{"id":10692,"date":"2026-02-14T02:16:02","date_gmt":"2026-02-14T02:16:02","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=10692"},"modified":"2025-12-23T06:07:29","modified_gmt":"2025-12-23T06:07:29","slug":"sop-for-automatic-capsule-filling-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/sop-for-automatic-capsule-filling-machine\/","title":{"rendered":"\u81ea\u52d5\u30ab\u30d7\u30bb\u30eb\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
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\u81ea\u52d5\u30ab\u30d7\u30bb\u30eb\u5145\u586b\u6a5f\u306e\u6a19\u6e96\u64cd\u4f5c\u624b\u9806<\/i><\/em><\/strong><\/p>

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

\u3053\u306eSOP\u3067\u306f\u3001\u81ea\u52d5\u30ab\u30d7\u30bb\u30eb\u5145\u586b\u6a5f\u306e\u64cd\u4f5c\u624b\u9806\u3092\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u6b63\u78ba\u306a\u5145\u586b\u91cd\u91cf\u3001\u5b89\u5b9a\u3057\u305f\u751f\u7523\u91cf\u3001\u305d\u3057\u3066\u30b3\u30f3\u30bf\u30df\u30cd\u30fc\u30b7\u30e7\u30f3\u30bc\u30ed\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u3053\u306e\u6a5f\u68b0\u306f\u7a7a\u306e\u30ab\u30d7\u30bb\u30eb\u3092\u53d6\u308a\u51fa\u3057\u3001\u30ad\u30e3\u30c3\u30d7\u3092\u672c\u4f53\u304b\u3089\u5206\u96e2\u3057\u3001\u7c89\u672b\u307e\u305f\u306f\u30da\u30ec\u30c3\u30c8\u3092\u5145\u586b\u3057\u3001\u518d\u3073\u9589\u3058\u3066\u3001\u5305\u88c5\u6e96\u5099\u306e\u305f\u3081\u306b\u30ab\u30d7\u30bb\u30eb\u3092\u6392\u51fa\u3057\u307e\u3059\u3002\u3053\u3053\u3067\u8aac\u660e\u3059\u308b\u3059\u3079\u3066\u306e\u624b\u9806\u306f\u3001cGMP\u8981\u4ef6\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>

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

\u3053\u306e\u624b\u9806\u306f\u3001\u5f53\u793e\u306e\u751f\u7523\u90e8\u9580\u306b\u3042\u308b\u81ea\u52d5\u30ab\u30d7\u30bb\u30eb\u5145\u586b\u6a5f\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u6a5f\u68b0\u306f\u3001\u786c\u30bc\u30e9\u30c1\u30f3\u30ab\u30d7\u30bb\u30eb\u306b\u7c89\u672b\u88fd\u5264\u3001\u30da\u30ec\u30c3\u30c8\u3001\u307e\u305f\u306f\u9846\u7c92\u3092\u5145\u586b\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6a5f\u68b0\u304c\u5bfe\u5fdc\u53ef\u80fd\u306a\u3059\u3079\u3066\u306e\u30ab\u30d7\u30bb\u30eb\u30b5\u30a4\u30ba\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u624b\u9806\u66f8\u306b\u306f\u3001\u7d44\u307f\u7acb\u3066\u624b\u9806\u3001\u64cd\u4f5c\u65b9\u6cd5\u3001\u5de5\u7a0b\u5185\u30c1\u30a7\u30c3\u30af\u3001\u30d0\u30c3\u30c1\u7d42\u4e86\u624b\u9806\u304c\u8a18\u8f09\u3055\u308c\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\u5b9f\u52d9\u3092\u62c5\u5f53\u3057\u307e\u3059\u3002\u6a5f\u68b0\u306e\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u3001\u88fd\u9020\u306e\u5b9f\u884c\u3001\u305d\u3057\u3066\u3059\u3079\u3066\u3092\u30ed\u30b0\u306b\u8a18\u9332\u3057\u307e\u3059\u3002\u554f\u984c\u306f\u30a8\u30b9\u30ab\u30ec\u30fc\u30b7\u30e7\u30f3\u3055\u308c\u307e\u3059\u304c\u3001\u65e5\u3005\u306e\u904b\u7528\u306f\u5f7c\u3089\u306e\u8cac\u4efb\u3067\u3059\u3002.<\/p>

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

\u751f\u7523\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306f\u8cac\u4efb\u3092\u8ca0\u3044\u307e\u3059\u3002\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u304c\u9069\u5207\u306b\u884c\u308f\u308c\u3001\u624b\u9806\u304c\u9075\u5b88\u3055\u308c\u3001\u3059\u3079\u3066\u304c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

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

5.1 \u307e\u305a\u3001\u5468\u56f2\u3092\u3088\u304f\u78ba\u8a8d\u3057\u307e\u3057\u3087\u3046\u3002\u6e05\u6383\u6e08\u307f\u3067\u3059\u304b\uff1f\u30de\u30b7\u30f3\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\u4f5c\u696d\u3092\u59cb\u3081\u308b\u524d\u306b\u3001\u57c3\u3001\u7c89\u672b\u306e\u6b8b\u308a\u3001\u524d\u56de\u306e\u30d0\u30c3\u30c1\u3067\u6b8b\u3063\u305f\u30ab\u30d7\u30bb\u30eb\u306a\u3069\u3092\u3059\u3079\u3066\u53d6\u308a\u9664\u3044\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.2 \u6a5f\u5668\u4f7f\u7528\u8a18\u9332\u7c3f\u3092\u958b\u304d\u3001\u65e5\u4ed8\u3001\u6642\u523b\u3001\u88fd\u54c1\u540d\u3001\u30d0\u30c3\u30c1\u756a\u53f7\u3001\u6c0f\u540d\u3092\u8a18\u5165\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3053\u306e\u8a18\u5165\u306f\u7701\u7565\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p>

5.3 \u300cCLEANED\uff08\u6d17\u6d44\u6e08\u307f\uff09\u300d\u30e9\u30d9\u30eb\u3092\u5265\u304c\u3057\u3001\u300cUNDER PROCESS\uff08\u51e6\u7406\u4e2d\uff09\u300d\u306b\u8cbc\u308a\u76f4\u3057\u307e\u3059\u3002\u73fe\u5728\u306e\u30d0\u30c3\u30c1\u306e\u8a73\u7d30\u3092\u8ffd\u52a0\u3057\u307e\u3059\u3002.<\/p>

5.4 IPQA\u3067\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\u306a\u3051\u308c\u3070\u751f\u7523\u306f\u3067\u304d\u307e\u305b\u3093\u3002.<\/p>

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

5.5.1 \u81ea\u52d5\u30e2\u30fc\u30c9\u306b\u5207\u308a\u66ff\u3048\u308b\u524d\u306b\u3001\u3059\u3079\u3066\u306e\u30ac\u30fc\u30c9\u3068\u30ab\u30d0\u30fc\u3092\u9589\u3058\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u524d\u9762\u30d1\u30cd\u30eb\u3001\u80cc\u9762\u30ab\u30d0\u30fc\u3001\u30db\u30c3\u30d1\u30fc\u306e\u84cb\u306a\u3069\u3001\u3059\u3079\u3066\u3067\u3059\u3002\u6a5f\u68b0\u306f\u624b\u304c\u4e2d\u306b\u5165\u3063\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u306f\u6c17\u306b\u3057\u307e\u305b\u3093\u3002.<\/p>

5.5.2 \u5b89\u5168\u30b9\u30a4\u30c3\u30c1\u3092\u3044\u3058\u3089\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u30a4\u30f3\u30bf\u30fc\u30ed\u30c3\u30af\u3092\u30d0\u30a4\u30d1\u30b9\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u30a4\u30f3\u30bf\u30fc\u30ed\u30c3\u30af\u306f\u602a\u6211\u3092\u3057\u306a\u3044\u305f\u3081\u306b\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308b\u3082\u306e\u3067\u3059\u3002.<\/p>

5.5.3 \u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u306e\u627f\u8a8d\u306a\u3057\u306e\u6539\u5909\u306f\u7981\u6b62\u3067\u3059\u3002\u3064\u307e\u308a\u3001\u72ec\u81ea\u306b\u4f55\u304b\u3092\u8ffd\u52a0\u3057\u305f\u308a\u3001\u524a\u9664\u3057\u305f\u308a\u3001\u300c\u6539\u826f\u300d\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u7981\u6b62\u3067\u3059\u3002.<\/p>

5.5.4 \u6a5f\u68b0\u306f\u52d5\u3044\u3066\u3044\u308b\uff1f\u624b\u3092\u51fa\u3055\u306a\u3044\u3067\u3002\u8abf\u6574\u3082\u6e05\u6383\u3082\u3001\u53ef\u52d5\u90e8\u3078\u306e\u6f64\u6ed1\u6cb9\u3082\u4e0d\u8981\u3002\u307e\u305a\u306f\u6a5f\u68b0\u3092\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u3057\u3001\u96fb\u6e90\u3092\u5207\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5.5 \u53d6\u308a\u4ed8\u3051\u3001\u5206\u89e3\u3001\u4fdd\u5b88\u3001\u6e05\u6383\u3092\u884c\u3046\u3068\u304d\u306f\u3001\u30e1\u30a4\u30f3\u30b9\u30a4\u30c3\u30c1\u3092\u5e38\u306b\u30aa\u30d5\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5.6 \u7dca\u6025\u505c\u6b62\u3001\u30c9\u30a2\u30a4\u30f3\u30bf\u30fc\u30ed\u30c3\u30af\u3001\u904e\u8ca0\u8377\u4fdd\u8b77 \u2013 \u3044\u305a\u308c\u3082\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\u3068\u8868\u9762\u306f\u3001\u67d4\u3089\u304b\u3044\u4e7e\u3044\u305f\u5e03\u3067\u62ed\u3044\u3066\u304f\u3060\u3055\u3044\u3002\u6eb6\u5264\u3084\u6c34\u306f\u96fb\u5b50\u90e8\u54c1\u3092\u640d\u50b7\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.5.8 \u5b89\u5168\u88c5\u7f6e\u306e\u70b9\u691c\u306f\u3001\u6a5f\u68b0\u304c\u81ea\u52d5\u904b\u8ee2\u3057\u3066\u3044\u308b\u72b6\u614b\u3067\u884c\u3044\u307e\u3059\u3002\u3053\u308c\u304c\u3001\u5b89\u5168\u88c5\u7f6e\u304c\u5b9f\u969b\u306b\u6a5f\u80fd\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3059\u308b\u552f\u4e00\u306e\u65b9\u6cd5\u3067\u3059\u3002.<\/p>

5.5.9 \u4ee5\u4e0b\u306e\u5b89\u5168\u6027\u30c1\u30a7\u30c3\u30af\u3092\u9031\u306b 1 \u56de\u5b9f\u884c\u3057\u3001\u8a18\u9332\u3057\u307e\u3059\u3002<\/p>

5.5.9.1 \u30da\u30f3\u30c0\u30f3\u30c8\u306e\u4e3b\u96fb\u6e90\u30b9\u30a4\u30c3\u30c1\u3092\u62bc\u3057\u307e\u3059\u3002\u96fb\u6e90\u306f\u5207\u308c\u307e\u3059\u304b\uff1f\u554f\u984c\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>

5.5.9.2 \u7dca\u6025\u505c\u6b62\u30dc\u30bf\u30f3\u3092\u62bc\u3057\u307e\u3059\u3002\u3059\u3079\u3066\u304c\u77ac\u6642\u306b\u505c\u6b62\u3059\u308b\u306f\u305a\u3067\u3059\u3002.<\/p>

5.5.9.3 \u80cc\u9762\u306e\u5b89\u5168\u30ab\u30d0\u30fc\u306b\u3042\u308b\u7dca\u6025\u30b9\u30a4\u30c3\u30c1\u3092\u8a66\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u7d50\u679c\u306f\u540c\u3058\u3067\u3001\u6a5f\u68b0\u306f\u505c\u6b62\u3057\u307e\u3059\u3002.<\/p>

5.5.9.4 \u524d\u9762\u30c9\u30a2\u3001\u80cc\u9762\u30c9\u30a2\u3001\u5de6\u30c9\u30a2\u3001\u53f3\u30c9\u30a2\u30921\u3064\u305a\u3064\u958b\u3051\u307e\u3059\u3002\u6a5f\u68b0\u306f\u6bce\u56de\u505c\u6b62\u3059\u308b\u306f\u305a\u3067\u3059\u3002.<\/p>

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

5.6.1 \u30ab\u30d7\u30bb\u30eb\u4ed5\u5206\u3051\u6a5f\u517c\u30a8\u30ec\u30d9\u30fc\u30bf\u30fc:<\/p>

5.6.1.1 \u30bd\u30fc\u30bf\u30fc\u30a8\u30ec\u30d9\u30fc\u30bf\u30fc\u30e6\u30cb\u30c3\u30c8\u3092\u30de\u30b7\u30f3\u306e\u30ab\u30d7\u30bb\u30eb\u30db\u30c3\u30d1\u30fc\u306b\u63a5\u7d9a\u3057\u307e\u3059\u3002\u3057\u3063\u304b\u308a\u3068\u63a5\u7d9a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.1.2 \u7a7a\u306e\u30ab\u30d7\u30bb\u30eb\u3092\u30bd\u30fc\u30bf\u30fc\u30db\u30c3\u30d1\u30fc\u306b\u6368\u3066\u3066\u304f\u3060\u3055\u3044\u3002\u8a70\u3081\u8fbc\u307f\u3059\u304e\u308b\u3068\u8a70\u307e\u308b\u6050\u308c\u304c\u3042\u308a\u307e\u3059\u306e\u3067\u3001\u3054\u6ce8\u610f\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.1.3 \u9078\u5225\u6a5f\u306f\u76f4\u5f84\u304c\u5408\u308f\u306a\u3044\u30ab\u30d7\u30bb\u30eb\u3092\u6392\u51fa\u3057\u307e\u3059\u3002\u6b63\u3057\u3044\u30b5\u30a4\u30ba\u306e\u30ab\u30d7\u30bb\u30eb\u3060\u3051\u304c\u6a5f\u68b0\u306e\u30db\u30c3\u30d1\u30fc\u306b\u9001\u3089\u308c\u307e\u3059\u3002.<\/p>

5.6.1.4 \u670d\u7528\u958b\u59cb\u304b\u3089\u6570\u5206\u9593\u306f\u6ce8\u610f\u6df1\u304f\u89b3\u5bdf\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30ab\u30d7\u30bb\u30eb\u306f\u675f\u306b\u306a\u3063\u305f\u308a\u3001\u30d6\u30ea\u30c3\u30b8\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306a\u304f\u3001\u30b9\u30e0\u30fc\u30ba\u306b\u6d41\u308c\u308b\u3088\u3046\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.2 \u30ab\u30d7\u30bb\u30eb\u306e\u65b9\u5411\u4ed8\u3051\u3068\u88c5\u586b:<\/p>

5.6.2.1 \u3059\u3079\u3066\u306e\u30ab\u30e0\u3092\u30e1\u30a4\u30f3\u30b7\u30e3\u30d5\u30c8\u306b\u53d6\u308a\u4ed8\u3051\u307e\u3059\u3002\u30ad\u30fc\u3092\u7de0\u3081\u4ed8\u3051\u3066\u3001\u52d5\u4f5c\u4e2d\u306b\u4f55\u3082\u6ed1\u3089\u306a\u3044\u3088\u3046\u306b\u3057\u307e\u3059\u3002.<\/p>

5.6.2.2 \u30ab\u30d7\u30bb\u30eb\u30ea\u30ea\u30fc\u30b9\u30d4\u30f3\u30d6\u30ed\u30c3\u30af\u306e\u9ad8\u3055\u3092\u8abf\u6574\u3057\u307e\u3059\u3002\u5404\u30ec\u30fc\u30b9\u30a6\u30a7\u30a4\u30b9\u30ed\u30c3\u30c8\u306b\u30ab\u30d7\u30bb\u30eb\u304c1\u3064\u3060\u3051\u843d\u3061\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002\u9ad8\u3059\u304e\u308b\u3068\u30ab\u30d7\u30bb\u30eb\u304c2\u3064\u843d\u3061\u3001\u4f4e\u3059\u304e\u308b\u3068\u30ab\u30d7\u30bb\u30eb\u304c\u7a7a\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>

5.6.2.3 \u30ab\u30d7\u30bb\u30eb\u306f\u3001\u30ad\u30e3\u30c3\u30d7\u3092\u4e0b\u5411\u304d\u306b\u3057\u305f\u308a\u3001\u672c\u4f53\u3092\u4e0b\u5411\u304d\u306b\u3057\u305f\u308a\u3057\u306a\u304c\u3089\u3001\u30e9\u30f3\u30c0\u30e0\u306b\u5411\u304d\u3092\u5909\u3048\u305f7\u672c\u306e\u5782\u76f4\u30c8\u30e9\u30c3\u30af\u3092\u8d70\u884c\u3057\u307e\u3059\u3002\u6574\u6d41\u5668\u306f\u30ab\u30d7\u30bb\u30eb\u3092\u5168\u3066\u53cd\u8ee2\u3055\u305b\u3001\u672c\u4f53\u3092\u4e0b\u5411\u304d\u306b\u3057\u3066\u304b\u3089\u3001\u30bb\u30b0\u30e1\u30f3\u30c8\u30d6\u30c3\u30b7\u30e5\u306b\u88c5\u586b\u3057\u307e\u3059\u3002.<\/p>

5.6.2.4 \u771f\u7a7a\u5438\u5f15\u306b\u3088\u308a\u30ad\u30e3\u30c3\u30d7\u304c\u672c\u4f53\u304b\u3089\u5206\u96e2\u3055\u308c\u307e\u3059\u3002\u672c\u4f53\u306f\u4e0b\u90e8\u306e\u30bb\u30b0\u30e1\u30f3\u30c8\u30d6\u30c3\u30b7\u30e5\u306b\u843d\u3061\u3001\u30ad\u30e3\u30c3\u30d7\u306f\u4e0a\u90e8\u306e\u30bb\u30b0\u30e1\u30f3\u30c8\u30d6\u30c3\u30b7\u30e5\u306b\u7559\u307e\u308a\u307e\u3059\u3002.<\/p>

5.6.2.5 2 \u3064\u306e\u30ed\u30fc\u30c7\u30a3\u30f3\u30b0 \u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u304c\u9023\u643a\u3057\u3066\u3001\u4e00\u5ea6\u306b 14 \u500b\u306e\u30ab\u30d7\u30bb\u30eb\u3092\u51e6\u7406\u3057\u307e\u3059\u3002.<\/p>

5.6.2.6 \u8a08\u91cf\u30d7\u30ec\u30fc\u30c8\u3092\u4e0b\u5074\u306e\u30bb\u30b0\u30e1\u30f3\u30c8\u306b\u5408\u308f\u305b\u307e\u3059\u3002\u7a74\u306e\u4f4d\u7f6e\u306f\u3069\u306e\u4f4d\u7f6e\u3067\u3082\u5b8c\u5168\u306b\u540c\u5fc3\u5186\u72b6\u306b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u3046\u3067\u306a\u3044\u3068\u3001\u5145\u586b\u304c\u305a\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002.<\/p>

5.6.2.7 \u30d1\u30f3\u30c1\u30ac\u30a4\u30c9\u30d7\u30ec\u30fc\u30c8\u3092\u8abf\u6574\u3057\u3001\u30d1\u30f3\u30c1\u304c\u8a08\u91cf\u30d7\u30ec\u30fc\u30c8\u306e\u7a74\u306b\u30b9\u30e0\u30fc\u30ba\u306b\u6ed1\u308a\u8fbc\u3080\u3088\u3046\u306b\u3057\u307e\u3059\u3002\u3053\u3053\u3067\u5f15\u3063\u304b\u304b\u308b\u3068\u3001\u30d1\u30f3\u30c1\u304c\u7834\u640d\u3059\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002.<\/p>

5.6.2.8 \u76ee\u6a19\u306e\u5145\u586b\u91cd\u91cf\u3092\u5f97\u308b\u305f\u3081\u306b\u3001\u30d1\u30f3\u30c1\u306e\u8cab\u5165\u6df1\u3055\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002\u8cab\u5165\u304c\u6df1\u3044\u307b\u3069\u3001\u5145\u586b\u91cd\u91cf\u306f\u5897\u52a0\u3057\u307e\u3059\u3002.<\/p>

5.6.2.9 \u88fd\u54c1\u306b\u9069\u3057\u305f\u539a\u3055\u306e\u30c9\u30fc\u30b8\u30f3\u30b0\u30c7\u30a3\u30b9\u30af\u3092\u9078\u629e\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u539a\u3055\u304c\u9069\u5207\u3067\u306a\u3044\u3068\u3001\u983b\u7e41\u306a\u8abf\u6574\u3068\u30c0\u30a6\u30f3\u30bf\u30a4\u30e0\u304c\u767a\u751f\u3057\u307e\u3059\u3002.<\/p>

5.6.2.10 \u4e0d\u826f\u54c1\u6392\u51fa\u30b7\u30b9\u30c6\u30e0\u306e\u7a7a\u6c17\u5727\u306f0.5\uff5e1.0 kg\/cm\u00b2\u306e\u7bc4\u56f2\u3067\u7dad\u6301\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u4e0d\u826f\u30ab\u30d7\u30bb\u30eb\u306f\u4e0d\u826f\u54c1\u6392\u51fa\u30dc\u30c3\u30af\u30b9\u306b\u62bc\u3057\u51fa\u3055\u308c\u307e\u3059\u3002.<\/p>

5.6.3 \u7c89\u672b\u5145\u586b\uff1a<\/strong><\/p>

5.6.3.1 \u85ac\u5264\u30db\u30c3\u30d1\u30fc\u306b\u7c89\u672b\u3092\u6295\u5165\u3057\u307e\u3059\u3002\u30b9\u30bf\u30fc\u30e9\u30fc\u304c\u81ea\u52d5\u7684\u306b\u7c89\u672b\u3092\u7c89\u672b\u69fd\u306b\u79fb\u3057\u307e\u3059\u3002.<\/p>

5.6.3.2 \u5bb9\u5668\u5185\u306e\u7c89\u672b\u30ec\u30d9\u30eb\u306f\u30bb\u30f3\u30b5\u30fc\u3067\u5236\u5fa1\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u660e\u3089\u304b\u306b\u7570\u5e38\u304c\u306a\u3044\u9650\u308a\u3001\u624b\u52d5\u3067\u8abf\u6574\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.3.3 \u30bf\u30f3\u30d4\u30f3\u30b0\u88c5\u7f6e\u306f\u3001\u8a08\u91cf\u30c7\u30a3\u30b9\u30af\u30925\u56de\u9023\u7d9a\u7684\u306b\u30bf\u30f3\u30d4\u30f3\u30b0\u3057\u3001\u7c89\u672b\u306e\u584a\u3092\u7a4d\u307f\u4e0a\u3052\u307e\u3059\u30026\u56de\u76ee\u306e\u30b9\u30c8\u30ed\u30fc\u30af\u3067\u3001\u3053\u306e\u584a\u304c\u30ab\u30d7\u30bb\u30eb\u672c\u4f53\u306b\u62bc\u3057\u8fbc\u307e\u308c\u307e\u3059\u3002.<\/p>

5.6.3.4 \u30c9\u30fc\u30b8\u30f3\u30b0\u30c7\u30a3\u30b9\u30af\u306e\u539a\u3055\u306f\u3001\u7c89\u4f53\u306e\u5d69\u5bc6\u5ea6\u3001\u76ee\u6a19\u5145\u586b\u91cd\u91cf\u3001\u304a\u3088\u3073\u6d41\u52d5\u7279\u6027\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u88fd\u54c1\u4ed5\u69d8\u66f8\u3092\u3054\u78ba\u8a8d\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.4 \u30da\u30ec\u30c3\u30c8\u5145\u586b\u88c5\u7f6e\uff08\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308b\u5834\u5408\uff09<\/p>

5.6.4.1 \u30da\u30ec\u30c3\u30c8\u5145\u586b\u306f\u4f53\u7a4d\u306b\u57fa\u3065\u3044\u3066\u884c\u308f\u308c\u307e\u3059\u3002\u76ee\u6a19\u91cd\u91cf\u306b\u9054\u3059\u308b\u3088\u3046\u306b\u8a08\u91cf\u30c1\u30e3\u30f3\u30d0\u30fc\u306e\u30b5\u30a4\u30ba\u3092\u8abf\u6574\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.4.2 \u6295\u4e0e\u91cf\u306f\u56fa\u5b9a\u5bb9\u5668\u3068\u53ef\u52d5\u30b9\u30e9\u30a4\u30c0\u30fc\u30d6\u30ed\u30c3\u30af\u304b\u3089\u4f9b\u7d66\u3055\u308c\u307e\u3059\u3002\u8abf\u6574\u30ce\u30d6\u3092\u56de\u3057\u3066\u5145\u586b\u91cd\u91cf\u3092\u8abf\u6574\u3057\u307e\u3059\u3002.<\/p>

5.6.4.3 \u30b9\u30e9\u30a4\u30c0\u30fc\u306e\u4f4d\u7f6e\u3092\u8a2d\u5b9a\u3059\u308b\u305f\u3081\u306e\u30011\u30df\u30af\u30ed\u30f3\u5358\u4f4d\u306e\u5206\u89e3\u80fd\u3092\u6301\u3064\u30c0\u30a4\u30e4\u30eb\u30b2\u30fc\u30b8\u304c\u3042\u308a\u307e\u3059\u3002\u76ee\u6e2c\u3067\u306f\u4e0d\u5341\u5206\u306a\u306e\u3067\u3001\u3053\u308c\u3092\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.4.4 \u5145\u586b\u6a5f\u69cb\u306f\u30da\u30ec\u30c3\u30c8\u3092\u512a\u3057\u304f\u53d6\u308a\u6271\u3046\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30da\u30ec\u30c3\u30c8\u3092\u6f70\u3057\u305f\u308a\u3001\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u3092\u640d\u50b7\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>

5.6.5 \u30ab\u30d7\u30bb\u30eb\u306e\u9589\u9396\u3068\u6392\u51fa:<\/p>

5.6.5.1 \u30af\u30ed\u30fc\u30b8\u30f3\u30b0\u30d4\u30f3\u304c\u30ad\u30e3\u30c3\u30d7\u3092\u672c\u4f53\u306b\u62bc\u3057\u8fbc\u307f\u3001\u30ed\u30c3\u30af\u3057\u307e\u3059\u3002\u5fae\u8abf\u6574\u30cd\u30b8\u3092\u4f7f\u7528\u3057\u3066\u30ed\u30c3\u30af\u9577\u3055\u3092\u8abf\u6574\u3057\u307e\u3059\u3002.<\/p>

5.6.5.2 \u30ab\u30d7\u30bb\u30eb\u306e\u30b5\u30a4\u30ba\u306b\u3088\u3063\u3066\u5fc5\u8981\u306a\u9589\u9396\u30d4\u30f3\u3082\u7570\u306a\u308a\u307e\u3059\u3002\u30ab\u30d7\u30bb\u30eb\u306e\u30b5\u30a4\u30ba\u3092\u5909\u66f4\u3059\u308b\u5834\u5408\u306f\u3001\u9589\u9396\u30d4\u30f3\u3082\u4ea4\u63db\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.5.3 \u5145\u586b\u3055\u308c\u9589\u3058\u3089\u308c\u305f\u30ab\u30d7\u30bb\u30eb\u306f\u6392\u51fa\u30d4\u30f3\u306b\u3088\u3063\u3066\u62bc\u3057\u51fa\u3055\u308c\u3001\u51fa\u53e3\u30b7\u30e5\u30fc\u30c8\u304b\u3089\u6ed1\u308a\u843d\u3061\u307e\u3059\u3002.<\/p>

5.6.5.4 \u6392\u51fa\u5f8c\u3001\u6b21\u306e\u30b5\u30a4\u30af\u30eb\u3067\u518d\u3073\u30d6\u30c3\u30b7\u30e5\u3092\u88c5\u586b\u3059\u308b\u524d\u306b\u3001\u5727\u7e2e\u7a7a\u6c17\u3068\u771f\u7a7a\u3067\u7a7a\u306e\u30d6\u30c3\u30b7\u30e5\u3092\u5439\u304d\u98db\u3070\u3057\u3066\u304d\u308c\u3044\u306b\u3057\u307e\u3059\u3002.<\/p>

5.7 \u64cd\u4f5c:<\/p>

5.7.1 \u4e3b\u96fb\u6e90\u3092\u30aa\u30f3\u306b\u3057\u3001\u5236\u5fa1\u30b7\u30b9\u30c6\u30e0\u304c\u5b8c\u5168\u306b\u8d77\u52d5\u3059\u308b\u307e\u3067\u5f85\u3061\u307e\u3059\u3002.<\/p>

5.7.2 \u81ea\u52d5\u30e2\u30fc\u30c9\u307e\u305f\u306f\u624b\u52d5\u30e2\u30fc\u30c9\u306b\u5207\u308a\u66ff\u3048\u308b\u524d\u306b\u3001\u30e2\u30fc\u30bf\u30fc\u30b7\u30e3\u30d5\u30c8\u306e\u30cf\u30f3\u30c9\u30db\u30a4\u30fc\u30eb\u3092\u56de\u3057\u3001\u30bf\u30ec\u30c3\u30c8\u30a2\u30bb\u30f3\u30d6\u30ea\u30921\u56de\u8ee2\u3055\u305b\u3066\u304f\u3060\u3055\u3044\u3002\u3059\u3079\u3066\u306e\u52d5\u4f5c\u3092\u6ce8\u610f\u6df1\u304f\u89b3\u5bdf\u3057\u3001\u5f15\u3063\u639b\u304b\u308a\u304c\u306a\u3044\u304b\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.3 \u81ea\u52d5\u30e2\u30fc\u30c9\u3067\u306f\u3001\u8d77\u52d5\u524d\u306b\u30de\u30b7\u30f3\u304c\u30bb\u30eb\u30d5\u30c1\u30a7\u30c3\u30af\u3092\u5b9f\u884c\u3057\u307e\u3059\u3002\u5b8c\u4e86\u3059\u308b\u307e\u3067\u304a\u5f85\u3061\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.4 \u30e1\u30a4\u30f3\u306e\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30d1\u30cd\u30eb\u753b\u9762\u306b\u306f\u3001\u81ea\u52d5\u3001\u30a2\u30e9\u30fc\u30e0\u3001\u88fd\u54c1\u3001\u9078\u629e\u3001\u30b5\u30f3\u30d7\u30eb\u306e\u30aa\u30d7\u30b7\u30e7\u30f3\u304c\u3042\u308a\u307e\u3059\u3002\u5fc5\u8981\u306a\u3082\u306e\u3092\u9078\u629e\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.5 \u81ea\u52d5\u6a5f\u80fd\u753b\u9762\u3067\u306f\u6b21\u306e\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u304c\u63d0\u4f9b\u3055\u308c\u307e\u3059\u3002<\/p>

5.7.5.1 \u958b\u59cb:<\/strong> \u3053\u308c\u3092\u62bc\u3059\u3068\u3001\u30de\u30b7\u30f3\u306f\u81ea\u52d5\u30e2\u30fc\u30c9\u306b\u5207\u308a\u66ff\u308f\u308a\u307e\u3059\u3002\u771f\u7a7a\u30dd\u30f3\u30d7\u3068\u30d6\u30ed\u30ef\u30fc\u304c\u81ea\u52d5\u7684\u306b\u4f5c\u52d5\u3057\u307e\u3059\u3002.<\/p>

5.7.5.2 \u505c\u6b62:<\/strong> \u3059\u3079\u3066\u3092\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u3057\u307e\u3059\u3002.<\/p>

5.7.5.3 \u6642\u9593\u306e\u30ea\u30bb\u30c3\u30c8:<\/strong> 3\u79d2\u9593\u62bc\u3057\u7d9a\u3051\u308b\u3068\u3001\u5b9f\u884c\u6642\u9593\u30ab\u30a6\u30f3\u30bf\u30fc\u304c\u30ea\u30bb\u30c3\u30c8\u3055\u308c\u307e\u3059\u3002.<\/p>

5.7.5.4 \u30a2\u30e9\u30fc\u30e0\u30b9\u30c6\u30fc\u30bf\u30b9: \u30a2\u30e9\u30fc\u30e0\u304c\u30a2\u30af\u30c6\u30a3\u30d6\u306e\u5834\u5408\u3001\u4f55\u304c\u554f\u984c\u306a\u306e\u304b\u304c\u8868\u793a\u3055\u308c\u307e\u3059\u3002\u4f55\u304b\u304c\u505c\u6b62\u3057\u305f\u5834\u5408\u306f\u3001\u307e\u305a\u3053\u3053\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.5.5 \u88fd\u54c1\u30ec\u30dd\u30fc\u30c8:<\/strong> \u7dcf\u751f\u7523\u6570\u3001\u672c\u65e5\u306e\u6570\u3001\u304a\u3088\u3073 1 \u6642\u9593\u3042\u305f\u308a\u306e\u30ab\u30d7\u30bb\u30eb\u6570\u3092\u8868\u793a\u3057\u307e\u3059\u3002.<\/p>

5.7.5.6 \u30c7\u30fc\u30bf\u5165\u529b:<\/strong> \u30d0\u30c3\u30c1\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u5165\u529b\u3059\u308b\u5834\u6240\u3067\u3059\u3002\u30d0\u30c3\u30c1\u30ec\u30b3\u30fc\u30c9\u3054\u3068\u306b\u5165\u529b\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.5.7 \u91cd\u91cf\u8a2d\u5b9a: \u8a31\u5bb9\u53ef\u80fd\u306a\u91cd\u91cf\u5909\u52d5\u9650\u5ea6\u3001\u5e73\u5747\u5316\u3059\u308b\u30ab\u30d7\u30bb\u30eb\u6570\u3001\u304a\u3088\u3073\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u9593\u9694\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002.<\/p>

5.7.5.8 \u30b5\u30f3\u30d7\u30eb\u8a2d\u5b9a:<\/strong> F8\u30ad\u30fc\u3092\u62bc\u3057\u3066\u3053\u3053\u3078\u79fb\u52d5\u3057\u307e\u3059\u3002\u30b5\u30f3\u30d7\u30eb\u63a1\u53d6\u3001\u81ea\u52d5\/\u624b\u52d5\u30e2\u30fc\u30c9\u3001\u98a8\u888b\u5f15\u304d\u3001\u30e2\u30fc\u30bf\u30fc\u306e\u30aa\u30f3\/\u30aa\u30d5\u306e\u30aa\u30d7\u30b7\u30e7\u30f3\u304c\u3042\u308a\u307e\u3059\u3002\u5fc5\u8981\u306a\u3082\u306e\u3092\u9078\u629e\u3059\u308b\u3068\u3001\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u3068\u8a08\u91cf\u30b7\u30fc\u30b1\u30f3\u30b9\u304c\u958b\u59cb\u3055\u308c\u307e\u3059\u3002.<\/p>

5.7.6 \u30ab\u30d7\u30bb\u30eb\u30db\u30c3\u30d1\u30fc\u306b\u30ab\u30d7\u30bb\u30eb\u3092\u5145\u586b\u3057\u307e\u3059\u3002\u88fd\u9020\u4e2d\u306b\u7a7a\u306b\u306a\u3089\u306a\u3044\u3088\u3046\u306b\u6ce8\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.7 \u300c\u30b9\u30bf\u30fc\u30c8\u300d\u3092\u62bc\u3057\u307e\u3059\u3002\u6700\u521d\u306e100\u500b\u307b\u3069\u306e\u30ab\u30d7\u30bb\u30eb\u306b\u6ce8\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u5145\u586b\u72b6\u614b\u304c\u6b63\u3057\u304f\u3001\u30ab\u30d7\u30bb\u30eb\u304c\u304d\u3061\u3093\u3068\u9589\u307e\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.7.8 \u30d0\u30c3\u30c1\u8a18\u9332\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306b\u5f93\u3063\u3066 IPQA \u30c1\u30a7\u30c3\u30af\u7528\u306e\u30b5\u30f3\u30d7\u30eb\u3092\u63a1\u53d6\u3057\u307e\u3059\u3002.<\/p>

5.8 \u30ab\u30d7\u30bb\u30eb\u306e\u7814\u78e8\u3068\u9078\u5225\uff1a<\/p>

5.8.1 \u5145\u586b\u3055\u308c\u305f\u30ab\u30d7\u30bb\u30eb\u306f\u6b21\u306b\u7814\u78e8\u6a5f\u304a\u3088\u3073\u9078\u5225\u30e6\u30cb\u30c3\u30c8\u3092\u901a\u904e\u3057\u307e\u3059\u3002.<\/p>

5.8.2 \u3053\u3053\u3067\u306f2\u3064\u306e\u30bd\u30fc\u30c8\u6bb5\u968e\u304c\u3042\u308a\u307e\u3059:<\/p>

5.8.2.1 \u30d7\u30ec\u30fc\u30c8 \u30bd\u30fc\u30bf\u30fc\u306f\u3001\u7de9\u3093\u3060\u30ab\u30d7\u30bb\u30eb\uff08\u6b63\u3057\u304f\u9589\u307e\u3089\u305a\u30ad\u30e3\u30c3\u30d7\u304c\u5916\u308c\u305f\u30ab\u30d7\u30bb\u30eb\uff09\u3092\u30ad\u30e3\u30c3\u30c1\u3057\u307e\u3059\u3002.<\/p>

5.8.2.2 \u30c9\u30e9\u30e0 \u30bd\u30fc\u30bf\u30fc\u306f\u3001\u76f4\u5f84\u306b\u554f\u984c\u304c\u3042\u308b\u30ab\u30d7\u30bb\u30eb (\u6955\u5186\u5f62\u3001\u5927\u304d\u3059\u304e\u308b\u3082\u306e\u3001\u307e\u3063\u3059\u3050\u8ee2\u304c\u3089\u306a\u3044\u3082\u306e\u306a\u3069) \u3092\u30ad\u30e3\u30c3\u30c1\u3057\u307e\u3059\u3002.<\/p>

5.8.3 \u30d7\u30ec\u30fc\u30c8\u30bd\u30fc\u30bf\u30fc\u306e\u8d77\u52d5\uff1a\u30ec\u30ae\u30e5\u30ec\u30fc\u30bf\u30fc\u306e\u30ce\u30d6\u3092\u30bc\u30ed\u306b\u8a2d\u5b9a\u3057\u3001\u96fb\u6e90\u30b9\u30a4\u30c3\u30c1\u3092\u5165\u308c\u3001\u30ce\u30d6\u3092\u6642\u8a08\u56de\u308a\u306b\u3086\u3063\u304f\u308a\u3068\u56de\u3057\u3066\u4e2d\u9593\u4f4d\u7f6e\u307e\u3067\u56de\u3057\u307e\u3059\u3002\u632f\u52d5\u304c\u6ed1\u3089\u304b\u3067\u3001\u30ac\u30bf\u30ac\u30bf\u3057\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30ac\u30bf\u30ac\u30bf\u3059\u308b\u5834\u5408\u306f\u3001\u96fb\u5727\u3092\u4e0b\u3052\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.8.4 \u30c9\u30e9\u30e0\u30bd\u30fc\u30bf\u30fc\u306e\u59cb\u52d5\uff1a\u7dd1\u306e\u30dc\u30bf\u30f3\u3092\u62bc\u3057\u307e\u3059\u3002\u6392\u51fa\u53e3\u304b\u3089\u898b\u3066\u6642\u8a08\u56de\u308a\u306b\u56de\u8ee2\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

5.8.5 \u6b21\u306b\u3001\u5145\u586b\u6a5f\u304b\u3089\u306e\u30ab\u30d7\u30bb\u30eb\u306e\u6d41\u308c\u3092\u30aa\u30f3\u306b\u3057\u307e\u3059\u3002.<\/p>

5.8.6 \u30ab\u30d7\u30bb\u30eb\u304c\u4ed5\u5206\u3051\u30d7\u30ec\u30fc\u30c8\u4e0a\u3092\u79fb\u52d5\u3059\u308b\u69d8\u5b50\u3092\u89b3\u5bdf\u3057\u307e\u3059\u3002\u52d5\u304d\u304c\u9045\u3059\u304e\u305f\u308a\u3001\u8a70\u307e\u3063\u305f\u308a\u3057\u3066\u3044\u307e\u305b\u3093\u304b\uff1f\u632f\u52d5\u3092\u5c11\u3057\u4e0a\u3052\u3066\u307f\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.8.7 \u7de9\u3093\u3060\u30ad\u30e3\u30c3\u30d7\u306f\u30d7\u30ec\u30fc\u30c8\u306e\u7a74\u304b\u3089\u843d\u3061\u3001\u826f\u54c1\u306e\u30ab\u30d7\u30bb\u30eb\u306f\u30c9\u30e9\u30e0\u30bd\u30fc\u30bf\u30fc\u306b\u9001\u3089\u308c\u307e\u3059\u3002.<\/p>

5.8.8 \u30c9\u30e9\u30e0\u306f\u30ab\u30d7\u30bb\u30eb\u3092\u9078\u5225\u30d7\u30ec\u30fc\u30c8\u4e0a\u3067\u56de\u8ee2\u3055\u305b\u307e\u3059\u3002\u5927\u304d\u3059\u304e\u308b\u30ab\u30d7\u30bb\u30eb\u3084\u6955\u5186\u5f62\u306e\u30ab\u30d7\u30bb\u30eb\u306f\u6355\u3089\u3048\u3089\u308c\u3001\u826f\u8cea\u306e\u30ab\u30d7\u30bb\u30eb\u306f\u901a\u904e\u3057\u307e\u3059\u3002.<\/p>

5.8.9 \u30c9\u30e9\u30e0\u4e0a\u90e8\u306b\u53d6\u308a\u4ed8\u3051\u3089\u308c\u305f\u30ca\u30a4\u30ed\u30f3\u30d6\u30e9\u30b7\u304c\u3001\u8a70\u307e\u3063\u305f\u4e0d\u826f\u30ab\u30d7\u30bb\u30eb\u3092\u53ce\u96c6\u30c8\u30ec\u30a4\u306b\u53e9\u304d\u843d\u3068\u3057\u307e\u3059\u3002\u53ce\u96c6\u30c8\u30ec\u30a4\u306f\u5b9a\u671f\u7684\u306b\u7a7a\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.8.10 \u9078\u5225\u6a5f\u304b\u3089\u51fa\u3066\u304d\u305f\u826f\u54c1\u306e\u30ab\u30d7\u30bb\u30eb\u306f\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u306b\u9032\u3080\u6e96\u5099\u304c\u6574\u3044\u307e\u3059\u3002.<\/p>

5.9 \u30d0\u30c3\u30c1\u51e6\u7406\u304c\u5b8c\u4e86\u3057\u305f\u3089\u3001\u6a5f\u68b0\u3092\u505c\u6b62\u3057\u307e\u3059\u3002\u30db\u30c3\u30d1\u30fc\u304b\u3089\u6b8b\u3063\u305f\u7c89\u672b\u3092\u53d6\u308a\u9664\u304d\u3001\u8abf\u6574\u624b\u9806\u306b\u5f93\u3063\u3066\u51e6\u7406\u3057\u307e\u3059\u3002.<\/p>

5.10 \u88fd\u54c1\u3068\u30d0\u30c3\u30c1\u60c5\u5831\u3092\u8a18\u8f09\u3057\u305f\u300c\u6d17\u6d44\u304c\u5fc5\u8981\u300d\u30e9\u30d9\u30eb\u3092\u6a5f\u68b0\u306b\u8cbc\u308a\u307e\u3059\u3002.<\/p>

5.11 \u6a5f\u5668\u6d17\u6d44SOP\u306b\u5f93\u3063\u3066\u81ea\u52d5\u30ab\u30d7\u30bb\u30eb\u5145\u586b\u6a5f\u3092\u6d17\u6d44\u3057\u307e\u3059\u3002.<\/p>

5.12 \u8a18\u9332: \u6a5f\u5668\u4f7f\u7528\u30ed\u30b0\u3001\u30d0\u30c3\u30c1\u751f\u7523\u8a18\u9332\u3001\u5de5\u7a0b\u5185\u30c1\u30a7\u30c3\u30af\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>\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 Automatic Capsule Filling Machine 1.0 OBJECTIVE: This SOP walks you through operating the Automatic Capsule Filling […]<\/p>\n","protected":false},"author":1,"featured_media":10695,"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":[57],"tags":[],"class_list":["post-10692","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-capsule-filling-equipment"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/10692","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=10692"}],"version-history":[{"count":4,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/10692\/revisions"}],"predecessor-version":[{"id":10698,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/10692\/revisions\/10698"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/10695"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=10692"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=10692"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=10692"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}