{"id":7972,"date":"2026-10-16T10:26:25","date_gmt":"2026-10-16T03:26:25","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-10-17T10:42:36","modified_gmt":"2026-10-17T03:42:36","slug":"perbpom-6-2025-stability-testing","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/ja\/perbpom-6-2025-stability-testing\/","title":{"rendered":"PerBPOM 6\/2025 \u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u5b89\u5b9a\u6027\u8a66\u9a13\uff1a\u63d0\u51fa\u66f8\u985e\u306b\u8a18\u8f09\u3059\u3079\u304d\u4e8b\u9805"},"content":{"rendered":"

\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306e\u5b89\u5b9a\u6027\u306b\u95a2\u3059\u308b\u8cc7\u6599\u3092\u7cbe\u67fb\u3059\u308b\u969b\u3001\u307b\u307c\u5fc5\u305a\u6700\u521d\u306b\u76ee\u306b\u4ed8\u304f2\u3064\u306e\u554f\u984c\u70b9\u306f\u3001\u73fe\u5730\u306e\u6e7f\u5ea6\u3092\u8003\u616e\u305b\u305a\u306b\u6d77\u5916\u306e\u30c7\u30fc\u30bf\u3092\u7121\u6761\u4ef6\u306b\u9069\u7528\u3057\u3066\u3044\u308b\u3053\u3068\u3068\u3001\u300c\u5ba4\u6e29\u3067\u4fdd\u7ba1\u3057\u3066\u304f\u3060\u3055\u3044\u300d\u3068\u3044\u3063\u305f\u66d6\u6627\u306a\u4fdd\u7ba1\u65b9\u6cd5\u306e\u8868\u793a\u3067\u3042\u308b\u3002\u201c<\/p>\n\n\n\n

\u3042\u306a\u305f\u304c\u30d6\u30e9\u30f3\u30c9\u30aa\u30fc\u30ca\u30fc\u3001\u8f38\u5165\u696d\u8005\u3001\u307e\u305f\u306f\u898f\u5236\u8cac\u4efb\u8005\u3067\u3042\u308b\u5834\u5408\u3001\u3053\u306e\u30ac\u30a4\u30c9\u306f PerBPOM 6\/2025 \u5b89\u5b9a\u6027\u8a66\u9a13<\/strong><\/a> \u898f\u5247\u304c\u53b3\u5bc6\u306b\u8981\u6c42\u3059\u308b\u4e8b\u9805\u3068\u3001\u63d0\u51fa\u66f8\u985e\u304c\u901a\u5e38\u3069\u306e\u3088\u3046\u306a\u70b9\u3067\u4e0d\u5341\u5206\u3068\u306a\u308b\u304b\u3092\u6982\u8aac\u3059\u308b\u3002.<\/p>\n\n\n\n

30\u2103\/65%\u76f8\u5bfe\u6e7f\u5ea6\u3067\u751f\u6210\u3055\u308c\u305f\u6d77\u5916\u30c7\u30fc\u30bf\u306b\u57fa\u3065\u3044\u3066\u4f5c\u6210\u3055\u308c\u305f\u6587\u66f8\u306f\u3001\u6700\u3082\u6ce8\u610f\u6df1\u3044\u8abf\u67fb\u3092\u5fc5\u8981\u3068\u3057\u307e\u3059\u3002\u8208\u5473\u6df1\u3044\u3053\u3068\u306b\u3001Product Registration Indonesia\uff08PRI\uff09\u306f\u30012026\u5e743\u670820\u65e5\u9803\u306b\u8abf\u6574\u671f\u9593\u304c\u7d42\u4e86\u3057\u3066\u4ee5\u6765\u3001BPOM\u304b\u3089\u5b89\u5b9a\u6027\u306b\u95a2\u3059\u308b\u554f\u3044\u5408\u308f\u305b\u3092\u53d7\u3051\u3066\u3044\u307e\u305b\u3093\u3002.  <\/strong><\/p>\n\n\n\n

\u3053\u308c\u306f\u6700\u8fd1\u306e\u4e8b\u4f8b\u8a18\u9332\u3092\u53cd\u6620\u3057\u305f\u3082\u306e\u3067\u3059\u304c\u3001\u904e\u53bb\u306e\u30c7\u30fc\u30bf\u304c\u81ea\u52d5\u7684\u306b\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u3001\u3042\u308b\u3044\u306f\u4eca\u5f8c\u306e\u5be9\u67fb\u3082\u540c\u69d8\u306b\u30b9\u30e0\u30fc\u30ba\u306b\u9032\u3080\u3068\u3044\u3046\u8a3c\u62e0\u3068\u6349\u3048\u308b\u3079\u304d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

\u3053\u306e\u898f\u5236\u81ea\u4f53\u306f\u3082\u306f\u3084\u76ee\u65b0\u3057\u3044\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u767b\u9332\u306b\u304a\u3044\u3066\u3001\u305d\u306e\u5b9f\u969b\u306e\u904b\u7528\u306f\u4f9d\u7136\u3068\u3057\u3066\u91cd\u8981\u306a\u7126\u70b9\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u4ee5\u4e0b\u3067\u306f\u3001\u516c\u5f0f\u306e\u898f\u5236\u8981\u4ef6\u3068\u3001\u73fe\u5834\u3067\u5b9f\u969b\u306b\u89b3\u5bdf\u3055\u308c\u308b\u72b6\u6cc1\u3068\u3092\u533a\u5225\u3057\u3066\u8aac\u660e\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n

\u3053\u306e\u30ac\u30a4\u30c9\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u4e3b\u306a\u7528\u8a9e<\/strong><\/h2>\n\n\n\n
\u5b66\u671f<\/strong><\/th>\u610f\u5473<\/strong><\/th><\/tr><\/thead>
BPOM<\/td>\u30d0\u30c0\u30f3\u30fb\u30da\u30f3\u30ac\u30ef\u30b9\u30fb\u30aa\u30d0\u30c8\u30fb\u30c0\u30f3\u30fb\u30de\u30ab\u30ca\u30f3\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u98df\u54c1\u533b\u85ac\u54c1\u5c40<\/td><\/tr>
PerBPOM<\/td>Peraturan BPOM\u3001BPOM\u9577\u5b98\u304c\u767a\u884c\u3059\u308b\u898f\u5247<\/td><\/tr>
RH<\/td>\u76f8\u5bfe\u6e7f\u5ea6<\/td><\/tr>
\u30be\u30fc\u30f3IVb<\/td>ASEAN\u306e\u57fa\u6e96\u6c17\u5019\u5e2f\uff08\u9ad8\u6e29\u591a\u6e7f\u6761\u4ef6\uff09\uff0830\u2103\u300175% RH\uff09<\/td><\/tr>
GMP<\/td>\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff08GMP\uff09<\/td><\/tr>
\u30cb\u30fc<\/td>Nomor Izin Edar\u3001\u8ca9\u58f2\u627f\u8a8d\u756a\u53f7<\/td><\/tr>
JDIH<\/td>Jaringan Dokumentasi dan Informasi Hukum\u3001\u516c\u5f0f\u6cd5\u7684\u6587\u66f8\u30cd\u30c3\u30c8\u30ef\u30fc\u30af<\/td><\/tr>
ASEAN<\/td>\u6771\u5357\u30a2\u30b8\u30a2\u8af8\u56fd\u9023\u5408<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

PerBPOM 6\/2025 \u5b89\u5b9a\u6027\u8a66\u9a13\uff1a\u7c21\u5358\u306a\u56de\u7b54<\/strong><\/h2>\n\n\n\n

PerBPOM 6\/2025 \u5b89\u5b9a\u6027\u8a66\u9a13<\/a> \u5b8c\u6210\u3057\u305f\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306f\u3001\u7269\u7406\u7684\u3001\u5316\u5b66\u7684\u3001\u5fae\u751f\u7269\u5b66\u7684\u5b89\u5b9a\u6027\u306b\u3064\u3044\u3066\u8a66\u9a13\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8a66\u9a13\u306b\u306f\u3001\u30be\u30fc\u30f3IVb\u6761\u4ef6\uff0830\u2103\uff0f75%RH\uff09\u3067\u306e\u9577\u671f\u8a66\u9a13\u3068\u52a0\u901f\u8a66\u9a13\uff0840\u2103\uff0f75%RH\uff09\u304c\u542b\u307e\u308c\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u8a66\u9a13\u6240\u307e\u305f\u306fGMP\u8a8d\u8a3c\u3092\u53d7\u3051\u305f\u793e\u5185\u8a66\u9a13\u6240\u3067\u5b9f\u65bd\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002. <\/p>\n\n\n\n

30\u2103\u300165%RH\u306a\u3069\u306e\u4f4e\u6e7f\u5ea6\u6761\u4ef6\u4e0b\u3067\u5f97\u3089\u308c\u305f\u30c7\u30fc\u30bf\u306f\u3001\u88fd\u54c1\u306e\u4e0d\u5b89\u5b9a\u6027\u3001\u52a0\u901f\u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u306e\u5165\u624b\u53ef\u80fd\u6027\u3001\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u5bb9\u5668\u306e\u5bc6\u9589\u30b7\u30b9\u30c6\u30e0\u306e\u7a2e\u985e\u306a\u3069\u306e\u91cd\u8981\u306a\u8981\u7d20\u3092\u8a55\u4fa1\u3057\u3001\u88cf\u4ed8\u3051\u3068\u306a\u308b\u30c7\u30fc\u30bf\u3067\u88dc\u5b8c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u898f\u5247\u3067\u306f\u3001\u4fdd\u7ba1\u306b\u95a2\u3059\u308b\u8a18\u8ff0\u306b\u306f\u300c\u5ba4\u6e29\u300d\u3067\u306f\u306a\u304f\u3001\u5177\u4f53\u7684\u306a\u6e29\u5ea6\u3092\u660e\u8a18\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

PerBPOM 6\/2025\u3068\u306f\u4f55\u304b\u3001\u305d\u3057\u3066\u305d\u308c\u304c\u3088\u308a\u5e83\u7bc4\u306a\u898f\u5247\u306b\u3069\u306e\u3088\u3046\u306b\u9069\u5408\u3059\u308b\u306e\u304b<\/strong><\/h2>\n\n\n\n

\u6cd5\u7684\u6839\u62e0\u3068\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb<\/strong><\/h3>\n\n\n\n

BPOM\u898f\u5247\u7b2c6\u53f7\uff082025\u5e74\uff09\u300c\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u5b89\u5b9a\u6027\u8a66\u9a13\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u300d\u306f\u30012025\u5e742\u670821\u65e5\u306b\u7f72\u540d\u3055\u308c\u30012025\u5e743\u670820\u65e5\u306b\u516c\u5e03\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u898f\u5247\u306f6\u3064\u306e\u6761\u9805\u30681\u3064\u306e\u4ed8\u5c5e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304b\u3089\u69cb\u6210\u3055\u308c\u3001\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u5b89\u5b9a\u6027\u304a\u3088\u3073\u4fdd\u5b58\u671f\u9593\u306b\u95a2\u3059\u308bASEAN\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002. <\/strong><\/p>\n\n\n\n

BPOM\u306f\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9HM.01.1.2.04.25.101\u3067\u3053\u306e\u898f\u5247\u3092\u767a\u8868\u3057\u305f\u3002\u540c\u6a5f\u95a2\u306b\u3088\u308b\u3068\u3001\u898f\u5247\u6848\u306e\u4f5c\u6210\u306f2023\u5e7410\u6708\u306b\u958b\u59cb\u3055\u308c\u3001\u5185\u90e8\u4f1a\u8b70\u3001\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3\u3001\u6cd5\u52d9\u7701\u3068\u306e\u8abf\u6574\u3092\u7d4c\u3066\u7f72\u540d\u306b\u81f3\u3063\u305f\u3068\u3044\u3046\u3002. <\/strong><\/p>\n\n\n\n

\u65e5\u4ed8<\/strong><\/th>\u30a4\u30d9\u30f3\u30c8<\/strong><\/th>\u30bd\u30fc\u30b9<\/strong><\/th><\/tr><\/thead>
2025\u5e742\u670821\u65e5<\/td>\u898f\u5247\u306b\u7f72\u540d<\/td>BPOM\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9 HM.01.1.2.04.25.101<\/td><\/tr>
2025\u5e743\u670820\u65e5<\/td>\u898f\u5247\u304c\u516c\u5e03\u3055\u308c\u305f<\/td>BPOM\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9 HM.01.1.2.04.25.101<\/td><\/tr>
2025\u5e744\u670829\u65e5<\/td>BPOM\u306e\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u304c\u767a\u8868\u3055\u308c\u307e\u3057\u305f<\/td>BPOM\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9 HM.01.1.2.04.25.101<\/td><\/tr>
2026\u5e743\u670820\u65e5\u9803<\/td>\u4ee5\u524d\u306e\u7814\u7a76\u3092\u6574\u5408\u3055\u305b\u308b\u305f\u3081\u306e1\u5e74\u9593\u306e\u7336\u4e88\u671f\u9593\u304c\u7d42\u4e86\u3057\u305f<\/td>\u540c\u30ea\u30ea\u30fc\u30b9\u306b\u304a\u3051\u308bBPOM\u9577\u5b98\u306e\u58f0\u660e<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

BPOM\u306f\u30012025\u5e744\u670815\u65e5\u6642\u70b9\u3067\u6709\u52b9\u306a\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u8ca9\u58f2\u627f\u8a8d\u4ef6\u6570\u304c6,173\u4ef6\u30012024\u5e74\u4e2d\u306b\u767a\u884c\u3055\u308c\u305f\u627f\u8a8d\u4ef6\u6570\u304c957\u4ef6\u3067\u3042\u308b\u3068\u5831\u544a\u3057\u305f\u3002\u307e\u305f\u3001\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u3059\u3079\u3066\u306e\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306b\u306f\u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u304c\u4ed8\u3044\u3066\u3044\u308b\u3068\u4ed8\u3051\u52a0\u3048\u3001\u5e02\u5834\u306b\u306f\u53e4\u3044\u7814\u7a76\u7d50\u679c\u304c\u5b58\u5728\u3059\u308b\u3053\u3068\u3092\u6539\u3081\u3066\u5f37\u8abf\u3057\u305f\u3002. <\/strong><\/p>\n\n\n\n

PerBPOM 32\/2022\u304a\u3088\u307315\/2024\u3068\u306e\u6bd4\u8f03<\/strong><\/h3>\n\n\n\n

2022\u5e74BPOM\u898f\u5247\u7b2c32\u53f7\u300c\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u767b\u9332\u306e\u57fa\u6e96\u53ca\u3073\u624b\u7d9a\u304d\u300d\u7b2c8\u6761\uff082024\u5e74BPOM\u898f\u5247\u7b2c15\u53f7\u306b\u3088\u308a\u6539\u6b63\uff09\u306f\u3001PerBPOM 6\/2025\u3068\u77db\u76fe\u3057\u306a\u3044\u9650\u308a\u3001\u5f15\u304d\u7d9a\u304d\u6709\u52b9\u3067\u3042\u308b\u3002\u65b0\u898f\u5247\u306f\u5b89\u5b9a\u6027\u306b\u95a2\u3059\u308b\u671f\u5f85\u4e8b\u9805\u3092\u7cbe\u7dfb\u5316\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u767b\u9332\u67a0\u7d44\u307f\u305d\u306e\u3082\u306e\u3092\u7f6e\u304d\u63db\u3048\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3002. <\/strong><\/p>\n\n\n\n

\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u767b\u9332\u7533\u8acb\u66f8\u985e\u3067\u306f\u3001\u4e21\u65b9\u306e\u6587\u66f8\u304c\u4f75\u305b\u3066\u5be9\u67fb\u3055\u308c\u307e\u3059\u3002\u53e4\u3044\u7533\u8acb\u66f8\u985e\u306e\u3069\u306e\u8a18\u8ff0\u304c\u3069\u3061\u3089\u306e\u6587\u66f8\u306b\u57fa\u3065\u3044\u3066\u3044\u308b\u304b\u306f\u3001\u63d0\u51fa\u524d\u306b\u898f\u5236\u30a2\u30c9\u30d0\u30a4\u30b6\u30fc\u306b\u78ba\u8a8d\u3059\u308b\u306e\u304c\u6700\u5584\u3067\u3059\u3002.<\/p>\n\n\n\n

PerBPOM 6\/2025\u306b\u57fa\u3065\u304f\u4e2d\u6838\u7684\u306a\u6280\u8853\u8981\u4ef6<\/strong><\/h2>\n\n\n\n

\u30be\u30fc\u30f3IVb\u306e\u9577\u671f\u72b6\u614b<\/strong><\/h3>\n\n\n\n

BPOM\u306e\u8cac\u4efb\u8005\u306f\u3001ASEAN\u5730\u57df\u306b\u304a\u3051\u308b\u4e00\u822c\u7684\u306a\u9577\u671f\u6c17\u5019\u6761\u4ef6\u3068\u3057\u3066\u3001\u6c17\u6e2930\u2103\u3001\u76f8\u5bfe\u6e7f\u5ea675%\u3092\u6319\u3052\u3066\u304a\u308a\u3001\u3053\u308c\u306f\u30be\u30fc\u30f3IVb\u3068\u3057\u3066\u77e5\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u30be\u30fc\u30f3IVb\u306f\u3001\u9ad8\u6e29\u591a\u6e7f\u306a\u6c17\u5019\u3092\u8868\u3059ASEAN\u306e\u57fa\u6e96\u3067\u3042\u308a\u3001\u305d\u306e\u305f\u3081\u6e7f\u5ea6\u306f\u6ce8\u76ee\u3059\u3079\u304d\u30d1\u30e9\u30e1\u30fc\u30bf\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002. <\/strong><\/p>\n\n\n\n

\u8a66\u9a13\u306f\u3001\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u8a66\u9a13\uff08\u9577\u671f\u8a66\u9a13\u3068\u3082\u547c\u3070\u308c\u308b\uff09\u3068\u52a0\u901f\u8a66\u9a13\u306e2\u3064\u306e\u8a66\u9a13\u3068\u3057\u3066\u5b9f\u65bd\u3055\u308c\u308b\u3002\u4ed8\u5c5e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3088\u308c\u3070\u3001\u3069\u3061\u3089\u306e\u8a66\u9a13\u306b\u304a\u3044\u3066\u3082\u3001\u6700\u7d42\u88fd\u54c1\u306e\u5341\u5206\u306a\u5b89\u5b9a\u6027\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u304c\u5f97\u3089\u308c\u308b\u3088\u3046\u3001\u8a66\u9a13\u983b\u5ea6\u306f\u5341\u5206\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002. <\/strong><\/p>\n\n\n\n

\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u5f37\u5ea6\u3001\u304a\u3088\u3073\u30d1\u30c3\u30b1\u30fc\u30b8<\/strong><\/h3>\n\n\n\n

\u4ed8\u5c5e\u6587\u66f8\u3067\u306f\u3001\u4fdd\u7ba1\u4e2d\u306b\u5909\u5316\u3057\u54c1\u8cea\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u7269\u7406\u7684\u3001\u5316\u5b66\u7684\u3001\u5fae\u751f\u7269\u5b66\u7684\u7279\u6027\u3092\u7db2\u7f85\u3059\u308b\u5b89\u5b9a\u6027\u8a66\u9a13\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u6709\u52b9\u6210\u5206\u306e\u5206\u6790\u306f\u3001\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306b\u65e2\u306b\u5b9a\u3081\u3089\u308c\u3066\u3044\u308b\u54c1\u8cea\u8981\u4ef6\u306b\u6e96\u62e0\u3057\u3066\u3044\u307e\u3059\u3002. <\/strong><\/p>\n\n\n\n

\u30d6\u30e9\u30b1\u30c3\u30c8\u6cd5\u3084\u30de\u30c8\u30ea\u30c3\u30af\u30b9\u6cd5\u3092\u7528\u3044\u306a\u3044\u9650\u308a\u3001\u8a66\u9a13\u3067\u306f\u5404\u6fc3\u5ea6\u304a\u3088\u3073\u5404\u5305\u88c5\u30b7\u30b9\u30c6\u30e0\u306e\u7a2e\u985e\u3092\u7db2\u7f85\u7684\u306b\u691c\u8a0e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u7279\u5b9a\u306e\u88fd\u54c1\u306b\u5bfe\u3057\u3066\u7e2e\u5c0f\u8a2d\u8a08\u304c\u8a31\u5bb9\u3055\u308c\u308b\u304b\u3069\u3046\u304b\u306f\u3001\u898f\u5236\u5f53\u5c40\u306e\u30a2\u30c9\u30d0\u30a4\u30b6\u30fc\u3068\u5354\u8b70\u3057\u3066\u5224\u65ad\u3059\u3079\u304d\u79d1\u5b66\u7684\u306a\u554f\u984c\u3067\u3042\u308b\u3002. <\/strong><\/p>\n\n\n\n

\u5b9f\u9a13\u5ba4\u306e\u8981\u4ef6<\/strong><\/h3>\n\n\n\n

BPOM\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u98df\u54c1\u533b\u85ac\u54c1\u76e3\u7763\u5e81\uff09\u306f\u3001\u8a66\u9a13\u306f\u8a8d\u5b9a\u3092\u53d7\u3051\u305f\u691c\u67fb\u6a5f\u95a2\u3001\u307e\u305f\u306f\u533b\u85ac\u54c1\u88fd\u9020\u7ba1\u7406\u57fa\u6e96\uff08GMP\uff09\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u305f\u793e\u5185\u691c\u67fb\u6a5f\u95a2\u3067\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u898f\u5b9a\u3057\u3066\u3044\u308b\u3002\u6d77\u5916\u306e\u65bd\u8a2d\u307e\u305f\u306f\u793e\u5185\u65bd\u8a2d\u3067\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u524d\u306b\u3001\u8a8d\u5b9a\u307e\u305f\u306fGMP\u8a8d\u8a3c\u306e\u6709\u7121\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002. <\/strong><\/p>\n\n\n\n

\u30e9\u30d9\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u4fdd\u7ba1\u65b9\u6cd5<\/strong><\/h3>\n\n\n\n

\u3053\u306e\u898f\u5247\u306f\u3001\u30e9\u30d9\u30eb\u306b\u8a18\u8f09\u3059\u308b\u5185\u5bb9\u3082\u898f\u5b9a\u3057\u3066\u3044\u307e\u3059\u3002PerBPOM 6\/2025\u306b\u57fa\u3065\u304d\u3001\u4fdd\u7ba1\u306b\u95a2\u3059\u308b\u8a18\u8ff0\u306b\u306f\u300c\u5ba4\u6e29\u300d\u3067\u306f\u306a\u304f\u3001\u5177\u4f53\u7684\u306a\u6e29\u5ea6\u3092\u660e\u8a18\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u8a18\u8f09\u3059\u308b\u6587\u8a00\u306f\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u3067\u5b9f\u969b\u306b\u78ba\u8a8d\u3055\u308c\u305f\u6761\u4ef6\u3068\u4e00\u81f4\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002. <\/strong><\/p>\n\n\n\n

\u8981\u4ef6<\/strong><\/th>\u898f\u5247\u306e\u5185\u5bb9<\/strong><\/th>\u78ba\u8a8d\u3059\u308b\u5834\u6240<\/strong><\/th><\/tr><\/thead>
\u9577\u671f\u72b6\u614b<\/td>30\u2103\u300175%RH\uff08\u30be\u30fc\u30f3IVb\uff09<\/td>BPOM\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u3001\u4ed8\u5c5e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/td><\/tr>
\u7814\u7a76\u306e\u7a2e\u985e<\/td>\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u304b\u3064\u9ad8\u901f<\/td>BPOM\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9\u3001\u4ed8\u5c5e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/td><\/tr>
\u30d1\u30e9\u30e1\u30fc\u30bf<\/td>\u7269\u7406\u7684\u3001\u5316\u5b66\u7684\u3001\u5fae\u751f\u7269\u5b66\u7684<\/td>\u4ed8\u5c5e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/td><\/tr>
\u7814\u7a76\u5ba4<\/td>\u8a8d\u5b9a\u3092\u53d7\u3051\u3066\u3044\u308b\u3001\u307e\u305f\u306f\u793e\u5185\u3067GMP\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b<\/td>BPOM\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9<\/td><\/tr>
\u30b9\u30c8\u30ec\u30fc\u30b8\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8<\/td>\u5b9a\u7fa9\u3055\u308c\u305f\u6e29\u5ea6\u3067\u3042\u308a\u3001\u300c\u5ba4\u6e29\u300d\u3067\u306f\u306a\u3044\u3002\u201c<\/td>\u4ed8\u5c5e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08\u7b2c IV \u7bc0\u3001, Pernyataan dan Penandaan<\/em>) <\/td><\/tr>
\u4f4e\u6e7f\u5ea6\u30c7\u30fc\u30bf<\/td>\u88dc\u8db3\u30c7\u30fc\u30bf<\/td>BPOM\u30d7\u30ec\u30b9\u30ea\u30ea\u30fc\u30b9<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

\u6d77\u5916\u30c7\u30fc\u30bf\uff0830\u2103\u3001\u76f8\u5bfe\u6e7f\u5ea665%\uff09\uff1a\u78ba\u8a8d\u3059\u3079\u304d\u4e8b\u4f8b<\/strong><\/h2>\n\n\n\n

BPOM\u306e\u8cac\u4efb\u8005\u306f\u3001\u4f8b\u3048\u307030\u2103\u3001\u76f8\u5bfe\u6e7f\u5ea665%\u3068\u3044\u3063\u305f\u3001\u8981\u6c42\u6761\u4ef6\u3092\u4e0b\u56de\u308b\u6761\u4ef6\u4e0b\u3067\u751f\u6210\u3055\u308c\u305f\u30c7\u30fc\u30bf\u306f\u3001\u79d1\u5b66\u7684\u8a55\u4fa1\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u88cf\u4ed8\u3051\u3068\u306a\u308b\u30c7\u30fc\u30bf\u3067\u88dc\u5b8c\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u91cd\u8981\u306a\u8981\u7d20\u306f\u3001\u89b3\u5bdf\u3055\u308c\u305f\u4e0d\u5b89\u5b9a\u6027\u306e\u6709\u7121\u3001\u52a0\u901f\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u5165\u624b\u53ef\u80fd\u6027\u3001\u304a\u3088\u3073\u5305\u88c5\u30b7\u30b9\u30c6\u30e0\u306e\u30bf\u30a4\u30d7\u3067\u3059\u3002. <\/strong><\/p>\n\n\n\n

\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001\u3053\u308c\u306f\u7533\u8acb\u524d\u306b\u6587\u66f8\u5316\u3055\u308c\u305f\u7acb\u5834\u304c\u5fc5\u8981\u3068\u306a\u308b\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3067\u3059\u3002\u7814\u7a76\u306f\u5b9f\u65bd\u3055\u308c\u305f\u5834\u6240\u3067\u306f\u59a5\u5f53\u3067\u3042\u3063\u3066\u3082\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u4f7f\u7528\u3055\u308c\u308b75%\u76f8\u5bfe\u6e7f\u5ea6\u57fa\u6e96\u5024\u3092\u4e0b\u56de\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

\u5341\u5206\u306a\u88cf\u4ed8\u3051\u30c7\u30fc\u30bf\u3068\u307f\u306a\u3055\u308c\u308b\u3082\u306e\u306f\u3001\u5358\u4e00\u306e\u6570\u5024\u3067\u6c7a\u307e\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u88fd\u54c1\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u305f\u3081\u3001\u30c1\u30a7\u30c3\u30af\u30dc\u30c3\u30af\u30b9\u3067\u306f\u306a\u304f\u3001\u898f\u5236\u304a\u3088\u3073\u79d1\u5b66\u7684\u306a\u5be9\u67fb\u9805\u76ee\u3068\u3057\u3066\u6271\u3044\u307e\u3059\u3002\u4ee5\u4e0b\u306e\u6c7a\u5b9a\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u5404\u30d5\u30a1\u30a4\u30eb\u304c\u3069\u306e\u6bb5\u968e\u306b\u3064\u306a\u304c\u308b\u304b\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

    \n
  1. \u9577\u671f\u8a66\u9a13\u306f30\u2103\u3001\u76f8\u5bfe\u6e7f\u5ea675%\u306e\u6761\u4ef6\u4e0b\u3067\u5b9f\u65bd\u3055\u308c\u307e\u3057\u305f\u304b\uff1f\u3082\u3057\u305d\u3046\u3067\u3042\u308c\u3070\u3001\u6b21\u306b\u8a66\u9a13\u5ba4\u306e\u72b6\u6cc1\u3068\u30e9\u30d9\u30eb\u306e\u6587\u8a00\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n\n\n\n
  2. \u8a66\u9a13\u306f30\u2103\u3001\u76f8\u5bfe\u6e7f\u5ea665%\u3001\u307e\u305f\u306f\u305d\u308c\u4ee5\u4e0b\u306e\u6761\u4ef6\u4e0b\u3067\u5b9f\u65bd\u3055\u308c\u307e\u3057\u305f\u304b\uff1f\u3082\u3057\u305d\u3046\u3067\u3042\u308c\u3070\u3001\u88cf\u4ed8\u3051\u3068\u306a\u308b\u30c7\u30fc\u30bf\u304c\u5fc5\u8981\u3067\u3059\u3002\u4e0d\u5b89\u5b9a\u6027\u3001\u52a0\u901f\u8a66\u9a13\u30c7\u30fc\u30bf\u3001\u304a\u3088\u3073\u5305\u88c5\u5f62\u614b\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n\n\n\n
  3. \u3053\u306e\u8abf\u67fb\u306f2025\u5e743\u670820\u65e5\u3088\u308a\u524d\u306b\u5b9f\u65bd\u3055\u308c\u305f\u3082\u306e\u3067\u3059\u304b\uff1f\u3082\u3057\u305d\u3046\u3067\u3042\u308c\u3070\u30012026\u5e743\u670820\u65e5\u9803\u306b\u7d42\u4e86\u3059\u308b1\u5e74\u9593\u306e\u671f\u9593\u304c\u7d4c\u904e\u3059\u308b\u524d\u306b\u3001\u8abf\u67fb\u5185\u5bb9\u304c\u8abf\u6574\u3055\u308c\u305f\u304b\u3069\u3046\u304b\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n\n\n\n
  4. \u4e0d\u660e\u306a\u70b9\u304c\u3042\u308c\u3070\u3001\u7533\u8acb\u307e\u305f\u306f\u66f4\u65b0\u524d\u306b\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u5be9\u67fb\u3092\u4f9d\u983c\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n<\/ol>\n\n\n\n
    \u30c7\u30fc\u30bf\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb<\/strong><\/th>\u57fa\u6e96\u6761\u4ef6<\/strong><\/th>\u30a2\u30c9\u30d0\u30a4\u30b6\u30fc\u3068\u306e\u6b21\u306e\u30b9\u30c6\u30c3\u30d7<\/strong><\/th><\/tr><\/thead>
    30\u2103\u3001\u76f8\u5bfe\u6e7f\u5ea675%\u306e\u6761\u4ef6\u4e0b\u3067\u306e\u8a66\u9a13\u3001\u8a8d\u5b9a\u3055\u308c\u305f\u8a66\u9a13\u6240\u306b\u3066\u5b9f\u65bd\u3002<\/td>\u30de\u30c3\u30c1\u30be\u30fc\u30f3IVb<\/td>\u30e9\u30d9\u30eb\u306e\u6587\u8a00\u3068\u30d0\u30c3\u30c1\u3054\u3068\u306e\u30ab\u30d0\u30fc\u7387\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044<\/td><\/tr>
    \u6d77\u5916\u3067\u306e\u7814\u7a76\uff0830\u2103\u3001\u76f8\u5bfe\u6e7f\u5ea665%\uff09<\/td>\u57fa\u6e96\u6e7f\u5ea6\u4ee5\u4e0b<\/td>\u8ffd\u52a0\u3059\u308b\u30b5\u30dd\u30fc\u30c8\u30c7\u30fc\u30bf\u3092\u5b9a\u7fa9\u3059\u308b<\/td><\/tr>
    \u7814\u7a76\u306f2025\u5e743\u6708\u307e\u3067\u306b\u5b8c\u4e86\u3059\u308b\u3002<\/td>\u4f4d\u7f6e\u5408\u308f\u305b\u30a6\u30a3\u30f3\u30c9\u30a6\u304c\u9589\u3058\u3089\u308c\u307e\u3057\u305f<\/td>\u8abf\u6574\u3055\u308c\u305f\u304b\u3069\u3046\u304b\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044<\/td><\/tr>
    \u30e9\u30d9\u30eb\u306b\u306f\u300c\u5ba4\u6e29\u300d\u3068\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002\u201c<\/td>\u898f\u5b9a\u6e29\u5ea6\u304c\u5fc5\u8981<\/td>\u30b5\u30dd\u30fc\u30c8\u3055\u308c\u3066\u3044\u308b\u6761\u4ef6\u304b\u3089\u66f8\u304d\u63db\u3048\u308b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    \u8abf\u6574\u671f\u9593\u304c\u7d42\u4e86\u3057\u305f\u5f8c\u306b\u4f55\u304c\u5909\u308f\u3063\u305f\u306e\u304b<\/strong><\/h2>\n\n\n\n

    BPOM\u9577\u5b98\u306f\u3001\u898f\u5247\u65bd\u884c\u524d\u306e\u5b89\u5b9a\u6027\u8abf\u67fb\u3092\u5b9f\u65bd\u6e08\u307f\u306e\u4f01\u696d\u306b\u5bfe\u3057\u3001\u898f\u5247\u516c\u5e03\u5f8c1\u5e74\u4ee5\u5185\u306b\u8abf\u67fb\u7d50\u679c\u3092\u4fee\u6b63\u3059\u308b\u3088\u3046\u8981\u8acb\u3057\u305f\u30022025\u5e743\u670820\u65e5\u304b\u3089\u8d77\u7b97\u3059\u308b\u3068\u3001\u305d\u306e\u671f\u9650\u306f2026\u5e743\u670820\u65e5\u9803\u3060\u3063\u305f\u3002. <\/strong><\/p>\n\n\n\n

    \u305d\u308c\u4ee5\u964d\u3001PRI\u306fBPOM\u304b\u3089\u5b89\u5b9a\u6027\u306b\u95a2\u3059\u308b\u554f\u3044\u5408\u308f\u305b\u3092\u53d7\u3051\u3066\u3044\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u3042\u304f\u307e\u3067\u3082\u89b3\u5bdf\u7d50\u679c\u3068\u3057\u3066\u5831\u544a\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u554f\u3044\u5408\u308f\u305b\u3060\u3051\u3067\u306f\u3001\u30d5\u30a1\u30a4\u30eb\u304c\u65e2\u306b\u30a2\u30e9\u30a4\u30e1\u30f3\u30c8\u3055\u308c\u3066\u3044\u308b\u306e\u304b\u3001\u3042\u308b\u3044\u306f\u8a55\u4fa1\u8005\u304c\u307e\u3060\u305d\u306e\u70b9\u3092\u6307\u6458\u3057\u3066\u3044\u306a\u3044\u3060\u3051\u306a\u306e\u304b\u3092\u5224\u65ad\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n

    \u8f38\u5165\u696d\u8005\u306b\u3068\u3063\u3066\u3001\u5b9f\u52d9\u4e0a\u306e\u554f\u984c\u306f\u66f8\u985e\u4f5c\u6210\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3069\u306e\u7814\u7a76\u304c\u3069\u306e\u4fdd\u7ba1\u306b\u95a2\u3059\u308b\u4e3b\u5f35\u3092\u88cf\u4ed8\u3051\u3066\u3044\u308b\u306e\u304b\u3092\u793a\u3059\u3053\u3068\u304c\u3067\u304d\u308b\u3067\u3057\u3087\u3046\u304b\uff1f\u3053\u3046\u3057\u305f\u8a18\u9332\u3092\u6574\u7406\u3057\u3066\u304a\u304f\u3053\u3068\u306f\u3001\u66f4\u65b0\u624b\u7d9a\u304d\u4e2d\u3088\u308a\u3082\u66f4\u65b0\u524d\u306e\u65b9\u304c\u5bb9\u6613\u3067\u3059\u3002.<\/p>\n\n\n\n

    \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u767b\u9332\u306b\u304a\u3051\u308b\u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u306e\u4f4d\u7f6e<\/strong><\/h2>\n\n\n\n

    \u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u767b\u9332\u7533\u8acb\u66f8\u985e\u306e\u4e00\u90e8\u3067\u3042\u308a\u3001\u5b89\u5168\u6027\u3001\u52b9\u80fd\u3001\u54c1\u8cea\u3001\u8868\u793a\u306b\u95a2\u3059\u308b\u8a3c\u62e0\u3068\u4e26\u3093\u3067\u91cd\u8981\u306a\u8cc7\u6599\u3067\u3059\u3002\u3053\u308c\u306f\u3001\u627f\u8a8d\u3055\u308c\u305f\u30e9\u30d9\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u8cde\u5473\u671f\u9650\u3068\u4fdd\u7ba1\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u8a18\u8ff0\u3092\u88cf\u4ed8\u3051\u308b\u3082\u306e\u3067\u3059\u3002. <\/strong><\/p>\n\n\n\n

    BPOM\u306f2025\u5e741\u6708\u304b\u30893\u6708\u306b\u304b\u3051\u3066262\u4ef6\u306e\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u8ca9\u58f2\u627f\u8a8d\u3092\u767a\u884c\u3057\u305f\u304c\u3001\u3053\u308c\u306f2024\u5e74\u7b2c1\u56db\u534a\u671f\u306e240\u4ef6\u3092\u4e0a\u56de\u308b\u3002\u3053\u306e\u4ef6\u6570\u3067\u3042\u308c\u3070\u3001\u30e9\u30d9\u30eb\u3068\u6574\u5408\u6027\u306e\u3042\u308b\u5b89\u5b9a\u6027\u306b\u95a2\u3059\u308b\u30bb\u30af\u30b7\u30e7\u30f3\u306e\u65b9\u304c\u8a55\u4fa1\u8005\u306b\u3068\u3063\u3066\u8aad\u307f\u3084\u3059\u3044\u3002. <\/strong><\/p>\n\n\n\n

    \u540c\u3058 Zone IVb \u306e\u8ad6\u7406\u304c\u3001\u751f\u751f\u7269\u88fd\u54c1\u306e\u4fdd\u5b58\u671f\u9593\u306e\u8a3c\u62e0\u3092\u5c0e\u304d\u307e\u3059\u3002 \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u3067\u30d7\u30ed\u30d0\u30a4\u30aa\u30c6\u30a3\u30af\u30b9\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8BPOM\u767b\u9332<\/a> \u88fd\u54c1\u30bf\u30a4\u30d7\u304c\u30d5\u30a1\u30a4\u30eb\u306e\u6b8b\u308a\u306e\u90e8\u5206\u3092\u5f62\u4f5c\u308a\u307e\u3059\u3002 \u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u30de\u30b0\u30cd\u30b7\u30a6\u30e0\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306e\u7a2e\u985e<\/a> \u30ab\u30d0\u30fc\u3002.<\/p>\n\n\n\n

    \u5916\u56fd\u306e\u4e8b\u696d\u8005\u306f\u3001\u767b\u9332\u3092\u7ba1\u7406\u3057\u3066\u3044\u308b\u306e\u304c\u8ab0\u304b\u3082\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 \u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u30e9\u30a4\u30bb\u30f3\u30b9\u6551\u6e08\u306b\u95a2\u3059\u308b\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3<\/a> \u3053\u308c\u306f\u3001\u73fe\u5730\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u30a2\u30ab\u30a6\u30f3\u30c8\u306b\u4f9d\u5b58\u3059\u308b\u3053\u3068\u304c\u3001\u3042\u308b\u30d6\u30e9\u30f3\u30c9\u306e\u30d5\u30a1\u30a4\u30eb\u4fee\u5fa9\u80fd\u529b\u3092\u3044\u304b\u306b\u5236\u9650\u3057\u305f\u304b\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

    \u79c1\u305f\u3061\u306e \u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u767b\u9332<\/a> \u672c\u30b5\u30fc\u30d3\u30b9\u306f\u3001\u63d0\u51fa\u524d\u306e\u30c7\u30fc\u30bf\u30ec\u30d3\u30e5\u30fc\u3092\u542b\u3080\u88dc\u8db3\u8cc7\u6599\u306e\u4f5c\u6210\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u304a\u308a\u3001\u5b89\u5b9a\u6027\u306b\u95a2\u3059\u308b\u7591\u554f\u70b9\u3092\u65e9\u671f\u306b\u898f\u5236\u30a2\u30c9\u30d0\u30a4\u30b6\u30fc\u306b\u76f8\u8ac7\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n

    \u88dc\u8db3\u5b89\u5b9a\u6027\u30d5\u30a1\u30a4\u30eb\u63d0\u51fa\u524d\u306e\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/strong><\/h2>\n\n\n\n

    \u3053\u306e\u30ea\u30b9\u30c8\u306f\u3001\u898f\u5236\u30a2\u30c9\u30d0\u30a4\u30b6\u30fc\u3078\u306e\u8cea\u554f\u4e8b\u9805\u3092\u6e96\u5099\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u81ea\u5df1\u7533\u544a\u306b\u3088\u308b\u66f8\u985e\u4f5c\u6210\u306b\u306f\u4f7f\u7528\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u56de\u7b54\u306f\u3001\u88fd\u54c1\u3001\u5305\u88c5\u3001\u304a\u3088\u3073\u8a66\u9a13\u8a2d\u8a08\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n

    \u30c1\u30a7\u30c3\u30af<\/strong><\/th>\u89e3\u6c7a\u3059\u3079\u304d\u554f\u984c<\/strong><\/th>\u53c2\u7167<\/strong><\/th><\/tr><\/thead>
    \u9577\u671f\u72b6\u614b<\/td>\u6c17\u6e29\u306f30\u2103\u3001\u6e7f\u5ea6\u306f75%\u3067\u3057\u305f\u304b\uff1f\u305d\u308c\u3068\u3082\u3001\u305d\u308c\u3092\u88cf\u4ed8\u3051\u308b\u30c7\u30fc\u30bf\u306f\u4fdd\u7ba1\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/td>PerBPOM 6\/2025<\/td><\/tr>
    \u7814\u7a76\u30c7\u30b6\u30a4\u30f3<\/td>\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u5b66\u7fd2\u3068\u52a0\u901f\u5b66\u7fd2\u306e\u4e21\u65b9\u304c\u5b9f\u65bd\u3055\u308c\u3066\u3044\u307e\u3059\u304b\uff1f<\/td>PerBPOM 6\/2025<\/td><\/tr>
    \u30d1\u30e9\u30e1\u30fc\u30bf<\/td>\u7d50\u679c\u306f\u3001\u7269\u7406\u7684\u3001\u5316\u5b66\u7684\u3001\u5fae\u751f\u7269\u5b66\u7684\u7279\u6027\u3092\u7db2\u7f85\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/td>PerBPOM 6\/2025<\/td><\/tr>
    \u30ab\u30d0\u30ec\u30c3\u30b8<\/td>\u3053\u306e\u30c7\u30fc\u30bf\u306f\u3001\u305d\u308c\u305e\u308c\u306e\u6fc3\u5ea6\u3068\u5305\u88c5\u5f62\u614b\u3092\u7db2\u7f85\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/td>PerBPOM 6\/2025<\/td><\/tr>
    \u7814\u7a76\u5ba4<\/td>\u305d\u306e\u65bd\u8a2d\u306f\u8a8d\u5b9a\u3092\u53d7\u3051\u3066\u3044\u307e\u3059\u304b\u3001\u305d\u308c\u3068\u3082\u793e\u5185\u306bGMP\u8a8d\u8a3c\u3092\u53d7\u3051\u305f\u7814\u7a76\u6240\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/td>PerBPOM 6\/2025<\/td><\/tr>
    \u30e9\u30d9\u30eb<\/td>\u4fdd\u7ba1\u306b\u95a2\u3059\u308b\u8a18\u8ff0\u306b\u306f\u3001\u660e\u78ba\u306a\u6e29\u5ea6\u6307\u5b9a\u304c\u3042\u308a\u307e\u3059\u304b\uff1f<\/td>PerBPOM 6\/2025<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    \u7d50\u8ad6\uff1a\u9759\u304b\u306a\u3046\u3061\u306b\u9699\u9593\u3092\u57cb\u3081\u3088\u3046<\/strong><\/h2>\n\n\n\n

    PerBPOM 6\/2025\u306e\u5b89\u5b9a\u6027\u8a66\u9a13\u306f\u5b8c\u4e86\u3057\u3001\u8abf\u6574\u671f\u9593\u3082\u7d42\u4e86\u3057\u307e\u3057\u305f\u3002\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001BPOM\u306f\u305d\u308c\u4ee5\u964d\u3001\u5b89\u5b9a\u6027\u306b\u95a2\u3059\u308b\u554f\u3044\u5408\u308f\u305b\u3092\u4e00\u5207\u884c\u3063\u3066\u3044\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u5fc3\u5f37\u3044\u3053\u3068\u3067\u3042\u308a\u3001\u7de0\u3081\u5207\u308a\u306b\u8ffd\u308f\u308c\u308b\u3053\u3068\u306a\u304f\u3001\u843d\u3061\u7740\u3044\u3066\u30c7\u30fc\u30bf\u3092\u898b\u76f4\u3059\u306e\u306b\u6700\u9069\u306a\u6642\u671f\u3067\u3059\u3002.<\/p>\n\n\n\n

    Product Registration Indonesia\u306f\u3001PerBPOM 6\/2025\u306b\u7167\u3089\u3057\u3066\u3001\u5b89\u5b9a\u6027\u8a66\u9a13\u3001\u691c\u67fb\u6a5f\u95a2\u306e\u72b6\u6cc1\u3001\u30e9\u30d9\u30eb\u8868\u793a\u3092\u5be9\u67fb\u3057\u3001\u5fc5\u8981\u306a\u88dc\u8db3\u30c7\u30fc\u30bf\u306b\u3064\u3044\u3066\u3054\u6848\u5185\u3044\u305f\u3057\u307e\u3059\u3002\u6b21\u56de\u306e\u7533\u8acb\u307e\u305f\u306f\u66f4\u65b0\u524d\u306b\u3001PRI\u306e\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u767b\u9332\u30c1\u30fc\u30e0\u306b\u3054\u9023\u7d61\u3044\u305f\u3060\u304d\u3001\u5b89\u5b9a\u6027\u30c7\u30fc\u30bf\u5be9\u67fb\u306e\u624b\u914d\u3092\u304a\u9858\u3044\u3044\u305f\u3057\u307e\u3059\u3002.<\/p>","protected":false},"excerpt":{"rendered":"

    When reviewing a supplement stability dossier, two red flags almost always stand out first: overseas data applied blindly without accounting for local humidity, and vague storage labels like “store at room temperature.” If you are a brand owner, importer, or regulatory lead, this guide to PerBPOM 6\/2025 stability testing outlines what the rule strictly requires and where dossiers usually fall short. Dossiers built on overseas data generated at 30 \u00b0C \/ 65% RH demand the closest attention. Interestingly, Product Registration Indonesia (PRI) has not received stability-related queries from BPOM since the alignment period ended around March 20, 2026.   While this reflects our recent case logs, it shouldn’t be taken […]<\/p>\n","protected":false},"author":13,"featured_media":7973,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[38],"tags":[],"country":[57],"class_list":["post-7972","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bpom-articles","country-indonesia"],"acf":[],"_links":{"self":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7972","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=7972"}],"version-history":[{"count":1,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7972\/revisions"}],"predecessor-version":[{"id":7974,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7972\/revisions\/7974"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/7973"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=7972"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=7972"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=7972"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=7972"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}