{"id":15889,"date":"2026-07-20T02:13:25","date_gmt":"2026-07-20T02:13:25","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=15889"},"modified":"2026-04-22T06:02:39","modified_gmt":"2026-04-22T06:02:39","slug":"list-of-sop-for-quality-assurance-in-pharmaceutical-industry","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/list-of-sop-for-quality-assurance-in-pharmaceutical-industry\/","title":{"rendered":"\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u54c1\u8cea\u4fdd\u8a3c\u306e\u305f\u3081\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u4e00\u89a7"},"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

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u54c1\u8cea\u4fdd\u8a3cSOP\u4e00\u89a7\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3002.<\/p>

\"\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u54c1\u8cea\u4fdd\u8a3c\u306e\u305f\u3081\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u4e00\u89a7\"
\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u54c1\u8cea\u4fdd\u8a3c\u306e\u305f\u3081\u306e\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u4e00\u89a7\u3002.<\/strong><\/em><\/figcaption><\/figure>

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

\u88fd\u85ac\u5de5\u5834\u5168\u4f53\u306b\u304a\u3051\u308b\u54c1\u8cea\u4fdd\u8a3c\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u306e\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306e\u4f5c\u6210\u3001\u7dad\u6301\u3001\u304a\u3088\u3073\u7ba1\u7406\u306b\u95a2\u3059\u308b\u624b\u9806\u3092\u5b9a\u3081\u308b\u3002\u305d\u306e\u76ee\u7684\u306f\u5358\u7d14\u660e\u5feb\u3067\u3042\u308b\u3002\u3059\u306a\u308f\u3061\u3001\u73fe\u5728\u6709\u52b9\u306a\u3059\u3079\u3066\u306eQA SOP\u3092\u78ba\u5b9f\u306b\u628a\u63e1\u3057\u3001\u5ec3\u6b62\u3055\u308c\u305f\u30d0\u30fc\u30b8\u30e7\u30f3\u3092\u3059\u3079\u3066\u4f7f\u7528\u505c\u6b62\u306b\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002.<\/p>

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

\u672c\u624b\u9806\u66f8\u306f\u3001\u54c1\u8cea\u4fdd\u8a3c\u90e8\u9580\u304c\u7ba1\u7406\u3059\u308bSOP\u306e\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u88fd\u9020\u3001\u54c1\u8cea\u7ba1\u7406\u3001\u5009\u5eab\u3001\u6280\u8853\u3001\u304a\u3088\u3073\u7ba1\u7406\u306e\u5404\u90e8\u9580\u306b\u304a\u3044\u3066\u73fe\u5728\u6709\u52b9\u306a\u3059\u3079\u3066\u306eQA SOP\u304c\u3001\u672c\u624b\u9806\u66f8\u306e\u9069\u7528\u7bc4\u56f2\u306b\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>

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

\u6587\u66f8\u7ba1\u7406\u62c5\u5f53\u8005\u517c\u54c1\u8cea\u4fdd\u8a3c\u62c5\u5f53\u8005<\/p>

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

QA\u8cac\u4efb\u8005\u3002.<\/p>

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

5.1 SOP\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306f\u7ba1\u7406\u6587\u66f8\u3068\u3057\u3066\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u3001\u5f53\u8a72\u62e0\u70b9\u3067\u6709\u52b9\u306a\u3059\u3079\u3066\u306e\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09SOP\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u65e5\u5e38\u7684\u306b\u306f\u3001\u6587\u66f8\u7ba1\u7406\u62c5\u5f53\u8005\u304c\u3053\u306e\u30ea\u30b9\u30c8\u306e\u7ba1\u7406\u3092\u62c5\u5f53\u3057\u3001\u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005\u304c\u305d\u306e\u696d\u52d9\u3092\u76f4\u63a5\u76e3\u7763\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>

5.2 \u3053\u306e\u30ea\u30b9\u30c8\u306f\u7ba1\u7406\u3055\u308c\u305f\u96fb\u5b50\u30d5\u30a1\u30a4\u30eb\u306b\u4fdd\u5b58\u3055\u308c\u3066\u304a\u308a\u3001\u305d\u306e\u30d5\u30a1\u30a4\u30eb\u306b\u306f\u56fa\u6709\u306e\u6587\u66f8\u756a\u53f7\u304c\u5272\u308a\u5f53\u3066\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u7d19\u306e\u30b3\u30d4\u30fc\u306f\u3001\u76e3\u67fb\u6642\u3084\u3001\u8ab0\u304b\u304c\u30aa\u30d5\u30e9\u30a4\u30f3\u3067\u30ea\u30b9\u30c8\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u5834\u5408\u306a\u3069\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u306e\u307f\u5370\u5237\u3055\u308c\u307e\u3059\u3002.<\/p>

5.3 \u65b0\u3057\u3044SOP\u3001\u6539\u8a02\u7248\u3001\u307e\u305f\u306f\u5ec3\u6b62\u304c\u627f\u8a8d\u3055\u308c\u308b\u305f\u3073\u306b\u3001\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306f1\u55b6\u696d\u65e5\u4ee5\u5185\u306b\u66f4\u65b0\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u66f4\u65b0\u306e\u305f\u3073\u306b\u3001\u6587\u66f8\u7ba1\u7406\u62c5\u5f53\u8005\u304c\u65e5\u4ed8\u3092\u8a18\u5165\u3057\u3001\u7f72\u540d\u3092\u884c\u3046\u3002.<\/p>

5.4 \u73fe\u884c\u306eSOP\u3092\u5165\u624b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u90e8\u7f72\u306f\u3001\u307e\u305a\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u3092\u78ba\u8a8d\u3057\u3001\u6b63\u3057\u3044\u30d0\u30fc\u30b8\u30e7\u30f3\u3092\u7279\u5b9a\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u4e0a\u3067\u300c\u6709\u52b9\u300d\u3068\u8868\u793a\u3055\u308c\u3066\u3044\u306a\u3044SOP\u306f\u3001\u4e00\u5207\u4f7f\u7528\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5 \u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306e\u69cb\u6210\uff1a<\/strong><\/h3>

5.5.1 \u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306f\u3001\u56fa\u5b9a\u3055\u308c\u305f\u5217\u306e\u30bb\u30c3\u30c8\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u5404\u884c\u306f 1 \u3064\u306e SOP \u306b\u5c5e\u3057\u3001\u5404\u5217\u306f\u305d\u306e SOP \u306b\u95a2\u3059\u308b 1 \u3064\u306e\u30c7\u30fc\u30bf\u30d5\u30a3\u30fc\u30eb\u30c9\u3092\u683c\u7d0d\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>

5.5.2 \u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306b\u8a18\u8f09\u3059\u3079\u304d\u9805\u76ee\u306f\u3001\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/p>

5.5.2.1 SOP\u756a\u53f7\uff1a\u521d\u56de\u516c\u958b\u6642\u306b\u4ed8\u4e0e\u3055\u308c\u308b\u4e00\u610f\u306e\u8b58\u5225\u5b50\u3002\u6539\u8a02\u3092\u7d4c\u3066\u3082\u3001\u3053\u306e\u756a\u53f7\u306f\u5909\u66f4\u3055\u308c\u306a\u3044\u3002.<\/p>

5.5.2.2 SOP\u306e\u30bf\u30a4\u30c8\u30eb\uff1a\u6587\u66f8\u306e\u30d8\u30c3\u30c0\u30fc\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5b8c\u5168\u306a\u30bf\u30a4\u30c8\u30eb\u3002.<\/p>

5.5.2.3 \u73fe\u5728\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\uff1a\u73fe\u5728\u6709\u52b9\u306aSOP\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u756a\u53f7\u3002\u6b63\u5f0f\u306a\u6539\u8a02\u304c\u884c\u308f\u308c\u308b\u305f\u3073\u306b\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u756a\u53f7\u304c1\u305a\u3064\u5897\u52a0\u3059\u308b\u3002.<\/p>

5.5.2.4 \u767a\u52b9\u65e5\uff1a\u672c\u30d0\u30fc\u30b8\u30e7\u30f3\u304c\u4f7f\u7528\u958b\u59cb\u3055\u308c\u305f\u65e5\u3002.<\/p>

5.5.2.5 \u6b21\u56de\u306e\u898b\u76f4\u3057\u6642\u671f\uff1a\u6b21\u56de\u306e\u5b9a\u671f\u7684\u306a\u898b\u76f4\u3057\u304c\u4e88\u5b9a\u3055\u308c\u3066\u3044\u308b\u6642\u671f\u3002\u5927\u307e\u304b\u306a\u76ee\u5b89\u3068\u3057\u3066\u3001\u3053\u308c\u306f\u767a\u52b9\u65e5\u304b\u30892\u5e74\u5f8c\u3068\u306a\u308b\u3002.<\/p>

5.5.2.6 \u6587\u66f8\u8cac\u4efb\u8005\uff1aSOP\u306e\u5185\u5bb9\u3092\u7ba1\u7406\u3059\u308b\u90e8\u9580\u307e\u305f\u306f\u5f79\u8077\u3002.<\/p>

5.5.2.7 \u30b9\u30c6\u30fc\u30bf\u30b9\uff1a\u4ee5\u4e0b\u306b\u5b9a\u7fa9\u3059\u308b4\u3064\u306e\u5024\u306e\u3044\u305a\u308c\u304b\u3002.<\/p>

5.5.2.7.1 \u5b9f\u65bd\u4e2d\uff1a\u8077\u54e1\u306f\u73fe\u5728\u3053\u306eSOP\u3092\u4f7f\u7528\u3057\u3066\u304a\u308a\u3001\u3053\u308c\u3092\u9075\u5b88\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>

5.5.2.7.2 \u6539\u8a02\u4e2d\uff1a\u65b0\u3057\u3044\u30d0\u30fc\u30b8\u30e7\u30f3\u304c\u4f5c\u6210\u4e2d\u3067\u3059\u3002\u3053\u306e\u30d5\u30a7\u30fc\u30ba\u306e\u9593\u3001\u65e7\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u300c\u6709\u52b9\u300d\u306e\u307e\u307e\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>

5.5.2.7.3 \u5ec3\u6b62\uff1aSOP\u3067\u5bfe\u8c61\u3068\u3057\u3066\u3044\u305f\u6d3b\u52d5\u306f\u3001\u5f53\u8a72\u62e0\u70b9\u3067\u306f\u3082\u306f\u3084\u5b9f\u65bd\u3055\u308c\u3066\u3044\u306a\u3044\u3002\u6709\u52b9\u306a\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u6b8b\u3063\u3066\u3044\u306a\u3044\u3002.<\/p>

5.5.2.7.4 \u30a2\u30fc\u30ab\u30a4\u30d6\u7248\uff1a\u65b0\u3057\u3044\u30a2\u30af\u30c6\u30a3\u30d6\u7248\u306b\u7f6e\u304d\u63db\u3048\u3089\u308c\u305f\u65e7\u30d0\u30fc\u30b8\u30e7\u30f3\u3002\u3053\u308c\u3089\u306f\u76e3\u67fb\u8a3c\u8de1\u3092\u4fdd\u5b58\u3059\u308b\u305f\u3081\u306b\u30d5\u30a1\u30a4\u30eb\u306b\u6b8b\u3055\u308c\u307e\u3059\u3002.<\/p>

5.5.3 \u30b5\u30a4\u30c8\u3054\u3068\u306e\u30cb\u30fc\u30ba\u306b\u5408\u308f\u305b\u3066\u3001\u5217\u3092\u8ffd\u52a0\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u53c2\u7167\u756a\u53f7\u3001\u95a2\u9023\u3059\u308b\u66f8\u5f0f\u3001\u304a\u3088\u3073\u7814\u4fee\u8981\u4ef6\u306a\u3069\u304c\u3001\u3088\u304f\u8ffd\u52a0\u3055\u308c\u308b\u9805\u76ee\u3067\u3059\u3002.<\/p>

5.5.4 \u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306fSOP\u756a\u53f7\u9806\u306b\u4e26\u3079\u66ff\u3048\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u540d\u524d\u3067\u691c\u7d22\u3057\u305f\u3044\u65b9\u306e\u305f\u3081\u306b\u3001SOP\u30bf\u30a4\u30c8\u30eb\u9806\u306b\u4e26\u3079\u66ff\u3048\u3089\u308c\u305f\u5225\u306e\u30d3\u30e5\u30fc\u304c\u3001\u5225\u306e\u30a4\u30f3\u30c7\u30c3\u30af\u30b9\u30bf\u30d6\u306b\u7528\u610f\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>

5.6 SOP\u306e\u5206\u985e\uff1a<\/strong><\/h3>

5.6.1 \u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u308b\u3059\u3079\u3066\u306eQA\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u306b\u306f\u3001\u305d\u306e\u5bfe\u8c61\u5185\u5bb9\u306b\u57fa\u3065\u3044\u3066\u30ab\u30c6\u30b4\u30ea\u30bf\u30b0\u304c\u4ed8\u4e0e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30ab\u30c6\u30b4\u30ea\u5206\u3051\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001\u30b9\u30bf\u30c3\u30d5\u306f\u7279\u5b9a\u306e\u624b\u9806\u66f8\u304c\u5fc5\u8981\u306b\u306a\u3063\u305f\u969b\u306b\u3001\u30ea\u30b9\u30c8\u5168\u4f53\u3092\u30b9\u30af\u30ed\u30fc\u30eb\u3057\u3066\u63a2\u3059\u624b\u9593\u304c\u7701\u3051\u307e\u3059\u3002.<\/p>

5.6.2 \u6a19\u6e96\u7684\u306a\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u306e\u5206\u985e\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\uff1a<\/strong><\/h4>

5.6.2.1 \u6587\u66f8\u7ba1\u7406\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\uff1a\u6587\u66f8\u306e\u4f5c\u6210\u3084\u30ec\u30d3\u30e5\u30fc\u304b\u3089\u3001\u627f\u8a8d\u3001\u767a\u884c\u3001\u3055\u3089\u306b\u306f\u4fdd\u5b58\u306b\u81f3\u308b\u307e\u3067\u306e\u3001\u901a\u5e38\u306e\u6587\u66f8\u7ba1\u7406\u696d\u52d9\u5168\u822c\u3002.<\/p>

5.6.2.2 \u5909\u66f4\u7ba1\u7406\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\uff08SOP\uff09\uff1a\u88fd\u54c1\u3001\u30d7\u30ed\u30bb\u30b9\u3001\u307e\u305f\u306f\u30b7\u30b9\u30c6\u30e0\u306b\u5bfe\u3059\u308b\u5909\u66f4\u6848\u306e\u5be9\u67fb\u304a\u3088\u3073\u627f\u8a8d\u3002.<\/p>

5.6.2.3 \u9038\u8131\u304a\u3088\u3073CAPA\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\uff1a\u624b\u9806\u304b\u3089\u306e\u9038\u8131\u3001\u304a\u3088\u3073\u305d\u308c\u3089\u3092\u89e3\u6c7a\u3059\u308b\u305f\u3081\u306e\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u3002.<\/p>

5.6.2.4 \u30ed\u30c3\u30c8\u30ea\u30ea\u30fc\u30b9\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\uff1a\u88fd\u9020\u304b\u3089\u5e02\u5834\u3078\u306e\u6700\u7d42\u30ea\u30ea\u30fc\u30b9\u306b\u81f3\u308b\u307e\u3067\u306e\u5404\u624b\u9806\u3002.<\/p>

5.6.2.5 \u82e6\u60c5\u5bfe\u5fdc\u6a19\u6e96\u4f5c\u696d\u624b\u9806\uff08SOP\uff09\uff1a\u88fd\u54c1\u306b\u95a2\u3059\u308b\u82e6\u60c5\u306e\u53d7\u4ed8\u3001\u8abf\u67fb\u3001\u304a\u3088\u3073\u89e3\u6c7a\u3002.<\/p>

5.6.2.6 \u76e3\u67fb\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\uff1a\u5185\u90e8\u76e3\u67fb\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u76e3\u67fb\u3001\u304a\u3088\u3073\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u691c\u67fb\u3002.<\/p>

5.6.2.7 \u7814\u4fee\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\uff1a\u65b0\u898f\u307e\u305f\u306f\u6539\u8a02\u3055\u308c\u305f\u624b\u9806\u306b\u3064\u3044\u3066\u3001\u30b9\u30bf\u30c3\u30d5\u3078\u306e\u7814\u4fee\u3092\u884c\u3046\u3002.<\/p>

5.6.2.8 \u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304a\u3088\u3073\u9069\u683c\u6027\u78ba\u8a8d\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\uff1a\u6a5f\u5668\u3001\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u3001\u304a\u3088\u3073\u30d7\u30ed\u30bb\u30b9\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u5168\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3002.<\/p>

5.6.2.9 \u74b0\u5883\u7ba1\u7406\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\uff1a\u6e29\u5ea6\u3001\u6e7f\u5ea6\u3001\u7c92\u5b50\u3001\u304a\u3088\u3073\u5fae\u751f\u7269\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3002.<\/p>

5.6.2.10 \u30ea\u30b3\u30fc\u30eb\u304a\u3088\u3073\u5e02\u5834\u5bfe\u5fdc\u306b\u95a2\u3059\u308b\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\uff1a\u88fd\u54c1\u306e\u30ea\u30b3\u30fc\u30eb\u304a\u3088\u3073\u95a2\u9023\u3059\u308b\u3042\u3089\u3086\u308b\u5e02\u5834\u5bfe\u5fdc\u3002.<\/p>

5.6.3 \u65b0\u898f\u306eSOP\u306f\u3059\u3079\u3066\u30011\u3064\u306e\u4e3b\u8981\u30ab\u30c6\u30b4\u30ea\u306b\u5272\u308a\u5f53\u3066\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5185\u5bb9\u304c\u8907\u6570\u306e\u5206\u91ce\u306b\u307e\u305f\u304c\u308b\u5834\u5408\u306f\u3001\u4e8c\u6b21\u30ab\u30c6\u30b4\u30ea\u3078\u306e\u76f8\u4e92\u53c2\u7167\u3082\u4f75\u305b\u3066\u8a18\u8f09\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>

5.7 \u30ea\u30b9\u30c8\u306b\u65b0\u3057\u3044SOP\u3092\u8ffd\u52a0\u3059\u308b\uff1a<\/strong><\/h3>

5.7.1 \u65b0\u3057\u3044SOP\u3092\u4f5c\u6210\u3059\u308b\u306b\u306f\u3001\u307e\u305a\u300c\u6587\u66f8\u4f5c\u6210\u4f9d\u983c\u66f8\u300d\u306b\u8a18\u5165\u3059\u308b\u3053\u3068\u304b\u3089\u59cb\u3081\u307e\u3059\u3002\u4f9d\u983c\u8005\u306f\u3001\u3053\u306e\u4f9d\u983c\u66f8\u306b\u3001\u63d0\u6848\u3059\u308b\u30bf\u30a4\u30c8\u30eb\u3001\u30ab\u30c6\u30b4\u30ea\u3001\u6587\u66f8\u8cac\u4efb\u8005\u3001\u304a\u3088\u3073SOP\u4f5c\u6210\u306e\u696d\u52d9\u4e0a\u306e\u7406\u7531\u3092\u8a18\u5165\u3057\u307e\u3059\u3002.<\/p>

5.7.2 \u305d\u306e\u5f8c\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u7ba1\u7406\u62c5\u5f53\u8005\u306f\u305d\u306e\u4f9d\u983c\u5185\u5bb9\u3092\u7cbe\u67fb\u3057\u3001\u985e\u4f3c\u3059\u308bSOP\u304c\u3059\u3067\u306b\u5b58\u5728\u3057\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002\u3082\u3057\u5b58\u5728\u3059\u308b\u5834\u5408\u306f\u3001\u305d\u306e\u4f9d\u983c\u306f\u3001\u73fe\u884c\u306eSOP\u3078\u306e\u53c2\u7167\u60c5\u5831\u3092\u6dfb\u3048\u3066\u4f9d\u983c\u8005\u306b\u8fd4\u9001\u3055\u308c\u308b\u3002.<\/p>

5.7.3 \u7533\u8acb\u304c\u627f\u8a8d\u3055\u308c\u308b\u3068\u3001\u6587\u66f8\u7ba1\u7406\u62c5\u5f53\u8005\u306f\u56fa\u6709\u306eSOP\u756a\u53f7\u3092\u5272\u308a\u5f53\u3066\u3001\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u4e0a\u306e\u8a72\u5f53\u3059\u308b\u4f4d\u7f6e\u3092\u78ba\u4fdd\u3059\u308b\u3002\u6700\u521d\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u304c\u767a\u884c\u3055\u308c\u308b\u307e\u3067\u306f\u3001\u30b9\u30c6\u30fc\u30bf\u30b9\u306f\u300c\u6539\u8a02\u4e2d\u300d\u306e\u307e\u307e\u3068\u306a\u308b\u3002.<\/p>

5.7.4 SOP\u306e\u8349\u6848\u4f5c\u6210\u306f\u3001\u6587\u66f8\u7ba1\u7406\u8005\u304c\u73fe\u5728\u306e\u6587\u66f8\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u7528\u3044\u3066\u884c\u3046\u3002\u305d\u306e\u8349\u6848\u306f\u3001\u95a2\u4fc2\u3059\u308b\u3059\u3079\u3066\u306e\u90e8\u7f72\u306b\u56de\u89a7\u3055\u308c\u3001\u691c\u8a0e\u3092\u53d7\u3051\u308b\u3002.<\/p>

5.7.5 \u6700\u7d42\u8349\u6848\u304c\u627f\u8a8d\u30fb\u7f72\u540d\u3055\u308c\u305f\u5f8c\u3001\u6587\u66f8\u7ba1\u7406\u62c5\u5f53\u8005\u306f\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306b\u767a\u52b9\u65e5\u3092\u8a18\u5165\u3057\u3001\u30b9\u30c6\u30fc\u30bf\u30b9\u3092\u300c\u30a2\u30af\u30c6\u30a3\u30d6\u300d\u306b\u5909\u66f4\u3059\u308b\u3002.<\/p>

5.7.6 \u627f\u8a8d\u3055\u308c\u305fSOP\u306f\u3001\u6587\u66f8\u914d\u5e03\u8a18\u9332\u3092\u901a\u3058\u3066\u3001\u5f71\u97ff\u3092\u53d7\u3051\u308b\u3059\u3079\u3066\u306e\u30e6\u30fc\u30b6\u30fc\u306b\u901a\u77e5\u3055\u308c\u308b\u3002\u65b0\u3057\u3044SOP\u306b\u95a2\u3059\u308b\u7814\u4fee\u306f\u3001\u767a\u884c\u304b\u308915\u65e5\u4ee5\u5185\u306b\u5b9f\u65bd\u3055\u308c\u308b\u3002.<\/p>

5.8 \u65e2\u5b58\u306eSOP\u306e\u6539\u8a02\uff1a<\/h3>

5.8.1 \u6539\u8a02\u304c\u5fc5\u8981\u3068\u306a\u308b\u8981\u56e0\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>

5.8.1.1 \u5b9a\u671f\u7684\u306a\u898b\u76f4\u3057\u3092\u884c\u3063\u305f\u7d50\u679c\u3001\u53cd\u6620\u3059\u3079\u304d\u66f4\u65b0\u4e8b\u9805\u304c\u898b\u3064\u304b\u3063\u305f\u3002.<\/p>

5.8.1.2 \u5909\u66f4\u7ba1\u7406\u63aa\u7f6e\u306b\u3088\u308a\u3001\u624b\u9806\u306e\u5909\u66f4\u304c\u5fc5\u8981\u3068\u306a\u308b\u3002.<\/p>

5.8.1.3 \u9038\u8131\u8abf\u67fb\u306f\u3001\u73fe\u5728\u306e\u624b\u9806\u306b\u304a\u3051\u308b\u4e0d\u5099\u3092\u660e\u3089\u304b\u306b\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u3002.<\/p>

5.8.1.4 \u898f\u5236\u306e\u6539\u6b63\u306b\u3088\u308a\u3001\u65b0\u305f\u306a\u8981\u4ef6\u304c\u5c0e\u5165\u3055\u308c\u308b\u3002.<\/p>

5.8.1.5 \u8a2d\u5099\u3084\u5de5\u7a0b\u306e\u5909\u66f4\u306b\u3088\u308a\u3001\u73fe\u884c\u306eSOP\u304c\u5b9f\u60c5\u3068\u4e56\u96e2\u3057\u3066\u3044\u308b\u3002.<\/p>

5.8.2 \u5909\u66f4\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u5909\u66f4\u4f9d\u983c\u3092\u63d0\u51fa\u3059\u308b\u3002\u5909\u66f4\u306e\u5185\u5bb9\u3068\u3001\u305d\u306e\u7406\u7531\u3092\u660e\u8a18\u3059\u308b\u3002.<\/p>

5.8.3 \u627f\u8a8d\u304c\u4e0b\u308a\u308b\u3068\u3001\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u7ba1\u7406\u62c5\u5f53\u8005\u306f\u3001\u73fe\u884c\u30d0\u30fc\u30b8\u30e7\u30f3\u3092\u305d\u306e\u307e\u307e\u516c\u958b\u3057\u305f\u307e\u307e\u3001\u65b0\u3057\u3044\u8349\u6848\u30d0\u30fc\u30b8\u30e7\u30f3\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u4e0a\u3067\u306f\u3001\u73fe\u884c\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u300c\u6709\u52b9\u300d\u3068\u8868\u793a\u3055\u308c\u3001\u65b0\u3057\u3044\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u300c\u6539\u8a02\u4e2d\u300d\u3068\u8868\u793a\u3055\u308c\u307e\u3059\u3002.<\/p>

5.8.4 \u6539\u8a02\u3055\u308c\u305fSOP\u304c\u627f\u8a8d\u3055\u308c\u3001\u767a\u52b9\u3059\u308b\u3068\u3001\u6587\u66f8\u7ba1\u7406\u62c5\u5f53\u8005\u306f\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u4e0a\u306e\u30b9\u30c6\u30fc\u30bf\u30b9\u3092\u5207\u308a\u66ff\u3048\u307e\u3059\u3002\u65b0\u3057\u3044\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u300c\u6709\u52b9\u300d\u306b\u6607\u683c\u3057\u3001\u65e7\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u300c\u30a2\u30fc\u30ab\u30a4\u30d6\u300d\u306b\u964d\u683c\u3057\u307e\u3059\u3002.<\/p>

5.8.5 \u5404\u30e6\u30fc\u30b6\u30fc\u90e8\u9580\u306b\u6563\u5728\u3057\u3066\u3044\u308b\u65e7\u30d0\u30fc\u30b8\u30e7\u30f3\u306e\u7d19\u5a92\u4f53\u3092\u3059\u3079\u3066\u63a2\u3057\u51fa\u3057\u3001\u8aa4\u3063\u3066\u6301\u3061\u51fa\u3055\u308c\u306a\u3044\u3088\u3046\u3001\u6d88\u5370\u3092\u62bc\u3059\u304b\u7834\u68c4\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.9 SOP\u306e\u64a4\u56de\uff1a<\/strong><\/h3>

5.9.1 \u64a4\u56de\u306f\u3001SOP\u306e\u5bfe\u8c61\u3068\u306a\u308b\u6d3b\u52d5\u304c\u5f53\u8a72\u62e0\u70b9\u3067\u5b9f\u65bd\u3055\u308c\u306a\u304f\u306a\u3063\u305f\u5834\u5408\u306b\u9069\u7528\u3055\u308c\u308b\u3002\u88fd\u9020\u4e2d\u6b62\u3068\u306a\u3063\u305f\u88fd\u54c1\u3001\u5ec3\u6b62\u3055\u308c\u308b\u8a2d\u5099\u3001\u3042\u308b\u3044\u306f2\u3064\u306e\u624b\u9806\u304c\u7d71\u5408\u3055\u308c\u308b\u5834\u5408\u306a\u3069\u304c\u3001\u5178\u578b\u7684\u306a\u5f15\u304d\u91d1\u3068\u306a\u308b\u3002.<\/p>

5.9.2 \u64a4\u56de\u4f9d\u983c\u306f\u5909\u66f4\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u884c\u308f\u308c\u308b\u3002\u3053\u306e\u4f9d\u983c\u306b\u306f\u7406\u7531\u304c\u660e\u8a18\u3055\u308c\u3001\u73fe\u5728\u9032\u884c\u4e2d\u306e\u696d\u52d9\u306b\u304a\u3044\u3066\u5f53\u8a72SOP\u306b\u4f9d\u5b58\u3057\u3066\u3044\u308b\u3082\u306e\u304c\u4e00\u5207\u306a\u3044\u3053\u3068\u304c\u78ba\u8a8d\u3055\u308c\u308b\u3002.<\/p>

5.9.3 \u627f\u8a8d\u5f8c\u3001\u6587\u66f8\u7ba1\u7406\u62c5\u5f53\u8005\u306f\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u4e0a\u306eSOP\u306e\u30b9\u30c6\u30fc\u30bf\u30b9\u3092\u300c\u6709\u52b9\u300d\u304b\u3089\u300c\u5ec3\u6b62\u300d\u306b\u5909\u66f4\u3059\u308b\u3002\u307e\u305f\u3001\u5ec3\u6b62\u306e\u6709\u52b9\u65e5\u3082\u8a18\u9332\u3055\u308c\u308b\u3002.<\/p>

5.9.4 \u5ec3\u6b62\u3055\u308c\u305fSOP\u306e\u3059\u3079\u3066\u306e\u5199\u3057\u306f\u3001\u5404\u5229\u7528\u90e8\u7f72\u304b\u3089\u56de\u53ce\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u539f\u672c\u306f\u3001\u8868\u7d19\u306b\u300c\u5ec3\u6b62\u300d\u306e\u30b9\u30bf\u30f3\u30d7\u3092\u62bc\u5370\u3057\u305f\u4e0a\u3067\u3001\u30a2\u30fc\u30ab\u30a4\u30d6\u5ba4\u3078\u9001\u4ed8\u3059\u308b\u3002.<\/p>

5.9.5 \u5f71\u97ff\u3092\u53d7\u3051\u308b\u3059\u3079\u3066\u306e\u8077\u54e1\u306b\u5bfe\u3057\u3001\u300c\u6587\u66f8\u914d\u5e03\u8a18\u9332\u300d\u3092\u901a\u3058\u3066\u64a4\u56de\u304c\u901a\u77e5\u3055\u308c\u308b\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u64a4\u56de\u3055\u308c\u305f\u624b\u9806\u3092\u4f9d\u7136\u3068\u3057\u3066\u9075\u5b88\u3057\u3066\u3057\u307e\u3046\u8005\u304c\u3044\u306a\u304f\u306a\u308b\u3002.<\/p>

5.10 \u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306e\u5b9a\u671f\u7684\u306a\u898b\u76f4\u3057\uff1a<\/strong><\/h3>

5.10.1 \u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005\u306f\u3001\u5e74\u306b2\u56de\u3001\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u5168\u4f53\u3092\u7cbe\u67fb\u3059\u308b\u3002\u3053\u306e\u7cbe\u67fb\u306e\u76ee\u7684\u306f\u3001\u3059\u3079\u3066\u306e\u8a18\u8f09\u5185\u5bb9\u304c\u6b63\u78ba\u3067\u3042\u308b\u3053\u3068\u3001\u304a\u3088\u3073\u6709\u52b9\u306aSOP\u304c\u6f0f\u308c\u306a\u304f\u7db2\u7f85\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3067\u3042\u308b\u3002.<\/p>

5.10.2 \u30ec\u30d3\u30e5\u30fc\u3067\u78ba\u8a8d\u3059\u3079\u304d\u4e8b\u9805\uff1a<\/p>

5.10.2.1 \u3059\u3079\u3066\u306e\u6709\u52b9\u306aSOP\u306b\u306f\u3001\u6709\u52b9\u306a\u767a\u52b9\u65e5\u304a\u3088\u3073\u5c06\u6765\u306e\u6539\u8a02\u65e5\u304c\u660e\u8a18\u3055\u308c\u3066\u3044\u308b\u3002.<\/p>

5.10.2.2 \u6b21\u306e\u898b\u76f4\u3057\u671f\u65e5\u309230\u65e5\u4ee5\u4e0a\u8d85\u904e\u3057\u3066\u904b\u7528\u3055\u308c\u3066\u3044\u308bSOP\u306f\u306a\u3044\u3002.<\/p>

5.10.2.3 \u53d6\u308a\u4e0b\u3052\u3089\u308c\u305f\u5404\u30a8\u30f3\u30c8\u30ea\u30fc\u306b\u306f\u3001\u53d6\u308a\u4e0b\u3052\u65e5\u3068\u53d6\u308a\u4e0b\u3052\u7406\u7531\u304c\u8a18\u9332\u3055\u308c\u308b\u3002.<\/p>

5.10.2.4 \u30ea\u30b9\u30c8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u6570\u91cf\u306f\u3001QA\u30d5\u30a1\u30a4\u30eb\u5ba4\u306b\u4fdd\u7ba1\u3055\u308c\u3066\u3044\u308b\u7f72\u540d\u6e08\u307f\u30de\u30b9\u30bf\u30fc\u306e\u6570\u91cf\u3068\u4e00\u81f4\u3057\u3066\u3044\u308b\u3002.<\/p>

5.10.3 \u30ec\u30d3\u30e5\u30fc\u306e\u904e\u7a0b\u3067\u5224\u660e\u3057\u305f\u4e0d\u5099\u306f\u300115\u55b6\u696d\u65e5\u4ee5\u5185\u306b\u662f\u6b63\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u4e0d\u5099\u304c\u7e70\u308a\u8fd4\u3057\u767a\u751f\u3059\u308b\u5834\u5408\u306f\u3001QA\u8cac\u4efb\u8005\u304c\u305d\u306e\u539f\u56e0\u7a76\u660e\u306b\u3042\u305f\u308b\u3002.<\/p>

5.10.4 \u30ec\u30d3\u30e5\u30fc\u304c\u5b8c\u4e86\u3059\u308b\u3068\u3001\u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005\u304c\u627f\u8a8d\u3092\u884c\u3046\u3002\u305d\u306e\u5f8c\u3001\u5b8c\u4e86\u3057\u305f\u30ec\u30d3\u30e5\u30fc\u306f\u300c\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u30fb\u30ec\u30d3\u30e5\u30fc\u30ed\u30b0\u300d\u306b\u8a18\u9332\u3055\u308c\u308b\u3002.<\/p>

5.11 \u30a2\u30af\u30bb\u30b9\u304a\u3088\u3073\u914d\u5e03\uff1a<\/strong><\/h3>

5.11.1 \u5de5\u5834\u306e\u30b9\u30bf\u30c3\u30d5\u306f\u3001\u793e\u5185\u6587\u66f8\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306b\u30a2\u30af\u30bb\u30b9\u3057\u307e\u3059\u3002\u95b2\u89a7\u6a29\u9650\u306f\u5168\u54e1\u306b\u4ed8\u4e0e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u66f8\u304d\u8fbc\u307f\u6a29\u9650\u306f\u6587\u66f8\u7ba1\u7406\u62c5\u5f53\u8005\u306e\u307f\u304c\u6709\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>

5.11.2 \u505c\u96fb\u3084\u30b7\u30b9\u30c6\u30e0\u306e\u505c\u6b62\u6642\u306b\u30aa\u30d5\u30e9\u30a4\u30f3\u3067\u53c2\u7167\u3067\u304d\u308b\u3088\u3046\u3001\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306e\u5370\u5237\u7269\u3092\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u4e8b\u52d9\u6240\u306b\u4fdd\u7ba1\u3057\u3066\u3044\u308b\u3002.<\/p>

5.11.3 \u898f\u5236\u5f53\u5c40\u306e\u691c\u67fb\u5b98\u3084\u76e3\u67fb\u5f79\u306a\u3069\u306e\u5916\u90e8\u95a2\u4fc2\u8005\u306f\u3001\u8981\u8acb\u306b\u5fdc\u3058\u3066\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u5916\u90e8\u304b\u3089\u306e\u30a2\u30af\u30bb\u30b9\u306f\u3059\u3079\u3066\u3001\u6587\u66f8\u7ba1\u7406\u62c5\u5f53\u8005\u304c\u30a2\u30af\u30bb\u30b9\u8a18\u9332\u7c3f\u306b\u8a18\u9332\u3057\u307e\u3059\u3002.<\/p>

5.11.4 \u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306f\u3001\u54c1\u8cea\u4fdd\u8a3c\u8cac\u4efb\u8005\u306e\u66f8\u9762\u306b\u3088\u308b\u627f\u8a8d\u304c\u306a\u3044\u9650\u308a\u3001\u3044\u304b\u306a\u308b\u5834\u5408\u3082\u7b2c\u4e09\u8005\u306b\u63d0\u4f9b\u3057\u3066\u306f\u306a\u3089\u306a\u3044\u3002\u5171\u6709\u3055\u308c\u308b\u30b3\u30d4\u30fc\u306b\u306f\u3001\u6a5f\u5bc6\u4fdd\u6301\u3092\u793a\u3059\u900f\u304b\u3057\u3092\u5165\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>

5.12 \u6587\u66f8\u306e\u4fdd\u5b58\uff1a<\/strong><\/h3>

5.12.1 \u3059\u3079\u3066\u306eSOP\u306e\u5168\u30d0\u30fc\u30b8\u30e7\u30f3\u306f\u3001\u5f53\u8a72\u65bd\u8a2d\u306eGMP\u8a18\u9332\u306e\u4e00\u90e8\u3068\u3057\u3066\u4fdd\u5b58\u3055\u308c\u308b\u3002\u73fe\u884c\u3001\u30a2\u30fc\u30ab\u30a4\u30d6\u6e08\u307f\u3001\u304a\u3088\u3073\u5ec3\u6b62\u3055\u308c\u305fSOP\u306f\u3001\u305d\u306e\u4f5c\u6210\u6642\u671f\u306b\u304b\u304b\u308f\u3089\u305a\u3001\u3059\u3079\u3066\u30d5\u30a1\u30a4\u30eb\u306b\u4fdd\u5b58\u3055\u308c\u308b\u3002.<\/p>

5.12.2 \u53d6\u308a\u4e0b\u3052\u3089\u308c\u305fSOP\u306b\u3064\u3044\u3066\u306f\u3001\u4fdd\u5b58\u671f\u9593\u306f\u53d6\u308a\u4e0b\u3052\u306e\u65e5\u304b\u30895\u5e74\u9593\u3068\u3059\u308b\u3002\u5f53\u8a72SOP\u304c\u30d0\u30c3\u30c1\u88fd\u9020\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u305f\u5834\u5408\u3001\u4fdd\u5b58\u671f\u9593\u306f\u3001\u305d\u306eSOP\u306b\u57fa\u3065\u3044\u3066\u88fd\u9020\u3055\u308c\u305f\u6700\u5f8c\u306e\u30d0\u30c3\u30c1\u306e\u6709\u52b9\u671f\u9650\u306b1\u5e74\u3092\u52a0\u3048\u305f\u671f\u9593\u3001\u307e\u305f\u306f5\u5e74\u9593\u306e\u3046\u3061\u3044\u305a\u308c\u304b\u9577\u3044\u65b9\u306e\u671f\u9593\u3068\u3059\u308b\u3002.<\/p>

5.12.3 \u6709\u52b9\u306aSOP\u306e\u30a2\u30fc\u30ab\u30a4\u30d6\u7248\u306f\u3001\u73fe\u884c\u7248\u304c\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u9650\u308a\u3001\u30d5\u30a1\u30a4\u30eb\u3068\u3057\u3066\u4fdd\u5b58\u3055\u308c\u308b\u3002\u73fe\u884c\u7248\u81ea\u4f53\u304c\u5ec3\u6b62\u3055\u308c\u308b\u3068\u3001\u30d0\u30fc\u30b8\u30e7\u30f3\u5c65\u6b74\u5168\u4f53\u306f\u4e0a\u8a18\u306e\u5ec3\u6b62\u898f\u5247\u306e\u5bfe\u8c61\u3068\u306a\u308b\u3002.<\/p>

5.12.4 \u30ea\u30f3\u30af\u3055\u308c\u305f\u30d0\u30fc\u30b8\u30e7\u30f3\u5c65\u6b74\u306f\u3001\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u81ea\u4f53\u306b\u4fdd\u5b58\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u4efb\u610f\u306eSOP\u756a\u53f7\u3092\u30af\u30ea\u30c3\u30af\u3059\u308b\u3068\u3001\u65e5\u4ed8\u3001\u4f5c\u6210\u8005\u3001\u6539\u8a02\u7406\u7531\u304c\u8a18\u8f09\u3055\u308c\u305f\u30d0\u30fc\u30b8\u30e7\u30f3\u5c65\u6b74\u304c\u8868\u793a\u3055\u308c\u307e\u3059\u3002.<\/p>

5.12.5 \u7d19\u306e\u539f\u672c\u306f\u3001\u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\u30d5\u30a1\u30a4\u30eb\u5ba4\u5185\u306e\u8010\u706b\u30ad\u30e3\u30d3\u30cd\u30c3\u30c8\u306b\u4fdd\u7ba1\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u96fb\u5b50\u7248\u306e\u539f\u672c\u306f\u3001\u6bce\u65e5\u3001\u793e\u5916\u306e\u30b5\u30fc\u30d0\u30fc\u306b\u30d0\u30c3\u30af\u30a2\u30c3\u30d7\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p>

5.13 \u76e3\u67fb\u3078\u306e\u6e96\u5099\u72b6\u6cc1\uff1a<\/strong><\/h3>

5.13.1 \u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u67fb\u5bdf\u306e\u969b\u3001\u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306f\u76e3\u67fb\u4eba\u304c\u8981\u6c42\u3059\u308b\u4e3b\u8981\u306a\u66f8\u985e\u306e\u4e00\u3064\u3067\u3042\u308b\u3002\u76e3\u67fb\u3067\u8981\u6c42\u304c\u3042\u3063\u305f\u5834\u5408\u306f\u3001\u6587\u66f8\u7ba1\u7406\u62c5\u5f53\u8005\u306f10\u5206\u4ee5\u5185\u306b\u6700\u65b0\u306e\u30ea\u30b9\u30c8\u3092\u53d6\u308a\u51fa\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002.<\/p>

5.13.2 \u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306b\u95a2\u3059\u308b\u4e00\u822c\u7684\u306a\u76e3\u67fb\u4e0a\u306e\u8cea\u554f\u306b\u306f\u3001\u6b21\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308b\uff1a<\/p>

5.13.2.1 \u73fe\u5728\u3001\u30ea\u30b9\u30c8\u306b\u306f\u3044\u304f\u3064\u306e\u6709\u52b9\u306aSOP\u304c\u63b2\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/p>

5.13.2.2 \u5404SOP\u306f\u6700\u5f8c\u306b\u3044\u3064\u898b\u76f4\u3055\u308c\u307e\u3057\u305f\u304b\uff1f<\/p>

5.13.2.3 \u7279\u5b9a\u306eSOP\u306b\u3064\u3044\u3066\u3001\u73fe\u884c\u30d0\u30fc\u30b8\u30e7\u30f3\u3068\u4ee5\u524d\u306e\u30d0\u30fc\u30b8\u30e7\u30f3\u3067\u306f\u3069\u306e\u3088\u3046\u306a\u5909\u66f4\u304c\u3042\u3063\u305f\u304b\uff1f<\/p>

5.13.2.4 \u30b5\u30a4\u30c8\u306f\u3001\u3059\u3079\u3066\u306e\u30e6\u30fc\u30b6\u30fc\u304c\u6b63\u3057\u3044\u30d0\u30fc\u30b8\u30e7\u30f3\u306eSOP\u3092\u6240\u6301\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u3069\u306e\u3088\u3046\u306b\u78ba\u8a8d\u3057\u3066\u3044\u308b\u306e\u304b\uff1f<\/p>

5.13.3 \u4e0a\u8a18\u306e\u8cea\u554f\u306b\u56de\u7b54\u3067\u304d\u308b\u3088\u3046\u3001\u6a19\u6e96\u306e\u76e3\u67fb\u8cc7\u6599\u4e00\u5f0f\u3092\u5e38\u5099\u3057\u3066\u304a\u304f\u3053\u3068\u3002\u76e3\u67fb\u8cc7\u6599\u4e00\u5f0f\u306f\u3001\u6bce\u6708\u7b2c1\u55b6\u696d\u65e5\u306b\u66f4\u65b0\u3055\u308c\u308b\u3002.<\/p>

5.13.4 \u76e3\u67fb\u4e2d\u306b\u767a\u898b\u3055\u308c\u305f\u4e0d\u5099\u306f\u3001\u3059\u3079\u3066\u9038\u8131\u3068\u3057\u3066\u6271\u308f\u308c\u308b\u3002\u73fe\u5834\u306e\u9038\u8131\u5bfe\u5fdc\u624b\u9806\u66f8\uff08SOP\uff09\u306b\u57fa\u3065\u304d\u9038\u8131\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3057\u300130\u65e5\u4ee5\u5185\u306b\u305d\u306e\u4e0d\u5099\u3092\u662f\u6b63\u3059\u308b\u3053\u3068\u3002.<\/p>

5.14 \u8a18\u9332\uff1a<\/strong><\/h3>

5.14.1 SOP\u306e\u7dcf\u89a7\u3002.<\/p>

5.14.2 \u8cc7\u6599\u8acb\u6c42\u66f8\u3002.<\/p>

5.14.3 \u6587\u66f8\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3002.<\/p>

5.14.4 \u6587\u66f8\u306e\u914d\u5e03\u8a18\u9332\u3002.<\/p>

5.14.5 \u30de\u30b9\u30bf\u30fc\u30ea\u30b9\u30c8\u306e\u30ec\u30d3\u30e5\u30fc\u30ed\u30b0\u3002.<\/p>

5.14.6 \u30a2\u30af\u30bb\u30b9\u30ec\u30b8\u30b9\u30bf\u3002.<\/p>

5.14.7 \u76e3\u67fb\u30d1\u30c3\u30af\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 \u54c1\u8cea\u4fdd\u8a3c\uff08QA\uff09\uff1a<\/strong> \u54c1\u8cea\u4fdd\u8a3c\u3002.<\/p>

6.3 CAPA\uff1a<\/strong> \u662f\u6b63\u63aa\u7f6e\u3068\u4e88\u9632\u63aa\u7f6e\u3002.<\/p>

6.4 GMP\uff1a <\/strong>\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 for managing the list of Quality Assurance SOPs in the Pharmaceutical Industry. 1.0 OBJECTIVE: To lay down […]<\/p>\n","protected":false},"author":1,"featured_media":16054,"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":[61],"tags":[],"class_list":["post-15889","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-technology"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/15889","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=15889"}],"version-history":[{"count":0,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/15889\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/16054"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=15889"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=15889"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=15889"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}