\u3067\u3001\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5185\u5bb9\u3092\u9075\u5b88\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

2.0 \u7bc4\u56f2:<\/b><\/strong><\/h2>

\u3053\u306e\u624b\u9806\u306f\u3001\u5f53\u793e\u306e\u751f\u7523\u30a8\u30ea\u30a2\u306b\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308b\u30c1\u30e5\u30fc\u30d6\u5145\u586b\u6a5f\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6a5f\u68b0\u306f\u3001\u534a\u56fa\u5f62\u7269\u3084\u7c98\u6027\u7269\u8cea\u3092\u69d8\u3005\u306a\u30b5\u30a4\u30ba\u306e\u91d1\u5c5e\u30c1\u30e5\u30fc\u30d6\u3001\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u30c1\u30e5\u30fc\u30d6\u3001\u30e9\u30df\u30cd\u30fc\u30c8\u30c1\u30e5\u30fc\u30d6\u306b\u5145\u586b\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u304b\u3089\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u307e\u3067\u3001\u7d44\u307f\u7acb\u3066\u3001\u64cd\u4f5c\u3001\u7a3c\u50cd\u4e2d\u306e\u54c1\u8cea\u30c1\u30a7\u30c3\u30af\u3001\u305d\u3057\u3066\u30d0\u30c3\u30c1\u7d42\u4e86\u5f8c\u306e\u4f5c\u696d\u624b\u9806\u306a\u3069\u3001\u3042\u3089\u3086\u308b\u3053\u3068\u3092\u7db2\u7f85\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>

3.0 \u8cac\u4efb:<\/b><\/strong><\/h2>

\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u3068\u88fd\u9020\u5316\u5b66\u8005\u306f\u3001\u3053\u306e\u88c5\u7f6e\u3092\u65e5\u3005\u7a3c\u50cd\u3055\u305b\u3066\u3044\u307e\u3059\u3002\u5f7c\u3089\u306f\u3053\u308c\u3089\u306e\u624b\u9806\u306b\u5f93\u3044\u3001\u767a\u751f\u3057\u305f\u4e8b\u8c61\u3092\u30ed\u30b0\u306b\u8a18\u9332\u3057\u307e\u3059\u3002\u4f55\u304b\u7570\u5e38\u304c\u3042\u308c\u3070\u3001\u30d5\u30e9\u30b0\u3092\u7acb\u3066\u307e\u3059\u3002.<\/p>

4.0 \u8aac\u660e\u8cac\u4efb:<\/b><\/strong><\/h2>

\u6700\u7d42\u7684\u306a\u8cac\u4efb\u306f\u751f\u7523\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306b\u3042\u308a\u307e\u3059\u3002\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u9069\u5207\u306a\u4eba\u6750\u304c\u9069\u5207\u306a\u696d\u52d9\u3092\u9042\u884c\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3001\u3053\u308c\u3089\u306f\u3059\u3079\u3066\u5f7c\u3089\u306e\u8cac\u4efb\u3067\u3059\u3002.<\/p>

5.0 \u624b\u9806:<\/b><\/strong><\/h2>

5.1 \u6e05\u6383\u30a8\u30ea\u30a2\u306b\u5165\u308a\u3001\u5468\u56f2\u3092\u3088\u304f\u898b\u56de\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6e05\u6f54\u3067\u3059\u304b\uff1f\u6a5f\u68b0\u306b\u300cCLEANED\uff08\u6e05\u6383\u6e08\u307f\uff09\u300d\u306e\u30e9\u30d9\u30eb\u304c\u4ed8\u3044\u3066\u3044\u308b\u304b\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u524d\u56de\u306e\u6d17\u6d44\u5f8c\u306e\u6b8b\u7559\u7269\u3084\u3001\u69d8\u3005\u306a\u30b4\u30df\u304c\u6563\u3089\u3070\u3063\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u554f\u984c\u3067\u3059\u3002\u4f5c\u696d\u3092\u9032\u3081\u308b\u524d\u306b\u6574\u7406\u3057\u307e\u3057\u3087\u3046\u3002.<\/p>

5.2 \u6a5f\u5668\u4f7f\u7528\u30ed\u30b0\u3092\u958b\u304d\u3001\u8a73\u7d30\u60c5\u5831\u3092\u5165\u529b\u3057\u307e\u3059\u3002\u4eca\u65e5\u306e\u65e5\u4ed8\u3001\u6642\u523b\u3001\u88fd\u54c1\u540d\u3001\u30d0\u30c3\u30c1\u756a\u53f7\u3001\u305d\u3057\u3066\u3042\u306a\u305f\u306e\u6c0f\u540d\u3067\u3059\u3002.<\/p>

5.3 \u300cCLEANED\uff08\u6d17\u6d44\u6e08\u307f\uff09\u300d\u30e9\u30d9\u30eb\u3092\u306f\u304c\u3057\u3001\u300cUNDER PROCESS\uff08\u51e6\u7406\u4e2d\uff09\u300d\u30e9\u30d9\u30eb\u3092\u8cbc\u308a\u307e\u3059\u3002\u305d\u3053\u306b\u73fe\u5728\u306e\u30d0\u30c3\u30c1\u60c5\u5831\u3092\u8a18\u5165\u3057\u307e\u3059\u3002.<\/p>

5.4 IPQA\u3092\u63a2\u3057\u51fa\u3057\u3066\u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u8a3c\u660e\u66f8\u3092\u53d6\u5f97\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u8a3c\u660e\u66f8\u304c\u624b\u5143\u306b\u306a\u3051\u308c\u3070\u4f55\u3082\u59cb\u307e\u308a\u307e\u305b\u3093\u3002.<\/p>

5.5 \u6ce8\u610f\u4e8b\u9805:<\/strong><\/h3>

5.5.1 \u81ea\u52d5\u30e2\u30fc\u30c9\u306b\u5207\u308a\u66ff\u3048\u308b\u524d\u306b\u3001\u3059\u3079\u3066\u306e\u30ac\u30fc\u30c9\u304c\u9589\u3058\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u524d\u9762\u30c9\u30a2\u3001\u80cc\u9762\u30d1\u30cd\u30eb\u3001\u30db\u30c3\u30d1\u30fc\u30ab\u30d0\u30fc\u306a\u3069\u3001\u3059\u3079\u3066\u3067\u3059\u3002\u6a5f\u68b0\u306f\u4f55\u304b\u554f\u984c\u304c\u3042\u3063\u3066\u3082\u8a8d\u8b58\u3067\u304d\u306a\u3044\u305f\u3081\u3001\u5fc5\u305a\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.5.2 \u5b89\u5168\u30b9\u30a4\u30c3\u30c1\u3068\u30a4\u30f3\u30bf\u30fc\u30ed\u30c3\u30af\u306f\u3001\u4f55\u3089\u304b\u306e\u7406\u7531\u304c\u3042\u3063\u3066\u5b58\u5728\u3057\u307e\u3059\u3002\u6c7a\u3057\u3066\u30d0\u30a4\u30d1\u30b9\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5.3 \u30de\u30b7\u30f3\u306b\u5909\u66f4\u3092\u52a0\u3048\u305f\u3044\u5834\u5408\u3001\u307e\u305a\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u90e8\u9580\u306e\u627f\u8a8d\u3092\u5f97\u3066\u304f\u3060\u3055\u3044\u3002\u8a31\u53ef\u306e\u306a\u3044\u5909\u66f4\u3001\u8ffd\u52a0\u3001\u307e\u305f\u306f\u5834\u5f53\u305f\u308a\u7684\u306a\u6539\u9020\u306f\u7981\u6b62\u3067\u3059\u3002.<\/p>

5.5.4 \u53ef\u52d5\u90e8\u54c1\u306f\u6307\u3092\u96e2\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6a5f\u68b0\u304c\u4f5c\u52d5\u4e2d\u306f\u3001\u4f55\u3082\u89e6\u308b\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u6e05\u6383\u3082\u8abf\u6574\u3082\u6ce8\u6cb9\u3082\u4e0d\u8981\u3067\u3059\u3002\u307e\u305a\u96fb\u6e90\u3092\u5207\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5.5 \u4f55\u304b\u3092\u53d6\u308a\u4ed8\u3051\u305f\u308a\u3001\u5206\u89e3\u3057\u305f\u308a\u3001\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3092\u884c\u3063\u305f\u308a\u3057\u3066\u3044\u307e\u3059\u304b? \u30e1\u30a4\u30f3\u30b9\u30a4\u30c3\u30c1\u306f OFF \u306b\u306a\u308a\u307e\u3059\u3002\u4ee5\u4e0a\u3067\u3059\u3002.<\/p>

5.5.6 \u7dca\u6025\u505c\u6b62\u88c5\u7f6e\u3001\u30c9\u30a2\u30bb\u30f3\u30b5\u30fc\u3001\u904e\u8ca0\u8377\u30c8\u30ea\u30c3\u30d7\u88c5\u7f6e\u306f\u3059\u3079\u3066\u6709\u52b9\u306b\u3057\u3066\u304a\u3044\u3066\u304f\u3060\u3055\u3044\u3002\u5b89\u5168\u88c5\u7f6e\u306f\u7121\u52b9\u306b\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5.7 \u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30d1\u30cd\u30eb\u306b\u307b\u3053\u308a\u304c\u4ed8\u7740\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u4e7e\u3044\u305f\u5e03\u3092\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u67d4\u3089\u304b\u3044\u5e03\u3092\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6c34\u3068\u96fb\u6c17\u90e8\u54c1\u306f\u6df7\u3056\u3089\u306a\u3044\u306e\u3067\u3001\u6eb6\u5264\u3082\u540c\u69d8\u3067\u3059\u3002.<\/p>

5.5.8 \u5145\u586b\u4e2d\u306f\u30db\u30c3\u30d1\u30fc\u306e\u84cb\u3092\u9589\u3081\u305f\u307e\u307e\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u4e0a\u304b\u3089\u306e\u6c5a\u67d3\u306f\u907f\u3051\u3089\u308c\u307e\u305b\u3093\u3002\u307e\u305f\u3001\u30ac\u30b9\u30b1\u30c3\u30c8\u306b\u3072\u3073\u5272\u308c\u3084\u6469\u8017\u304c\u306a\u3044\u304b\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5.9 \u6bce\u9031\u3001\u6b21\u306e\u5b89\u5168\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u78ba\u8a8d\u3057\u3066\u8a18\u9332\u3057\u307e\u3059\u3002<\/p>

5.5.9.1 \u30e1\u30a4\u30f3\u30b9\u30a4\u30c3\u30c1\u304b\u3089\u96fb\u6e90\u3092\u5207\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304b? \u8a66\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5.9.2 \u7dca\u6025\u505c\u6b62\u30dc\u30bf\u30f3\u3092\u8efd\u304f\u62bc\u3057\u307e\u3059\u3002\u3059\u3079\u3066\u304c\u3059\u3050\u306b\u505c\u6b62\u3057\u307e\u3059\u304b\uff1f<\/p>

5.5.9.3 \u30b5\u30a4\u30af\u30eb\u306e\u9014\u4e2d\u3067\u30ac\u30fc\u30c9\u30c9\u30a2\u3092\u958b\u3051\u307e\u3059\u3002\u6a5f\u68b0\u306f\u30d5\u30ea\u30fc\u30ba\u3059\u308b\u306f\u305a\u3067\u3059\u3002.<\/p>

5.5.9.4 \u30db\u30c3\u30d1\u30fc\u5185\u306e\u4f4e\u30ec\u30d9\u30eb\u30bb\u30f3\u30b5\u30fc\u306f\u6b63\u5e38\u306b\u6a5f\u80fd\u3057\u3066\u3044\u307e\u3059\u304b\uff1f\u30dd\u30f3\u30d7\u3092\u7a7a\u306e\u72b6\u614b\u3067\u4f7f\u7528\u3059\u308b\u3068\u3001\u30bb\u30f3\u30b5\u30fc\u304c\u3059\u3050\u306b\u6d88\u8017\u3057\u3066\u3057\u307e\u3044\u307e\u3059\u3002.<\/p>

5.6 \u7d44\u307f\u7acb\u3066:<\/strong><\/h3>

5.6.1 \u30db\u30c3\u30d1\u30fc\u3068\u88fd\u54c1\u4f9b\u7d66\u30b7\u30b9\u30c6\u30e0:<\/p>

5.6.1.1 \u30db\u30c3\u30d1\u30fc\u3092\u53d6\u308a\u4ed8\u3051\u308b\u524d\u306b\u3001\u30db\u30c3\u30d1\u30fc\u3092\u70b9\u691c\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u304d\u308c\u3044\u3067\u3059\u304b\uff1f\u4e7e\u71e5\u3057\u3066\u3044\u307e\u3059\u304b\uff1f\u524d\u56de\u306e\u6c5a\u308c\u304c\u6b8b\u3063\u3066\u3044\u307e\u305b\u3093\u304b\uff1f\u554f\u984c\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>

5.6.1.2 \u30d5\u30ec\u30fc\u30e0\u4e0a\u306e\u6240\u5b9a\u306e\u4f4d\u7f6e\u306b\u6301\u3061\u4e0a\u3052\u307e\u3059\u3002\u52d5\u4f5c\u4e2d\u306b\u52d5\u304b\u306a\u3044\u3088\u3046\u306b\u3057\u3063\u304b\u308a\u3068\u56fa\u5b9a\u3057\u307e\u3059\u3002.<\/p>

5.6.1.3 \u88fd\u54c1\u306b\u3088\u3063\u3066\u306f\u3001\u9069\u5207\u306a\u6d41\u52d5\u3092\u5f97\u308b\u305f\u3081\u306b\u71b1\u304c\u5fc5\u8981\u3067\u3059\u3002\u305d\u306e\u3088\u3046\u306a\u88fd\u54c1\u306e\u5834\u5408\u306f\u3001\u30b8\u30e3\u30b1\u30c3\u30c8\u4ed8\u304d\u30db\u30c3\u30d1\u30fc\u3092\u6e29\u5ea6\u5236\u5fa1\u30e6\u30cb\u30c3\u30c8\u306b\u63a5\u7d9a\u3057\u3001\u76ee\u6a19\u6e29\u5ea6\u3092\u8a2d\u5b9a\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.1.4 \u3059\u3079\u3066\u306e\u30ac\u30b9\u30b1\u30c3\u30c8\u3068O\u30ea\u30f3\u30b0\u3092\u76ee\u8996\u3067\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30b7\u30fc\u30eb\u304c1\u3064\u3067\u3082\u4e0d\u826f\u3060\u3068\u3001\u6f0f\u308c\u308b\u3079\u304d\u3067\u306f\u306a\u3044\u5834\u6240\u304b\u3089\u88fd\u54c1\u304c\u6f0f\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002.<\/p>

5.6.1.5 \u30db\u30c3\u30d1\u30fc\u304b\u3089\u8a08\u91cf\u30dd\u30f3\u30d7\u307e\u3067\u306e\u4f9b\u7d66\u30e9\u30a4\u30f3\u3092\u63a5\u7d9a\u3057\u307e\u3059\u3002\u30e9\u30a4\u30f3\u5185\u306b\u9589\u3058\u8fbc\u3081\u3089\u308c\u305f\u7a7a\u6c17\u3092\u629c\u304d\u307e\u3059\u3002.<\/p>

5.6.2 \u6295\u4e0e\u304a\u3088\u3073\u5145\u586b\u30a2\u30bb\u30f3\u30d6\u30ea:<\/p>

5.6.2.1 \u5fc5\u8981\u306a\u5145\u586b\u91cf\u306b\u5408\u308f\u305b\u3066\u8a08\u91cf\u30b7\u30ea\u30f3\u30c0\u30fc\u3092\u304a\u9078\u3073\u304f\u3060\u3055\u3044\u3002\u30b5\u30a4\u30ba\u304c\u5408\u308f\u306a\u3044\u3068\u3001\u4e00\u65e5\u4e2d\u6a5f\u68b0\u3068\u683c\u95d8\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>

5.6.2.2 \u30c1\u30e5\u30fc\u30d6\u306e\u76f4\u5f84\u306b\u5408\u3063\u305f\u5145\u586b\u30ce\u30ba\u30eb\u3092\u53d6\u308a\u4ed8\u3051\u307e\u3059\u3002\u5927\u304d\u3059\u304e\u308b\u3068\u5165\u308a\u307e\u305b\u3093\u3057\u3001\u5c0f\u3055\u3059\u304e\u308b\u3068\u6f0f\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002.<\/p>

5.6.2.3 \u30ce\u30ba\u30eb\u306e\u6df1\u3055\u3092\u8abf\u6574\u3057\u3001\u30c1\u30e5\u30fc\u30d6\u306e\u5e95\u8fd1\u304f\u307e\u3067\u5c4a\u304f\u3088\u3046\u306b\u3057\u307e\u3059\u3002\u4e0b\u304b\u3089\u5145\u586b\u3059\u308b\u3053\u3068\u3067\u3001\u7a7a\u6c17\u3092\u9589\u3058\u8fbc\u3081\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u62bc\u3057\u51fa\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>

5.6.2.4 \u3059\u3079\u3066\u306e\u7d99\u624b\u3092\u7de0\u3081\u4ed8\u3051\u307e\u3059\u304c\u3001\u7de0\u3081\u3059\u304e\u306b\u306f\u6ce8\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30ce\u30ba\u30eb\u306e\u306d\u3058\u5c71\u304c\u659c\u3081\u306b\u306a\u3063\u3066\u3044\u308b\u3068\u3001\u5927\u304d\u306a\u640d\u5931\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002.<\/p>

5.6.2.5 \u30ce\u30ba\u30eb\u306e\u4f4d\u7f6e\u3092\u76ee\u8996\u3067\u78ba\u8a8d\u3057\u307e\u3059\u3002\u30ce\u30ba\u30eb\u306f\u30c1\u30e5\u30fc\u30d6\u306e\u4f4d\u7f6e\u306e\u771f\u4e0a\u306b\u6765\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.6.3 \u30c1\u30e5\u30fc\u30d6\u30cf\u30f3\u30c9\u30ea\u30f3\u30b0\u30b7\u30b9\u30c6\u30e0:<\/strong><\/h3>

5.6.3.1 \u30c1\u30e5\u30fc\u30d6\u306e\u76f4\u5f84\u306b\u5408\u3063\u305f\u30c1\u30e5\u30fc\u30d6\u30ab\u30c3\u30d7\u3092\u4ea4\u63db\u3057\u307e\u3059\u3002\u901a\u5e38\u3001\u30b5\u30a4\u30ba\u30e9\u30d9\u30eb\u304c\u4ed8\u3044\u3066\u3044\u307e\u3059\u3002.<\/p>

5.6.3.2 \u5404\u30ab\u30c3\u30d7\u3092\u30bf\u30ec\u30c3\u30c8\u307e\u305f\u306f\u30b3\u30f3\u30d9\u30a2\u306e\u30dd\u30b1\u30c3\u30c8\u306b\u3057\u3063\u304b\u308a\u3068\u56fa\u5b9a\u3057\u307e\u3059\u3002\u30ab\u30c3\u30d7\u304c\u7de9\u3093\u3067\u3044\u308b\u3068\u30c1\u30e5\u30fc\u30d6\u304c\u8a70\u307e\u3063\u3066\u3057\u307e\u3044\u307e\u3059\u3002.<\/p>

5.6.3.3 \u30aa\u30ea\u30a8\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u3067\u306f\u3001\u30c1\u30e5\u30fc\u30d6\u3092\u53cd\u8ee2\u3055\u305b\u3066\u958b\u53e3\u90e8\u3092\u4e0a\u5411\u304d\u306b\u3057\u307e\u3059\u3002\u5b9f\u969b\u306b\u624b\u3067\u30c1\u30e5\u30fc\u30d6\u3092\u901a\u3057\u3066\u307f\u3066\u3001\u6b63\u3057\u304f\u6a5f\u80fd\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.3.4 \u30bf\u30ec\u30c3\u30c8\u3092\u624b\u52d5\u30671\u56de\u8ee2\u3055\u305b\u3066\u3001\u5f15\u3063\u639b\u304b\u308a\u3084\u7c97\u3044\u90e8\u5206\u304c\u306a\u3044\u304b\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

5.6.3.5 \u30c1\u30e5\u30fc\u30d6\u30de\u30ac\u30b8\u30f3\u306b\u5f3e\u4e38\u3092\u88c5\u586b\u3057\u3001\u5f3e\u4e38\u304c\u30ab\u30c3\u30d7\u306b\u304d\u3061\u3093\u3068\u843d\u3061\u308b\u304b\u78ba\u8a8d\u3057\u307e\u3059\u3002\u5f3e\u4e38\u306f\u30ab\u30c3\u30d7\u306b\u5f15\u3063\u304b\u304b\u308b\u3053\u3068\u306a\u304f\u3001\u304d\u308c\u3044\u306b\u843d\u3061\u3066\u3044\u304f\u306f\u305a\u3067\u3059\u3002.<\/p>

5.6.4 \u30b7\u30fc\u30ea\u30f3\u30b0\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u306e\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7:<\/strong><\/h3>

5.6.4.1 \u91d1\u5c5e\u7ba1\u306f\u5727\u7740\u3001\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u3084\u30e9\u30df\u30cd\u30fc\u30c8\u306f\u71b1\u878d\u7740\u3057\u307e\u3059\u3002\u4f5c\u696d\u5185\u5bb9\u306b\u5fdc\u3058\u3066\u9069\u5207\u306a\u30c4\u30fc\u30eb\u3092\u53d6\u308a\u4ed8\u3051\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.4.2 \u5727\u7740\u3059\u308b\u969b\u306f\u3001\u30c1\u30e5\u30fc\u30d6\u306e\u4ed5\u69d8\u66f8\u306b\u5f93\u3063\u3066\u30b8\u30e7\u30fc\u5727\u529b\u3092\u8a2d\u5b9a\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30b8\u30e7\u30fc\u5727\u529b\u304c\u4f4e\u3059\u304e\u308b\u3068\u6f0f\u308c\u304c\u767a\u751f\u3057\u3001\u9ad8\u3059\u304e\u308b\u3068\u30c1\u30e5\u30fc\u30d6\u304c\u7834\u640d\u3057\u307e\u3059\u3002.<\/p>

5.6.4.3 \u30d2\u30fc\u30c8\u30b7\u30fc\u30eb\u306e\u5834\u5408\u306f\u6e29\u5ea6\u3092\u8abf\u6574\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30e9\u30df\u30cd\u30fc\u30c8\u30c1\u30e5\u30fc\u30d6\u306e\u5834\u5408\u306f\u901a\u5e38380\u2103\uff5e420\u2103\u304c\u5fc5\u8981\u3067\u3059\u3002\u30e1\u30fc\u30ab\u30fc\u306e\u30c7\u30fc\u30bf\u3092\u3054\u78ba\u8a8d\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.4.4 \u30c9\u30a6\u30a7\u30eb\u30bf\u30a4\u30e0\uff08\u30b7\u30fc\u30e9\u30fc\u306e\u4fdd\u6301\u6642\u9593\uff09\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002\u592a\u3044\u30c1\u30e5\u30fc\u30d6\u306e\u5834\u5408\u306f\u3001\u3088\u308a\u9577\u3044\u6642\u9593\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>

5.6.4.5 \u30d0\u30c3\u30c1\u30b3\u30fc\u30c0\u30fc\u3092\u30af\u30ea\u30f3\u30d7\u307e\u305f\u306f\u30b7\u30fc\u30eb\u306e\u6b63\u3057\u3044\u4f4d\u7f6e\u306b\u53d6\u308a\u4ed8\u3051\u307e\u3059\u3002\u30b9\u30af\u30e9\u30c3\u30d7\u30c1\u30e5\u30fc\u30d6\u3067\u8a66\u5c04\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.4.6 \u30d0\u30c3\u30c1\u756a\u53f7\u3001\u88fd\u9020\u65e5\u3001\u6709\u52b9\u671f\u9650\u3092\u8a18\u5165\u3057\u305f\u6b63\u3057\u3044\u30b3\u30fc\u30c7\u30a3\u30f3\u30b0\u30c0\u30a4\u307e\u305f\u306f\u30a4\u30f3\u30af\u30ea\u30dc\u30f3\u3092\u88c5\u7740\u3057\u307e\u3059\u3002.<\/p>

5.7 \u64cd\u4f5c:<\/strong><\/h3>

5.7.1 \u30e1\u30a4\u30f3\u30d6\u30ec\u30fc\u30ab\u30fc\u3092\u30aa\u30f3\u306b\u3057\u307e\u3059\u3002\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30d1\u30cd\u30eb\u306e\u8d77\u52d5\u30eb\u30fc\u30c1\u30f3\u304c\u5b8c\u4e86\u3059\u308b\u307e\u3067\u5f85\u3061\u307e\u3059\u3002.<\/p>

5.7.2 \u6a5f\u68b0\u3092\u624b\u52d5\u30671\u30b5\u30a4\u30af\u30eb\u5206\u52d5\u304b\u3057\u307e\u3059\u3002\u3059\u3079\u3066\u306e\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002\u4f55\u304b\u554f\u984c\u304c\u3042\u308c\u3070\u3001500\u672c\u306e\u30c1\u30e5\u30fc\u30d6\u3092\u691c\u67fb\u3057\u305f\u5f8c\u3067\u306f\u306a\u304f\u3001\u4eca\u3059\u3050\u4fee\u6b63\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.3 \u88fd\u54c1\u3092\u30db\u30c3\u30d1\u30fc\u306b\u3086\u3063\u304f\u308a\u3068\u6ce8\u304e\u5165\u308c\u307e\u3059\u3002\u6025\u6fc0\u306b\u6295\u5165\u3059\u308b\u3068\u6df7\u5408\u7269\u306b\u7a7a\u6c17\u304c\u6df7\u5165\u3057\u3001\u6c17\u6ce1\u304c\u767a\u751f\u3059\u308b\u3068\u5145\u586b\u304c\u4e0d\u5747\u4e00\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>

5.7.4 \u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30d1\u30cd\u30eb\u3067\u5145\u586b\u91cd\u91cf\u3092\u5165\u529b\u3057\u307e\u3059\u3002\u30d0\u30c3\u30c1\u30ec\u30b3\u30fc\u30c9\u306b\u76ee\u6a19\u5024\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u8a31\u5bb9\u7bc4\u56f2\u306f \u901a\u5e38\u00b12%<\/strong>.<\/p>

5.7.5 HMI\u753b\u9762\u3067\u6b21\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002<\/p>

5.7.5.1 \u5145\u586b\u91cf\uff1a\u76ee\u6a19\u91cd\u91cf\u306b\u9054\u3059\u308b\u307e\u3067\u30d4\u30b9\u30c8\u30f3\u306e\u30b9\u30c8\u30ed\u30fc\u30af\u3092\u8abf\u6574\u3057\u307e\u3059\u3002\u8a66\u9a13\u7ba1\u3092\u3044\u304f\u3064\u304b\u901a\u3057\u3066\u91cd\u91cf\u3092\u6e2c\u5b9a\u3057\u307e\u3059\u3002.<\/p>

5.7.5.2 \u6a5f\u68b0\u901f\u5ea6\uff1a\u539a\u3044\u88fd\u54c1\u306f\u901f\u5ea6\u304c\u9045\u304f\u306a\u308a\u307e\u3059\u3002\u8584\u3044\u88fd\u54c1\u306f\u901f\u5ea6\u304c\u901f\u304f\u306a\u308a\u307e\u3059\u3002\u901a\u5e38\u306f1\u5206\u9593\u306b25\uff5e60\u672c\u3067\u3059\u3002.<\/p>

5.7.5.3 \u30b7\u30fc\u30eb\u6e29\u5ea6\uff1a\u30e9\u30df\u30cd\u30fc\u30c8\u306e\u307f\u3002\u63a8\u5968\u8a2d\u5b9a\u304b\u3089\u958b\u59cb\u3057\u3001\u30b7\u30fc\u30eb\u304c\u4fdd\u6301\u3055\u308c\u306a\u3044\u5834\u5408\u306f\u8abf\u6574\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.5.4 \u30b7\u30fc\u30eb\u6642\u9593\uff1a\u30b8\u30e7\u30fc\u304c\u30af\u30e9\u30f3\u30d7\u3059\u308b\u6642\u9593\u3002\u30c1\u30e5\u30fc\u30d6\u306e\u6750\u8cea\u306e\u539a\u3055\u306b\u5fdc\u3058\u3066\u8abf\u6574\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.5.5 \u5727\u7740\u5727\u529b\uff1a\u91d1\u5c5e\u7ba1\u306e\u5834\u5408\u3002\u3072\u3073\u5272\u308c\u306e\u306a\u3044\u304d\u308c\u3044\u306a\u6298\u308a\u76ee\u306b\u306a\u308b\u307e\u3067\u3001\u5727\u529b\u3092\u4e0a\u3052\u305f\u308a\u4e0b\u3052\u305f\u308a\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.5.6 \u30ab\u30a6\u30f3\u30bf\u30fc: \u30bc\u30ed\u306b\u30ea\u30bb\u30c3\u30c8\u3057\u307e\u3059\u3002\u30d0\u30c3\u30c1\u76ee\u6a19\u6570\u91cf\u3092\u5165\u529b\u3057\u307e\u3059\u3002.<\/p>

5.7.6 \u30c1\u30e5\u30fc\u30d6\u30de\u30ac\u30b8\u30f3\u304c\u6e80\u676f\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30c1\u30e5\u30fc\u30d6\u304c\u56fa\u7740\u3057\u305f\u308a\u5909\u5f62\u3057\u305f\u308a\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.7 START\u3092\u62bc\u3057\u307e\u3059\u3002\u3053\u3053\u304b\u3089\u306f\u6a5f\u68b0\u304c\u5236\u5fa1\u3092\u7d9a\u3051\u307e\u3059\u3002<\/p>

5.7.7.1 \u30de\u30ac\u30b8\u30f3\u304b\u3089\u30c1\u30e5\u30fc\u30d6\u3092\u53d6\u308a\u51fa\u3057\u307e\u3059\u3002.<\/p>

5.7.7.2 \u305d\u308c\u3092\u30ab\u30c3\u30d7\u306e\u4e2d\u306b\u843d\u3068\u3057\u3001\u958b\u53e3\u90e8\u3092\u4e0a\u5411\u304d\u306b\u3057\u307e\u3059\u3002.<\/p>

5.7.7.3 \u5145\u586b\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u306b\u30a4\u30f3\u30c7\u30c3\u30af\u30b9\u3092\u4ed8\u3051\u3001\u30ce\u30ba\u30eb\u3092\u4e0b\u3052\u307e\u3059\u3002.<\/p>

5.7.7.4 \u30ce\u30ba\u30eb\u304c\u4e0a\u65b9\u306b\u5f15\u3063\u8fbc\u3093\u3060\u72b6\u614b\u3067\u88fd\u54c1\u3092\u5410\u51fa\u3057\u307e\u3059\u3002.<\/p>

5.7.7.5 \u5727\u7740\u307e\u305f\u306f\u30d2\u30fc\u30c8\u30b7\u30fc\u30eb\u306e\u305f\u3081\u306b\u30b7\u30fc\u30ea\u30f3\u30b0\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u306b\u79fb\u52d5\u3057\u307e\u3059\u3002.<\/p>

5.7.7.6 \u5bc6\u5c01\u3055\u308c\u305f\u7aef\u306b\u30d0\u30c3\u30c1\u30b3\u30fc\u30c9\u3092\u5370\u5237\u3057\u307e\u3059\u3002.<\/p>

5.7.7.7 \u5b8c\u6210\u3057\u305f\u30c1\u30e5\u30fc\u30d6\u3092\u30a2\u30a6\u30c8\u30d5\u30a3\u30fc\u30c9\u30b3\u30f3\u30d9\u30a2\u306b\u6392\u51fa\u3057\u307e\u3059\u3002.<\/p>

5.7.8 \u76f4\u3061\u306b\u30b5\u30f3\u30d7\u30eb\u3092\u63a1\u53d6\u3057\u3001\u5145\u586b\u91cd\u91cf\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30b7\u30fc\u30eb\u3092\u70b9\u691c\u3057\u3001\u30b3\u30fc\u30c9\u3092\u8aad\u307f\u53d6\u3063\u3066\u304f\u3060\u3055\u3044\u3002\u4f55\u304b\u7570\u5e38\u304c\u3042\u308c\u3070\u3001\u88fd\u54c1\u3092\u5ec3\u68c4\u3059\u308b\u524d\u306b\u505c\u6b62\u3057\u3066\u8abf\u6574\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.9 \u904b\u8ee2\u4e2d\u306f\u6a5f\u68b0\u306e\u72b6\u614b\u3092\u5e38\u306b\u76e3\u8996\u3057\u3001\u6307\u5b9a\u3055\u308c\u305f\u9593\u9694\u3067\u91cd\u8981\u306a\u6e2c\u5b9a\u5024\u3092\u30d0\u30c3\u30c1\u30b7\u30fc\u30c8\u306b\u8a18\u9332\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.8 \u5de5\u7a0b\u5185\u54c1\u8cea\u30c1\u30a7\u30c3\u30af:<\/strong><\/h3>

5.8.1 \u30d0\u30c3\u30c1\u306e\u958b\u59cb\u6642\u3001\u4e2d\u9593\u6642\u3001\u7d42\u4e86\u6642\u306b\u30c1\u30e5\u30fc\u30d6\u3092\u629c\u304d\u53d6\u308a\u3001\u91cd\u91cf\u30c1\u30a7\u30c3\u30af\u3092\u884c\u3046\u3002\u307e\u305f\u3001\u30d0\u30c3\u30c1\u8a18\u9332\u3067\u6307\u5b9a\u3055\u308c\u305f\u983b\u5ea6\u3067\u5b9f\u65bd\u3059\u308b\u3002.<\/p>

5.8.2 \u5145\u586b\u3055\u308c\u305f\u30c1\u30e5\u30fc\u30d6\u3092\u5f37\u304f\u63e1\u308a\u307e\u3059\u3002\u30b7\u30fc\u30eb\u90e8\u5206\u306b\u6ce8\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u88fd\u54c1\u304c\u6f0f\u308c\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u30c1\u30e5\u30fc\u30d6\u3092\u4e0d\u826f\u54c1\u3068\u3057\u3001\u6a5f\u68b0\u3092\u8abf\u6574\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.8.3 \u30b5\u30f3\u30d7\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3059\u3079\u3066\u306e\u30d0\u30c3\u30c1\u30b3\u30fc\u30c9\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u5224\u8aad\u53ef\u80fd\u3067\u3001\u5b8c\u5168\u306a\u30b3\u30fc\u30c9\u304c\u6b63\u3057\u3044\u5834\u6240\u306b\u8a18\u5165\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.8.4 \u5916\u89b3\u4e0a\u306e\u554f\u984c\uff08\u30c1\u30e5\u30fc\u30d6\u672c\u4f53\u306e\u3078\u3053\u307f\u3001\u5370\u5237\u306e\u50b7\u3001\u66f2\u304c\u3063\u305f\u30af\u30ea\u30f3\u30d7\u3001\u5909\u5f62\u3057\u305f\u30b7\u30e7\u30eb\u30c0\u30fc\uff09\u304c\u306a\u3044\u304b\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

5.8.5 \u3059\u3079\u3066\u3092\u8a18\u9332\u3057\u307e\u3057\u3087\u3046\u3002\u6642\u9593\u3001\u7d50\u679c\u3001\u30a4\u30cb\u30b7\u30e3\u30eb\u306a\u3069\u3002\u8a18\u9332\u304c\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u306f\u3001\u4f55\u3082\u8d77\u3053\u3089\u306a\u304b\u3063\u305f\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002.<\/p>

5.9 \u898f\u5b9a\u306e\u30d0\u30c3\u30c1\u91cf\u306b\u9054\u3057\u305f\u3089\u3001\u6a5f\u68b0\u3092\u505c\u6b62\u3057\u307e\u3059\u3002\u30db\u30c3\u30d1\u30fc\u304b\u3089\u6b8b\u308a\u306e\u88fd\u54c1\u3092\u3059\u304f\u3044\u53d6\u308a\u3001\u6b69\u7559\u307e\u308a\u8abf\u6574\u624b\u9806\u306b\u5f93\u3063\u3066\u51e6\u7406\u3057\u307e\u3059\u3002.<\/p>

5.10 \u8cbc\u308a\u4ed8\u3051\u308b \u201c\u300c\u6e05\u6383\u3059\u308b\u300d\u201d<\/strong> \u6a5f\u68b0\u306b\u30e9\u30d9\u30eb\u3092\u8cbc\u3063\u3066\u304f\u3060\u3055\u3044\u3002\u88fd\u54c1\u540d\u3068\u30d0\u30c3\u30c1\u756a\u53f7\u3092\u8a18\u8f09\u3057\u3066\u3001\u6e05\u6383\u54e1\u304c\u4f55\u3092\u6271\u3063\u3066\u3044\u308b\u306e\u304b\u308f\u304b\u308b\u3088\u3046\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.11 \u30c1\u30e5\u30fc\u30d6\u5145\u586b\u6a5f\u6d17\u6d44SOP\u306b\u5f93\u3063\u3066\u6a5f\u5668\u3092\u6d17\u6d44\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u88fd\u54c1\u306b\u3088\u3063\u3066\u5fc5\u8981\u306a\u6d17\u6d44\u5264\u306f\u7570\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.12 \u8a18\u9332:<\/strong><\/h3>

\u8a2d\u5099\u4f7f\u7528\u30ed\u30b0\u3001\u30d0\u30c3\u30c1\u751f\u7523\u8a18\u9332\u3001\u5de5\u7a0b\u5185\u691c\u67fb\u30ed\u30b0\u3001\u6e05\u6383\u8a18\u9332\u3002.<\/p>

6.0 \u7565\u8a9e:<\/b><\/strong><\/h2>

6.1 \u6a19\u6e96\u64cd\u4f5c\u624b\u9806:<\/strong> \u6a19\u6e96\u64cd\u4f5c\u624b\u9806\u3002.<\/p>

6.2 IPQA:<\/strong> \u5de5\u7a0b\u5185\u54c1\u8cea\u4fdd\u8a3c\u3002.<\/p>

6.3 BMR:<\/strong> \u30d0\u30c3\u30c1\u88fd\u9020\u8a18\u9332\u3002.<\/p>

6.4 cGMP:<\/strong> \u73fe\u5728\u306e\u9069\u6b63\u88fd\u9020\u898f\u7bc4\u3002.<\/p>

6.5 \u30d2\u30e5\u30fc\u30de\u30f3\u30de\u30b7\u30f3\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9:<\/strong> \u30d2\u30e5\u30fc\u30de\u30f3\u30de\u30b7\u30f3\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\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":"

Standard Operating Procedure of Tube Filling Machine 1.0 OBJECTIVE: This SOP tells you how to run the Tube Filling Machine […]<\/p>\n","protected":false},"author":1,"featured_media":10805,"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":[60],"tags":[],"class_list":["post-10803","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-equipment"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/10803","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=10803"}],"version-history":[{"count":8,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/10803\/revisions"}],"predecessor-version":[{"id":10812,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/10803\/revisions\/10812"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/10805"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=10803"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=10803"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=10803"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}