{"id":11589,"date":"2019-06-22T14:48:02","date_gmt":"2019-06-22T05:48:02","guid":{"rendered":"https:\/\/www.fsz.co.jp\/?post_type=knowledge&#038;p=11589"},"modified":"2025-04-04T10:52:25","modified_gmt":"2025-04-04T01:52:25","slug":"11589","status":"publish","type":"news","link":"https:\/\/www.fsz.co.jp\/?news=11589","title":{"rendered":"\u30b5\u30a4\u30c8\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u3068\u306f"},"content":{"rendered":"\n<p>Site Master File\uff5cSMF<\/p>\n\n\n\n<p>\u30b5\u30a4\u30c8\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u306f\u88fd\u9020\u696d\u8005\u306e\u4e00\u822c\u7684\u306a\u60c5\u5831\u3084\u3001\u88fd\u9020\u696d\u8005\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3001\u4eba\u4e8b\u3001\u5404\u62e0\u70b9\u306e\u65bd\u8a2d\u3068\u8a2d\u5099\u3001\u6587\u66f8\u3001\u88fd\u54c1\u3001\u54c1\u8cea\u7ba1\u7406\u3001\u6d41\u901a\u3001\u82e6\u60c5\u3001\u88fd\u54c1\u6b20\u9665\u53ca\u3073\u56de\u53ce\u3001\u81ea\u5df1\u70b9\u691c\u306a\u3069\u3092\u307e\u3068\u3081\u305f\u8cc7\u6599\u3067\u3059\u3002PIC\/S GMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3067\u8981\u6c42\u3055\u308c\u308b\u6587\u66f8\u306e\uff11\u3064\u3067\u3042\u308a\u3001\u72ec\u7acb\u884c\u653f\u6cd5\u4eba\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u3067\u3082\u5b9a\u671f\u9069\u5408\u6027\u8abf\u67fb\u7533\u8acb\u6642\u306a\u3069\u306b\u3082\u5229\u7528\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<div class=\"wp-block-columns has-2-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><p>[su_document url=&#8221;https:\/\/www.fsz.co.jp\/wp-content\/uploads\/2019\/06\/sinsa379.pdf&#8221; width=&#8221;200&#8243; height=&#8221;620&#8243;]<\/p>\n\n\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p>\u53c2\u8003\u8cc7\u6599\u3000PMDA<br>\u300c\u533b\u85ac\u54c1\u7b49\u9069\u5408\u6027\u8abf\u67fb\u306e\u7533\u8acb\u306b\u5f53\u305f\u3063\u3066\u63d0\u51fa\u3059\u3079\u304d\u8cc7\u6599\u306b\u3064\u3044\u3066\u300d<br>\u5e73\u621027\u5e746\u670818\u65e5\u4ed8<br>\u533b\u85ac\u54c1\u88fd\u9020\u6240\u6982\u8981\uff08\u5916\u56fd\u88fd\u9020\u6240\u7528\uff09<\/p>\n<\/div>\n<\/div>\n\n\n\n<table class=\"wp-block-table is-style-stripes\"><tbody><tr><td>#<\/td><td>\u82f1\u8a9e<\/td><td>\u65e5\u672c\u8a9e<\/td><\/tr><tr><td>1<\/td><td>GENERAL INFORMATION ON THE MANUFACTURER<\/td><td>\u88fd\u9020\u696d\u8005\u306e\u4e00\u822c\u7684\u60c5\u5831<\/td><\/tr><tr><td>1.1<\/td><td>Contact information on the manufacturer<\/td><td>\u88fd\u9020\u696d\u8005\u306e\u9023\u7d61\u5148\u60c5\u5831<\/td><\/tr><tr><td>1.2<\/td><td>Authorised pharmaceutical manufacturing activities of the site.<\/td><td>\u30b5\u30a4\u30c8\u3067\u8a8d\u53ef\u3055\u308c\u305f\u88fd\u85ac\u306e\u751f\u7523\u6d3b\u52d5<\/td><\/tr><tr><td>1.3<\/td><td>Any other manufacturing activities carried out on the site<\/td><td>\u30b5\u30a4\u30c8\u3067\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u4ed6\u306e\u751f\u7523\u6d3b\u52d5\uff08\u3042\u308c\u3070\u975e\u88fd\u85ac\u306e\u751f\u7523\u6d3b\u52d5\uff09<\/td><\/tr><tr><td>2<\/td><td>QUALITY MANAGEMENT SYSTEM OF THE MANUFACTURER<\/td><td>\u88fd\u9020\u696d\u8005\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td>2.1<\/td><td>The quality management system of the manufacturer<\/td><td>\u88fd\u9020\u696d\u8005\u306e\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td>2.2<\/td><td>Release procedure of finished products<\/td><td>\u6700\u7d42\u88fd\u54c1\u306e\u51fa\u8377\u624b\u9806<\/td><\/tr><tr><td>2.3<\/td><td>Management of suppliers and contractors<\/td><td>\u4f9b\u7d66\u8005\u53ca\u3073\u5951\u7d04\u8005\u306e\u7ba1\u7406<\/td><\/tr><tr><td>2.4<\/td><td>Quality Risk Management (QRM)<\/td><td>\u54c1\u8cea\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/td><\/tr><tr><td>2.5<\/td><td>Product Quality Reviews<\/td><td>\u88fd\u54c1\u54c1\u8cea\u30ec\u30d3\u30e5\u30fc<\/td><\/tr><tr><td>3<\/td><td>PERSONNEL<\/td><td>\u4eba\u4e8b<\/td><\/tr><tr><td>4<\/td><td>PREMISES AND EQUIPMENT<\/td><td>\u65bd\u8a2d\u3068\u8a2d\u5099<\/td><\/tr><tr><td>4.1<\/td><td>Premises<\/td><td>\u65bd\u8a2d<br><\/td><\/tr><tr><td>4.1.1<\/td><td>Brief description of heating, ventilation and air conditioning (HVAC) systems<\/td><td>\u6696\u623f\u3001\u63db\u6c17\u304a\u3088\u3073\u30a8\u30a2\u30b3\u30f3\u30c7\u30a3\u30b7\u30e7\u30cb\u30f3\u30b0(HVAC)\u30b7\u30b9\u30c6\u30e0\u306e\u7c21\u6f54\u306a\u8a18\u8ff0<br><\/td><\/tr><tr><td>4.1.2<\/td><td>Brief description of water systems<\/td><td>\u6c34\u306e\u30b7\u30b9\u30c6\u30e0\u306e\u7c21\u6f54\u306a\u8a18\u8ff0<br><\/td><\/tr><tr><td>4.1.3<\/td><td>Brief description of other relevant utilities, such as steam, compressed air, nitrogen, etc.<\/td><td>\u84b8\u6c17\u3001\u5727\u7e2e\u7a7a\u6c17\u3001\u7a92\u7d20\u7b49\u306e\u4ed6\u306e\u95a2\u9023\u30e6\u30fc\u30c6\u30a3\u30ea\u30c6\u30a3\u306e\u7c21\u6f54\u306a\u8a18\u8ff0<br><\/td><\/tr><tr><td>4.2<\/td><td>Equipment<\/td><td>\u8a2d\u5099<br><\/td><\/tr><tr><td>4.2.1<\/td><td>Listing of major production and control laboratory equipment with critical pieces of equipment identified should be provided in Appendix 8.<\/td><td>\u4e3b\u8981\u88fd\u9020\u8a2d\u5099\u53ca\u3073\u5b9f\u9a13\u8a2d\u5099\u306e\u30ea\u30b9\u30c8<br><\/td><\/tr><tr><td>4.2.2<\/td><td>Cleaning and sanitation<\/td><td>\u6383\u9664\u53ca\u3073\u885b\u751f<br><\/td><\/tr><tr><td>4.2.3<\/td><td>GMP critical computerised systems<\/td><td>GMP\u306e\u91cd\u8981\u306a\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u5316\u30b7\u30b9\u30c6\u30e0<br><\/td><\/tr><tr><td>5<\/td><td>DOCUMENTATION<\/td><td>\u6587\u66f8<br><\/td><\/tr><tr><td>6<\/td><td>PRODUCTION<\/td><td>\u88fd\u54c1<br><\/td><\/tr><tr><td>6.1<\/td><td>Type of products<\/td><td>\u88fd\u54c1\u306e\u30bf\u30a4\u30d7<\/td><\/tr><tr><td>6.2<\/td><td>Process validation&nbsp;<\/td><td>\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<br><\/td><\/tr><tr><td>6.3<\/td><td>Material management and warehousing<\/td><td>\u539f\u6750\u6599\u306e\u7ba1\u7406\u3068\u5009\u5eab\u7ba1\u7406<br><\/td><\/tr><tr><td>7<\/td><td>QUALITY CONTROL (QC)<\/td><td>\u54c1\u8cea\u7ba1\u7406<br><\/td><\/tr><tr><td>8<\/td><td>DISTRIBUTION, COMPLAINTS, PRODUCT DEFECTS AND RECALLS<\/td><td>\u6d41\u901a\u3001\u82e6\u60c5\u3001\u88fd\u54c1\u6b20\u9665\u3000\u53ca\u3073\u3000\u56de\u53ce<br><\/td><\/tr><tr><td>8.1<\/td><td>Distribution<\/td><td>\u6d41\u901a<br><\/td><\/tr><tr><td>8.2<\/td><td>Complaints, product defects and recalls<\/td><td>\u82e6\u60c5\u3001\u88fd\u54c1\u6b20\u9665\u3000\u53ca\u3073\u3000\u56de\u53ce<br><\/td><\/tr><tr><td>9<\/td><td>SELF INSPECTIONS<\/td><td>\u81ea\u5df1\u70b9\u691c<\/td><\/tr><\/tbody><\/table>\n\n\n\n<h3 class=\"wp-block-heading\">\u30b5\u30a4\u30c8\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\uff08SMF\uff09\u7ba1\u7406\u696d\u52d9\u304c\u304a\u3053\u306a\u3048\u307e\u3059\u3002<\/h3>\n\n\n\n<p>\u3053\u306e\u8cc7\u6599\u3082\u5404\u62e0\u70b9\u3067\u5225\u3005\u306b\u4f5c\u6210\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001\uff11\u3064\u306e\u30b7\u30b9\u30c6\u30e0\u306b\u767b\u9332\u3057\u3066\u4e00\u5143\u7ba1\u7406\u3057\u307e\u3059\u3002\u5185\u5bb9\u306b\u5909\u66f4\u306a\u3069\u304c\u3042\u3063\u305f\u5834\u5408\u306b\u306f\u3001\u305d\u306e\u7ba1\u7406\u8005\u304c\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u52d5\u304b\u3057\u3001\u95a2\u4fc2\u8005\u306b\u5909\u66f4\u5185\u5bb9\u3092\u5468\u77e5\u3057\u306a\u304c\u3089\u60c5\u5831\u3092\u6700\u65b0\u5316\u3067\u304d\u307e\u3059\u306e\u3067\u3001\u5927\u5909\u6709\u52b9\u3067\u52b9\u7387\u7684\u306a\u7ba1\u7406\u65b9\u6cd5\u3067\u3059\u3002\u307e\u305f\u3001\u5404\u62e0\u70b9\u3067\u5171\u901a\u306e\u60c5\u5831\uff08\u4f8b\u3048\u3070\u3001\u4f1a\u793e\u60c5\u5831\u7b49\uff09\u3092\u4e00\u5143\u7ba1\u7406\u3057\u3066\u3044\u308b\u306e\u3067\u3001\uff11\u56de\u306e\u4fee\u6b63\u3067\u5b8c\u4e86\u3057\u307e\u3059\u306e\u3067\u3001\u4f5c\u696d\u306e\u52b9\u7387\u5316\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>\u5229\u70b9\u306e\u307e\u3068\u3081<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>\u5831\u544a\u8cc7\u6599\u4f5c\u6210\u6642\u9593\u304c\u3059\u304f\u306a\u304f\u306a\u308a\u3001\u3088\u308a\u6df1\u3044\u8003\u5bdf\u306b\u6642\u9593\u304c\u4f7f\u3048\u308b<\/li><li>\u7d4c\u7def\u3001\u5185\u5bb9\u306e\u9593\u9055\u3048\u304c\u306a\u304f\u306a\u308a\u3001\u7167\u67fb\u306e\u3082\u308c\u304c\u306a\u304f\u306a\u308b<\/li><li>\u60c5\u5831\uff08\u30a4\u30d9\u30f3\u30c8\u60c5\u5831\u3001\u5de5\u5834\u306a\u3069\u306e\u30de\u30b9\u30bf\u30fc\u60c5\u5831\uff09\u304c\u4e00\u5143\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u306e\u3067\u3001\u5404\u5831\u544a\u3067\u60c5\u5831\u306e\u6574\u5408\u6027\u304c\u53d6\u308c\u308b<\/li><\/ol>\n\n\n\n<p><strong>\u30ec\u30dd\u30fc\u30c8\u51fa\u529b\u307e\u3067\u306e\u7c21\u5358\uff13\u30b9\u30c6\u30c3\u30d7<\/strong><\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>\u54c1\u8cea\u30a4\u30d9\u30f3\u30c8\u7ba1\u7406\u3092\u884c\u3044\u3001\u305d\u306e\u60c5\u5831\u3092\u84c4\u7a4d\u3057\u307e\u3059\u3002<\/li><li>\u51fa\u529b\u3057\u305f\u3044\u30ec\u30dd\u30fc\u30c8\u306e\u30d5\u30a9\u30fc\u30de\u30c3\u30c8\u3068\u30ec\u30dd\u30fc\u30c8\u306b\u51fa\u529b\u3057\u305f\u3044\u60c5\u5831\u306e\u5b9a\u7fa9\u3092QA\u30c0\u30f4\u30a3\u30f3\u30c1\u306b\u767b\u9332\u3057\u307e\u3059\u3002<br>\u9038\u8131\u3001\u5909\u66f4\u7ba1\u7406\u306a\u3069\u306e\u7a2e\u5225\u3001\u671f\u9593\u3001\u5e74\u9593\u767a\u751f\u4ef6\u6570\uff08\u88fd\u54c1\u5225\u3001\u5de5\u5834\u5225\u3001\u5de5\u7a0b\u5225\u306a\u3069\uff09<\/li><li>\u30ec\u30dd\u30fc\u30c8\u3092\u51fa\u529b\u3057\u307e\u3059\u3002<\/li><\/ol>\n\n\n\n<h3 class=\"wp-block-heading\">\u73fe\u5728\u5bfe\u5fdc\u691c\u8a0e\u4e2d<\/h3>\n\n\n\n<p>Annual Report CFR part314<br>GMP \u69d8\u5f0f2,3 \u533b\u85ac\u54c1\u88fd\u9020\u6240\u6982\u8981\uff08\u56fd\u5185\u88fd\u9020\u6240\u7528\u30fb\u5916\u56fd\u88fd\u9020\u6240\u7528\uff09<br>GMP \u5b9f\u5730\u8abf\u67fb<br>QMS \u69d8\u5f0f2 \u8abf\u67fb\u5bfe\u8c61\u65bd\u8a2d\u306e\u6982\u8981<br>GCTP \u69d8\u5f0f2,3 \u518d\u751f\u533b\u7642\u7b49\u88fd\u54c1\u88fd\u9020\u6240\u6982\u8981\uff08\u56fd\u5185\u88fd\u9020\u6240\u7528\u30fb\u5916\u56fd\u88fd\u9020\u6240\u7528\uff09<\/p>\n","protected":false},"featured_media":0,"template":"","news_category":[74],"class_list":["post-11589","news","type-news","status-publish","hentry","news_category-fszblog-pharma"],"_links":{"self":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news\/11589","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/news"}],"about":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=\/wp\/v2\/types\/news"}],"wp:attachment":[{"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=11589"}],"wp:term":[{"taxonomy":"news_category","embeddable":true,"href":"https:\/\/www.fsz.co.jp\/index.php?rest_route=%2Fwp%2Fv2%2Fnews_category&post=11589"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}