{"id":17532,"date":"2026-08-21T05:50:41","date_gmt":"2026-08-21T05:50:41","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=17532"},"modified":"2026-05-15T06:00:06","modified_gmt":"2026-05-15T06:00:06","slug":"sop-for-sealing-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/sop-for-sealing-machine\/","title":{"rendered":"\u30b7\u30fc\u30eb\u6a5f\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09"},"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

\u30b7\u30fc\u30ea\u30f3\u30b0\u30de\u30b7\u30f3\u306e\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\u3002.<\/p>

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

\u751f\u7523\u90e8\u9580\u306b\u304a\u3044\u3066\u3001\u4e00\u6b21\u5305\u88c5\u6750\u304a\u3088\u3073\u4e8c\u6b21\u5305\u88c5\u6750\u306e\u5bc6\u5c01\u306b\u4f7f\u7528\u3059\u308b\u5bc6\u5c01\u6a5f\u306e\u64cd\u4f5c\u624b\u9806\u3092\u5b9a\u3081\u308b\u3002.<\/p>

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

\u672c\u624b\u9806\u66f8\u306f\u3001\u5305\u88c5\u30e9\u30a4\u30f3\u5185\u306b\u304a\u3051\u308b\u30b9\u30c8\u30ea\u30c3\u30d7\u30b7\u30fc\u30eb\u3001\u30d1\u30a6\u30c1\u30b7\u30fc\u30eb\u3001\u304a\u3088\u3073\u30d6\u30ea\u30b9\u30bf\u30fc\u30b7\u30fc\u30eb\u4f5c\u696d\u306b\u7528\u3044\u3089\u308c\u308b\u30b7\u30fc\u30eb\u6a5f\u306e\u64cd\u4f5c\u624b\u9806\u3092\u898f\u5b9a\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002.<\/p>

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

\u68b1\u5305\u4f5c\u696d\u54e1\u30fb\u751f\u7523\u62c5\u5f53<\/p>

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

\u751f\u7523\u8cac\u4efb\u8005\u3002.<\/p>

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

5.1 \u68b1\u5305\u5ba4\u3068\u30b7\u30fc\u30eb\u88c5\u7f6e\u3092\u78ba\u8a8d\u3059\u308b\u3002\u30b7\u30d5\u30c8\u958b\u59cb\u524d\u306b\u3001\u6a5f\u68b0\u306b\u300cCLEANED\u300d\u3068\u66f8\u304b\u308c\u305f\u30b9\u30c6\u30fc\u30bf\u30b9\u30bf\u30b0\u304c\u8cbc\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002.<\/p>

5.2 \u6a5f\u5668\u4f7f\u7528\u8a18\u9332\u306b\u8a18\u5165\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u64cd\u4f5c\u8005\u306e\u6c0f\u540d\u3001\u88fd\u54c1\u30b3\u30fc\u30c9\u3001\u65e5\u4ed8\u3001\u304a\u3088\u3073\u4f7f\u7528\u958b\u59cb\u6642\u523b\u3092\u8a18\u5165\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.3 \u6a5f\u68b0\u304b\u3089\u300cCLEANED\u300d\u306e\u30bf\u30b0\u3092\u53d6\u308a\u5916\u3057\u3001\u305d\u306e\u4ee3\u308f\u308a\u306b\u300cUNDER PROCESS\u300d\u306e\u30bf\u30b0\u3092\u8cbc\u308a\u4ed8\u3051\u308b\u3002.<\/p>

5.4 IPQA\u30c1\u30fc\u30e0\u306b\u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u8a3c\u660e\u66f8\u306e\u767a\u884c\u3092\u4f9d\u983c\u3059\u308b\u3002\u8a3c\u660e\u66f8\u304c\u767a\u884c\u3055\u308c\u308b\u307e\u3067\u3001\u8d70\u884c\u306e\u958b\u59cb\u3092\u4fdd\u7559\u3068\u3059\u308b\u3002.<\/p>

5.5 \u4e3b\u8981\u306a\u5b89\u5168\u898f\u5247\uff1a<\/strong><\/h3>

5.5.1 \u30b7\u30fc\u30eb\u30ed\u30fc\u30e9\u30fc\u304a\u3088\u3073\u767a\u71b1\u4f53\u306f\u975e\u5e38\u306b\u9ad8\u6e29\u306b\u306a\u308a\u307e\u3059\u3002\u624b\u3001\u9aea\u3001\u304a\u3088\u3073\u306f\u3060\u3051\u305f\u8863\u670d\u3092\u3001\u5e38\u306b\u71b1\u6e90\u304b\u3089\u9060\u3056\u3051\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5.2 \u6a5f\u68b0\u306e\u96fb\u6e90\u304c\u5165\u3063\u3066\u3044\u308b\u9593\u306f\u3001\u30ed\u30fc\u30e9\u30fc\u306e\u631f\u307f\u8fbc\u307f\u90e8\u3084\u30b7\u30fc\u30eb\u30b8\u30e7\u30fc\u306b\u6c7a\u3057\u3066\u624b\u3092\u5165\u308c\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u307b\u3093\u306e\u4e00\u77ac\u3067\u3001\u91cd\u5927\u306a\u631f\u307f\u8fbc\u307f\u4e8b\u6545\u304c\u767a\u751f\u3059\u308b\u304a\u305d\u308c\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.5.3 \u5149\u96fb\u30bb\u30f3\u30b5\u30fc\u3001\u8fd1\u63a5\u30b9\u30a4\u30c3\u30c1\u3001\u307e\u305f\u306f\u5149\u5e55\u3092\u8986\u3063\u305f\u308a\u3001\u30c6\u30fc\u30d7\u3067\u585e\u3044\u3060\u308a\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u3053\u308c\u3089\u306e\u30bb\u30f3\u30b5\u30fc\u306f\u3001\u5371\u967a\u304c\u691c\u77e5\u3055\u308c\u308b\u3068\u6a5f\u68b0\u3092\u505c\u6b62\u3055\u305b\u307e\u3059\u3002.<\/p>

5.5.4 \u96fb\u6e90\u3092\u5207\u3063\u3066\u304b\u3089\u3001\u5c11\u306a\u304f\u3068\u308210\u5206\u9593\u306f\u5f85\u3063\u3066\u304b\u3089\u3001\u9ad8\u6e29\u306b\u306a\u3063\u3066\u3044\u308b\u90e8\u5206\u306b\u89e6\u308c\u3066\u304f\u3060\u3055\u3044\u3002\u30ed\u30fc\u30e9\u30fc\u3084\u30d7\u30ec\u30fc\u30c8\u306f\u3001\u96fb\u6e90\u3092\u5207\u3063\u3066\u304b\u3089\u3082\u9577\u6642\u9593\u71b1\u3092\u4fdd\u3061\u7d9a\u3051\u307e\u3059\u3002.<\/p>

5.5.5 \u5236\u5fa1\u76e4\u3092\u958b\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u306f\u3001\u8a13\u7df4\u3092\u53d7\u3051\u305f\u96fb\u6c17\u6280\u8853\u8005\u306e\u307f\u3067\u3059\u3002\u5236\u5fa1\u76e4\u5185\u306b\u306f\u901a\u96fb\u4e2d\u306e\u56de\u8def\u304c\u3042\u308a\u3001\u91cd\u5927\u306a\u611f\u96fb\u4e8b\u6545\u3092\u5f15\u304d\u8d77\u3053\u3059\u304a\u305d\u308c\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.5.6 \u6728\u88fd\u307e\u305f\u306f\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u88fd\u306e\u30b9\u30af\u30ec\u30fc\u30d1\u30fc\u3092\u4f7f\u7528\u3057\u3066\u3001\u30b7\u30fc\u30eb\u90e8\u5206\u306b\u304f\u3063\u3064\u3044\u305f\u7269\u8cea\u3092\u53d6\u308a\u9664\u3044\u3066\u304f\u3060\u3055\u3044\u3002\u767a\u71b1\u4f53\u306e\u8fd1\u304f\u3067\u306f\u3001\u91d1\u5c5e\u88fd\u306e\u5de5\u5177\u3092\u7d76\u5bfe\u306b\u4f7f\u7528\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5.7 \u672c\u4f53\u306e\u5916\u5074\u306f\u3001\u8efd\u304f\u6e7f\u3089\u305b\u305f\u5e03\u306e\u307f\u3067\u62ed\u3044\u3066\u304f\u3060\u3055\u3044\u3002\u30e2\u30fc\u30bf\u30fc\u30cf\u30a6\u30b8\u30f3\u30b0\u3084\u99c6\u52d5\u30d9\u30eb\u30c8\u306b\u6db2\u4f53\u304c\u89e6\u308c\u306a\u3044\u3088\u3046\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5.8 \u64cd\u4f5c\u8005\u306f\u3001\u5b9f\u9a13\u306e\u5168\u5de5\u7a0b\u3092\u901a\u3058\u3066\u3001\u767d\u8863\u3001\u8010\u5207\u65ad\u6027\u624b\u888b\u3001\u5b89\u5168\u30e1\u30ac\u30cd\u3001\u304a\u3088\u3073\u30d8\u30a2\u30cd\u30c3\u30c8\u3092\u7740\u7528\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>

5.5.9 \u4ee5\u4e0b\u306e\u5b89\u5168\u30b7\u30b9\u30c6\u30e0\u306e\u70b9\u691c\u3092\u6bce\u9031\u5b9f\u65bd\u3059\u308b\u3053\u3068\uff1a<\/p>

5.5.9.1 \u4e3b\u906e\u65ad\u5668\u3092\u30aa\u30d5\u306b\u3057\u3001\u3059\u3079\u3066\u306e\u8868\u793a\u30e9\u30f3\u30d7\u304c\u6d88\u706f\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002.<\/p>

5.5.9.2 \u30e1\u30a4\u30f3\u30d1\u30cd\u30eb\u306e\u975e\u5e38\u505c\u6b62\u30dc\u30bf\u30f3\u3092\u62bc\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30ed\u30fc\u30e9\u30fc\u306f1\u56de\u8ee2\u4ee5\u5185\u306b\u505c\u6b62\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>

5.5.9.3 \u30c6\u30b9\u30c8\u30ed\u30c3\u30c9\u3092\u4f7f\u3063\u3066\u5149\u96fb\u30ab\u30fc\u30c6\u30f3\u3092\u906e\u65ad\u3059\u308b\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u6a5f\u68b0\u306f\u76f4\u3061\u306b\u5b89\u5168\u72b6\u614b\u306b\u79fb\u884c\u3059\u308b\u306f\u305a\u3067\u3042\u308b\u3002.<\/p>

5.5.9.4 \u5404\u30ac\u30fc\u30c9\u30c9\u30a2\u3092\u958b\u304f\u3002\u3044\u305a\u308c\u304b\u306e\u30c9\u30a2\u304c\u6301\u3061\u4e0a\u3052\u3089\u308c\u305f\u5834\u5408\u3001\u99c6\u52d5\u30b7\u30b9\u30c6\u30e0\u306f\u96fb\u6e90\u3092\u906e\u65ad\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>

5.5.9.5 \u30ec\u30d3\u30e5\u30fc\u306e\u7d50\u679c\u3092\u300c\u5b89\u5168\u70b9\u691c\u8a18\u9332\u7c3f\u300d\u306b\u8a18\u8f09\u3059\u308b\u3002.<\/p>

5.6 \u30de\u30b7\u30f3\u306e\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\uff1a<\/strong><\/h3>

5.6.1 \u6750\u6599\u5dfb\u304d\u53d6\u308a\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\uff1a<\/b><\/strong><\/h4>

5.6.1.1 \u30b7\u30fc\u30ea\u30f3\u30b0\u30d5\u30a3\u30eb\u30e0\u306e\u30ea\u30fc\u30eb\u3092\u5dfb\u304d\u51fa\u3057\u30b7\u30e3\u30d5\u30c8\u306b\u53d6\u308a\u4ed8\u3051\u307e\u3059\u3002\u30b3\u30a2\u306f\u3001\u30b7\u30e3\u30d5\u30c8\u306e\u30d0\u30c3\u30af\u30d7\u30ec\u30fc\u30c8\u306b\u3074\u3063\u305f\u308a\u3068\u63a5\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.6.1.2 \u30ea\u30fc\u30eb\u306e\u30e9\u30d9\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u30d5\u30a3\u30eb\u30e0\u306e\u7a2e\u985e\u3068\u30ed\u30c3\u30c8\u756a\u53f7\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u305d\u306e\u30d5\u30a3\u30eb\u30e0\u306f\u3001\u5f53\u8a72\u30ed\u30c3\u30c8\u306e\u90e8\u54c1\u8868\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3082\u306e\u3068\u4e00\u81f4\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.6.1.3 \u6a5f\u68b0\u306e\u30c9\u30a2\u306b\u63b2\u793a\u3055\u308c\u3066\u3044\u308b\u7d4c\u8def\u56f3\u306b\u793a\u3059\u3088\u3046\u306b\u3001\u30d5\u30a3\u30eb\u30e0\u3092\u30ac\u30a4\u30c9\u30ed\u30fc\u30e9\u30fc\u306b\u901a\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.1.4 \u30d6\u30ec\u30fc\u30ad\u30ce\u30d6\u3092\u4f7f\u3063\u3066\u5dfb\u304d\u51fa\u3057\u5f35\u529b\u3092\u8abf\u6574\u3057\u307e\u3059\u3002\u30d5\u30a3\u30eb\u30e0\u306e\u5f35\u529b\u304c\u7de9\u3059\u304e\u308b\u3068\u3001\u30b7\u30fc\u30eb\u6642\u306b\u3057\u308f\u304c\u5bc4\u308a\u307e\u3059\u3002\u5f35\u529b\u304c\u5f37\u3059\u304e\u308b\u3068\u3001\u4f5c\u696d\u4e2d\u306b\u30d5\u30a3\u30eb\u30e0\u304c\u5207\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002.<\/p>

5.6.1.5 \u30d5\u30a3\u30eb\u30e0\u306e\u7aef\u304c\u6a5f\u68b0\u306e\u4e2d\u5fc3\u7dda\u3068\u5e73\u884c\u306b\u306a\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30d5\u30a3\u30eb\u30e0\u306e\u4f4d\u7f6e\u304c\u305a\u308c\u3066\u3044\u308b\u3068\u3001\u30b7\u30fc\u30eb\u304c\u4e2d\u5fc3\u304b\u3089\u305a\u308c\u3066\u3057\u307e\u3044\u307e\u3059\u3002.<\/p>

5.6.2 \u52a0\u71b1\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\uff1a<\/b><\/strong><\/h4>

5.6.2.1 \u30b7\u30fc\u30ea\u30f3\u30b0\u6a5f\u306f\u30012\u672c\u306e\u52a0\u71b1\u30ed\u30fc\u30e9\u30fc\u307e\u305f\u306f2\u679a\u306e\u52a0\u71b1\u30d7\u30e9\u30c6\u30f3\u3092\u7528\u3044\u3066\u3001\u30d5\u30a3\u30eb\u30e0\u306e\u5c64\u540c\u58eb\u3092\u63a5\u7740\u3059\u308b\u3002\u71b1\u306b\u3088\u3063\u3066\u30d5\u30a3\u30eb\u30e0\u8868\u9762\u306e\u30e9\u30c3\u30ab\u30fc\u30b3\u30fc\u30c6\u30a3\u30f3\u30b0\u304c\u6eb6\u3051\u3001\u5727\u529b\u306b\u3088\u3063\u3066\u4e21\u9762\u304c\u878d\u5408\u3059\u308b\u3002.<\/p>

5.6.2.2 \u5236\u5fa1\u30d1\u30cd\u30eb\u3067\u30b7\u30fc\u30eb\u6e29\u5ea6\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002\u8a2d\u5b9a\u7bc4\u56f2\u306f\u3001\u30d5\u30a3\u30eb\u30e0\u306e\u7a2e\u985e\u306b\u5fdc\u3058\u3066120\u00b0C\u304b\u3089200\u00b0C\u306e\u9593\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>

5.6.2.3 \u6750\u6599\u3092\u4f9b\u7d66\u3059\u308b\u524d\u306b\u3001\u767a\u71b1\u4f53\u304c\u8a2d\u5b9a\u6e29\u5ea6\u306b\u9054\u3059\u308b\u306e\u3092\u5f85\u3063\u3066\u304f\u3060\u3055\u3044\u3002\u307b\u3068\u3093\u3069\u306e\u6a5f\u68b0\u3067\u306f\u300115\u5206\u304b\u308920\u5206\u306e\u30a6\u30a9\u30fc\u30e0\u30a2\u30c3\u30d7\u6642\u9593\u304c\u9069\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>

5.6.2.4 \u5916\u90e8\u63a5\u89e6\u5f0f\u30d7\u30ed\u30fc\u30d6\u3092\u4f7f\u7528\u3057\u3066\u6e29\u5ea6\u3092\u78ba\u8a8d\u3059\u308b\u3002\u8868\u793a\u5024\u306f\u3001\u30d7\u30ed\u30fc\u30d6\u306e\u6e2c\u5b9a\u5024\u3068\u00b13\u00b0C\u4ee5\u5185\u306e\u8aa4\u5dee\u306e\u7bc4\u56f2\u5185\u3067\u4e00\u81f4\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>

5.6.2.5 \u30ed\u30fc\u30e9\u30fc\u306e\u8868\u9762\u307e\u305f\u306f\u30d7\u30e9\u30c6\u30f3\u306e\u8868\u9762\u306b\u3001\u50b7\u3001\u3078\u3053\u307f\u3001\u307e\u305f\u306f\u7126\u3052\u8de1\u304c\u306a\u3044\u304b\u70b9\u691c\u3059\u308b\u3002\u8868\u9762\u304c\u640d\u50b7\u3057\u3066\u3044\u308b\u3068\u3001\u3069\u306e\u30b7\u30fc\u30eb\u306b\u3082\u5f31\u70b9\u304c\u751f\u3058\u308b\u3002.<\/p>

5.6.3 \u88fd\u54c1\u4f9b\u7d66\u88c5\u7f6e\uff1a<\/b><\/strong><\/h4>

5.6.3.1 \u88fd\u54c1\u4f9b\u7d66\u88c5\u7f6e\u306f\u3001\u9320\u5264\u3001\u30ab\u30d7\u30bb\u30eb\u3001\u307e\u305f\u306f\u5c0f\u888b\u3092\u3001\u6240\u5b9a\u306e\u30d1\u30bf\u30fc\u30f3\u306b\u5f93\u3063\u3066\u4e0b\u5074\u306e\u30d5\u30a3\u30eb\u30e0\u4e0a\u306b\u914d\u7f6e\u3057\u307e\u3059\u3002\u5404\u30dd\u30b1\u30c3\u30c8\u307e\u305f\u306f\u30b9\u30da\u30fc\u30b9\u306b\u306f\u3001\u305d\u306e\u30d0\u30c3\u30c1\u306b\u5b9a\u3081\u3089\u308c\u305f\u6b63\u3057\u3044\u6570\u91cf\u304c\u53ce\u3081\u3089\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>

5.6.3.2 \u88fd\u54c1\u306b\u5408\u308f\u305b\u3066\u4f9b\u7d66\u30b7\u30e5\u30fc\u30c8\u3092\u8abf\u6574\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30b7\u30e5\u30fc\u30c8\u304c\u5e83\u3044\u3068\u30011\u3064\u306e\u30dd\u30b1\u30c3\u30c8\u306b\u3064\u304d2\u500b\u305a\u3064\u6295\u5165\u3055\u308c\u307e\u3059\u3002\u30b7\u30e5\u30fc\u30c8\u304c\u72ed\u3044\u3068\u3001\u30dd\u30b1\u30c3\u30c8\u3092\u98db\u3070\u3057\u3066\u3057\u307e\u3044\u307e\u3059\u3002.<\/p>

5.6.3.3 \u30d5\u30a3\u30fc\u30c0\u30fc\u306e\u30bf\u30a4\u30df\u30f3\u30b0\u3092\u30d5\u30a3\u30eb\u30e0\u306e\u901f\u5ea6\u306b\u5408\u308f\u305b\u3066\u8abf\u6574\u3059\u308b\u3002\u88fd\u54c1\u306f\u3001\u30d5\u30a3\u30eb\u30e0\u304c\u30b7\u30fc\u30eb\u30be\u30fc\u30f3\u306b\u5165\u308b\u76f4\u524d\u306b\u5404\u30dd\u30b1\u30c3\u30c8\u306b\u53ce\u307e\u308b\u3088\u3046\u306b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>

5.6.3.4 \u30d5\u30a3\u30fc\u30c0\u30fc\u30c8\u30e9\u30c3\u30af\u306b\u307b\u3053\u308a\u3001\u4e7e\u3044\u305f\u30b7\u30ed\u30c3\u30d7\u3001\u307e\u305f\u306f\u904e\u53bb\u306e\u30d0\u30c3\u30c1\u306e\u6b8b\u6e23\u304c\u306a\u3044\u304b\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30c8\u30e9\u30c3\u30af\u304c\u6c5a\u308c\u3066\u3044\u308b\u3068\u3001\u7d66\u7d19\u4e0d\u826f\u3084\u30e9\u30a4\u30f3\u306e\u8a70\u307e\u308a\u306e\u539f\u56e0\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.6.3.5 \u30b7\u30fc\u30ea\u30f3\u30b0\u3092\u884c\u308f\u306a\u3044\u72b6\u614b\u3067\u77ed\u6642\u9593\u306e\u8a66\u904b\u8ee2\u3092\u884c\u3044\u3001\u3059\u3079\u3066\u306e\u30dd\u30b1\u30c3\u30c8\u304c1\u500b\u306e\u88fd\u54c1\u3092\u78ba\u5b9f\u306b\u53d6\u308a\u8fbc\u3080\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u30d2\u30fc\u30bf\u30fc\u306e\u96fb\u6e90\u3092\u5165\u308c\u308b\u524d\u306b\u3001\u30d5\u30a3\u30fc\u30c0\u30fc\u306e\u4e0d\u5177\u5408\u304c\u3042\u308c\u3070\u4fee\u6b63\u3059\u308b\u3002.<\/p>

5.6.4 \u5207\u65ad\u30fb\u30a8\u30f3\u30dc\u30b9\u52a0\u5de5\u7528\u30c4\u30fc\u30eb\uff1a<\/b><\/strong><\/h4>

5.6.4.1 \u30b7\u30fc\u30eb\u5de5\u7a0b\u306e\u5f8c\u3001\u30b7\u30fc\u30eb\u3055\u308c\u305f\u30a6\u30a7\u30d6\u306f\u3001\u5207\u65ad\u30ca\u30a4\u30d5\u307e\u305f\u306f\u30d1\u30f3\u30c1\u30c0\u30a4\u306e\u4e0b\u3092\u901a\u904e\u3059\u308b\u3002\u3053\u306e\u5de5\u7a0b\u306b\u3088\u308a\u3001\u30a6\u30a7\u30d6\u306f\u6700\u7d42\u7684\u306a\u30d1\u30c3\u30af\u306b\u5206\u5272\u3055\u308c\u308b\u3002.<\/p>

5.6.4.2 \u30d1\u30c3\u30b1\u30fc\u30b8\u30b5\u30a4\u30ba\u306b\u9069\u3057\u305f\u88c1\u65ad\u30c0\u30a4\u3092\u53d6\u308a\u4ed8\u3051\u3066\u304f\u3060\u3055\u3044\u3002\u30af\u30e9\u30f3\u30d7\u30dc\u30eb\u30c8\u3067\u30c0\u30a4\u3092\u56fa\u5b9a\u3057\u3001\u30c0\u30a4\u30d7\u30ec\u30fc\u30c8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5024\u306b\u5f93\u3063\u3066\u7de0\u3081\u4ed8\u3051\u30c8\u30eb\u30af\u3092\u52a0\u3048\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.6.4.3 \u30a8\u30f3\u30dc\u30b9\u30d7\u30ec\u30fc\u30c8\u306b\u6b63\u3057\u3044\u30ed\u30c3\u30c8\u756a\u53f7\u304a\u3088\u3073\u6709\u52b9\u671f\u9650\u306e\u8a18\u8f09\u304c\u3042\u308b\u304b\u78ba\u8a8d\u3059\u308b\u3002\u9593\u9055\u3063\u305f\u30d7\u30ec\u30fc\u30c8\u3092\u4f7f\u7528\u3059\u308b\u3068\u3001\u3059\u3079\u3066\u306e\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u8aa4\u3063\u305f\u60c5\u5831\u304c\u5370\u5237\u3055\u308c\u3066\u3057\u307e\u3046\u3002.<\/p>

5.6.4.4 \u30d5\u30a3\u30eb\u30e0\u3092\u7834\u308b\u3053\u3068\u306a\u304f\u3001\u30c6\u30ad\u30b9\u30c8\u304c\u9bae\u660e\u306b\u5370\u5237\u3055\u308c\u308b\u3088\u3046\u306b\u30a8\u30f3\u30dc\u30b9\u5727\u3092\u8a2d\u5b9a\u3059\u308b\u3002\u30c6\u30b9\u30c8\u30d1\u30c3\u30af\u30925\u56de\u5b9f\u884c\u3057\u3001\u62e1\u5927\u93e1\u3092\u4f7f\u3063\u3066\u30c6\u30ad\u30b9\u30c8\u3092\u78ba\u8a8d\u3059\u308b\u3002.<\/p>

5.6.4.5 \u5207\u65ad\u30a8\u30ea\u30a2\u304b\u3089\u3059\u3079\u3066\u306e\u5207\u308a\u304f\u305a\u3092\u56de\u53ce\u3059\u308b\u3002\u30b7\u30d5\u30c8\u7d42\u4e86\u6642\u306b\u3001\u5305\u88c5\u5ec3\u68c4\u7269\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\uff08SOP\uff09\u306b\u5f93\u3063\u3066\u3001\u5207\u308a\u304f\u305a\u3092\u51e6\u5206\u3059\u308b\u3002.<\/p>

5.7 \u30b7\u30fc\u30eb\u30d1\u30e9\u30e1\u30fc\u30bf\uff1a<\/strong><\/h3>

5.7.1 \u826f\u597d\u306a\u30b7\u30fc\u30eb\u6027\u306f\u3001\u6e29\u5ea6\u3001\u5727\u529b\u3001\u304a\u3088\u3073\u4fdd\u6301\u6642\u9593\u306e3\u3064\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u306b\u4f9d\u5b58\u3057\u307e\u3059\u3002\u305d\u308c\u305e\u308c\u306b\u3064\u3044\u3066\u3001\u4f7f\u7528\u3059\u308b\u30d5\u30a3\u30eb\u30e0\u306e\u7a2e\u985e\u3084\u88fd\u54c1\u306b\u5408\u308f\u305b\u3066\u8a2d\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.7.2 \u6e29\u5ea6\u306b\u3088\u3063\u3066\u3001\u30e9\u30c3\u30ab\u30fc\u5857\u819c\u306e\u6eb6\u878d\u5ea6\u304c\u6c7a\u307e\u308a\u307e\u3059\u3002\u8a2d\u5b9a\u6e29\u5ea6\u304c\u4f4e\u3059\u304e\u308b\u3068\u3001\u5bc6\u7740\u6027\u304c\u5f31\u304f\u306a\u308a\u307e\u3059\u3002\u8a2d\u5b9a\u6e29\u5ea6\u304c\u9ad8\u3059\u304e\u308b\u3068\u3001\u5857\u819c\u304c\u7126\u3052\u3066\u6f0f\u308c\u306e\u539f\u56e0\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>

5.7.3 \u30b7\u30fc\u30eb\u5de5\u7a0b\u3067\u306f\u3001\u5727\u529b\u306b\u3088\u3063\u30662\u679a\u306e\u30d5\u30a3\u30eb\u30e0\u5c64\u304c\u62bc\u3057\u4ed8\u3051\u3089\u308c\u307e\u3059\u3002\u307b\u3068\u3093\u3069\u306e\u6a5f\u68b0\u3067\u306f\u3001\u30b7\u30fc\u30eb\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u30673\uff5e6 bar\u306e\u7a7a\u6c17\u5727\u304c\u7528\u3044\u3089\u308c\u307e\u3059\u3002.<\/p>

5.7.4 \u4fdd\u6301\u6642\u9593\u306f\u3001\u30d5\u30a3\u30eb\u30e0\u304c\u71b1\u3068\u5727\u529b\u306b\u3055\u3089\u3055\u308c\u3066\u3044\u308b\u671f\u9593\u306e\u3053\u3068\u3067\u3059\u3002\u8584\u3044\u30d5\u30a3\u30eb\u30e0\u306e\u5834\u5408\u306f\u3001\u4fdd\u6301\u6642\u9593\u3092\u77ed\u304f\u3057\u3066\u3082\u554f\u984c\u3042\u308a\u307e\u305b\u3093\u3002\u539a\u3044\u30d5\u30a3\u30eb\u30e0\u306e\u5834\u5408\u306f\u3001\u5341\u5206\u306a\u63a5\u7740\u5f37\u5ea6\u3092\u5f97\u308b\u305f\u3081\u306b\u3001\u3088\u308a\u9577\u3044\u4fdd\u6301\u6642\u9593\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>

5.7.5 \u5404\u5b9f\u884c\u306e\u958b\u59cb\u6642\u306b\u3001\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u30d1\u30cd\u30eb\u306b3\u3064\u306e\u5024\u3092\u3059\u3079\u3066\u5165\u529b\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u300c\u30b9\u30bf\u30fc\u30c8\u300d\u30dc\u30bf\u30f3\u3092\u62bc\u3059\u524d\u306b\u3001\u3053\u308c\u3089\u306e\u5024\u304c\u30d0\u30c3\u30c1\u5145\u586b\u8a18\u9332\u3068\u4e00\u81f4\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

5.7.6 \u624b\u30672\u5c64\u306e\u30d5\u30a3\u30eb\u30e0\u3092\u5f15\u3063\u5f35\u3063\u3066\u3001\u30b7\u30fc\u30eb\u72b6\u614b\u3092\u30c6\u30b9\u30c8\u3059\u308b\u3002\u30b7\u30fc\u30eb\u304c\u3057\u3063\u304b\u308a\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u30d5\u30a3\u30eb\u30e0\u304c\u304d\u308c\u3044\u306b\u5265\u304c\u308c\u308b\u306e\u3067\u306f\u306a\u304f\u3001\u30d5\u30a3\u30eb\u30e0\u81ea\u4f53\u304c\u7834\u308c\u308b\u3002.<\/p>

5.7.7 \u5404\u30ab\u30fc\u30c8\u30f3\u304b\u30891\u30d1\u30c3\u30af\u305a\u3064\u62bd\u51fa\u3057\u3001\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u3092\u884c\u3063\u3066\u30b7\u30fc\u30eb\u54c1\u8cea\u3092\u78ba\u8a8d\u3059\u308b\u3002\u30d1\u30c3\u30af\u3092\u771f\u7a7a\u72b6\u614b\u306e\u30e1\u30c1\u30ec\u30f3\u30d6\u30eb\u30fc\u6eb6\u6db2\u306b\u6d78\u3057\u3001\u67d3\u6599\u306e\u6d78\u5165\u304c\u306a\u3044\u304b\u78ba\u8a8d\u3059\u308b\u3002.<\/p>

5.8 \u5236\u5fa1\u30b7\u30b9\u30c6\u30e0\uff1a<\/strong><\/h3>

5.8.1 \u30b7\u30fc\u30eb\u6a5f\u306e\u5236\u5fa1\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u524d\u9762\u30d1\u30cd\u30eb\u306b\u642d\u8f09\u3055\u308c\u305f\u30bf\u30c3\u30c1\u30b9\u30af\u30ea\u30fc\u30f3\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u3092\u63a1\u7528\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306fPLC\u4e0a\u3067\u52d5\u4f5c\u3057\u3001\u5171\u901a\u306e\u30c7\u30fc\u30bf\u30d0\u30b9\u3092\u4ecb\u3057\u3066\u3001\u6a5f\u68b0\u4e0a\u306e\u3059\u3079\u3066\u306e\u30bb\u30f3\u30b5\u30fc\u3001\u99c6\u52d5\u88c5\u7f6e\u3001\u304a\u3088\u3073\u30d2\u30fc\u30bf\u30fc\u3068\u63a5\u7d9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>

5.8.2 \u30e1\u30a4\u30f3\u30ad\u30fc\u30b9\u30a4\u30c3\u30c1\u3067\u30b7\u30b9\u30c6\u30e0\u306e\u96fb\u6e90\u3092\u5165\u308c\u307e\u3059\u3002\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306b\u306f\u3001\u8d77\u52d5\u30ed\u30b4\u304c\u8868\u793a\u3055\u308c\u305f\u5f8c\u3001\u30ed\u30b0\u30a4\u30f3\u753b\u9762\u304c\u8868\u793a\u3055\u308c\u307e\u3059\u3002.<\/p>

5.8.3 \u500b\u4eba\u306e\u8a8d\u8a3c\u60c5\u5831\u3092\u4f7f\u7528\u3057\u3066\u30ed\u30b0\u30a4\u30f3\u3057\u307e\u3059\u3002\u5404\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306b\u306f\u56fa\u6709\u306eID\u304c\u5272\u308a\u5f53\u3066\u3089\u308c\u3066\u304a\u308a\u3001\u305d\u306eID\u306b\u3088\u3063\u3066\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306e\u64cd\u4f5c\u304c\u76e3\u67fb\u8a3c\u8de1\u306b\u95a2\u9023\u4ed8\u3051\u3089\u308c\u307e\u3059\u3002.<\/p>

5.8.4 \u30e1\u30cb\u30e5\u30fc\u30c4\u30ea\u30fc\u306b\u306f\u3001\u300c\u751f\u7523\u300d\u3001\u300c\u30ec\u30b7\u30d4\u300d\u3001\u300c\u4fdd\u5b88\u300d\u3001\u300c\u30ec\u30dd\u30fc\u30c8\u300d\u3001\u300c\u30e6\u30fc\u30b6\u30fc\u300d\u3068\u3044\u3046\u5404\u5206\u5c90\u304c\u3042\u308a\u307e\u3059\u3002\u5404\u5206\u5c90\u306b\u306f\u3001\u95a2\u9023\u3059\u308b\u4e00\u9023\u306e\u6a5f\u80fd\u304c\u7528\u610f\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>

5.8.4.1 \u30d7\u30ed\u30c0\u30af\u30b7\u30e7\u30f3\uff1a\u958b\u59cb\u3001\u505c\u6b62\u3001\u4e00\u6642\u505c\u6b62\u3001\u518d\u958b\u306e\u5404\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3068\u3001\u30e9\u30a4\u30d6\u51fa\u529b\u30ab\u30a6\u30f3\u30bf\u30fc\u3092\u8868\u793a\u3057\u307e\u3059\u3002.<\/p>

5.8.4.2 \u30ec\u30b7\u30d4\uff1a\u5404\u88fd\u54c1\u306e\u30b7\u30fc\u30eb\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u4fdd\u5b58\u3057\u307e\u3059\u3002\u4fdd\u5b58\u3055\u308c\u305f\u30ec\u30b7\u30d4\u3092\u7de8\u96c6\u3067\u304d\u308b\u306e\u306f\u3001\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306e\u6a29\u9650\u3092\u6301\u3064\u30e6\u30fc\u30b6\u30fc\u306e\u307f\u3067\u3059\u3002.<\/p>

5.8.4.3 \u4fdd\u5b88\uff1a\u5f53\u8a72\u6a5f\u68b0\u306e\u30b5\u30fc\u30d3\u30b9\u5b9f\u65bd\u4e88\u5b9a\u65e5\u304a\u3088\u3073\u90e8\u54c1\u4ea4\u63db\u5c65\u6b74\u3092\u8ffd\u8de1\u3059\u308b\u3002.<\/p>

5.8.4.4 \u30ec\u30dd\u30fc\u30c8\uff1a\u30d0\u30c3\u30c1\u51fa\u529b\u306e\u6982\u8981\u3068\u3001\u305d\u306e\u30b7\u30d5\u30c8\u4e2d\u306b\u767a\u751f\u3057\u305f\u969c\u5bb3\u30a4\u30d9\u30f3\u30c8\u3092\u307e\u3068\u3081\u3066\u5370\u5237\u3057\u307e\u3059\u3002.<\/p>

5.8.4.5 \u30e6\u30fc\u30b6\u30fc\uff1a\u30b7\u30b9\u30c6\u30e0\u4e0a\u306e\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u30a2\u30ab\u30a6\u30f3\u30c8\u304a\u3088\u3073\u30a2\u30af\u30bb\u30b9\u6a29\u9650\u3092\u7ba1\u7406\u3057\u307e\u3059\u3002.<\/p>

5.8.5 \u30c8\u30ec\u30f3\u30c9\u30b0\u30e9\u30d5\u306b\u306f\u3001\u904e\u53bb60\u5206\u9593\u306e\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u306e\u6e29\u5ea6\u304a\u3088\u3073\u5727\u529b\u6e2c\u5b9a\u5024\u304c\u8868\u793a\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u30b0\u30e9\u30d5\u3092\u4f7f\u7528\u3057\u3066\u3001\u30d7\u30ed\u30bb\u30b9\u5024\u306e\u7de9\u3084\u304b\u306a\u5909\u52d5\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.8.6 \u30a4\u30d9\u30f3\u30c8\u30ed\u30b0\u306b\u306f\u3001\u6a5f\u68b0\u306e\u30dc\u30bf\u30f3\u64cd\u4f5c\u3001\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u5909\u66f4\u3001\u304a\u3088\u3073\u6545\u969c\u306e\u3059\u3079\u3066\u304c\u8a18\u9332\u3055\u308c\u307e\u3059\u3002\u3053\u306e\u30ed\u30b0\u306f\u3001\u3069\u306e\u30e6\u30fc\u30b6\u30fc\u3082\u7de8\u96c6\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002.<\/p>

5.8.7 \u52e4\u52d9\u7d42\u4e86\u6642\u306b\u306f\u3001\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u30ed\u30b0\u30aa\u30d5\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u753b\u9762\u304c\u30ed\u30c3\u30af\u3055\u308c\u3001\u6b21\u306e\u30e6\u30fc\u30b6\u30fc\u304c\u30ed\u30b0\u30a4\u30f3\u3059\u308b\u307e\u3067\u64cd\u4f5c\u3092\u884c\u3046\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002.<\/p>

5.9 \u672c\u756a\u30d0\u30c3\u30c1\u306e\u5b9f\u884c\uff1a<\/strong><\/h3>

5.9.1 \u52a0\u71b1\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u304c\u8a2d\u5b9a\u6e29\u5ea6\u306b\u9054\u3057\u3001\u30c7\u30a3\u30b9\u30d7\u30ec\u30a4\u306b\u8868\u793a\u3055\u308c\u308b\u6e29\u5ea6\u5024\u304c\u5b89\u5b9a\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30d2\u30fc\u30bf\u30fc\u306e\u6e29\u5ea6\u304c\u76ee\u6a19\u6e29\u5ea6\u306e\u00b12\u00b0C\u306e\u7bc4\u56f2\u5185\u3067\u5b89\u5b9a\u3059\u308b\u307e\u3067\u3001\u672c\u6a5f\u306f\u751f\u7523\u6e96\u5099\u304c\u6574\u3063\u305f\u3068\u306f\u307f\u306a\u3055\u308c\u307e\u305b\u3093\u3002.<\/p>

5.9.2 \u300cRecipe\u300d\u30d6\u30e9\u30f3\u30c1\u3092\u958b\u304d\u3001\u305d\u306e\u30d0\u30c3\u30c1\u306e\u88fd\u54c1\u30ec\u30b7\u30d4\u3092\u8aad\u307f\u8fbc\u307f\u307e\u3059\u3002.<\/p>

5.9.3 \u7a4d\u8f09\u3055\u308c\u305f\u5404\u5024\u306b\u3064\u3044\u3066\u3001\u627f\u8a8d\u6e08\u307f\u306e\u30d0\u30c3\u30c1\u68b1\u5305\u8a18\u9332\uff08BPR\uff09\u3068\u7167\u5408\u3059\u308b\u3002\u4e0d\u4e00\u81f4\u304c\u3042\u308b\u5834\u5408\u306f\u3001\u30b7\u30d5\u30c8\u76e3\u7763\u8005\u306b\u5831\u544a\u3059\u308b\u3002.<\/p>

5.9.4 \u88fd\u54c1\u304c\u5165\u3063\u3066\u3044\u306a\u3044\u30d1\u30c3\u30af\u30925\u500b\u7528\u3044\u3066\u3001\u8a66\u9a13\u30b5\u30a4\u30af\u30eb\u3092\u5b9f\u884c\u3059\u308b\u3002\u7a7a\u306e\u30d1\u30c3\u30af\u306b\u3064\u3044\u3066\u3001\u30b7\u30fc\u30eb\u54c1\u8cea\u3068\u30a8\u30f3\u30dc\u30b9\u52a0\u5de5\u306e\u9bae\u660e\u3055\u3092\u78ba\u8a8d\u3059\u308b\u3002.<\/p>

5.9.5 \u8a66\u904b\u8ee2\u306b\u5408\u683c\u3057\u305f\u3089\u3001\u5b9f\u969b\u306e\u88fd\u54c1\u3092\u30d5\u30a3\u30fc\u30c0\u30fc\u306b\u30bb\u30c3\u30c8\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u8a2d\u5b9a\u304c\u6b63\u3057\u304f\u898b\u3048\u308b\u5834\u5408\u3067\u3082\u3001\u8a66\u904b\u8ee2\u306e\u30b9\u30c6\u30c3\u30d7\u3092\u7701\u7565\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p>

5.9.6 \u300cProduction\u300d\u30d6\u30e9\u30f3\u30c1\u306e\u300cStart\u300d\u30dc\u30bf\u30f3\u3092\u62bc\u3057\u307e\u3059\u3002\u30c9\u30e9\u30a4\u30d6\u304c\u4f5c\u52d5\u3057\u300120\u79d2\u4ee5\u5185\u306b\u6700\u521d\u306e\u30d1\u30c3\u30af\u304c\u6392\u51fa\u30b7\u30e5\u30fc\u30c8\u306b\u73fe\u308c\u307e\u3059\u3002.<\/p>

5.9.7 \u51fa\u529b\u90e8\u304b\u3089\u6700\u521d\u306e20\u500b\u306e\u5bc6\u5c01\u30d1\u30c3\u30af\u3092\u53d6\u308a\u51fa\u3057\u307e\u3059\u3002\u5404\u30d1\u30c3\u30af\u306b\u3064\u3044\u3066\u3001\u6f0f\u308c\u3001\u3057\u308f\u3001\u5370\u5237\u30df\u30b9\u3001\u307e\u305f\u306f\u5185\u5bb9\u7269\u306e\u6b20\u843d\u304c\u306a\u3044\u304b\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

5.9.8 \u6700\u521d\u306e\u51fa\u529b\u304c\u3059\u3079\u3066\u306e\u54c1\u8cea\u30c1\u30a7\u30c3\u30af\u3092\u6e80\u305f\u3057\u305f\u3089\u3001\u8a66\u9a13\u3092\u7d99\u7d9a\u3059\u308b\u3002\u8a66\u9a13\u4e2d\u306f30\u5206\u9593\u9694\u3067\u30b5\u30f3\u30d7\u30eb\u30d1\u30c3\u30af\u3092\u63a1\u53d6\u3059\u308b\u3002.<\/p>

5.9.9 \u30d0\u30c3\u30c1\u7d42\u4e86\u6642\u306e\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u5be9\u67fb\u7528\u306b\u3001\u3059\u3079\u3066\u306e\u30b5\u30f3\u30d7\u30eb\u3092\u4fdd\u7ba1\u3057\u3066\u304a\u304f\u3053\u3068\u3002\u30b5\u30f3\u30d7\u30eb\u30d1\u30c3\u30af\u3092\u30e1\u30a4\u30f3\u306e\u30d0\u30c3\u30c1\u306e\u6d41\u308c\u306b\u623b\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002.<\/p>

5.10 \u624b\u76f4\u3057\u304a\u3088\u3073\u4e0d\u826f\u54c1\uff1a<\/strong><\/h3>

5.10.1 \u691c\u67fb\u306b\u4e0d\u5408\u683c\u3068\u306a\u3063\u305f\u30d1\u30c3\u30af\u306f\u3001\u3059\u3079\u3066\u4e0d\u826f\u54c1\u7528\u30b3\u30f3\u30c6\u30ca\u306b\u5165\u308c\u3089\u308c\u308b\u3002\u3053\u306e\u30b3\u30f3\u30c6\u30ca\u306b\u306f\u660e\u78ba\u306a\u8868\u793a\u304c\u3055\u308c\u3001\u826f\u54c1\u3068\u306f\u5225\u306b\u4fdd\u7ba1\u3055\u308c\u308b\u3002.<\/p>

5.10.2 \u307e\u305f\u3001\u3053\u306e\u6a5f\u68b0\u306b\u306f\u3001\u65e2\u77e5\u306e\u6b20\u9665\u304c\u3042\u308b\u30d1\u30c3\u30b1\u30fc\u30b8\u3092\u6392\u9664\u3059\u308b\u81ea\u52d5\u6392\u9664\u30b7\u30b9\u30c6\u30e0\u3082\u5099\u308f\u3063\u3066\u3044\u307e\u3059\uff1a<\/p>

5.10.2.1 \u91cd\u91cf\u30c1\u30a7\u30c3\u30af\u306b\u3088\u308b\u4e0d\u9069\u5408 \u2013 \u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u91cd\u91cf\u304c\u3001\u30ec\u30b7\u30d4\u3067\u8a2d\u5b9a\u3055\u308c\u305f\u4e0b\u9650\u5024\u3092\u4e0b\u56de\u3063\u305f\u5834\u5408\u306b\u30c8\u30ea\u30ac\u30fc\u3055\u308c\u307e\u3059\u3002.<\/p>

5.10.2.2 \u8996\u899a\u691c\u67fb\u306b\u3088\u308b\u4e0d\u826f\u5224\u5b9a \u2013 \u30ab\u30e1\u30e9\u304c\u5370\u5237\u4e0d\u826f\u3001\u88fd\u54c1\u306e\u6b20\u54c1\u3001\u307e\u305f\u306f\u30b7\u30fc\u30eb\u30a8\u30c3\u30b8\u306e\u4e0d\u5177\u5408\u3092\u691c\u51fa\u3057\u305f\u5834\u5408\u306b\u30c8\u30ea\u30ac\u30fc\u3055\u308c\u308b\u3002.<\/p>

5.10.3 \u4e0d\u5408\u683c\u3068\u306a\u3063\u305f\u3059\u3079\u3066\u306e\u68b1\u5305\u30922\u6642\u9593\u4ee5\u5185\u306b\u70b9\u691c\u3059\u308b\u3053\u3068\u3002\u65e9\u671f\u306b\u70b9\u691c\u3092\u884c\u3046\u3053\u3068\u3067\u3001\u6b20\u9665\u306e\u50be\u5411\u3092\u628a\u63e1\u3057\u3001\u6839\u672c\u539f\u56e0\u3092\u8fc5\u901f\u306b\u7279\u5b9a\u30fb\u662f\u6b63\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p>

5.10.4 \u4e0d\u5408\u683c\u54c1\u3092\u300c\u624b\u76f4\u3057\u300d\u300c\u5ec3\u68c4\u300d\u300c\u30b5\u30f3\u30d7\u30eb\u300d\u306e\u5404\u30b0\u30eb\u30fc\u30d7\u306b\u5206\u985e\u3059\u308b\uff1a<\/p>

5.10.4.1 \u30ea\u30ef\u30fc\u30af\u30d1\u30c3\u30af\u306f\u958b\u5c01\u3057\u3001\u78ba\u8a8d\u5f8c\u306b\u88fd\u54c1\u3092\u30d5\u30a3\u30fc\u30c0\u30fc\u306b\u623b\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>

5.10.4.2 \u30b9\u30af\u30e9\u30c3\u30d7\u30d1\u30c3\u30af\u306b\u306f\u88fd\u54c1\u3068\u3057\u3066\u306e\u4fa1\u5024\u304c\u6b8b\u3063\u3066\u3044\u306a\u3044\u305f\u3081\u3001\u5ec3\u68c4\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u306b\u5f93\u3063\u3066\u7834\u68c4\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>

5.10.4.3 \u6b20\u9665\u304c\u65b0\u898f\u307e\u305f\u306f\u7570\u5e38\u306a\u3082\u306e\u3067\u3042\u308b\u5834\u5408\u3001\u30b5\u30f3\u30d7\u30eb\u30d1\u30c3\u30af\u306f\u6839\u672c\u539f\u56e0\u306e\u5206\u6790\u306e\u305f\u3081\u306b\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u90e8\u9580\u306b\u9001\u3089\u308c\u308b\u3002.<\/p>

5.10.5 \u5404\u30b7\u30d5\u30c8\u306e\u7d42\u4e86\u6642\u306b\u3001\u300c\u4e0d\u826f\u54c1\u8a18\u9332\u300d\u306b\u8a18\u5165\u3059\u308b\u3053\u3068\u3002\u3053\u306e\u8a18\u9332\u306b\u306f\u3001\u4e0d\u826f\u54c1\u306e\u7dcf\u6570\u306b\u52a0\u3048\u3001\u5404\u30d1\u30c3\u30b1\u30fc\u30b8\u3054\u3068\u306e\u4e0d\u826f\u54c1\u533a\u5206\u3092\u660e\u8a18\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>

5.11 \u5b9f\u884c\u7d42\u4e86\uff1a<\/strong><\/h3>

5.11.1 \u751f\u7523\u30e9\u30a4\u30f3\u306e\u300c\u505c\u6b62\u300d\u30dc\u30bf\u30f3\u3092\u62bc\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6b21\u306e\u64cd\u4f5c\u3092\u884c\u3046\u524d\u306b\u3001\u30e9\u30a4\u30f3\u4e0a\u306e\u3059\u3079\u3066\u306e\u30d1\u30c3\u30b1\u30fc\u30b8\u304c\u5b8c\u5168\u306b\u6392\u51fa\u3055\u308c\u308b\u307e\u3067\u5f85\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.11.2 \u5236\u5fa1\u30d1\u30cd\u30eb\u3067\u30d2\u30fc\u30bf\u30fc\u306e\u8a2d\u5b9a\u5024\u3092\u30bc\u30ed\u306b\u4e0b\u3052\u307e\u3059\u3002\u305d\u306e\u5f8c15\u5206\u304b\u3051\u3066\u3001\u30d2\u30fc\u30bf\u30fc\u306f\u5f90\u3005\u306b\u51b7\u5374\u3055\u308c\u307e\u3059\u3002.<\/p>

5.11.3 \u30b7\u30fc\u30eb\u30b9\u30c6\u30fc\u30b7\u30e7\u30f3\u306e\u5074\u9762\u306b\u3042\u308b\u30a2\u30f3\u30ed\u30fc\u30c9\u30ec\u30d0\u30fc\u3092\u4f7f\u7528\u3057\u3066\u3001\u30ed\u30fc\u30e9\u30fc\u306e\u5727\u529b\u3092\u89e3\u653e\u3057\u307e\u3059\u3002\u3053\u306e\u624b\u9806\u306b\u3088\u308a\u3001\u30ed\u30fc\u30e9\u30fc\u304c\u591c\u9593\u306b\u304f\u3063\u3064\u3044\u3066\u3057\u307e\u3046\u306e\u3092\u9632\u304e\u307e\u3059\u3002.<\/p>

5.11.4 \u5dfb\u304d\u51fa\u3057\u8ef8\u304a\u3088\u3073\u5dfb\u304d\u53d6\u308a\u8ef8\u306b\u6b8b\u3063\u3066\u3044\u308b\u30d5\u30a3\u30eb\u30e0\u3092\u3059\u3079\u3066\u53d6\u308a\u9664\u3044\u3066\u304f\u3060\u3055\u3044\u3002\u30d5\u30a3\u30eb\u30e0\u30ed\u30fc\u30eb\u306f\u3001\u30e9\u30d9\u30eb\u3092\u5265\u304c\u3055\u306a\u3044\u307e\u307e\u3001\u30d5\u30a3\u30eb\u30e0\u4fdd\u7ba1\u5ba4\u306b\u4fdd\u7ba1\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.11.5 \u30d5\u30a3\u30fc\u30c0\u30fc\u304b\u3089\u6563\u3089\u3070\u3063\u305f\u88fd\u54c1\u3092\u53d6\u308a\u9664\u3044\u3066\u304f\u3060\u3055\u3044\u3002\u672a\u4f7f\u7528\u306e\u88fd\u54c1\u306f\u3001\u6240\u5b9a\u306e\u8fd4\u54c1\u7528\u7d19\u3092\u6dfb\u4ed8\u3057\u3066\u30d0\u30eb\u30af\u5009\u5eab\u3078\u8fd4\u5374\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.11.6 \u3092\u88c5\u7740\u3059\u308b \u201c\u300c\u6e05\u6383\u3059\u308b\u300d\u201d<\/strong> \u6a5f\u68b0\u306b\u8cbc\u3089\u308c\u305f\u30bf\u30b0\u3002.<\/p>

5.11.7 \u5b9a\u3081\u3089\u308c\u305f\u6d17\u6d44SOP\u306b\u5f93\u3063\u3066\u3001\u30b7\u30fc\u30eb\u6a5f\u3092\u6d17\u6d44\u3059\u308b\u3002.<\/p>

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

5.12.1 \u6a5f\u5668\u4f7f\u7528\u30ed\u30b0\u3002.<\/p>

5.12.2 \u30d0\u30c3\u30c1\u68b1\u5305\u8a18\u9332\u3002.<\/p>

5.12.3 \u30b7\u30fc\u30eb\u54c1\u8cea\u8a66\u9a13\u8a18\u9332\u3002.<\/p>

5.12.4 \u5b89\u5168\u70b9\u691c\u53f0\u5e33\u3002.<\/p>

5.12.5 \u30ec\u30b3\u30fc\u30c9\u306e\u62d2\u5426\u3002.<\/p>

5.12.6 \u6e05\u6383\u8a18\u9332\u3002.<\/p>

6.0 \u7565\u8a9e:<\/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 QA\uff1a<\/strong> \u54c1\u8cea\u4fdd\u8a3c\u3002.<\/p>

6.4 \u500b\u4eba\u7528\u4fdd\u8b77\u5177:<\/strong> \u500b\u4eba\u7528\u4fdd\u8b77\u5177\u3002.<\/p>

6.5 \u90e8\u54c1\u8868\uff08BOM\uff09\uff1a<\/strong> \u90e8\u54c1\u8868\u3002.<\/p>

6.6 BPR\uff1a<\/strong> \u4e00\u62ec\u68b1\u5305\u8a18\u9332\u3002.<\/p>

6.7 PLC\uff1a<\/strong> \u30d7\u30ed\u30b0\u30e9\u30de\u30d6\u30eb\u30fb\u30ed\u30b8\u30c3\u30af\u30fb\u30b3\u30f3\u30c8\u30ed\u30fc\u30e9\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 Sealing Machine. 1.0 OBJECTIVE: To define the Operating Procedure of Sealing Machine used for sealing primary […]<\/p>\n","protected":false},"author":1,"featured_media":17493,"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":[56],"tags":[],"class_list":["post-17532","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-packaging-equipment"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/17532","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=17532"}],"version-history":[{"count":1,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/17532\/revisions"}],"predecessor-version":[{"id":21603,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/17532\/revisions\/21603"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/17493"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=17532"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=17532"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=17532"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}