{"id":7889,"date":"2026-10-08T13:29:40","date_gmt":"2026-10-08T06:29:40","guid":{"rendered":"https:\/\/productregistrationindonesia.com\/"},"modified":"2026-10-08T13:34:22","modified_gmt":"2026-10-08T06:34:22","slug":"perbpom-27-2025-facility-audit","status":"publish","type":"post","link":"https:\/\/productregistrationindonesia.com\/ja\/perbpom-27-2025-facility-audit\/","title":{"rendered":"PerBPOM 27\/2025 \u65bd\u8a2d\u76e3\u67fb\uff1aBPOM\u691c\u8a3c\u62c5\u5f53\u8005\u304c\u5b9f\u969b\u306b\u30c1\u30a7\u30c3\u30af\u3059\u308b\u5185\u5bb9"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u5916\u56fd\u306e\u8f38\u5165\u696d\u8005\u3001\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6301\u8005\u3001\u54c1\u8cea\u7ba1\u7406\u8005\u304c\u76f4\u9762\u3059\u308b <strong>PerBPOM 27\/2025 \u65bd\u8a2d\u76e3\u67fb<\/strong>, \u5f7c\u3089\u306f\u3001\u516c\u8868\u3055\u308c\u3066\u3044\u308b\u898f\u5247\u306b\u5bfe\u3059\u308b\u5358\u7d14\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30a7\u30c3\u30af\u3092\u671f\u5f85\u3059\u308b\u3053\u3068\u304c\u591a\u3044\u3002\u3057\u304b\u3057\u3001\u6211\u3005\u306e\u7d4c\u9a13\u3067\u306f\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u57fa\u6e96\u306f\u3042\u304f\u307e\u3067\u3082\u57fa\u672c\u3068\u306a\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u7d50\u679c\u3092\u5de6\u53f3\u3059\u308b\u306e\u306f\u3001\u691c\u8a3c\u8005\u304c\u305d\u308c\u3092\u7279\u5b9a\u306e\u65bd\u8a2d\u3084\u30d5\u30a1\u30a4\u30eb\u306b\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3059\u308b\u304b\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u8a18\u4e8b\u306f\u3001\u533b\u85ac\u54c1\u3001\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u3001\u52a0\u5de5\u98df\u54c1\u3068\u3044\u3063\u305f\u5206\u91ce\u3067\u6d3b\u52d5\u3059\u308b\u898f\u5236\u95a2\u9023\u8cac\u4efb\u8005\u3084\u54c1\u8cea\u7ba1\u7406\u8005\u5411\u3051\u306b\u66f8\u304b\u308c\u3066\u3044\u307e\u3059\u3002\u898f\u5236\u6761\u6587\u306b\u57fa\u3065\u3044\u3066\u30c1\u30fc\u30e0\u304c\u5b8c\u5168\u306a\u30d5\u30a1\u30a4\u30eb\u3092\u4f5c\u6210\u3057\u3066\u3044\u305f\u3068\u3057\u3066\u3082\u3001\u691c\u8a3c\u62c5\u5f53\u8005\u306e\u5b9f\u52d9\u7684\u306a\u89e3\u91c8\u306b\u3088\u3063\u3066\u306f\u3001\u6e96\u62e0\u3057\u3066\u3044\u308b\u3068\u601d\u3063\u3066\u3044\u305f\u624b\u9806\u304c\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u306e\u5bfe\u8c61\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2026\u5e74\u306b\u30b8\u30e3\u30ab\u30eb\u30bf\u306eBBPOM\u65bd\u8a2d\u3067\u884c\u308f\u308c\u305f\u67fb\u5bdf\u3067\u3001\u79c1\u305f\u3061\u306f\u3053\u306e\u3053\u3068\u3092\u76ee\u306e\u5f53\u305f\u308a\u306b\u3057\u307e\u3057\u305f\u3002\u79c1\u305f\u3061\u306e\u30c1\u30fc\u30e0\u306fCAPA\u30dd\u30a4\u30f3\u30c8\u3068\u6574\u5408\u3057\u3066\u3044\u308b\u3068\u5224\u65ad\u3057\u305f\u6e29\u5ea6\u30de\u30c3\u30d4\u30f3\u30b0\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u7528\u3044\u3066\u3082\u3001\u6700\u521d\u306e\u8a55\u4fa1\u3067\u306f\u6307\u6458\u4e8b\u9805\u304c\u672a\u89e3\u6c7a\u306e\u307e\u307e\u6b8b\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u305d\u306e\u4e8b\u4f8b\u3092\u8a73\u3057\u304f\u89e3\u8aac\u3057\u3001PerBPOM 27\/2025\u304c\u5bfe\u8c61\u3068\u3059\u308b\u7bc4\u56f2\u3092\u8aac\u660e\u3059\u308b\u3068\u3068\u3082\u306b\u3001\u691c\u8a3c\u8005\u304c\u898f\u5b9a\u3092\u6587\u66f8\u5316\u3055\u308c\u305f\u898f\u5247\u3068\u306f\u7570\u306a\u308b\u89e3\u91c8\u3092\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u7b87\u6240\u3092\u793a\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3067\u306f\u306a\u304f\u3001\u3042\u304f\u307e\u3067\u4e8b\u4f8b\u306e\u4e00\u3064\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PerBPOM 27\/2025\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f\u307e\u305f\u3001\u8ab0\u304c\u65bd\u8a2d\u76e3\u67fb\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PerBPOM 27\/2025 \u306f\u3001Peraturan Badan Pengawas Obat dan Makanan Nomor 27 Tahun 2025 \u3067\u3042\u308a\u3001\u533b\u85ac\u54c1\u3001\u6f22\u65b9\u85ac\u3001\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u3001\u52a0\u5de5\u98df\u54c1\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u306e\u30e9\u30a4\u30bb\u30f3\u30b9\u306e\u4e0b\u3067\u30d3\u30b8\u30cd\u30b9\u3068\u88fd\u54c1\u306e\u57fa\u6e96\u3092\u8a2d\u5b9a\u3059\u308b BPOM \u898f\u5236\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6b63\u5f0f\u306a\u30bf\u30a4\u30c8\u30eb\u306f\u3001\u300c\u30b9\u30bf\u30f3\u30c0\u30fc\u30eb\u30fb\u30b1\u30ae\u30a2\u30bf\u30f3\u30fb\u30a6\u30b5\u30cf\u30fb\u30c0\u30f3\u30fb\u30d7\u30ed\u30c9\u30a5\u30af\u30fb\u30d1\u30c0\u30fb\u30da\u30cb\u30a8\u30ec\u30f3\u30ac\u30e9\u30fc\u30f3\u30fb\u30da\u30ea\u30b8\u30ca\u30f3\u30fb\u30d9\u30eb\u30b5\u30cf\u30fb\u30d9\u30eb\u30d0\u30b7\u30b9\u30fb\u30ea\u30b7\u30b3\u30fb\u30b5\u30d6\u30bb\u30af\u30bf\u30fc\u30fb\u30aa\u30d0\u30c8\u30fb\u30c0\u30f3\u30fb\u30de\u30ab\u30ca\u30f3\u300d\u3067\u3059\u3002\u306e\u7b2c 5 \u6761\u7b2c 7 \u9805\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002 <a href=\"https:\/\/peraturan.bpk.go.id\/Details\/319773\/\" target=\"_blank\" rel=\"noopener\">\u30da\u30e9\u30c8\u30a5\u30e9\u30f3 \u30da\u30e1\u30ea\u30f3\u30bf (PP) No. 28\/2025<\/a>, \u306f\u3001PerBPOM No. 10\/2021 \u3092\u5ec3\u6b62\u3057\u30012025 \u5e74 10 \u6708 3 \u65e5\u306b\u767a\u52b9\u3057\u305f\u3002.<strong>&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">BPOM\u306f\u57fa\u6e96\u3092\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u85ac\u54c1\u6210\u5206\u3001\u751f\u85ac\u3001\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3001\u533b\u85ac\u90e8\u5916\u54c1\u304a\u3088\u3073\u5316\u7ca7\u54c1\u3001\u52a0\u5de5\u98df\u54c1\u306e3\u3064\u306e\u5206\u91ce\u306b\u5206\u985e\u3057\u3066\u3044\u307e\u3059\u3002\u5404\u5206\u91ce\u306f\u3001\u8ca9\u58f2\u627f\u8a8d\u3001\u9069\u6b63\u88fd\u9020\u304a\u3088\u3073\u6d41\u901a\u8a8d\u8a3c\u3001\u5e83\u544a\u627f\u8a8d\u3001\u81e8\u5e8a\u8a66\u9a13\u304a\u3088\u3073\u524d\u81e8\u5e8a\u8a66\u9a13\u898f\u5247\u3092\u7db2\u7f85\u3057\u3066\u304a\u308a\u3001\u3059\u3079\u3066\u96fb\u5b50\u7684\u306b\u63d0\u51fa\u3055\u308c\u307e\u3059\u3002 <a href=\"https:\/\/oss.go.id\" target=\"_blank\" rel=\"noopener\">OSS<\/a>.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>PerBPOM 27\/2025\u306b\u57fa\u3065\u304f\u30b0\u30eb\u30fc\u30d7<\/th><th>\u88fd\u54c1<\/th><th>\u65bd\u8a2d\u306b\u95a2\u9023\u3057\u305f\u512a\u826f\u4e8b\u4f8b\u8a8d\u8a3c<\/th><\/tr><\/thead><tbody><tr><td>\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u85ac\u54c1\u6210\u5206<\/td><td>\u533b\u85ac\u54c1\u304a\u3088\u3073\u6709\u52b9\u6210\u5206<\/td><td>CPOB\u306f\u751f\u7523\u7528\u3001CDOB\u306f\u6d41\u901a\u7528<\/td><\/tr><tr><td>\u30cf\u30fc\u30d6\u85ac\u3001\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1<\/td><td>\u30aa\u30d0\u30c8\u30fb\u30d0\u30cf\u30f3\u30fb\u30a2\u30e9\u30e0\uff08OBA\uff09\u3001\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1<\/td><td>\u4f1d\u7d71\u533b\u85ac\u54c1\u88fd\u9020\u306e\u305f\u3081\u306eCPOTB\u3001\u5316\u7ca7\u54c1\u88fd\u9020\u306e\u305f\u3081\u306eCPKB<\/td><\/tr><tr><td>\u52a0\u5de5\u98df\u54c1<\/td><td>\u5305\u88c5\u98df\u54c1\u304a\u3088\u3073\u98f2\u6599<\/td><td>IP-CPPOB<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u51fa\u5178\uff1aBPOM\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u98df\u54c1\u533b\u85ac\u54c1\u76e3\u7763\u5e81\uff09\u306ePerBPOM 27\/2025\u306b\u95a2\u3059\u308b\u898f\u5236\u30da\u30fc\u30b8\u3002\u5206\u304b\u308a\u3084\u3059\u304f\u3059\u308b\u305f\u3081\u306b\u7c21\u7565\u5316\u3057\u3066\u3044\u307e\u3059\u3002\u3054\u81ea\u8eab\u306e\u6d3b\u52d5\u306b\u5408\u3063\u305f\u6b63\u78ba\u306a\u8a3c\u660e\u66f8\u306b\u3064\u3044\u3066\u306f\u3001\u898f\u5236\u4ed8\u5c5e\u66f8\u3092\u3054\u78ba\u8a8d\u304f\u3060\u3055\u3044\u3002.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PerBPOM 27\/2025 \u65bd\u8a2d\u76e3\u67fb\uff1a\u6838\u5fc3\u7684\u306a\u7b54\u3048<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PerBPOM 27\/2025\u65bd\u8a2d\u76e3\u67fb\u3068\u306f\u3001\u4e8b\u696d\u8005\u306e\u65bd\u8a2d\u3001\u4fdd\u7ba1\u6761\u4ef6\u3001\u8a2d\u5099\u3001\u8a18\u9332\u3001\u304a\u3088\u3073\u4eba\u54e1\u304c\u3001\u8a8d\u53ef\u3055\u308c\u305f\u4e8b\u696d\u6d3b\u52d5\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092BPOM\u304c\u691c\u8a3c\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u5f53\u793e\u306e\u7d4c\u9a13\u3067\u306f\u3001\u6587\u66f8\u8a55\u4fa1\u3001\u65bd\u8a2d\u691c\u8a3c\u3001\u304a\u3088\u3073\u662f\u6b63\u63aa\u7f6e\u306e3\u6bb5\u968e\u3067\u5b9f\u65bd\u3055\u308c\u307e\u3059\u3002.<strong>&nbsp;<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u30b9\u30c6\u30fc\u30b81\uff1aOSS\u63d0\u51fa\u5f8c\u306e\u6587\u66f8\u8a55\u4fa1<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">OSS\u3067\u30d5\u30a1\u30a4\u30eb\u304c\u8a55\u4fa1\u3055\u308c\u305f\u5f8c\u3001BBPOM\u306f\u624b\u7d9a\u304d\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001\u8ffd\u52a0\u306e\u8a3c\u62e0\u3092\u6c42\u3081\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002BBPOM\u30b8\u30e3\u30ab\u30eb\u30bf\u4e8b\u52d9\u6240\u306b\u304a\u3051\u308b2026\u5e74\u306e\u4e8b\u4f8b\u3067\u306f\u3001\u76e3\u67fb\u65e5\u304c\u6c7a\u5b9a\u3055\u308c\u308b\u524d\u306e3\u67085\u65e5\u306b\u3001\u4e8b\u52d9\u6240\u304b\u308927\u4ef6\u306e\u8ffd\u52a0\u66f8\u985e\u306e\u63d0\u51fa\u3092\u6c42\u3081\u3089\u308c\u307e\u3057\u305f\u3002.<strong>&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u3001OSS\u3078\u306e\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u304c\u5b8c\u5168\u306a\u8cc7\u6599\u3060\u3068\u8003\u3048\u3066\u3044\u308b\u30c1\u30fc\u30e0\u306f\u3001\u6700\u521d\u306e\u6570\u9031\u9593\u3092\u7121\u99c4\u306b\u3057\u3066\u3057\u307e\u3044\u307e\u3059\u3002\u79c1\u305f\u3061\u306f\u3053\u306e\u8a55\u4fa1\u3092\u76e3\u67fb\u306e\u7b2c\u4e00\u6bb5\u968e\u3068\u4f4d\u7f6e\u3065\u3051\u3001\u73fe\u5834\u3067\u306f\u306a\u304f\u66f8\u9762\u3067\u51e6\u7406\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u30b9\u30c6\u30fc\u30b82\uff1a\u65bd\u8a2d\u691c\u8a3c<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u3053\u3067\u306f\u3001\u4fdd\u7ba1\u304a\u3088\u3073\u904b\u7528\u6761\u4ef6\u304c\u57fa\u6e96\u306b\u7167\u3089\u3057\u3066\u691c\u8a3c\u3055\u308c\u307e\u3059\u3002\u5f53\u793e\u306e\u7d4c\u9a13\u3067\u306f\u3001\u4f1d\u7d71\u533b\u85ac\u54c1\u3084\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u306e\u8f38\u5165\u696d\u8005\u306f\u3001\u5009\u5eab\u306e\u6e29\u5ea6\u7ba1\u7406\u306b\u95a2\u3057\u3066\u3001\u76e3\u8996\u88c5\u7f6e\u306e\u8a2d\u7f6e\u5834\u6240\u3084\u6821\u6b63\u306e\u8a3c\u660e\u65b9\u6cd5\u306a\u3069\u3001\u53b3\u3057\u3044\u8cea\u554f\u306b\u76f4\u9762\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u30b9\u30c6\u30fc\u30b83\uff1a\u662f\u6b63\u63aa\u7f6e\uff08CAPA\uff09<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">CAPA\u3068\u306f\u3001\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u306e\u7565\u3067\u3059\u3002BBPOM\u306f\u8abf\u67fb\u7d50\u679c\u3092\u4e00\u89a7\u306b\u3057\u3001\u4f01\u696d\u306f\u305d\u308c\u305e\u308c\u306b\u8a3c\u62e0\u3092\u6dfb\u3048\u3066\u56de\u7b54\u3057\u307e\u3059\u3002.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">BBPOM \u30b8\u30e3\u30ab\u30eb\u30bf\u3067\u306e\u5b9f\u969b\u306e PerBPOM 27\/2025 \u65bd\u8a2d\u76e3\u67fb\u4e8b\u4ef6<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u8868\u306f\u3001\u6f22\u65b9\u85ac\u304a\u3088\u3073\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u8f38\u5165\u696d\u8005\u306b\u5bfe\u3057\u3066\u5b9f\u65bd\u3055\u308c\u305f2026\u5e74\u306e\u76e3\u67fbPRI\u306e\u4e00\u4f8b\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u306f\u5358\u4e00\u306e\u4e8b\u4f8b\u3067\u3042\u308a\u3001BBPOM\u306e\u6a19\u6e96\u7684\u306a\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u307e\u305f\u3001\u5404\u4e8b\u52d9\u6240\u3084\u691c\u8a3c\u62c5\u5f53\u8005\u306b\u3088\u3063\u3066\u5bfe\u5fdc\u306f\u7570\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>2026\u5e74<\/th><th>\u3069\u3046\u3057\u305f\u306e<\/th><th>\u305d\u308c\u304c\u79c1\u305f\u3061\u306b\u6559\u3048\u3066\u304f\u308c\u305f\u3053\u3068<\/th><\/tr><\/thead><tbody><tr><td>3\u67085\u65e5<\/td><td>OSS\u8a55\u4fa1\u5f8c\u3001BBPOM\u306f\u76e3\u67fb\u306e\u5b9f\u65bd\u3092\u4e88\u5b9a\u3059\u308b\u524d\u306b\u3001\u3055\u3089\u306b27\u4ef6\u306e\u6587\u66f8\u3092\u8981\u6c42\u3057\u305f\u3002.<\/td><td>\u66f8\u985e\u5be9\u67fb\u306f\u5f62\u5f0f\u7684\u306a\u624b\u7d9a\u304d\u3067\u306f\u306a\u304f\u3001\u901a\u904e\u70b9\u3067\u3042\u308b\u3002.<\/td><\/tr><tr><td>3\u670827\u65e5<\/td><td>CAPA\u30ea\u30af\u30a8\u30b9\u30c8\u304c\u767a\u884c\u3055\u308c\u307e\u3057\u305f\u3002\u30e1\u30fc\u30eb\u3067\u8fd4\u4fe1\u3057\u307e\u3057\u305f\u3002.<\/td><td>\u66f8\u5f0f\u306b\u95a2\u3059\u308b\u6307\u793a\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u4e00\u90e8\u3067\u3059\u3002.<\/td><\/tr><tr><td>4\u670818\u65e5<\/td><td>\u6700\u521d\u306e\u8a55\u4fa1\u3067\u306f\u3001\u5009\u5eab\u306e\u6e29\u5ea6\u30de\u30c3\u30d4\u30f3\u30b0\u306b\u95a2\u3059\u308b\u8abf\u67fb\u7d50\u679c\u304c\u672a\u89e3\u6c7a\u306e\u307e\u307e\u6b8b\u3055\u308c\u305f\u3002.<\/td><td>\u6b63\u3057\u3044\u30d7\u30ed\u30c8\u30b3\u30eb\u3067\u3042\u3063\u3066\u3082\u3001\u691c\u8a3c\u8005\u306e\u8aad\u307f\u53d6\u308a\u3092\u898b\u9003\u3059\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/td><\/tr><tr><td>5\u670813\u65e5<\/td><td>CAPA\uff08\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff09\u5b8c\u4e86\u901a\u77e5\u66f8\u304c\u767a\u884c\u3055\u308c\u307e\u3057\u305f\u3002.<\/td><td>3\u67085\u65e5\u306e\u6587\u66f8\u63d0\u51fa\u8981\u6c42\u304b\u3089\u5b8c\u4e86\u307e\u3067\u7d0410\u9031\u9593\u304b\u304b\u308a\u3001\u305d\u306e\u9593\u306b1\u56de\u306e\u4fee\u6b63\u4f5c\u696d\u304c\u3042\u3063\u305f\u3002.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">\u6e29\u5ea6\u30de\u30c3\u30d4\u30f3\u30b0\u306e\u7d50\u679c<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u6700\u521d\u306e\u8a55\u4fa1\u306b\u304a\u3044\u3066\u3001\u5f53\u30c1\u30fc\u30e0\u306f\u30de\u30c3\u30d4\u30f3\u30b0\u624b\u9806\u304cCAPA\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3068\u5224\u65ad\u3057\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001BBPOM\u306f\u3001\u6700\u9ad8\u6e29\u5ea6\u306e\u6e2c\u5b9a\u57fa\u6e96\u3092\u5e73\u5747\u5024\u3067\u306f\u306a\u304f\u3001\u5b9f\u969b\u306b\u8a18\u9332\u3055\u308c\u305f\u6700\u9ad8\u6e29\u5ea6\u306b\u8a2d\u5b9a\u3059\u308b\u3053\u3068\u3001\u304a\u3088\u3073\u3059\u3079\u3066\u306e\u76e3\u8996\u6a5f\u5668\u306e\u6821\u6b63\u8a3c\u660e\u66f8\u3092\u63d0\u51fa\u3059\u308b\u3053\u3068\u3092\u8981\u6c42\u3057\u307e\u3057\u305f\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u304c\u4eca\u56de\u306e\u4e8b\u4f8b\u304b\u3089\u5f97\u3089\u308c\u308b\u5b9f\u8df5\u7684\u306a\u6559\u8a13\u3067\u3042\u308b\u3002\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u3001\u3053\u306e\u691c\u8a3c\u8005\u304c\u8981\u4ef6\u3092\u89e3\u91c8\u3057\u305f\u5185\u5bb9\u3068\u4e00\u81f4\u3057\u3066\u304a\u3089\u305a\u3001\u898f\u5247\u3092\u8aad\u307f\u76f4\u3057\u305f\u3060\u3051\u3067\u306f\u305d\u306e\u77db\u76fe\u306b\u6c17\u3065\u304b\u306a\u304b\u3063\u305f\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PerBPOM 27\/2025\u65bd\u8a2d\u76e3\u67fb\u7d50\u679c\u304c\u691c\u8a3c\u8005\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u7406\u7531<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u898f\u5247\u306f\u57fa\u6e96\u3092\u5b9a\u3081\u308b\u3082\u306e\u3067\u3059\u304c\u3001\u305d\u308c\u3092\u9069\u7528\u3059\u308b\u306e\u306f\u4eba\u9593\u3067\u3059\u3002\u79c1\u305f\u3061\u306e\u7d4c\u9a13\u3067\u306f\u30012\u4eba\u306e\u691c\u8a3c\u8005\u304c\u540c\u3058\u6761\u9805\u3092\u8aad\u3093\u3067\u3082\u3001\u8981\u6c42\u3059\u308b\u8a3c\u62e0\u304c\u7570\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u3001\u305d\u306e\u305f\u3081\u3001\u3042\u308b\u76e3\u67fb\u306e\u7d50\u679c\u304c\u5225\u306e\u90e8\u7f72\u3084\u76e3\u67fb\u30e9\u30a6\u30f3\u30c9\u306b\u305d\u306e\u307e\u307e\u5f15\u304d\u7d99\u304c\u308c\u308b\u3053\u3068\u306f\u307b\u3068\u3093\u3069\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f53\u793e\u3067\u306f\u3001\u6280\u8853\u7684\u306a\u624b\u9806\u3092\u7b56\u5b9a\u3059\u308b\u524d\u306b\u3001BPOM\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u98df\u54c1\u533b\u85ac\u54c1\u76e3\u7763\u5e81\uff09\u3068\u76f4\u63a5\u9762\u8ac7\u3057\u3001\u89e3\u91c8\u3068\u63d0\u51fa\u7d4c\u8def\u3092\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3092\u539f\u5247\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u30d7\u30ed\u30c8\u30b3\u30eb\u4f5c\u6210\u524d\u306e\u77ed\u3044\u6253\u3061\u5408\u308f\u305b\u306f\u30012\u56de\u76ee\u306e\u4fee\u6b63\u4f5c\u696d\u306b\u304b\u304b\u308b\u8cbb\u7528\u3088\u308a\u3082\u306f\u308b\u304b\u306b\u5b89\u4fa1\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u304c\u3001\u79c1\u305f\u3061\u304c\u666e\u904d\u7684\u306a\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u306e\u516c\u958b\u3092\u907f\u3051\u3066\u3044\u308b\u7406\u7531\u3067\u3082\u3042\u308a\u307e\u3059\u3002\u3042\u308b\u76e3\u67fb\u304b\u3089\u30b3\u30d4\u30fc\u3057\u305f\u30ea\u30b9\u30c8\u306f\u3001\u3042\u308b\u90e8\u7f72\u306b\u306f\u9069\u5207\u3067\u3082\u3001\u5225\u306e\u90e8\u7f72\u306b\u306f\u4e0d\u5b8c\u5168\u3067\u3042\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u3001\u305d\u306e\u30ea\u30b9\u30c8\u3060\u3051\u306b\u57fa\u3065\u3044\u3066\u884c\u52d5\u3059\u308b\u3068\u3001\u6307\u6458\u4e8b\u9805\u304c\u672a\u89e3\u6c7a\u306e\u307e\u307e\u6b8b\u3063\u3066\u3057\u307e\u3046\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u610f\u601d\u6c7a\u5b9a\u30d7\u30ed\u30bb\u30b9\uff1aPerBPOM 27\/2025\u306b\u57fa\u3065\u304f\u65bd\u8a2d\u76e3\u67fb\u306f\u8cb4\u793e\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u304b\uff1f<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u8cb4\u793e\u88fd\u54c1\u306f\u533b\u7642\u6a5f\u5668\u307e\u305f\u306f\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u3067\u3059\u304b\uff1f\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u4e0b\u8a18\u306e\u533b\u7642\u6a5f\u5668\u306e\u9805\u3067\u8aac\u660e\u3059\u308b\u30b1\u30e1\u30f3\u30b1\u30b9\uff08Kemenkes\uff09\u306e\u627f\u8a8d\u7d4c\u8def\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002\u8a72\u5f53\u3057\u306a\u3044\u5834\u5408\u306f\u3001\u6b21\u306e\u624b\u9806\u306b\u9032\u3093\u3067\u304f\u3060\u3055\u3044\u3002.<\/li>\n\n\n\n<li>\u305d\u308c\u306f\u533b\u85ac\u54c1\u3001\u6f22\u65b9\u85ac\u3001\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u3001\u307e\u305f\u306f\u52a0\u5de5\u98df\u54c1\u3067\u3059\u304b\uff1f\u3082\u3057\u305d\u3046\u3067\u3042\u308c\u3070\u3001PerBPOM 27\/2025\u304c\u53c2\u7167\u898f\u5236\u3068\u306a\u308a\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u88fd\u9020\u3001\u8f38\u5165\u3001\u8ca9\u58f2\u306e\u3044\u305a\u308c\u306b\u8a72\u5f53\u3057\u307e\u3059\u304b\uff1f \u3042\u306a\u305f\u306e\u5f79\u5272\u306b\u3088\u3063\u3066\u3001\u9069\u7528\u3055\u308c\u308b\u512a\u826f\u4e8b\u4f8b\u8a8d\u8a3c\u3084\u65bd\u8a2d\u57fa\u6e96\u304c\u6c7a\u307e\u308a\u307e\u3059\u3002.<\/li>\n\n\n\n<li>\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u81ea\u4f53\u304c\u4e0d\u660e\u78ba\u3067\u3059\u304b\uff1f\u307e\u305a\u305d\u308c\u3092\u89e3\u6c7a\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <strong>\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\u306e\u6c7a\u5b9a\u3002.<\/strong><\/li>\n<\/ol>\n\n\n\n<figure class=\"wp-block-embed is-type-wp-embed is-provider-product-registration-indonesia wp-block-embed-product-registration-indonesia\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"XSHysAZ2fq\"><a href=\"https:\/\/productregistrationindonesia.com\/ja\/product-category-determination\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\uff1a\u5316\u7ca7\u54c1\u3001\u6e96\u533b\u85ac\u54c1\u3001\u305d\u308c\u3068\u3082\u305d\u306e\u4ed6\uff1f<\/a><\/blockquote><iframe class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u300c\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u88fd\u54c1\u30ab\u30c6\u30b4\u30ea\u30fc\uff1a\u5316\u7ca7\u54c1\u3001\u6e96\u533b\u85ac\u54c1\u3001\u305d\u308c\u3068\u3082\u305d\u306e\u4ed6\uff1f\u300d\u2014\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u88fd\u54c1\u767b\u9332\" src=\"https:\/\/productregistrationindonesia.com\/product-category-determination\/embed\/#?secret=6hL5dIE0Ql#?secret=XSHysAZ2fq\" data-secret=\"XSHysAZ2fq\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">\u8f38\u5165\u696d\u8005\u3001\u8ca9\u58f2\u696d\u8005\u3001\u88fd\u9020\u696d\u8005\u306b\u5bfe\u3059\u308bBPOM\u65bd\u8a2d\u76e3\u67fb\u8981\u4ef6<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">BPOM\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306e\u65bd\u8a2d\u76e3\u67fb\u8981\u4ef6\u306f\u3001\u8a31\u53ef\u3092\u53d7\u3051\u308b\u4e8b\u696d\u5185\u5bb9\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u751f\u7523\u8005\u306f\u9069\u6b63\u751f\u7523\u898f\u7bc4\uff08GMP\uff09\u8a8d\u8a3c\u3001\u6d41\u901a\u696d\u8005\u306f\u9069\u6b63\u6d41\u901a\u898f\u7bc4\uff08GDP\uff09\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002\u8f38\u5165\u696d\u8005\u306b\u3064\u3044\u3066\u306f\u3001\u4fdd\u7ba1\u8a2d\u5099\u3068\u8a18\u9332\u7ba1\u7406\u4f53\u5236\u306e\u6574\u5099\u72b6\u6cc1\u304c\u8a55\u4fa1\u57fa\u6e96\u3068\u306a\u308a\u307e\u3059\u3002.<strong>&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5316\u7ca7\u54c1\u5de5\u5834\u5411\u3051\u306b\u306f\u3001Peraturan BPOM Nomor 8 Tahun 2026 tentang Sertifikasi Cara Pembuatan Kosmetik yang Baik (CPKB) \u304c 2026 \u5e74 4 \u6708 21 \u65e5\u306b\u7f72\u540d\u3055\u308c\u3001PerBPOM No. 33\/2021 \u306b\u4ee3\u308f\u3063\u3066 2026 \u5e74 4 \u6708 29 \u65e5\u306b\u767a\u52b9\u3057\u307e\u3057\u305f\u3002\u30ac\u30a4\u30c9\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/ckpb-certification-indonesia\/\">CPKB\u8a8d\u5b9a\u8a66\u9a13\u306e\u843d\u3068\u3057\u7a74<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5316\u7ca7\u54c1\u8f38\u5165\u696d\u8005\u306f\u3001\u65bd\u8a2d\u691c\u67fb\u524d\u306b\u6280\u8853\u62c5\u5f53\u8005\u3092\u914d\u7f6e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002 <a href=\"https:\/\/jdih.pom.go.id\/preview\/slide\/1413\/21\/2022\" target=\"_blank\" rel=\"noopener\">Peraturan BPOM Nomor 21 Tahun 2022 tentang Tata Cara Pengajuan Notifikasi Kosmetika<\/a>. \u3053\u308c\u306b\u3064\u3044\u3066\u306f\u4ee5\u4e0b\u3067\u8aac\u660e\u3057\u307e\u3059 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/technical-person-in-charge-bpom\/\">BPOM\u62c5\u5f53\u6280\u8853\u8cac\u4efb\u8005<\/a>. \u767b\u9332\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u3061\u3089\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/cosmetic-product-registration\/\">\u5316\u7ca7\u54c1\u767b\u9332<\/a> \u30b5\u30fc\u30d3\u30b9\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3084\u30cf\u30fc\u30d6\u533b\u85ac\u54c1\u306e\u8f38\u5165\u696d\u8005\u306f\u3001\u65bd\u8a2d\u306e\u6e96\u5099\u72b6\u6cc1\u304c\u767b\u9332\u306b\u3069\u306e\u3088\u3046\u306b\u95a2\u9023\u3057\u3066\u3044\u308b\u304b\u3092\u5f53\u793e\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3067\u78ba\u8a8d\u3067\u304d\u307e\u3059\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/food-supplements-registration\/\">\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u306e\u767b\u9332<\/a> \u30b5\u30fc\u30d3\u30b9\u3068\u5f53\u793e\u306e <a href=\"https:\/\/productregistrationindonesia.com\/ja\/bpom-certification-indonesia-2026\/\">BPOM\u8a8d\u8a3c\u30ac\u30a4\u30c9<\/a>. \u73fe\u5730\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6709\u8005\u3092\u5fc5\u8981\u3068\u3059\u308b\u6d77\u5916\u30d6\u30e9\u30f3\u30c9\u30aa\u30fc\u30ca\u30fc\u306f\u3001\u5f53\u793e\u306e <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/license-holder-service-in-indonesia\/\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u30e9\u30a4\u30bb\u30f3\u30b9\u4fdd\u6301\u8005\u5411\u3051\u30b5\u30fc\u30d3\u30b9<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u767b\u9332\uff1aPerBPOM 27\/2025\u306e\u9069\u7528\u7bc4\u56f2<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332\u306f\u3001\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u98df\u54c1\u533b\u85ac\u54c1\u76e3\u7763\u5e81\uff08BPOM\uff09\u898f\u524727\/2025\u306b\u57fa\u3065\u3044\u3066\u884c\u308f\u308c\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u898f\u5247\u306f\u3001\u533b\u85ac\u54c1\u3001\u6f22\u65b9\u85ac\u3001\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\u3001\u533b\u85ac\u90e8\u5916\u54c1\u3001\u5316\u7ca7\u54c1\u3001\u52a0\u5de5\u98df\u54c1\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\uff08IVD\uff09\u306f\u4fdd\u5065\u7701\uff08Kemenkes\uff09\u306b\u3088\u3063\u3066\u8a8d\u53ef\u3055\u308c\u308b\u305f\u3081\u3001BPOM\u306e\u76e3\u67fb\u8a08\u753b\u3092\u305d\u306e\u307e\u307e\u518d\u5229\u7528\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u306e <a href=\"https:\/\/jdih.kemkes.go.id\/documents\/peraturan-menteri-kesehatan-nomor-62-tahun-2017\" target=\"_blank\" rel=\"noopener\">JDIH\u30b1\u30e1\u30f3\u30b1\u30b9\u8a18\u9332<\/a> Permenkes No. 62\/2017 \u3067\u306f\u3001Permenkes No. 5 Tahun 2026 tentang Perbekalan Kesehatan \u306b\u3088\u3063\u3066\u53d6\u308a\u6d88\u3055\u308c\u305f\u3053\u3068\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u306e <a href=\"https:\/\/jdih.kemkes.go.id\/documents\/peraturan-menteri-kesehatan-nomor-5-tahun-2026\" target=\"_blank\" rel=\"noopener\">2026\u5e74\u898f\u5236<\/a> \u672c\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u533b\u7642\u6a5f\u5668\u306e\u8ca9\u58f2\u627f\u8a8d\uff08IZIN EDAR\uff09\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u305f\u3081\u30012017\u5e74\u306e\u898f\u5247\u306b\u57fa\u3065\u3044\u3066\u4f5c\u6210\u3055\u308c\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u306f\u6700\u65b0\u306e\u60c5\u5831\u3067\u306f\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u53e4\u3044\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u53c2\u7167\u3059\u308b\u524d\u306b\u3001\u6700\u65b0\u306e\u898f\u5247\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30c7\u30d0\u30a4\u30b9\u30eb\u30fc\u30c8\u306b\u3064\u3044\u3066\u306f\u3001\u6bd4\u8f03\u8868\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/productregistrationindonesia.com\/ja\/indonesia-ivd-registration-vs-medical-device\/\">\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u7642\u6a5f\u5668\u306e\u767b\u9332<\/a> \u305d\u3057\u3066\u79c1\u305f\u3061\u306e <a href=\"https:\/\/productregistrationindonesia.com\/ja\/services\/medical-device-registration-indonesia\/\">\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u306e\u767b\u9332<\/a> \u30b5\u30fc\u30d3\u30b9\u3002\u65bd\u8a2d\u304a\u3088\u3073\u914d\u9001\u306b\u95a2\u3059\u308b\u8981\u4ef6\u306f\u3001\u30b1\u30e1\u30f3\u30b1\u30b9\u306e\u898f\u5247\u306b\u5f93\u3046\u5fc5\u8981\u304c\u3042\u308a\u3001\u5225\u9014\u8a08\u753b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">PerBPOM 27\/2025\u65bd\u8a2d\u76e3\u67fb\u3078\u306e\u6e96\u5099\u65b9\u6cd5<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u4e0b\u306e\u9805\u76ee\u306f\u3001\u76e3\u67fb\u524d\u306b\u5f53\u30c1\u30fc\u30e0\u304c\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u3068\u78ba\u8a8d\u3059\u308b\u5185\u5bb9\u3092\u53cd\u6620\u3057\u305f\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u3089\u306f\u3042\u304f\u307e\u3067\u3082\u6982\u8981\u3067\u3042\u308a\u3001\u500b\u5225\u306e\u30b1\u30fc\u30b9\u306b\u5fdc\u3058\u305f\u691c\u8a0e\u306b\u4ee3\u308f\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u306a\u305c\u306a\u3089\u3001\u9069\u5207\u306a\u8a3c\u62e0\u306f\u3001\u304a\u5ba2\u69d8\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3001\u6240\u5c5e\u90e8\u7f72\u3001\u304a\u3088\u3073\u691c\u8a3c\u62c5\u5f53\u8005\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u304b\u3089\u3067\u3059\u3002.<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u6280\u8853\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b\u524d\u306b\u3001\u691c\u8a3c\u8005\u306e\u89e3\u91c8\u3092\u65e9\u3081\u306b\u3001\u3067\u304d\u308c\u3070\u76f4\u63a5\u78ba\u8a8d\u3059\u308b\u3088\u3046\u306b\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n\n\n\n<li>OSS\u8a55\u4fa1\u306f\u6700\u521d\u306e\u76e3\u67fb\u30e9\u30a6\u30f3\u30c9\u3068\u6349\u3048\u3001\u8ffd\u52a0\u306e\u6587\u66f8\u63d0\u51fa\u8981\u6c42\u304c\u3042\u308b\u3053\u3068\u3092\u60f3\u5b9a\u3057\u3066\u304a\u3044\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n\n\n\n<li>\u8a02\u6b63\u4f9d\u983c\u66f8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u66f8\u5f0f\u6307\u793a\uff08\u30d5\u30a1\u30a4\u30eb\u306e\u7a2e\u985e\u3084\u8a3c\u62e0\u306e\u6dfb\u4ed8\u65b9\u6cd5\u306a\u3069\uff09\u306f\u3001\u6587\u5b57\u901a\u308a\u306b\u8aad\u3093\u3067\u304f\u3060\u3055\u3044\u3002.<\/li>\n\n\n\n<li>\u691c\u8a3c\u8005\u304c\u5404\u6e2c\u5b9a\u5024\u3092\u3069\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3057\u3066\u3044\u308b\u304b\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u4f8b\u3048\u3070\u3001\u5b9f\u969b\u306e\u6700\u9ad8\u6e29\u5ea6\u3068\u5e73\u5747\u5024\u306a\u3069\u3067\u3059\u3002.<\/li>\n\n\n\n<li>\u76e3\u8996\u6a5f\u5668\u306e\u6821\u6b63\u8a3c\u660e\u66f8\u306f\u624b\u5143\u306b\u4fdd\u7ba1\u3057\u3001\u5c11\u306a\u304f\u3068\u30821\u56de\u306e\u4fee\u6b63\u4f5c\u696d\u3092\u884c\u3046\u305f\u3081\u306e\u6642\u9593\u3092\u78ba\u4fdd\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u308c\u305e\u308c\u306e\u30dd\u30a4\u30f3\u30c8\u306f\u4e00\u898b\u5358\u7d14\u306b\u805e\u3053\u3048\u307e\u3059\u304c\u3001\u305d\u308c\u3092\u7279\u5b9a\u306e\u5009\u5eab\u3001\u88fd\u54c1\u69cb\u6210\u3001BBPOM\u30aa\u30d5\u30a3\u30b9\u306b\u9069\u7528\u3059\u308b\u969b\u306b\u30df\u30b9\u304c\u767a\u751f\u3057\u3084\u3059\u304f\u3001\u65e9\u671f\u306b\u30ec\u30d3\u30e5\u30fc\u3092\u884c\u3046\u3053\u3068\u3067\u6700\u3082\u6642\u9593\u3092\u7bc0\u7d04\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u3053\u306e\u8a18\u4e8b\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u4e3b\u8981\u306a\u7528\u8a9e\u3068\u7565\u8a9e<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>BPOM: \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\u56fd\u5bb6\u533b\u85ac\u54c1\u98df\u54c1\u7ba1\u7406\u5e81\u3002.<\/li>\n\n\n\n<li>BBPOM: Balai Besar Pengawas Obat dan Makanan\u3001BBPOM \u30b8\u30e3\u30ab\u30eb\u30bf\u306a\u3069\u306e BPOM \u5730\u57df\u672c\u90e8\u3002.<\/li>\n\n\n\n<li>PerBPOM: Peraturan Badan Pengawas Obat dan Makanan\u3001BPOM \u898f\u5236\u3002.<\/li>\n\n\n\n<li>PP: Peraturan Pemerintah\u3001\u653f\u5e9c\u898f\u5236\u3002.<\/li>\n\n\n\n<li>\u30da\u30eb\u30e1\u30f3\u30b1\u30b9: \u30da\u30e9\u30c8\u30a5\u30e9\u30f3\u30fb\u30e1\u30f3\u30c6\u30ea\u30fb\u30b1\u30bb\u30cf\u30bf\u30f3\u3001\u4fdd\u5065\u898f\u5236\u5927\u81e3\u3002.<\/li>\n\n\n\n<li>\u30b1\u30e1\u30f3\u30b1\u30b9: \u30b1\u30e1\u30f3\u30c6\u30ea\u30a2\u30f3\u30fb\u30b1\u30bb\u30cf\u30bf\u30f3\u3001\u4fdd\u5065\u7701\u3002.<\/li>\n\n\n\n<li>OSS\uff1a\u30aa\u30f3\u30e9\u30a4\u30f3\u5358\u4e00\u7533\u8acb\u30b7\u30b9\u30c6\u30e0\u3002\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u306e\u56fd\u5bb6\u4e8b\u696d\u8a31\u53ef\u5236\u5ea6\u3002.<\/li>\n\n\n\n<li>CAPA\uff1a\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u3002\u76e3\u67fb\u7d50\u679c\u3092\u53d7\u3051\u3066\u884c\u308f\u308c\u308b\u662f\u6b63\u30d7\u30ed\u30bb\u30b9\u3002.<\/li>\n\n\n\n<li>CPOB: Cara Pembuatan Obat yang Baik\u3001\u533b\u85ac\u54c1\u306e\u9069\u6b63\u88fd\u9020\u57fa\u6e96\u3002.<\/li>\n\n\n\n<li>CPOTB: Cara Pembuatan Obat Traditional yang Baik\u3001\u4f1d\u7d71\u533b\u5b66\u306e\u9069\u6b63\u88fd\u9020\u57fa\u6e96\u3002.<\/li>\n\n\n\n<li>CPKB: Cara Pembuatan Kosmetik yang Baik\u3001\u5316\u7ca7\u54c1\u306e\u9069\u6b63\u88fd\u9020\u57fa\u6e96\u3002.<\/li>\n\n\n\n<li>CDOB: Cara Distribusi Obat yang Baik\u3001\u533b\u85ac\u54c1\u306e\u9069\u6b63\u6d41\u901a\u6163\u884c\u3002.<\/li>\n\n\n\n<li>IP-CPPOB: Izin Penerapan Cara Produksi Pangan Olahan yang Baik\u3001\u52a0\u5de5\u98df\u54c1\u306e\u9069\u6b63\u88fd\u9020\u57fa\u6e96\u627f\u8a8d\u3002.<\/li>\n\n\n\n<li>OBA: \u30aa\u30d0\u30c8\u30fb\u30d0\u30cf\u30f3\u30fb\u30a2\u30e9\u30e0\u3001\u30cf\u30fc\u30d6\u307e\u305f\u306f\u5929\u7136\u6210\u5206\u306e\u85ac\u3002.<\/li>\n\n\n\n<li>JDIH: Jaringan Dokumentasi dan Informasi Hukum\u3001\u5168\u56fd\u7684\u306a\u6cd5\u7684\u6587\u66f8\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3002.<\/li>\n\n\n\n<li>\u691c\u8a3c\u8005\uff1a\u76e3\u67fb\u4e2d\u306b\u6587\u66f8\u3084\u65bd\u8a2d\u3092\u8a55\u4fa1\u3059\u308bBPOM\uff08\u30a4\u30f3\u30c9\u30cd\u30b7\u30a2\u98df\u54c1\u533b\u85ac\u54c1\u76e3\u7763\u5e81\uff09\u306e\u8077\u54e1\u3002.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u9650\u754c<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001PerBPOM 27\/2025\u306e\u9069\u7528\u7bc4\u56f2\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3001\u4e8b\u4f8b\u3092\u4e00\u3064\u7d39\u4ecb\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u3001BBPOM\u306e\u6a19\u6e96\u7684\u306a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3092\u5b9a\u3081\u305f\u308a\u3001\u3059\u3079\u3066\u306e\u76e3\u67fb\u8981\u4ef6\u3092\u5217\u6319\u3057\u305f\u308a\u3001\u3054\u81ea\u8eab\u306e\u30d5\u30a1\u30a4\u30eb\u306e\u30ec\u30d3\u30e5\u30fc\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u89e3\u91c8\u306f\u5909\u66f4\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u884c\u52d5\u3092\u8d77\u3053\u3059\u524d\u306b\u6700\u65b0\u306e\u898f\u5247\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u7d50\u8ad6\uff1a\u76e3\u67fb\u306b\u5099\u3048\u3088\u3046<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PerBPOM 27\/2025\u306b\u57fa\u3065\u304f\u65bd\u8a2d\u76e3\u67fb\u306b\u304a\u3051\u308b\u9045\u5ef6\u306f\u5fc5\u305a\u3057\u3082\u907f\u3051\u3089\u308c\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u4e8b\u524d\u306b\u8a08\u753b\u3092\u7acb\u3066\u308b\u3053\u3068\u306f\u5bb9\u6613\u3067\u3059\u3002\u4e0a\u8a18\u306e\u30b1\u30fc\u30b9\u3067\u306f\u3001\u898f\u5236\u306e\u89e3\u91c8\u306b\u8aa4\u308a\u304c\u3042\u3063\u305f\u306e\u3067\u306f\u306a\u304f\u3001\u691c\u8a3c\u8005\u304c\u8981\u4ef6\u306e\u4e00\u3064\u3092\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3057\u305f\u304b\u306b\u554f\u984c\u304c\u3042\u308a\u307e\u3057\u305f\u3002\u89e3\u91c8\u3092\u65e9\u671f\u306b\u78ba\u8a8d\u3057\u3001\u4fee\u6b63\u306e\u305f\u3081\u306e\u6642\u9593\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u3001\u79c1\u305f\u3061\u304c\u63d0\u4f9b\u3067\u304d\u308b\u6700\u3082\u5b9f\u8df5\u7684\u306a\u6559\u8a13\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Product Registration Indonesia\u306f\u3001BPOM\u65bd\u8a2d\u76e3\u67fb\u306e\u524d\u304a\u3088\u3073\u76e3\u67fb\u4e2d\u306b\u3001\u8f38\u5165\u696d\u8005\u3001\u30d6\u30e9\u30f3\u30c9\u30aa\u30fc\u30ca\u30fc\u3001\u54c1\u8cea\u7ba1\u7406\u8005\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\u5f53\u793e\u306e\u30c1\u30fc\u30e0\u306f\u3001\u4e0a\u8a18\u306e\u3088\u3046\u306a\u4e8b\u4f8b\u3092\u53c2\u8003\u306b\u3001\u521d\u671f\u6587\u66f8\u30ec\u30d3\u30e5\u30fc\u3001\u5009\u5eab\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30a7\u30c3\u30af\u3001BPOM\u3068\u306e\u76f4\u63a5\u7684\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3001CAPA\u306e\u89e3\u6c7a\u3092\u652f\u63f4\u3067\u304d\u307e\u3059\u3002\u7d50\u679c\u3068\u6240\u8981\u6642\u9593\u306f\u691c\u8a3c\u8005\u3068\u30d5\u30a1\u30a4\u30eb\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u304c\u3001\u65e9\u671f\u30ec\u30d3\u30e5\u30fc\u3092\u884c\u3046\u3053\u3068\u3067\u3001\u56de\u907f\u53ef\u80fd\u306a\u4fee\u6b63\u3092\u6e1b\u3089\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>PerBPOM 27\/2025\u76e3\u67fb\u3092\u81ea\u4fe1\u3092\u6301\u3063\u3066\u4e57\u308a\u5207\u308b\u6e96\u5099\u306f\u3067\u304d\u3066\u3044\u307e\u3059\u304b\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u533b\u85ac\u54c1\u3001\u5065\u5eb7\u88dc\u52a9\u98df\u54c1\u3001\u5316\u7ca7\u54c1\u3001\u98df\u54c1\u3068\u3044\u3063\u305f\u5206\u91ce\u306b\u304a\u3044\u3066\u3001\u65b0\u898f\u65bd\u8a2d\u306e\u67fb\u5bdf\u6e96\u5099\u3084\u672a\u89e3\u6c7a\u306e\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u306e\u89e3\u6c7a\u306b\u53d6\u308a\u7d44\u3080\u969b\u3001\u898f\u5236\u6587\u66f8\u3068\u691c\u8a3c\u8005\u306e\u671f\u5f85\u3068\u306e\u30ae\u30e3\u30c3\u30d7\u3092\u57cb\u3081\u308b\u304a\u624b\u4f1d\u3044\u3092\u3044\u305f\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u4e0b\u8a18\u306e\u9023\u7d61\u30d5\u30a9\u30fc\u30e0\u306b\u3054\u8a18\u5165\u304f\u3060\u3055\u3044<\/strong> \u898f\u5236\u95a2\u9023\u30c1\u30fc\u30e0\u3068\u306e\u65bd\u8a2d\u76e3\u67fb\u6e96\u5099\u306b\u95a2\u3059\u308b\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3\u3092\u3054\u4e88\u7d04\u304f\u3060\u3055\u3044\u3002\u304a\u5ba2\u69d8\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ed\u30fc\u30c9\u30de\u30c3\u30d7\u3092\u78ba\u8a8d\u3057\u3001BPOM\u76e3\u67fb\u30d7\u30ed\u30bb\u30b9\u3092\u3088\u308a\u660e\u78ba\u306a\u898b\u901a\u3057\u306e\u3082\u3068\u3067\u9032\u3081\u3089\u308c\u308b\u3088\u3046\u30b5\u30dd\u30fc\u30c8\u3044\u305f\u3057\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>When foreign importers, license holders, and quality managers face a PerBPOM 27\/2025 Facility Audit, they often expect a straightforward compliance check against the published rules. In our experience, the written standards are only a baseline. What decides the outcome is how a verifier applies them to a specific facility and file. This article is written for regulatory affairs leads and quality managers operating across the drug, health supplement, quasi-drug, cosmetic, and processed food sectors. While your team might prepare a complete file based on the regulation text, a verifier&#8217;s practical interpretation can still turn a step you assumed was compliant into a CAPA finding. We saw this firsthand in a [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":7890,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[38],"tags":[],"country":[57],"class_list":["post-7889","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\/7889","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/comments?post=7889"}],"version-history":[{"count":3,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7889\/revisions"}],"predecessor-version":[{"id":7894,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/posts\/7889\/revisions\/7894"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media\/7890"}],"wp:attachment":[{"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/media?parent=7889"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/categories?post=7889"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/tags?post=7889"},{"taxonomy":"country","embeddable":true,"href":"https:\/\/productregistrationindonesia.com\/ja\/wp-json\/wp\/v2\/country?post=7889"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}