{"id":8743,"date":"2025-12-22T01:22:18","date_gmt":"2025-12-22T01:22:18","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=8743"},"modified":"2026-02-05T02:48:49","modified_gmt":"2026-02-05T02:48:49","slug":"sop-for-capsule-counting-machine","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/ja\/sop-for-capsule-counting-machine\/","title":{"rendered":"\u30ab\u30d7\u30bb\u30eb\u8a08\u6570\u6a5f\u306e\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u3001\u64cd\u4f5c\u3001\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3\u306b\u95a2\u3059\u308bSOP"},"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

\u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30bf\u30fcSOP\u6587\u66f8\u306f\u3001\u88fd\u85ac\u65bd\u8a2d\u306b\u304a\u3051\u308b\u30ab\u30d7\u30bb\u30eb\u8a08\u6570\u65b9\u6cd5\u3092\u898f\u5b9a\u3059\u308bGMP\u8981\u4ef6\u3067\u3059\u3002\u6a19\u6e96\u64cd\u4f5c\u624b\u9806\u304c\u306a\u3051\u308c\u3070\u3001\u8a08\u6570\u306f\u4e3b\u89b3\u7684\u306b\u306a\u308a\u3001\u4e00\u8cab\u6027\u304c\u306a\u304f\u306a\u308a\u3001\u30ea\u30b9\u30af\u304c\u9ad8\u307e\u308a\u307e\u3059\u3002.<\/p>

\"\u8aac\u660e\u66f8\u4ed8\u304d\u306e\u30ab\u30d7\u30bb\u30eb\u8a08\u6570\u6a5f\u3002.\"
\u30ab\u30d7\u30bb\u30eb\u8a08\u6570\u6a5f\u306eSOP<\/strong><\/figcaption><\/figure>

\u4ee5\u4e0b\u3067\u306f\u3001\u88fd\u85ac\u696d\u754c\u3067\u4e00\u822c\u7684\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30bf\u30fc\u306eSOP\u3092\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002\u3053\u308c\u3089\u3092\u53c2\u8003\u306b\u3001\u8cb4\u65bd\u8a2d\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u5408\u308f\u305b\u3066\u30ab\u30b9\u30bf\u30de\u30a4\u30ba\u3055\u308c\u305fSOP\u3092\u4f5c\u6210\u3044\u305f\u3060\u304f\u3053\u3068\u3082\u3001\u3059\u3050\u306b\u3054\u5229\u7528\u3044\u305f\u3060\u3051\u308b\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3092\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3057\u3066\u3044\u305f\u3060\u304f\u3053\u3068\u3082\u53ef\u80fd\u3067\u3059\u3002.<\/p>

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

\u3053\u306e\u9320\u5264\uff0f\u30ab\u30d7\u30bb\u30eb\u8a08\u6570\u6a5fSOP\u306e\u76ee\u7684\u306f\u3001\u30ab\u30d7\u30bb\u30eb\u8a08\u6570\u6a5f\u306e\u6e96\u5099\u3001\u64cd\u4f5c\u3001\u691c\u8a3c\u3001\u8a18\u9332\u3001\u304a\u3088\u3073\u6d17\u6d44\u306e\u624b\u9806\u3092\u6bb5\u968e\u7684\u306b\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u3053\u306e\u624b\u9806\u306b\u3088\u308a\u3001\u5404\u30dc\u30c8\u30eb\u3001\u30d1\u30a6\u30c1\u3001\u307e\u305f\u306f\u5bb9\u5668\u306b\u30d0\u30c3\u30c1\u88fd\u9020\u8a18\u9332\uff08BMR\uff09\u306b\u5f93\u3063\u3066\u6b63\u3057\u3044\u6570\u306e\u30ab\u30d7\u30bb\u30eb\u304c\u78ba\u5b9f\u306b\u88c5\u586b\u3055\u308c\u307e\u3059\u3002.<\/p>

\u3053\u306e SOP \u306f\u3001\u30ab\u30d7\u30bb\u30eb\u8a08\u6570\u64cd\u4f5c\u4e2d\u306e\u8a08\u6570\u30a8\u30e9\u30fc\u3001\u53d6\u308a\u9055\u3048\u3001\u76f8\u4e92\u6c5a\u67d3\u3001\u9038\u8131\u3092\u9632\u3050\u3053\u3068\u3082\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>

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

\u3053\u306eSOP\u306f\u4ee5\u4e0b\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>

2.0.1: \u88fd\u9020\u30a8\u30ea\u30a2\u307e\u305f\u306f\u5305\u88c5\u30a8\u30ea\u30a2\u3067\u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30c8\u696d\u52d9\u306b\u5272\u308a\u5f53\u3066\u3089\u308c\u305f\u3059\u3079\u3066\u306e\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u3002.<\/p>

2.0.2: \u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30c8\u4f5c\u696d\u3092\u76e3\u7763\u3059\u308b\u751f\u7523\u76e3\u7763\u8005\u3002.<\/p>

2.0.3: \u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u78ba\u8a8d\u3068\u627f\u8a8d\u3092\u62c5\u5f53\u3059\u308b\u54c1\u8cea\u4fdd\u8a3c (QA) \u62c5\u5f53\u8005\u3002.<\/p>

2.0.4: \u7d4c\u53e3\u56fa\u5f62\u5264\u5f62\u306b\u4f7f\u7528\u3055\u308c\u308b\u534a\u81ea\u52d5\u307e\u305f\u306f\u81ea\u52d5\u306e\u30ab\u30d7\u30bb\u30eb\u8a08\u6570\u6a5f\u3002.<\/p>

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

3.0.1: SOP \u304c\u9075\u5b88\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u8cac\u4efb\u3092\u8ca0\u3046\u5f93\u696d\u54e1\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>

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

3.1.1: \u8d77\u52d5\u524d\u306b\u6a5f\u68b0\u3068\u6750\u6599\u3092\u6e96\u5099\u3057\u307e\u3059\u3002.<\/p>

3.1.2: \u3053\u306eSOP\u306b\u5f93\u3063\u3066\u30ab\u30d7\u30bb\u30eb\u307e\u305f\u306f\u9320\u5264\u8a08\u6570\u6a5f\u3092\u64cd\u4f5c\u3057\u307e\u3059\u3002.<\/p>

3.1.3: \u30ab\u30d7\u30bb\u30eb\u306e\u30b5\u30a4\u30ba\u3001\u6570\u91cf\u3001\u901f\u5ea6\u3001\u30d0\u30c3\u30c1\u306e\u8a73\u7d30\u304c\u6b63\u3057\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

3.1.4: \u5fc5\u8981\u306b\u5fdc\u3058\u3066\u5de5\u7a0b\u5185\u30c1\u30a7\u30c3\u30af\u3001\u6a5f\u68b0\u8abf\u6574\u3001\u505c\u6b62\u3092\u5b9f\u884c\u3057\u307e\u3059\u3002.<\/p>

3.1.5: \u3059\u3079\u3066\u306e\u30c7\u30fc\u30bf\u3092 BMR \u3068\u95a2\u9023\u30ed\u30b0\u306b\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u3067\u8a18\u9332\u3057\u307e\u3059\u3002.<\/p>

3.1.6: \u4e0d\u4e00\u81f4\u3084\u7570\u5e38\u304c\u3042\u3063\u305f\u5834\u5408\u306f\u3001\u76f4\u3061\u306b\u88fd\u9020\u7ba1\u7406\u8005\u306b\u5831\u544a\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

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

3.2.1: \u64cd\u4f5c\u524d\u306b\u6a5f\u68b0\u306e\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u304c\u6b63\u3057\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

3.2.2: \u627f\u8a8d\u3055\u308c\u305f BMR \u306b\u5f93\u3063\u3066\u30ab\u30a6\u30f3\u30c8\u304c\u5b9f\u884c\u3055\u308c\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

3.2.3: \u64cd\u4f5c\u524d\u5f8c\u306e\u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

3.2.4: \u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u304b\u3089\u5831\u544a\u3055\u308c\u305f\u77db\u76fe\u3084\u7570\u5e38\u3092\u8abf\u67fb\u3057\u307e\u3059\u3002.<\/p>

3.2.5: \u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u304c GMP\u3001\u5b89\u5168\u6027\u3001\u304a\u3088\u3073\u6587\u66f8\u5316\u306e\u57fa\u6e96\u306b\u5f93\u3063\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: \u5b8c\u4e86\u3057\u305f BMR \u30a8\u30f3\u30c8\u30ea\u3001\u30d7\u30ed\u30bb\u30b9\u4e2d\u306e\u30c1\u30a7\u30c3\u30af\u3001\u304a\u3088\u3073\u30ed\u30b0\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

3.3.2: SOP\u3001GMP\u3001\u304a\u3088\u3073\u898f\u5236\u8981\u4ef6\u3078\u306e\u6e96\u62e0\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

3.3.3: \u6e05\u6383\u3068\u6587\u66f8\u306e\u78ba\u8a8d\u3092\u884c\u3063\u305f\u5f8c\u3001\u6b21\u306e\u30d0\u30c3\u30c1\u306b\u30ea\u30ea\u30fc\u30b9\u3059\u308b\u524d\u306b\u6a5f\u5668\u3092\u627f\u8a8d\u3057\u307e\u3059\u3002.<\/p>

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

\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306f\u3001\u30a2\u30af\u30c6\u30a3\u30d3\u30c6\u30a3\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001\u4ee5\u4e0b\u306b\u30ea\u30b9\u30c8\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u306a\u6750\u6599\u304c\u3059\u3079\u3066\u63c3\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

4.0.1: \u6b63\u3057\u3044\u30ab\u30d7\u30bb\u30eb\u30b5\u30a4\u30ba\u306b\u5408\u308f\u305b\u3066\u3059\u3079\u3066\u306e\u90e8\u54c1\u304c\u7d44\u307f\u7acb\u3066\u3089\u308c\u305f\u9320\u5264\/\u30ab\u30d7\u30bb\u30eb\u8a08\u6570\u6a5f\u3002.<\/p>

4.0.2: BMR \u3067\u6307\u5b9a\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u30dc\u30c8\u30eb\u3001\u30dd\u30fc\u30c1\u3001\u307e\u305f\u306f\u5bb9\u5668\u3092\u7a7a\u306b\u3057\u307e\u3059\u3002.<\/p>

4.0.3: \u30d0\u30c3\u30c1\u88fd\u9020\u8a18\u9332 (BMR)\u3002.<\/p>

4.0.4: \u30d0\u30fc\u30b3\u30fc\u30c9\u307e\u305f\u306f\u5370\u5237\u3055\u308c\u305f\u30e9\u30d9\u30eb (\u8a72\u5f53\u3059\u308b\u5834\u5408)\u3002.<\/p>

4.0.5: \u30af\u30ea\u30fc\u30cb\u30f3\u30b0 \u30c4\u30fc\u30eb: \u30d6\u30e9\u30b7\u3001\u627f\u8a8d\u3055\u308c\u305f\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u5264\u3001\u7cf8\u304f\u305a\u306e\u51fa\u306a\u3044\u30ef\u30a4\u30d7\u3002.<\/p>

4.0.6: \u624b\u888b\u3068\u4fdd\u8b77\u670d\u3002.<\/p>

4.0.7: \u6821\u6b63\u91cd\u91cf\uff08\u91cd\u91cf\u30d9\u30fc\u30b9\u306e\u691c\u8a3c\u3092\u4f7f\u7528\u3059\u308b\u5834\u5408\uff09\u3002.<\/p>

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

\u8ab0\u3082\u304c\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308b\u624b\u9806\u306f\u6b21\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>

5.1 SOP\u76ee\u7684\u306e\u691c\u8a3c<\/b><\/strong><\/h3>

5.1.1: \u59cb\u3081\u308b\u524d\u306b\u3001BMR \u3068\u3053\u306e SOP \u3092\u8aad\u3093\u3067\u7406\u89e3\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.1.2: \u88fd\u54c1\u540d\u3001\u5f37\u5ea6\u3001\u30ab\u30d7\u30bb\u30eb\u30b5\u30a4\u30ba\u3001\u30d0\u30c3\u30c1\u756a\u53f7\u3001\u5145\u586b\u91cf\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

5.2 \u64cd\u4f5c\u524d\u306e\u8a2d\u5b9a<\/b><\/strong><\/h3>

5.2.1: \u6a5f\u68b0\u304c\u6e05\u6f54\u3067\u3001\u6a5f\u5668\u30b9\u30c6\u30fc\u30bf\u30b9 \u30e9\u30d9\u30eb\u306b\u300c\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u6e08\u307f\u300d\u3068\u8868\u793a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

5.2.2: \u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30bf\u30fc\u3092\u300c\u30aa\u30f3\u300d\u306b\u3057\u307e\u3059\u3002.<\/p>

5.2.3: \u9078\u629e:<\/p>

5.2.3.1: \u6b63\u3057\u3044\u30ab\u30d7\u30bb\u30eb\u30b5\u30a4\u30ba<\/p>

5.2.3.2: \u30dc\u30c8\u30eb\u3042\u305f\u308a\u306e\u5fc5\u8981\u6570\u91cf<\/p>

5.2.3.3: \u751f\u7523\u901f\u5ea6\u307e\u305f\u306f\u632f\u52d5\u30ec\u30d9\u30eb<\/p>

5.2.3.4: \u30d0\u30c3\u30c1\u306e\u8a73\u7d30\uff08\u30de\u30b7\u30f3\u306b\u5165\u529b\u304c\u5fc5\u8981\u306a\u5834\u5408\uff09<\/p>

5.2.4: \u5c11\u6570\u306e\u9320\u5264\u307e\u305f\u306f\u30ab\u30d7\u30bb\u30eb\u3067\u7c21\u5358\u306a\u30c6\u30b9\u30c8\u3092\u5b9f\u884c\u3057\u307e\u3059\u3002.<\/p>

5.2.5: \u30db\u30c3\u30d1\u30fc\u3068\u30b7\u30e5\u30fc\u30c8\u3092\u901a\u308b\u30b9\u30e0\u30fc\u30ba\u306a\u52d5\u304d\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

5.2.6: \u5149\u96fb\u5f0f\u307e\u305f\u306f\u6a5f\u68b0\u5f0f\u30bb\u30f3\u30b5\u30fc\u304c\u6b63\u3057\u304f\u8aad\u307f\u53d6\u308c\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002.<\/p>

5.2.7: \u30ab\u30d7\u30bb\u30eb\u304c\u8a70\u307e\u3063\u305f\u308a\u30d6\u30ea\u30c3\u30b8\u3057\u305f\u308a\u3059\u308b\u5834\u5408\u306f\u3001\u632f\u52d5\u307e\u305f\u306f\u6d41\u308c\u306e\u89d2\u5ea6\u3092\u8abf\u6574\u3057\u307e\u3059\u3002.<\/p>

5.2.8: \u5b9f\u884c\u524d\u306e\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b\u88fd\u9020\u30b9\u30fc\u30d1\u30fc\u30d0\u30a4\u30b6\u30fc\u306b\u9023\u7d61\u3057\u307e\u3059\u3002.<\/p>

5.3 \u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30c8\u64cd\u4f5c<\/b><\/strong><\/h3>

5.3.1: \u9320\u5264\u307e\u305f\u306f\u30ab\u30d7\u30bb\u30eb\u3092\u30db\u30c3\u30d1\u30fc\u306b\u9759\u304b\u306b\u6ce8\u304e\u5165\u308c\u307e\u3059\u3002\u904e\u5270\u5145\u586b\u306b\u6ce8\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>

5.3.2: \u7d99\u7d9a\u7684\u304b\u3064\u5b89\u5b9a\u3057\u305f\u6d41\u308c\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002.<\/p>

5.3.3: \u627f\u8a8d\u3055\u308c\u305f\u8a2d\u5b9a\u306b\u5f93\u3063\u3066\u30ab\u30a6\u30f3\u30c8\u64cd\u4f5c\u3092\u958b\u59cb\u3057\u307e\u3059\u3002.<\/p>

5.3.4: \u89b3\u5bdf:<\/p>

5.3.4.1: \u30ab\u30d7\u30bb\u30eb\u306e\u6d41\u308c<\/p>

5.3.4.2: \u30bb\u30f3\u30b5\u30fc\u6027\u80fd<\/p>

5.3.4.3: \u30dc\u30c8\u30eb\u306e\u4f4d\u7f6e\u5408\u308f\u305b<\/p>

5.3.4.4: \u30ab\u30a6\u30f3\u30c8\u306e\u4e00\u8cab\u6027<\/p>

5.3.5: \u6b21\u306e\u5834\u5408\u306b\u306f\u76f4\u3061\u306b\u6a5f\u68b0\u3092\u505c\u6b62\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>

5.3.5.1: \u59a8\u5bb3\u304c\u767a\u751f\u3059\u308b<\/p>

5.3.5.2: \u30ab\u30d7\u30bb\u30eb\u307e\u305f\u306f\u9320\u5264\u304c\u8df3\u306d\u305f\u308a\u4e8c\u91cd\u30ab\u30a6\u30f3\u30c8\u3055\u308c\u305f\u308a\u3057\u305f\u5834\u5408<\/p>

5.3.5.3: \u305a\u308c\u304c\u898b\u3089\u308c\u308b<\/p>

5.3.6: \u518d\u958b\u3059\u308b\u524d\u306b\u554f\u984c\u3092\u4fee\u6b63\u3057\u307e\u3059\u3002.<\/p>

5.3.7: \u30d0\u30c3\u30c1\u5168\u4f53\u304c\u5b8c\u4e86\u3059\u308b\u307e\u3067\u64cd\u4f5c\u3092\u7d9a\u884c\u3057\u307e\u3059\u3002.<\/p>

5.4 \u5de5\u7a0b\u5185\u691c\u8a3c<\/b><\/strong><\/h3>

5.4.1: \u5b9a\u671f\u7684\u306b\u30ab\u30a6\u30f3\u30bf\u691c\u8a3c\u3092\u5b9f\u884c\u3059\u308b\uff08BMR\u306b\u5f93\u3063\u3066\uff09<\/p>

5.4.2: \u6e80\u305f\u3055\u308c\u305f\u30b3\u30f3\u30c6\u30ca\u3092\u30e9\u30f3\u30c0\u30e0\u306b\u9078\u629e\u3057\u307e\u3059\u3002.<\/p>

5.4.3: \u6b21\u306e\u3044\u305a\u308c\u304b\u306e\u65b9\u6cd5\u3067\u30ab\u30a6\u30f3\u30c8\u3092\u691c\u8a3c\u3057\u307e\u3059\u3002<\/p>

5.4.3.1: \u624b\u4f5c\u696d\u306b\u3088\u308b\u518d\u96c6\u8a08<\/p>

5.4.3.2: \u5e73\u5747\u30ab\u30d7\u30bb\u30eb\u91cd\u91cf\u3092\u4f7f\u7528\u3057\u305f\u91cd\u91cf\u30c1\u30a7\u30c3\u30af<\/p>

5.4.4: \u4e0d\u4e00\u81f4\u304c\u898b\u3064\u304b\u3063\u305f\u5834\u5408:<\/p>

5.4.4.1: \u30de\u30b7\u30f3\u3092\u505c\u6b62\u3059\u308b<\/p>

5.4.4.2: \u5f71\u97ff\u3092\u53d7\u3051\u308b\u30b3\u30f3\u30c6\u30ca\u3092\u9694\u96e2\u3059\u308b<\/p>

5.4.4.3: \u554f\u984c\u3092\u518d\u5ea6\u96c6\u8a08\u3057\u3066\u4fee\u6b63\u3059\u308b<\/p>

5.4.5: \u7d50\u679c\u3092\u3059\u3050\u306b BMR \u306b\u8a18\u9332\u3057\u307e\u3059\u3002.<\/p>

5.4.6: \u5c0f\u3055\u306a\u5909\u5316\u3082\u7121\u8996\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002.<\/p>

5.5 \u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u8981\u4ef6<\/b><\/strong><\/h3>

5.5.1: \u3059\u3079\u3066\u306e\u6a5f\u68b0\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u30c1\u30a7\u30c3\u30af\u3001\u4fee\u6b63\u3001\u304a\u3088\u3073\u30ab\u30a6\u30f3\u30c8\u3092\u6b21\u306e\u5834\u6240\u306b\u8a18\u9332\u3057\u307e\u3059\u3002<\/p>

5.5.1.1: BMR<\/p>

5.5.1.2: \u6a5f\u5668\u30ed\u30b0\u30d6\u30c3\u30af<\/p>

5.5.1.3: \u5de5\u7a0b\u5185\u7ba1\u7406\u30b7\u30fc\u30c8<\/p>

5.5.2: \u6587\u66f8\u5316\u306f\u30a2\u30af\u30c6\u30a3\u30d3\u30c6\u30a3\u306e\u5b9f\u884c\u6642\u306b\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u3001\u5f8c\u304b\u3089\u884c\u3046\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002.<\/p>

5.5.3: \u8a18\u9332:<\/p>

5.5.3.1: \u30de\u30b7\u30f3\u8a2d\u5b9a<\/p>

5.5.3.2: \u30ab\u30d7\u30bb\u30eb\u306e\u7dcf\u6570<\/p>

5.5.3.3: \u62d2\u5426<\/p>

5.5.3.4: \u884c\u308f\u308c\u305f\u8abf\u6574<\/p>

5.5.3.5: \u65e5\u4ed8\u3068\u6642\u523b\u3092\u542b\u3080\u30aa\u30da\u30ec\u30fc\u30bf\u306e\u30a4\u30cb\u30b7\u30e3\u30eb<\/p>

5.5.4: \u300c\u66f8\u304b\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306f\u3001\u884c\u308f\u308c\u3066\u3044\u306a\u3044\u3068\u307f\u306a\u3055\u308c\u307e\u3059\u3002\u300d\u201c<\/p>

5.6 \u64cd\u4f5c\u5f8c\u306e\u6e05\u6383\u3068\u30b7\u30e3\u30c3\u30c8\u30c0\u30a6\u30f3<\/b><\/strong><\/h3>

5.6.1: \u6a5f\u68b0\u306e\u96fb\u6e90\u3092\u30aa\u30d5\u306b\u3057\u307e\u3059\u3002.<\/p>

5.6.2: \u30db\u30c3\u30d1\u30fc\u3001\u30b7\u30e5\u30fc\u30c8\u3001\u30c8\u30ec\u30a4\u304b\u3089\u6b8b\u308a\u306e\u30ab\u30d7\u30bb\u30eb\u3092\u3059\u3079\u3066\u53d6\u308a\u9664\u304d\u307e\u3059\u3002.<\/p>

5.6.3: \u63a5\u89e6\u90e8\u54c1\u3092\u614e\u91cd\u306b\u5206\u89e3\u3057\u307e\u3059\u3002.<\/p>

5.6.4: \u627f\u8a8d\u3055\u308c\u305f\u6d17\u6d44\u5264\u3092\u4f7f\u7528\u3057\u3066\u5404\u90e8\u54c1\u3092\u6d17\u6d44\u3057\u307e\u3059\u3002.<\/p>

5.6.5: \u7c89\u672b\u3001\u6b8b\u7559\u7269\u3001\u307b\u3053\u308a\u3092\u3059\u3079\u3066\u9664\u53bb\u3057\u307e\u3059\u3002.<\/p>

5.6.6: \u7cf8\u304f\u305a\u306e\u51fa\u306a\u3044\u5e03\u3067\u6a5f\u68b0\u306e\u8868\u9762\u3092\u62ed\u304d\u307e\u3059\u3002.<\/p>

5.6.7: \u843d\u3061\u305f\u30ab\u30d7\u30bb\u30eb\u3084\u6b8b\u7559\u7269\u3092\u53d6\u308a\u9664\u304f\u305f\u3081\u306b\u5468\u56f2\u306e\u30a8\u30ea\u30a2\u3092\u6e05\u6383\u3057\u307e\u3059\u3002.<\/p>

5.6.8: \u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3092\u5b9f\u884c\u3057\u3001\u305d\u308c\u3092\u6587\u66f8\u5316\u3057\u307e\u3059\u3002.<\/p>

5.6.9: \u6b21\u306e\u5185\u5bb9\u3092\u542b\u3080\u6a5f\u5668\u6e05\u6383\u30ed\u30b0\u306b\u7f72\u540d\u3057\u307e\u3059\u3002<\/p>

5.6.9.1: \u30d0\u30c3\u30c1\u756a\u53f7<\/p>

5.6.9.2: \u88fd\u54c1\u540d<\/p>

5.6.9.3: \u6e05\u6383\u65e5\u6642<\/p>

5.6.9.4: \u30aa\u30da\u30ec\u30fc\u30bf\u306e\u30a4\u30cb\u30b7\u30e3\u30eb<\/p>

5.6.10: \u76e3\u7763\u8005\u3068 QA \u306f\u3001\u6a5f\u68b0\u3092\u89e3\u653e\u3059\u308b\u524d\u306b\u6e05\u6383\u3092\u691c\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

6.0 \u53d7\u3051\u5165\u308c\u57fa\u6e96<\/b><\/strong><\/h2>

6.0.1: \u3059\u3079\u3066\u306e\u5bb9\u5668\u306b\u306f\u3001BMR \u306b\u5f93\u3063\u305f\u6b63\u78ba\u306a\u6570\u306e\u30ab\u30d7\u30bb\u30eb\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

6.0.2: \u76f8\u4e92\u6c5a\u67d3\u3084\u6df7\u540c\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>

6.0.3: \u5b8c\u5168\u304b\u3064\u6b63\u78ba\u306a\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u306e\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3002.<\/p>

6.0.4: \u30ea\u30ea\u30fc\u30b9\u524d\u306b\u6a5f\u68b0\u3092\u6b8b\u7559\u7269\u304c\u306a\u3044\u3088\u3046\u306b\u6e05\u6383\u3057\u307e\u3059\u3002.<\/p>

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

7.0.1: BMR<\/b><\/strong>: \u30d0\u30c3\u30c1\u56fa\u6709\u306e\u6307\u793a\u3092\u542b\u3080\u30d0\u30c3\u30c1\u88fd\u9020\u30ec\u30b3\u30fc\u30c9\u3002.<\/p>

7.0.2: \u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30bf\u30fc<\/b><\/strong>: \u30ab\u30d7\u30bb\u30eb\u3092\u6570\u3048\u3066\u5bb9\u5668\u306b\u8a70\u3081\u308b\u6a5f\u68b0\u3002.<\/p>

7.0.3:\u00a0\u30e9\u30a4\u30f3\u30af\u30ea\u30a2\u30e9\u30f3\u30b9<\/b><\/strong>: \u524d\u306e\u30d0\u30c3\u30c1\u306e\u6750\u6599\u304c\u305d\u306e\u30a8\u30ea\u30a2\u306b\u6b8b\u3063\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3002.<\/p>

7.0.4:\u00a0\u5de5\u7a0b\u5185\u30c1\u30a7\u30c3\u30af<\/b><\/strong>: \u6b63\u78ba\u6027\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u64cd\u4f5c\u4e2d\u306b\u691c\u8a3c\u3057\u307e\u3059\u3002.<\/p>

\u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30bf\u30fcSOP PDF\u3092\u7121\u6599\u3067\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<\/b><\/strong><\/h2>

\u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30bf\u30fcSOP PDF\u3092\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9<\/i><\/b><\/u><\/em><\/strong><\/a><\/p>

\u5f0a\u793e\u304c\u3054\u7528\u610f\u3057\u305f\u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30bf\u30fcSOP 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\u30b9\u30c6\u30c3\u30d7\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>

\u9069\u5207\u306aSOP\u306f\u9069\u5207\u306a\u6a5f\u68b0\u3067\u6a5f\u80fd\u3057\u307e\u3059<\/b><\/strong><\/h2>

\u30ab\u30d7\u30bb\u30eb\u30ab\u30a6\u30f3\u30bf\u30fcSOP\u306f\u3001\u4f5c\u696d\u624b\u9806\u3092\u4f53\u7cfb\u5316\u3057\u3001\u30df\u30b9\u3092\u6e1b\u3089\u3057\u3001\u65bd\u8a2d\u304b\u3089\u51fa\u8377\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u30e6\u30cb\u30c3\u30c8\u304c\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u304a\u6301\u3061\u306e\u6a5f\u68b0\u304c\u6b63\u78ba\u306b\u52d5\u4f5c\u3057\u3001\u4e00\u8cab\u3057\u305f\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3092\u767a\u63ee\u3059\u308b\u3053\u3068\u306f\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002.<\/p>

\u3053\u308c\u306f\u3001Finetech\u306e\u3088\u3046\u306a\u9069\u5207\u306a\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u9078\u3093\u3060\u5834\u5408\u306b\u306e\u307f\u5b9f\u73fe\u53ef\u80fd\u3067\u3059\u3002\u79c1\u305f\u3061\u306f30\u5e74\u4ee5\u4e0a\u306b\u308f\u305f\u308a\u3001\u88fd\u85ac\u696d\u754c\u306b\u9ad8\u54c1\u8cea\u306a\u6a5f\u5668\u3092\u63d0\u4f9b\u3057\u3066\u304d\u307e\u3057\u305f\u3002.<\/p>

\u79c1\u305f\u3061\u306e \u30ab\u30d7\u30bb\u30eb\u8a08\u6570\u6a5f<\/u><\/a>\u00a0\u6b63\u78ba\u306a\u8a08\u6570\u3001\u30b9\u30e0\u30fc\u30ba\u306a\u30ab\u30d7\u30bb\u30eb\u30d5\u30ed\u30fc\u3001\u305d\u3057\u3066\u30d0\u30c3\u30c1\u9593\u306e\u8fc5\u901f\u306a\u5207\u308a\u66ff\u3048\u3092\u5b9f\u73fe\u3059\u308b\u305f\u3081\u306b\u7279\u5225\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002Finetech\u306a\u3089\u3001\u5e38\u306b\u30b7\u30f3\u30d7\u30eb\u304b\u3064\u6b63\u78ba\u306a\u8a08\u6570\u30d7\u30ed\u30bb\u30b9\u3092\u5b9f\u73fe\u3059\u308b\u6a5f\u5668\u3092\u624b\u306b\u5165\u308c\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>

\u4eca\u3059\u3050\u898b\u7a4d\u3082\u308a\u3092\u53d6\u5f97<\/i><\/u><\/em><\/a>\u00a0\u3059\u3050\u306b\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":"

A capsule counter SOP document is a GMP requirement that controls how capsule counting must be performed in a pharmaceutical […]<\/p>\n","protected":false},"author":1,"featured_media":8745,"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":[88],"tags":[],"class_list":["post-8743","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pills-counting-machine-resources"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/8743","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=8743"}],"version-history":[{"count":10,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/8743\/revisions"}],"predecessor-version":[{"id":8759,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/posts\/8743\/revisions\/8759"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media\/8745"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/media?parent=8743"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/categories?post=8743"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/ja\/wp-json\/wp\/v2\/tags?post=8743"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}