{"id":9386,"date":"2026-01-07T02:06:51","date_gmt":"2026-01-07T02:06:51","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=9386"},"modified":"2025-11-27T02:11:29","modified_gmt":"2025-11-27T02:11:29","slug":"ampoule-filling-and-sealing-machine-sop","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/ampoule-filling-and-sealing-machine-sop\/","title":{"rendered":"\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30b7\u30fc\u30eb\u6a5fSOP"},"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

\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u3068\u5bc6\u5c01<\/span><\/a> \u7121\u83cc\u533b\u85ac\u54c1\u88fd\u9020\u306b\u304a\u3044\u3066\u6700\u3082\u7e4a\u7d30\u306a\u5de5\u7a0b\u306e\u4e00\u3064\u3067\u3059\u3002\u4f5c\u696d\u54e1\u304c\u7570\u306a\u308b\u624b\u9806\u3092\u8e0f\u3093\u3060\u308a\u3001\u8a18\u61b6\u306b\u983c\u3063\u305f\u308a\u3059\u308b\u3068\u3001\u6c5a\u67d3\u3001\u904e\u5270\u5145\u586b\u3001\u7834\u640d\u3001\u30d0\u30c3\u30c1\u4e0d\u826f\u306e\u30ea\u30b9\u30af\u304c\u9ad8\u307e\u308a\u307e\u3059\u3002.<\/p>

\u305d\u306e\u305f\u3081\u3001\u4eca\u65e5\u3067\u306f\u3059\u3079\u3066\u306e\u65bd\u8a2d\u3067\u3001\u6700\u521d\u304b\u3089\u6700\u5f8c\u307e\u3067\u5404\u30b9\u30c6\u30c3\u30d7\u3092\u30ac\u30a4\u30c9\u3059\u308b\u660e\u78ba\u306a\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u304a\u3088\u3073\u5bc6\u5c01\u6a5f\u306e SOP \u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>

\"\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30b7\u30fc\u30eb\u6a5fSOP\"
\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30b7\u30fc\u30eb\u6a5fSOP\u3002.<\/strong><\/em><\/figcaption><\/figure>

\u305d\u3053\u3067\u3001\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30b7\u30fc\u30eb\u6a5f\u3092\u4f7f\u7528\u3059\u308b\u969b\u306b\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u304c\u9075\u5b88\u3059\u3079\u304dSOP\uff08\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\uff09\u3092\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002\u6700\u5f8c\u307e\u3067\u304a\u8aad\u307f\u3044\u305f\u3060\u304f\u3068\u3001SOP\u306ePDF\u7248\u3092\u7121\u6599\u3067\u5165\u624b\u3067\u304d\u307e\u3059\u3002.<\/p>

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

\u3053\u306eSOP\u306e\u76ee\u7684\u306f\u3001\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30fb\u5bc6\u5c01\u6a5f\u306e\u6b63\u3057\u3044\u64cd\u4f5c\u3001\u6e05\u6383\u3001\u4fdd\u5b88\u65b9\u6cd5\u3092\u8aac\u660e\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u3053\u306e\u6587\u66f8\u306f\u3001\u3059\u3079\u3066\u306e\u30a2\u30f3\u30d7\u30eb\u304c\u898f\u5b9a\u306b\u5f93\u3063\u3066\u6b63\u78ba\u306b\u5145\u586b\u30fb\u5bc6\u5c01\u3055\u308c\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002 GMP\u8981\u4ef6<\/u><\/a>.<\/p>

\u3053\u306e\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u304a\u3088\u3073\u5bc6\u5c01\u6a5f\u306e SOP \u624b\u9806\u306f\u3001\u751f\u7523\u4e2d\u306e\u6c5a\u67d3\u3001\u6f0f\u308c\u3001\u7834\u640d\u3001\u6df7\u540c\u3001\u54c1\u8cea\u4e0d\u826f\u3092\u9632\u3050\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002.<\/p>

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

SOP \u306f\u4ee5\u4e0b\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>

2.0.1: \u7121\u83cc\u88fd\u9020\u30a8\u30ea\u30a2\u3067\u5b9f\u884c\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u304a\u3088\u3073\u5bc6\u5c01\u64cd\u4f5c\u3002.<\/p>

2.0.2: \u30ac\u30e9\u30b9 \u30a2\u30f3\u30d7\u30eb\u306e\u5145\u586b\u3001\u4e8b\u524d\u30ac\u30b9\u5145\u586b\u3001\u4e8b\u5f8c\u30ac\u30b9\u5145\u586b\u3001\u304a\u3088\u3073\u708e\u5bc6\u5c01\u306b\u4f7f\u7528\u3059\u308b\u6a5f\u68b0\u306e\u7a2e\u985e\u3002.<\/p>

2.0.3: \u8a66\u9a13\u30d0\u30c3\u30c1\u3001\u691c\u8a3c\u5b9f\u884c\u3001\u5546\u7528\u30d0\u30c3\u30c1\u3092\u542b\u3080\u751f\u7523\u30d0\u30c3\u30c1\u3002.<\/p>

2.0.4: \u6a5f\u68b0\u306e\u64cd\u4f5c\u3001\u6e05\u6383\u306e\u8a2d\u5b9a\u3001\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3001\u5de5\u7a0b\u5185\u54c1\u8cea\u30c1\u30a7\u30c3\u30af\u306b\u95a2\u308f\u308b\u30b9\u30bf\u30c3\u30d5\u3002.<\/p>

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

3.1 \u6f14\u7b97\u5b50<\/b><\/strong><\/h3>

3.1.1: \u64cd\u4f5c\u304a\u3088\u3073\u6e05\u6383\u4e2d\u306f\u3001\u3053\u306e SOP \u306b\u624b\u9806\u306b\u5f93\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

3.1.2: \u6a5f\u68b0\u306e\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u3001\u6ec5\u83cc\u3001\u5145\u586b\u3001\u5bc6\u5c01\u3001\u304a\u3088\u3073\u6587\u66f8\u5316\u304c\u6b63\u3057\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

3.1.3: \u5145\u586b\u30df\u30b9\u3001\u30a2\u30f3\u30d7\u30eb\u7834\u640d\u3001\u708e\u306e\u554f\u984c\u3001\u6c5a\u67d3\u30ea\u30b9\u30af\u306a\u3069\u306e\u7570\u5e38\u3092\u5831\u544a\u3057\u307e\u3059\u3002.<\/p>

3.2 \u751f\u7523\u7ba1\u7406\u8005<\/b><\/strong><\/h3>

3.2.1: \u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u304c\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u53d7\u3051\u3001\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

3.2.2: \u958b\u59cb\u3059\u308b\u524d\u306b\u3001\u6a5f\u68b0\u306e\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u3001\u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3001\u30d0\u30c3\u30c1\u306e\u8a73\u7d30\u304c\u6b63\u3057\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

3.2.3: \u9038\u8131\u307e\u305f\u306f\u6545\u969c\u304c\u5831\u544a\u3055\u308c\u3001\u8a18\u9332\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

3.3 \u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09<\/b><\/strong><\/h3>

3.3.1: \u88fd\u9020\u524d\u3068\u88fd\u9020\u5f8c\u306b\u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u30c1\u30a7\u30c3\u30af\u3092\u5b9f\u884c\u3057\u307e\u3059\u3002.<\/p>

3.3.2: \u5145\u586b\u91cf\u3001\u30b7\u30fc\u30eb\u54c1\u8cea\u3001\u7834\u640d\u7387\u3001\u6574\u5408\u6027\u306a\u3069\u306e\u91cd\u8981\u306a\u30d1\u30e9\u30e1\u30fc\u30bf\u3092\u691c\u8a3c\u3057\u307e\u3059\u3002.<\/p>

3.3.3: \u6d17\u6d44\u8a18\u9332\u3001\u30d0\u30c3\u30c1\u6587\u66f8\u3001\u30d7\u30ed\u30bb\u30b9\u9038\u8131\u3092\u627f\u8a8d\u3057\u307e\u3059\u3002.<\/p>

4.0 \u5b89\u5168\u4e0a\u306e\u6ce8\u610f<\/b><\/strong><\/h2>

4.0.1: \u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u5f93\u3063\u3066\u6ec5\u83cc\u30ac\u30a6\u30f3\u3068 PPE \u3092\u7740\u7528\u3057\u307e\u3059\u3002.<\/p>

4.0.2: \u30cf\u30f3\u30c9\u30eb \u30ac\u30e9\u30b9\u30a2\u30f3\u30d7\u30eb<\/u><\/a>\u00a0\u5207\u308a\u50b7\u3084\u7834\u640d\u3092\u9632\u3050\u305f\u3081\u3001\u614e\u91cd\u306b\u884c\u3063\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

4.0.3: \u6ec5\u83cc\u90e8\u54c1\uff08\u91dd\u3001\u88fd\u54c1\u7d4c\u8def\uff09\u306b\u7d20\u624b\u3067\u89e6\u308c\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p>

4.0.4: \u88f8\u706b\u304a\u3088\u3073\u5bc6\u9589\u9818\u57df\u306b\u624b\u3092\u8fd1\u3065\u3051\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p>

4.0.5: \u7834\u640d\u3057\u305f\u30a2\u30f3\u30d7\u30eb\u306f\u6307\u5b9a\u3055\u308c\u305f\u92ed\u5229\u7269\u5bb9\u5668\u306b\u5ec3\u68c4\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.0 \u5fc5\u8981\u306a\u6750\u6599\u3068\u6a5f\u5668<\/b><\/strong><\/h2>

5.0.1: \u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30b7\u30fc\u30eb\u6a5f<\/p>

5.0.2: \u6ec5\u83cc\u30a2\u30f3\u30d7\u30eb<\/p>

5.0.3: \u6ec5\u83cc\u88fd\u54c1\u6eb6\u6db2<\/p>

5.0.4: \u30e9\u30d9\u30eb\u3068\u30d0\u30c3\u30c1\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8<\/p>

5.0.5: \u6d17\u6d44\u5264\uff08\u691c\u8a3c\u6e08\u307f\uff09<\/p>

5.0.6: \u6f64\u6ed1\u5264\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\u3001\u975e\u6c5a\u67d3\u6027\uff09<\/p>

5.0.7: \u5fae\u8abf\u6574\u306e\u305f\u3081\u306e\u30c4\u30fc\u30eb<\/p>

5.0.8: PPE\u3068\u6ec5\u83cc\u30ac\u30a6\u30f3<\/p>

6.0 \u624b\u9806<\/b><\/strong><\/h2>

6.1 \u904b\u7528\u524d\u306e\u6d3b\u52d5<\/b><\/strong><\/h3>

6.1.1: \u6a5f\u68b0\u304a\u3088\u3073\u305d\u306e\u5468\u56f2\u306b\u4ee5\u524d\u306e\u30d0\u30c3\u30c1\u306e\u6750\u6599\u304c\u6b8b\u3089\u306a\u3044\u3088\u3046\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

6.1.2: \u53e4\u3044\u30e9\u30d9\u30eb\u3001\u30ab\u30fc\u30c8\u30f3\u3001\u30c4\u30fc\u30eb\u3001\u6b8b\u3063\u305f\u30a2\u30f3\u30d7\u30eb\u3092\u53d6\u308a\u9664\u304d\u307e\u3059\u3002.<\/p>

6.1.3: QA \u306f\u958b\u59cb\u524d\u306b\u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u306b\u7f72\u540d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

6.1.4: \u6a5f\u68b0\u304c\u6e05\u6f54\u3067\u3042\u308a\u3001\u3059\u3079\u3066\u306e\u90e8\u54c1\u304c\u6b63\u3057\u304f\u7d44\u307f\u7acb\u3066\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

6.1.5: \u6f64\u6ed1\u30dd\u30a4\u30f3\u30c8\u3092\u78ba\u8a8d\u3057\u307e\u3059\uff08\u88fd\u54c1\u3068\u63a5\u89e6\u3057\u306a\u3044\u9762\u306e\u307f\uff09\u3002.<\/p>

6.1.6: \u6ec5\u83cc\u90e8\u54c1\u304c\u6ec5\u83cc\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\uff08\u30aa\u30fc\u30c8\u30af\u30ec\u30fc\u30d6\u307e\u305f\u306f \u4e7e\u71b1\u6ec5\u83cc<\/u><\/a>).<\/p>

6.1.7: \u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306e\u5727\u529b\u3001\u6e29\u5ea6\u3001\u6e7f\u5ea6\u304c\u5236\u9650\u7bc4\u56f2\u5185\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

6.1.8: \u5c64\u6d41\u6c17\u6d41 (LAF) \u304c\u30aa\u30f3\u306b\u306a\u3063\u3066\u3044\u3066\u3001\u6b63\u3057\u304f\u6a5f\u80fd\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

6.2 \u30de\u30b7\u30f3\u306e\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7<\/b><\/strong><\/h3>

6.2.1: \u30a2\u30f3\u30d7\u30eb\u306e\u30b5\u30a4\u30ba\u3068\u30bf\u30a4\u30d7\uff081ml\u30012ml\u30015ml\u300110ml\u306a\u3069\uff09\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002.<\/p>

6.2.2: \u30a2\u30f3\u30d7\u30eb\u306e\u30b5\u30a4\u30ba\u306b\u5fdc\u3058\u3066\u5145\u586b\u91dd\u306e\u9ad8\u3055\u3068\u6df1\u3055\u3092\u8abf\u6574\u3057\u307e\u3059\u3002.<\/p>

6.2.3: \u708e\u306e\u9ad8\u3055\u3001\u5f37\u5ea6\u3001\u30d0\u30fc\u30ca\u30fc\u306e\u4f4d\u7f6e\u5408\u308f\u305b\u3092\u8a2d\u5b9a\u3057\u307e\u3059\u3002.<\/p>

6.2.4: HMI \u307e\u305f\u306f\u6a5f\u68b0\u5f0f\u30c0\u30a4\u30e4\u30eb\u3067\u5145\u586b\u91cf\u3092\u8abf\u6574\u3057\u307e\u3059\u3002.<\/p>

6.2.5: \u7a7a\u306e\u30a2\u30f3\u30d7\u30eb\u3092\u30c6\u30b9\u30c8\u5b9f\u884c\u3057\u3066\u3001\u4f4d\u7f6e\u5408\u308f\u305b\u3068\u30b9\u30e0\u30fc\u30ba\u306a\u52d5\u304d\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

6.3 \u5145\u586b\u64cd\u4f5c<\/b><\/strong><\/h3>

6.3.1: \u6ec5\u83cc\u30a2\u30f3\u30d7\u30eb\u3092\u4f9b\u7d66\u30c8\u30ec\u30a4\u306b\u88c5\u586b\u3057\u307e\u3059\u3002.<\/p>

6.3.2: \u9996\u306e\u63d0\u793a\u65b9\u5411\u304c\u9069\u5207\u3067\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

6.3.3: \u7a92\u7d20\u30ac\u30b9\u30d1\u30fc\u30b8\u8a2d\u5b9a\u3092\u6709\u52b9\u306b\u3057\u307e\u3059\u3002.<\/p>

6.3.4: \u88fd\u54c1\u8981\u4ef6\u306b\u57fa\u3065\u3044\u3066\u5727\u529b\u3092\u8abf\u6574\u3057\u307e\u3059\u3002.<\/p>

6.3.5: \u521d\u671f\u30c1\u30a7\u30c3\u30af\u306e\u305f\u3081\u3001\u30de\u30b7\u30f3\u3092\u4f4e\u901f\u3067\u59cb\u52d5\u3057\u307e\u3059\u3002.<\/p>

6.3.6: \u6821\u6b63\u3055\u308c\u305f\u30b7\u30ea\u30f3\u30c0\u30fc\u3092\u4f7f\u7528\u3057\u3066\u5145\u586b\u91cf\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

6.3.7: \u8a31\u5bb9\u9650\u5ea6\u5185\u306b\u306a\u308b\u307e\u3067\u5145\u586b\u91cf\u3092\u8abf\u6574\u3057\u307e\u3059\u3002.<\/p>

6.3.8: QA \u627f\u8a8d\u5f8c\u306b\u306e\u307f\u901a\u5e38\u306e\u751f\u7523\u901f\u5ea6\u306b\u5207\u308a\u66ff\u3048\u307e\u3059\u3002.<\/p>

6.4 \u30b7\u30fc\u30ea\u30f3\u30b0\u64cd\u4f5c<\/b><\/strong><\/h3>

6.4.1: \u30a2\u30f3\u30d7\u30eb\u306e\u9996\u304c\u708e\u306e\u4e0b\u306b\u6b63\u3057\u304f\u914d\u7f6e\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

6.4.2: \u5747\u4e00\u306a\u5bc6\u5c01\u306e\u305f\u3081\u306b\u30a2\u30f3\u30d7\u30eb\u306e\u56de\u8ee2\u901f\u5ea6\u3092\u8abf\u6574\u3057\u307e\u3059\u3002.<\/p>

6.4.3: \u5404\u30b7\u30d5\u30c8\u306e\u958b\u59cb\u6642\u306b\u708e\u306e\u5927\u304d\u3055\u3068\u6e29\u5ea6\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

6.4.4: \u30b7\u30fc\u30eb\u54c1\u8cea\u3092\u89b3\u5bdf\u3057\u307e\u3059\u3002\u3072\u3073\u5272\u308c\u3084\u9ed2\u305a\u307f\u304c\u306a\u304f\u3001\u6ed1\u3089\u304b\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>

6.5 \u5de5\u7a0b\u5185\u54c1\u8cea\u30c1\u30a7\u30c3\u30af\uff08IPQC\uff09<\/b><\/strong><\/h3>

6.5.1: 15\uff5e30\u5206\u3054\u3068\u306b\u3001\u307e\u305f\u306f\u30d0\u30c3\u30c1\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u5f93\u3063\u3066IPQC\u3092\u5b9f\u884c\u3057\u307e\u3059\u3002.<\/p>

6.5.2: \u30c1\u30a7\u30c3\u30af\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>

6.5.2.1: \u5145\u586b\u91cf\u3068\u91cd\u91cf<\/p>

6.5.2.2: \u30b7\u30fc\u30eb\u306e\u5b8c\u5168\u6027<\/p>

6.5.2.3: \u5916\u89b3\uff08\u7c92\u5b50\u3084\u713c\u3051\u305f\u30ac\u30e9\u30b9\u304c\u306a\u3044\uff09<\/p>

6.5.2.4: \u7834\u640d\u7387\uff08\u898f\u5b9a\u9650\u5ea6\u672a\u6e80\uff09<\/p>

6.5.2.5: \u9069\u5207\u306a\u30a2\u30f3\u30d7\u30eb\u306e\u9ad8\u3055\u3068\u6bdb\u7d30\u7ba1\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb<\/p>

6.5.2.6: \u6e29\u5ea6\u3068\u7a92\u7d20\u306e\u8a2d\u5b9a<\/p>

6.5.3: QA \u306f\u5404\u30c1\u30a7\u30c3\u30af\u3092\u6587\u66f8\u5316\u3057\u3066\u7f72\u540d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

6.6 \u4e0d\u5408\u683c\u30a2\u30f3\u30d7\u30eb\u306e\u53d6\u308a\u6271\u3044<\/b><\/strong><\/h3>

6.6.1: \u7834\u640d\u3057\u305f\u30a2\u30f3\u30d7\u30eb\u3001\u5145\u586b\u4e0d\u8db3\u306e\u30a2\u30f3\u30d7\u30eb\u3001\u307e\u305f\u306f\u5bc6\u5c01\u304c\u4e0d\u9069\u5207\u306a\u30a2\u30f3\u30d7\u30eb\u306f\u5225\u3005\u306b\u53ce\u96c6\u3057\u307e\u3059\u3002.<\/p>

6.6.2: \u4e0d\u5408\u683c\u54c1\u306e\u6570\u3092\u8a18\u9332\u3057\u307e\u3059\u3002.<\/p>

6.6.3: \u5ec3\u68c4\u7269\u51e6\u7406SOP\u306b\u5f93\u3063\u3066\u5ec3\u68c4\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

6.7 \u30d0\u30c3\u30c1\u306e\u5b8c\u4e86<\/b><\/strong><\/h3>

6.7.1: \u3059\u3079\u3066\u306e\u30a2\u30f3\u30d7\u30eb\u304c\u51e6\u7406\u3055\u308c\u305f\u3089\u6a5f\u68b0\u3092\u505c\u6b62\u3057\u307e\u3059\u3002.<\/p>

6.7.2: \u30c8\u30e9\u30c3\u30af\u304b\u3089\u6b8b\u308a\u306e\u30a2\u30f3\u30d7\u30eb\u3092\u53d6\u308a\u9664\u304d\u307e\u3059\u3002.<\/p>

6.7.3: \u5145\u586b\u3055\u308c\u5bc6\u5c01\u3055\u308c\u305f\u30a2\u30f3\u30d7\u30eb\u306e\u7dcf\u6570\u3092\u6570\u3048\u307e\u3059\u3002.<\/p>

6.7.4: \u6700\u7d42\u30ab\u30a6\u30f3\u30c8\u3092\u30d0\u30c3\u30c1\u53ce\u91cf\u306e\u4e88\u60f3\u5024\u3068\u6bd4\u8f03\u3057\u307e\u3059\u3002.<\/p>

7.0 \u6e05\u6383\u624b\u9806<\/b><\/strong><\/h2>

7.1 \u30dd\u30b9\u30c8\u30d7\u30ed\u30c0\u30af\u30b7\u30e7\u30f3\u30af\u30ea\u30fc\u30cb\u30f3\u30b0<\/b><\/strong><\/h3>

7.1.1: \u6a5f\u68b0\u3068\u30ac\u30b9\u306e\u4f9b\u7d66\u3092\u30aa\u30d5\u306b\u3057\u307e\u3059\u3002.<\/p>

7.1.2: \u6e05\u6383\u3059\u308b\u524d\u306b\u6a5f\u68b0\u304c\u51b7\u3081\u308b\u306e\u3092\u5f85\u3061\u307e\u3059\u3002.<\/p>

7.1.3: \u5145\u586b\u91dd\u3001\u30c1\u30e5\u30fc\u30d6\u3001\u88fd\u54c1\u63a5\u89e6\u90e8\u54c1\u3092\u53d6\u308a\u5916\u3057\u307e\u3059\u3002.<\/p>

7.1.4: \u691c\u8a3c\u6e08\u307f\u306e\u6d17\u6d44\u5264\u3092\u4f7f\u7528\u3057\u3066\u3053\u308c\u3089\u3092\u6d17\u6d44\u3057\u307e\u3059\u3002.<\/p>

7.1.5: WFI\u3067\u30ea\u30f3\u30b9\uff08\u6ce8\u5c04\u7528\u6c34<\/u><\/a>\uff09\u3092\u30af\u30ea\u30c3\u30af\u3057\u307e\u3059\u3002.<\/p>

7.1.6: \u3059\u3079\u3066\u306e\u90e8\u54c1\u3092\u4e7e\u71e5\u3055\u305b\u3001\u6ec5\u83cc\u306b\u51fa\u3057\u307e\u3059\u3002.<\/p>

7.2 \u6a5f\u5668\u672c\u4f53\u306e\u6d17\u6d44<\/b><\/strong><\/h3>

7.2.1: \u627f\u8a8d\u3055\u308c\u305f\u6d88\u6bd2\u5264\u3092\u4f7f\u7528\u3057\u3066\u5916\u90e8\u8868\u9762\u3092\u62ed\u304d\u307e\u3059\u3002.<\/p>

7.2.2: \u6b8b\u7559\u7269\u3001\u6db2\u4f53\u3001\u307e\u305f\u306f\u307b\u3053\u308a\u304c\u6b8b\u3063\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

7.2.3: \u5b8c\u5168\u306b\u4e7e\u3044\u305f\u5f8c\u306b\u306e\u307f\u7d44\u307f\u7acb\u3066\u76f4\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

8.0 \u30e1\u30f3\u30c6\u30ca\u30f3\u30b9<\/b><\/strong><\/h2>

8.0.1: \u6a5f\u68b0\u7684\u306a\u30c1\u30a7\u30c3\u30af: \u30d9\u30eb\u30c8\u3001\u30d9\u30a2\u30ea\u30f3\u30b0\u3001\u30a2\u30e9\u30a4\u30e1\u30f3\u30c8\u3001\u304a\u3088\u3073\u6f64\u6ed1\u3002.<\/p>

8.0.2: \u5145\u586b\u91cf\u30b7\u30b9\u30c6\u30e0\u306e\u6821\u6b63\u3002.<\/p>

8.0.3: \u708e\u306e\u8abf\u6574\u3068\u30d0\u30fc\u30ca\u30fc\u306e\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u3002.<\/p>

8.0.4: \u6469\u8017\u3057\u305f\u91dd\u307e\u305f\u306f\u30b4\u30e0\u90e8\u54c1\u306e\u4ea4\u63db\u3002.<\/p>

8.0.5: \u3059\u3079\u3066\u306e\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u6d3b\u52d5\u3092\u6a5f\u68b0\u306e\u30ed\u30b0\u30d6\u30c3\u30af\u306b\u8a18\u9332\u3057\u307e\u3059\u3002.<\/p>

9.0 \u5b9a\u7fa9<\/b><\/strong><\/h2>

9.0.1: \u5145\u586b\u91dd<\/b><\/strong>: \u6ec5\u83cc\u6db2\u3092\u30a2\u30f3\u30d7\u30eb\u306b\u79fb\u3057\u307e\u3059\u3002.<\/p>

9.0.2: \u4e8b\u524d\u30ac\u30b9\u51e6\u7406<\/b><\/strong>: \u5145\u586b\u524d\u306b\u7a7a\u6c17\u3092\u9664\u53bb\u3057\u307e\u3059\uff08\u9178\u7d20\u306b\u654f\u611f\u306a\u88fd\u54c1\u306e\u5834\u5408\uff09\u3002.<\/p>

9.0.3: \u30ac\u30b9\u51e6\u7406\u5f8c<\/b><\/strong>: \u30b7\u30fc\u30eb\u524d\u306e\u6700\u7d42\u7684\u306a\u30d8\u30c3\u30c9\u30b9\u30da\u30fc\u30b9\u306e\u8abf\u6574\u3002.<\/p>

9.0.4: \u708e\u5c01\u3058<\/b><\/strong>: \u5236\u5fa1\u3055\u308c\u305f\u708e\u3092\u4f7f\u7528\u3057\u3066\u30a2\u30f3\u30d7\u30eb\u306e\u9996\u3092\u6eb6\u304b\u3057\u3066\u9589\u3058\u307e\u3059\u3002.<\/p>

9.0.5: \u5de5\u7a0b\u5185\u30c1\u30a7\u30c3\u30af\uff08IPQC\uff09<\/b><\/strong>: \u751f\u7523\u4e2d\u306e\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u306e\u54c1\u8cea\u30c1\u30a7\u30c3\u30af\u3002.<\/p>

\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30b7\u30fc\u30eb\u6a5f\u306eSOP PDF\u3092\u7121\u6599\u3067\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<\/b><\/strong><\/h2>

\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30b7\u30fc\u30eb\u6a5f\u306eSOP PDF\u3092\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<\/i><\/b><\/u><\/em><\/strong><\/a><\/p>

\u5f0a\u793e\u304c\u3054\u7528\u610f\u3057\u305f\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30b7\u30fc\u30eb\u6a5fSOP PDF\u306f\u3001\u88fd\u9020\u73fe\u5834\u306e\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u5411\u3051\u306b\u8a2d\u8a08\u3055\u308c\u305f\u3001\u3059\u3050\u306b\u4f7f\u7528\u3067\u304d\u308b\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306f\u3059\u3079\u3066\u306e\u5de5\u7a0b\u304cGMP\u57fa\u6e96\u306b\u53b3\u5bc6\u306b\u6e96\u62e0\u3057\u3066\u5b9f\u884c\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u8fc5\u901f\u306b\u78ba\u8a8d\u3067\u304d\u307e\u3059\u3002.<\/p>

\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u6a5f\u5668\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3067\u3001SOP \u306e\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u304c\u6700\u5927\u9650\u306b\u9ad8\u307e\u308a\u307e\u3059<\/b><\/strong><\/h2>

\u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30fb\u30b7\u30fc\u30eb\u6a5f\u306e\u660e\u78ba\u306aSOP\uff08\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\uff09\u306f\u3001\u5b89\u5168\u306a\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30f3\u306e\u57fa\u76e4\u3067\u3059\u3002\u30d0\u30c3\u30c1\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u3001\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306e\u9023\u643a\u3092\u7dad\u6301\u3057\u3001\u65bd\u8a2d\u304b\u3089\u51fa\u8377\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u30a2\u30f3\u30d7\u30eb\u304cGMP\u306e\u8981\u6c42\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002.<\/p>

\u3057\u304b\u3057\u3001\u3069\u3093\u306a\u306b\u826f\u304f\u66f8\u304b\u308c\u305fSOP\u3067\u3082\u3001\u9069\u5207\u306a\u6a5f\u68b0\u304c\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u3001\u305d\u306e\u52b9\u679c\u306f\u767a\u63ee\u3055\u308c\u307e\u305b\u3093\u3002\u305d\u3057\u3066\u3001\u305d\u306e\u6a5f\u68b0\u3092\u624b\u306b\u5165\u308c\u308b\u306b\u306f\u3001Finetech\u304c\u6700\u9069\u306a\u9078\u629e\u80a2\u3067\u3059\u3002.<\/p>

\u79c1\u305f\u3061\u306e \u30a2\u30f3\u30d7\u30eb\u5145\u586b\u30b7\u30fc\u30eb\u6a5f<\/u><\/a>\u00a0\u7cbe\u5bc6\u3067\u30b9\u30e0\u30fc\u30ba\u306a\u64cd\u4f5c\u6027\u3001\u305d\u3057\u3066GMP\u3078\u306e\u5b8c\u5168\u6e96\u62e0\u3092\u5b9f\u73fe\u3059\u308b\u8a2d\u8a08\u3067\u3059\u300230\u5e74\u4ee5\u4e0a\u306e\u7d4c\u9a13\u306b\u57fa\u3065\u304d\u3001\u304a\u5ba2\u69d8\u306e\u30cb\u30fc\u30ba\u306b\u6700\u9069\u306a\u6a5f\u5668\u3092\u3054\u63d0\u6848\u3044\u305f\u3057\u307e\u3059\u3002.<\/p>

\u5c02\u9580\u5bb6\u3068\u306e\u7c21\u5358\u306a\u96fb\u8a71\u76f8\u8ac7\u3092\u3054\u4e88\u7d04\u304f\u3060\u3055\u3044<\/i><\/u><\/em><\/a>\u00a0\u4eca\u65e5\uff01 <\/i><\/em><\/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":"

Ampoule filling and sealing is one of the most delicate steps in sterile pharmaceutical production. If operators follow different methods […]<\/p>\n","protected":false},"author":1,"featured_media":9391,"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-9386","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\/9386","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=9386"}],"version-history":[{"count":8,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/9386\/revisions"}],"predecessor-version":[{"id":9395,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/9386\/revisions\/9395"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/9391"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=9386"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=9386"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=9386"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}