[{"@context":"http:\/\/schema.org\/","@type":"BlogPosting","@id":"https:\/\/wiki.edu.vn\/all2jp\/wiki10\/archives\/279#BlogPosting","mainEntityOfPage":"https:\/\/wiki.edu.vn\/all2jp\/wiki10\/archives\/279","headline":"\u662f\u6b63\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e – \u30a6\u30a3\u30ad\u30da\u30c7\u30a3\u30a2","name":"\u662f\u6b63\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e – \u30a6\u30a3\u30ad\u30da\u30c7\u30a3\u30a2","description":"before-content-x4 \u4fee\u6b63\u304a\u3088\u3073\u4e88\u9632\u884c\u52d5\uff08CAPA\uff09 \uff08\u300c\u4fee\u6b63\u3068\u4e88\u9632\u63aa\u7f6e\u300d\uff09\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u3053\u308c\u306f\u3001GMP\u306b\u6e96\u62e0\u3057\u305f\u4f5c\u696d\uff08\u512a\u308c\u305f\u88fd\u9020\u696d\uff09\u306e\u4e00\u90e8\u3067\u3059\u3002\u77db\u76fe\/\u9038\u8131\/\u30a8\u30e9\u30fc\u306e\u5b9f\u884c\u304c\u4f53\u7cfb\u7684\u306b\u8abf\u3079\u3089\u308c\u3001\u662f\u6b63\u63aa\u7f6e\uff08\u662f\u6b63\u63aa\u7f6e\uff09\u304c\u884c\u308f\u308c\u3001\u4e88\u9632\u63aa\u7f6e\u304c\u5b9f\u884c\u3055\u308c\u307e\u3059\u3002\u306a\u3069\u306e\u4ed6\u306e\u54c1\u8cea\u7ba1\u7406\u57fa\u6e96\u3068\u306f\u5bfe\u7167\u7684\u3067\u3059B. ISO 9001-\u533b\u7642\u6a5f\u5668\u74b0\u5883\u306eISO 13485\u6a19\u6e96\u3067\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u3053\u308c\u306f\u4e3b\u306b\u3001\u3088\u308a\u826f\u3044\u88fd\u54c1\u306e\u610f\u5473\u3067\u306e\u7d99\u7d9a\u7684\u306a\u6539\u5584\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u306a\u304f\u3001\u85ac\u7269\u304a\u3088\u3073\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u306e\u305f\u3081\u306e\u8a72\u5f53\u3059\u308b\u6cd5\u7684\u898f\u5b9a\u3068\u6280\u8853\u7684\u898f\u7bc4\u306b\u57fa\u3065\u3044\u305f\u8981\u4ef6\u306e\u9038\u8131\u306e\u6392\u9664\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3059\u3002 after-content-x4 \u4fee\u6b63\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u5143\u3005EU GMP\u30ac\u30a4\u30c9\u3067\u306f\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3067\u3057\u305f\u3002\u305f\u3060\u3057\u3001CAPA\u30b7\u30b9\u30c6\u30e0\u306e\u8981\u7d20\u306f\u3001CAPA\u3068\u547c\u3070\u308c\u3066\u3044\u306a\u304f\u3066\u3082\u3001\u4e8b\u524d\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002 \u300cCAPA\u300d\u3068\u3044\u3046\u7528\u8a9e\u306f\u3001\u3082\u3068\u3082\u3068\u533b\u7642\u6a5f\u5668\u306e\u898f\u5247\u304b\u3089\u6765\u3066\u3044\u307e\u3059\u3002\u5b9f\u969b\u306e\u30b7\u30b9\u30c6\u30e0\u8981\u7d20\u306e\u8aac\u660e\u306f\u3001DIN EN ISO 9001\u3001ISO 13485\u3001\u304a\u3088\u3073FDA 21 CFR 820\u3067\u884c\u308f\u308c\u307e\u3057\u305f\u3002\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u8abf\u548c\u30bf\u30b9\u30af\u30d5\u30a9\u30fc\u30b9\uff08GHTF\uff09\u306f\u3001\u3053\u306e\u54c1\u8cea\u4fdd\u8a3c\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b\u500b\u3005\u306e\u8981\u7d20\u3068\u305d\u306e\u4ed6\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u8abf\u548c\u3055\u305b\u307e\u3057\u305f\u3002 CAPA\u306e\u539f\u5247\u306f\u3001FDA\u306e\u300c\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u30ac\u30a4\u30c0\u30f3\u30b9\u300d\u3092\u8ffd\u52a0\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u30012006\u5e74\u306b\u6700\u521d\u306b\u5c0e\u5165\u3055\u308c\u307e\u3057\u305f\u3002 2008\u5e74\u4ee5\u6765\u3001CAPA\u306e\u539f\u5247\u306f\u3001ICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3Q10 Pharmaceutical","datePublished":"2019-07-10","dateModified":"2019-07-10","author":{"@type":"Person","@id":"https:\/\/wiki.edu.vn\/all2jp\/wiki10\/archives\/author\/lordneo#Person","name":"lordneo","url":"https:\/\/wiki.edu.vn\/all2jp\/wiki10\/archives\/author\/lordneo","image":{"@type":"ImageObject","@id":"https:\/\/secure.gravatar.com\/avatar\/44a4cee54c4c053e967fe3e7d054edd4?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/44a4cee54c4c053e967fe3e7d054edd4?s=96&d=mm&r=g","height":96,"width":96}},"publisher":{"@type":"Organization","name":"Enzyklop\u00e4die","logo":{"@type":"ImageObject","@id":"https:\/\/wiki.edu.vn\/wiki4\/wp-content\/uploads\/2023\/08\/download.jpg","url":"https:\/\/wiki.edu.vn\/wiki4\/wp-content\/uploads\/2023\/08\/download.jpg","width":600,"height":60}},"image":{"@type":"ImageObject","@id":"https:\/\/wiki.edu.vn\/wiki4\/wp-content\/uploads\/2023\/08\/download.jpg","url":"https:\/\/wiki.edu.vn\/wiki4\/wp-content\/uploads\/2023\/08\/download.jpg","width":100,"height":100},"url":"https:\/\/wiki.edu.vn\/all2jp\/wiki10\/archives\/279","wordCount":168,"articleBody":"     (adsbygoogle = window.adsbygoogle || []).push({});before-content-x4\u4fee\u6b63\u304a\u3088\u3073\u4e88\u9632\u884c\u52d5\uff08CAPA\uff09 \uff08\u300c\u4fee\u6b63\u3068\u4e88\u9632\u63aa\u7f6e\u300d\uff09\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08QMS\uff09\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u3053\u308c\u306f\u3001GMP\u306b\u6e96\u62e0\u3057\u305f\u4f5c\u696d\uff08\u512a\u308c\u305f\u88fd\u9020\u696d\uff09\u306e\u4e00\u90e8\u3067\u3059\u3002\u77db\u76fe\/\u9038\u8131\/\u30a8\u30e9\u30fc\u306e\u5b9f\u884c\u304c\u4f53\u7cfb\u7684\u306b\u8abf\u3079\u3089\u308c\u3001\u662f\u6b63\u63aa\u7f6e\uff08\u662f\u6b63\u63aa\u7f6e\uff09\u304c\u884c\u308f\u308c\u3001\u4e88\u9632\u63aa\u7f6e\u304c\u5b9f\u884c\u3055\u308c\u307e\u3059\u3002\u306a\u3069\u306e\u4ed6\u306e\u54c1\u8cea\u7ba1\u7406\u57fa\u6e96\u3068\u306f\u5bfe\u7167\u7684\u3067\u3059B. ISO 9001-\u533b\u7642\u6a5f\u5668\u74b0\u5883\u306eISO 13485\u6a19\u6e96\u3067\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u3053\u308c\u306f\u4e3b\u306b\u3001\u3088\u308a\u826f\u3044\u88fd\u54c1\u306e\u610f\u5473\u3067\u306e\u7d99\u7d9a\u7684\u306a\u6539\u5584\u30d7\u30ed\u30bb\u30b9\u3067\u306f\u306a\u304f\u3001\u85ac\u7269\u304a\u3088\u3073\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u306e\u305f\u3081\u306e\u8a72\u5f53\u3059\u308b\u6cd5\u7684\u898f\u5b9a\u3068\u6280\u8853\u7684\u898f\u7bc4\u306b\u57fa\u3065\u3044\u305f\u8981\u4ef6\u306e\u9038\u8131\u306e\u6392\u9664\u306b\u95a2\u3059\u308b\u3082\u306e\u3067\u3059\u3002        (adsbygoogle = window.adsbygoogle || []).push({});after-content-x4\u4fee\u6b63\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u5143\u3005EU GMP\u30ac\u30a4\u30c9\u3067\u306f\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3067\u3057\u305f\u3002\u305f\u3060\u3057\u3001CAPA\u30b7\u30b9\u30c6\u30e0\u306e\u8981\u7d20\u306f\u3001CAPA\u3068\u547c\u3070\u308c\u3066\u3044\u306a\u304f\u3066\u3082\u3001\u4e8b\u524d\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002 \u300cCAPA\u300d\u3068\u3044\u3046\u7528\u8a9e\u306f\u3001\u3082\u3068\u3082\u3068\u533b\u7642\u6a5f\u5668\u306e\u898f\u5247\u304b\u3089\u6765\u3066\u3044\u307e\u3059\u3002\u5b9f\u969b\u306e\u30b7\u30b9\u30c6\u30e0\u8981\u7d20\u306e\u8aac\u660e\u306f\u3001DIN EN ISO 9001\u3001ISO 13485\u3001\u304a\u3088\u3073FDA 21 CFR 820\u3067\u884c\u308f\u308c\u307e\u3057\u305f\u3002\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u8abf\u548c\u30bf\u30b9\u30af\u30d5\u30a9\u30fc\u30b9\uff08GHTF\uff09\u306f\u3001\u3053\u306e\u54c1\u8cea\u4fdd\u8a3c\u30b7\u30b9\u30c6\u30e0\u306b\u95a2\u3059\u308b\u500b\u3005\u306e\u8981\u7d20\u3068\u305d\u306e\u4ed6\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u8abf\u548c\u3055\u305b\u307e\u3057\u305f\u3002 CAPA\u306e\u539f\u5247\u306f\u3001FDA\u306e\u300c\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u30ac\u30a4\u30c0\u30f3\u30b9\u300d\u3092\u8ffd\u52a0\u3059\u308b\u3053\u3068\u306b\u3088\u308a\u30012006\u5e74\u306b\u6700\u521d\u306b\u5c0e\u5165\u3055\u308c\u307e\u3057\u305f\u3002 2008\u5e74\u4ee5\u6765\u3001CAPA\u306e\u539f\u5247\u306f\u3001ICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3Q10 Pharmaceutical Quality Systems\u306b\u57fa\u3065\u3044\u3066\u3001QMS\u306e\u8981\u7d20\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002 2011\u5e74\u3001\u3053\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u3001EU GMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u65b0\u305f\u306b\u4f5c\u6210\u3055\u308c\u305f\u7b2c3\u90e8\u3067\u63a1\u7528\u3055\u308c\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u4e00\u90e8\u304cEU GMP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u4ed6\u306e\u7ae0\u306b\u7d71\u5408\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001\u88fd\u85ac\u30e1\u30fc\u30ab\u30fc\u306b\u306f\u5225\u306eCAPA\u30b7\u30b9\u30c6\u30e0\u304c\u5fc5\u9808\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u308c\u3089\u306f\u4f1a\u793e\u306e\u62d8\u675f\u529b\u304c\u3042\u308b\u3068\u8003\u3048\u3089\u308c\u3066\u3044\u307e\u3059\u3002 \u4fee\u6b63\u304a\u3088\u3073\u4e88\u9632\u884c\u52d5\uff08CAPA\uff09\u306f\u3001\u54c1\u8cea\u7ba1\u7406\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u30a8\u30e9\u30fc\u306e\u8abf\u67fb\u306b\u5f93\u3044\u307e\u3059\u3002\u591a\u304f\u306e\u5834\u5408\u3001\u8a66\u9a13\u524d\u306b\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u5bfe\u7b56\u307e\u305f\u306f\u76f4\u63a5\u7684\u306a\u4fee\u6b63\u3092\u958b\u59cb\u3059\u308b\u305f\u3081\u306b\u3001\u30a8\u30e9\u30fc\u306e\u62e1\u5f35\u52b9\u679c\uff08\u300c\u5373\u6642\u30a2\u30af\u30b7\u30e7\u30f3\u300d\u307e\u305f\u306f\u300c\u4fee\u6b63\u300d\uff09\u304c\u56de\u907f\u3055\u308c\u307e\u3059\u3002\u5f8c\u8005\u306f\u307e\u3060CAPA\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002        (adsbygoogle = window.adsbygoogle || []).push({});after-content-x4CAPA\u30d7\u30ed\u30bb\u30b9\u306e\u30bf\u30b9\u30af\u306f\u3001\u9069\u5207\u306a\u63aa\u7f6e\uff08\u662f\u6b63\u63aa\u7f6e\uff09\u3092\u901a\u3058\u3066\u7406\u7531\u304c\u898b\u3064\u304b\u3063\u305f\u30a8\u30e9\u30fc\u307e\u305f\u306f\u9038\u8131\u3092\u4f53\u7cfb\u7684\u306b\u6539\u5584\u3059\u308b\u304b\u3001\u5c06\u6765\uff08\u4e88\u9632\u63aa\u7f6e\uff09\u3092\u56de\u907f\u3059\u308b\u3053\u3068\u3067\u3059\u3002 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