{"id":708,"date":"2016-09-02T05:36:12","date_gmt":"2016-09-01T20:36:12","guid":{"rendered":"http:\/\/www.jsqa.jp\/wp2\/seikabutsu\/open\/glp%e9%83%a8%e4%bc%9a\/oecd-glp%e6%96%87%e6%9b%b8%ef%bc%88no-1-15%e8%8b%b1%e6%96%87%e3%83%bb%e5%92%8c%e8%a8%b3%e3%80%80%e5%af%be%e6%af%94%e8%a1%a8%ef%bc%89\/"},"modified":"2017-10-30T10:03:03","modified_gmt":"2017-10-30T01:03:03","slug":"oecd-glp%e6%96%87%e6%9b%b8%ef%bc%88no-1-15%e8%8b%b1%e6%96%87%e3%83%bb%e5%92%8c%e8%a8%b3%e3%80%80%e5%af%be%e6%af%94%e8%a1%a8%ef%bc%89","status":"publish","type":"page","link":"https:\/\/jsqa.com\/wp2\/seikabutsu\/open\/glp_bukai\/oecd-glp%e6%96%87%e6%9b%b8%ef%bc%88no-1-15%e8%8b%b1%e6%96%87%e3%83%bb%e5%92%8c%e8%a8%b3%e3%80%80%e5%af%be%e6%af%94%e8%a1%a8%ef%bc%89\/","title":{"rendered":"OECD GLP\u6587\u66f8\uff08No.1-15\u82f1\u6587\u30fb\u548c\u8a33\u3000\u5bfe\u6bd4\u8868\uff09"},"content":{"rendered":"

GLP\u90e8\u4f1a<\/h2>\n

OECD GLP\u6587\u66f8\uff08No.1-15\u82f1\u6587\u30fb\u548c\u8a33\u3000\u5bfe\u6bd4\u8868\uff09<\/strong><\/h3>\n

 <\/p>\n

\u76ee\u7684\u3068\u6982\u8981<\/h4>\n

\u672c\u6587\u66f8\u306fSeries on Principles of Good Laboratory Practice and Compliance Monitoring, No.1 \u304b\u308915\u306e\u6587\u66f8\u3092\u7ffb\u8a33\u3057\u305f\u3082\u306e\u3067\u3042\u308b\u3002\u5de6\u5074\u306b\u82f1\u6587\u3001\u53f3\u5074\u306b\u548c\u8a33\u3092\u914d\u7f6e\u3057\u305f\u5bfe\u6bd4\u8868\u5f62\u5f0f\u3068\u3057\u305f\u3002\u3053\u306e\u5bfe\u6bd4\u8868\u306f\u3001OECD GLP\u306e\u7406\u89e3\u3068\u305d\u306e\u9075\u5b88\u3092\u76ee\u7684\u3068\u3057\u3066\u3001\u4e3b\u306b\u65e5\u672cQA\u7814\u7a76\u4f1a\u304c\u7814\u7a76\u4f1a\u5185\u306e\u52c9\u5f37\u4f1a\u8cc7\u6599\u3068\u3057\u3066\u4f5c\u6210\u3057\u3066\u3044\u305f\u7ffb\u8a33\u6587\u66f8\u3092\u57fa\u306b\u3001\u5404\u7701\u5e81\u3068\u65e5\u672cQA\u7814\u7a76\u4f1a\u304c\u5171\u540c\u3067\u5b8c\u6210 \u3055\u305b\u305f\u3082\u306e\u3067\u3042\u308b\u3002<\/p>\n

\u5229\u7528\u306b\u3042\u305f\u3063\u3066\u306e\u7559\u610f\u70b9<\/strong><\/h4>\n
    \n
  1. \u5404\u6587\u66f8\u3068\u3082\u76ee\u6b21\u3088\u308a\u524d\u306e\u90e8\u5206\uff08\u8868\u7d19\u3001About the OECD\u3001Foreword\u306a\u3069\u306e\u90e8\u5206\uff09\u306f\u6bd4\u8f03\u8868\u306b\u7d44\u307f\u8fbc\u3093\u3067\u3044\u306a\u3044\u3002<\/li>\n
  2. \u3053\u306e\u8a33\u306f\u3042\u304f\u307e\u3067\u3082OECD GLP\u306e\u7406\u89e3\u3068\u305d\u306e\u9075\u5b88\u306e\u305f\u3081\u306e\u52c9\u5f37\u7528\u8cc7\u6599\u3068\u3057\u3066\u63d0\u4f9b\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u5b8c\u5168\u306a\u7ffb\u8a33\u3068\u3057\u3066\u306f\u672a\u3060\u4f5c\u6210\u9014\u4e0a\u306b\u3042\u308b\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u3092\u3054\u7406\u89e3\u3044\u305f\u3060\u304d\u305f\u3044\u3002\u4f8b\u3048\u3070\u3001Ensure\u3001Should\u306a\u3069\u3001\u539f\u6587\u306e\u30cb\u30e5\u30a2\u30f3\u30b9\u3092\u5b8c\u5168\u306b\u306f\u4f1d\u3048\u5207\u308c\u3066\u3044\u306a\u3044\u7528\u8a9e\u3001\u3042\u308b\u3044\u306fField test\u306a\u3069\uff08\u201c\u5703\u5834\u8a66\u9a13\u201d\u3092\u610f\u5473\u3059\u308b\u5834\u5408\u3082\u3042\u308b\u304c\u3001\u91ce\u5916\u8a66\u9a13\u3014\u6c34\u751f\u751f\u7269\u7fa4\u96c6\u306e\u30ea\u30b9\u30af\u8a55\u4fa1\u306e\u305f\u3081\u306e\u5927\u898f\u6a21\u6c34\u7cfb\u8a66\u9a13\u3082\u542b\u3080\u3015\u3092\u610f\u5473\u3059\u308b\u5834\u5408\u3082\u3042\u308b\uff09\u6b63\u78ba\u306a\u7ffb\u8a33\u304c\u3067\u304d\u3066\u3044\u306a\u3044\u90e8\u5206\u3082\u3042\u308b\u3053\u3068\u3092\u3054\u5bb9\u8d66\u9858\u3044\u305f\u3044\u3002\u4eca\u5f8c\u3001\u5404\u6587\u66f8\u3068\u3082\u305d\u306e\u5185\u5bb9\u306e\u3088\u308a\u6df1\u3044\u7406\u89e3\u3092\u9032\u3081\u306a\u304c\u3089\u3001\u5408\u308f\u305b\u3066\u3088\u308a\u826f\u3044\u7ffb\u8a33\u3078\u3068\u6539\u8a02\u4f5c\u696d\u3092\u9032\u3081\u308b\u3064\u3082\u308a\u3067\u3042\u308b\u3002<\/li>\n
  3. \u56fd\u5185\u5404GLP\u3067\u306f\u3001\u6761\u6587\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u7528\u8a9e\u304c\u7570\u306a\u308b\u3082\u306e\u3082\u3042\u308b\u3002\u4eca\u56de\u306e\u7ffb\u8a33\u3067\u306f\u7528\u8a9e\u3092\u305d\u306e\u3069\u308c\u304b\u306b\u7d71\u4e00\u3059\u308b\u3053\u3068\u306f\u884c\u3063\u3066\u3044\u306a\u3044\u3002\u307e\u305f\u3001 \u4f8b\u3048\u3070\u3001Inspection\u3001Audit\u306e\u548c\u8a33\u306a\u3069\u3001\u7528\u8a9e\u304c\u4e00\u3064\u306e\u6587\u66f8\u5185\u3067\u306f\u7d71\u4e00\u3055\u308c\u3066\u3044\u308b\u3082\u306e\u306e\u3001\u6587\u66f8\u9593\u3067\u306f\u5fc5\u305a\u3057\u3082\u7d71\u4e00\u3055\u308c\u3066\u3044\u306a\u3044\u3082\u306e\u3082\u3042\u308b\u3002\u3053\u308c\u3089\u306e\u9055\u3044\u306b\u3064\u3044\u3066\u306f\u3001\u6dfb\u4ed8\u306e\u7528\u8a9e\u6bd4\u8f03\u8868\u3092\u53c2\u7167\u3057\u3066\u3044\u305f\u3060\u304d\u305f\u3044\u3002<\/li>\n<\/ol>\n

    \u3053\u306e\u5bfe\u6bd4\u8868\u306f\u3001\u4ee5\u4e0b\u306e\u7686\u69d8\u3092\u306f\u3058\u3081\u591a\u304f\u306e\u65b9\u3005\u306e\u5354\u529b\u3068\u652f\u63f4\u3092\u5f97\u3066\u3067\u304d\u3042\u304c\u3063\u305f\u3082\u306e\u3067\u3059\u3002\u3053\u3053\u306b\u6df1\u304f\u8b1d\u610f\u3092\u8868\u3057\u307e\u3059\u3002<\/p>\n

    \u539a\u751f\u52b4\u50cd\u7701 \u533b\u85ac\u98df\u54c1\u5c40\u5be9\u67fb\u7ba1\u7406\u8ab2 \u533b\u7642\u6a5f\u5668\u5be9\u67fb\u7ba1\u7406\u5ba4\u4e26\u3073\u306b\u5316\u5b66\u7269\u8cea\u5b89\u5168\u5bfe\u7b56\u5ba4
    \n\u72ec\u7acb\u884c\u653f\u6cd5\u4eba \u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb \u4fe1\u983c\u6027\u4fdd\u8a3c\u90e8
    \n\u539a\u751f\u52b4\u50cd\u7701 \u52b4\u50cd\u57fa\u6e96\u5c40\u5b89\u5168\u885b\u751f\u90e8 \u5316\u5b66\u7269\u8cea\u5bfe\u7b56\u8ab2
    \n\u72ec\u7acb\u884c\u653f\u6cd5\u4eba \u52b4\u50cd\u5b89\u5168\u885b\u751f\u7dcf\u5408\u7814\u7a76\u6240
    \n\u7d4c\u6e08\u7523\u696d\u7701 \u88fd\u9020\u7523\u696d\u5c40\u5316\u5b66\u7269\u8cea\u7ba1\u7406\u8ab2 \u5316\u5b66\u7269\u8cea\u5b89\u5168\u5ba4
    \n\u72ec\u7acb\u884c\u653f\u6cd5\u4eba \u88fd\u54c1\u8a55\u4fa1\u6280\u8853\u57fa\u76e4\u6a5f\u69cb \u5316\u5b66\u7269\u8cea\u7ba1\u7406\u30bb\u30f3\u30bf\u30fc\u5b89\u5168\u5be9\u67fb\u8ab2
    \n\u8fb2\u6797\u6c34\u7523\u7701 \u6d88\u8cbb\u30fb\u5b89\u5168\u5c40\u755c\u6c34\u7523\u5b89\u5168\u7ba1\u7406\u8ab2\u4e26\u3073\u306b\u8fb2\u7523\u5b89\u5168\u7ba1\u7406\u8ab2\u8fb2\u85ac\u5bfe\u7b56\u5ba4
    \n\u8fb2\u6797\u6c34\u7523\u7701 \u52d5\u7269\u533b\u85ac\u54c1\u691c\u67fb\u6240 \u4f01\u753b\u9023\u7d61\u5ba4\u6280\u8853\u6307\u5c0e\u8ab2
    \n\u72ec\u7acb\u884c\u653f\u6cd5\u4eba \u8fb2\u6797\u6c34\u7523\u6d88\u8cbb\u5b89\u5168\u30bb\u30f3\u30bf\u30fc \u80a5\u98fc\u6599\u5b89\u5168\u691c\u67fb\u90e8\u4e26\u3073\u306b\u8fb2\u85ac\u691c\u67fb\u90e8
    \n\u74b0\u5883\u7701 \u7dcf\u5408\u74b0\u5883\u653f\u7b56\u5c40\u74b0\u5883\u4fdd\u5065\u90e8 \u4f01\u753b\u8ab2\u5316\u5b66\u7269\u8cea\u5be9\u67fb\u5ba4
    \n\u65e5\u672cQA\u7814\u7a76\u4f1aGLP\u90e8\u4f1a\u4e26\u3073\u306b\u6709\u5fd7\u306e\u7686\u69d8<\/p>\n

    \u307e\u305f\u3001\u4eca\u5f8c\u7d99\u7d9a\u3057\u3066\u3044\u304f\u6539\u8a02\u4f5c\u696d\u306b\u3082\uff0c\u3053\u308c\u307e\u3067\u540c\u69d8\u306e\u3054\u5354\u529b\u3092\u3044\u305f\u3060\u3051\u307e\u3059\u3088\u3046\u304a\u9858\u3044\u7533\u3057\u4e0a\u3052\u307e\u3059\u3002<\/p>\n

    2008\u5e743\u670831\u65e5
    \n\uff08\u65e5\u672cQA\u7814\u7a76\u4f1a\u3000\u96dc\u8cc0\u4fee\u30fb\u67cf\u6728\u7531\u7f8e\u5b50\uff09<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
    1<\/td>\nOECD Principles of Good Laboratory Practice<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    2<\/td>\nRevised Guides for Compliance Monitoring Procedures for GLP<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    3<\/td>\nRevised Guidance for the Laboratory Inspections and Study Audits<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    4<\/td>\nQuality Assurance and GLP<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    5<\/td>\nCompliance of Laboratory Suppliers with GLP Principles<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    6<\/td>\nThe Application of the GLP Principles to Field Studies<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    7<\/td>\nThe Application of the GLP Principles to Short-term Studies<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    8<\/td>\nThe Role and Responsibilities of the Study Director in GLP Studies<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    9<\/td>\nGuidance for the Preparation of GLP Inspection Reports<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    10<\/td>\nThe Application of the Principles of GLP to Computerised Systems<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    11<\/td>\nThe Role and Responsibilities of the Sponsor<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    12<\/td>\nRequesting and Carrying Out Inspections and Study Audits in Another Country<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    13<\/td>\nThe Application of the GLP to Multi-Site Studies<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    14<\/td>\nThe Application of the Principles of GLP to in vitro studies<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    15<\/td>\nEstablishment and Control of Archives with the Principles of GLP<\/td>\n\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/tr>\n
    GLP\u7528\u8a9e\u6bd4\u8f03\u8868 \u3000\"\"\u30d5\u30a1\u30a4\u30eb<\/a>\u3000\"\"\u30d5\u30a1\u30a4\u30eb<\/a><\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

     <\/p>\n","protected":false},"excerpt":{"rendered":"

    GLP\u90e8\u4f1a OECD GLP\u6587\u66f8\uff08No.1-15\u82f1\u6587\u30fb\u548c\u8a33\u3000\u5bfe\u6bd4\u8868\uff09   \u76ee\u7684\u3068\u6982\u8981 \u672c\u6587\u66f8\u306fSeries on Principles of Good Laboratory Practice and Compl […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":643,"menu_order":4,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/jsqa.com\/wp2\/wp-json\/wp\/v2\/pages\/708"}],"collection":[{"href":"https:\/\/jsqa.com\/wp2\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/jsqa.com\/wp2\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/jsqa.com\/wp2\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/jsqa.com\/wp2\/wp-json\/wp\/v2\/comments?post=708"}],"version-history":[{"count":19,"href":"https:\/\/jsqa.com\/wp2\/wp-json\/wp\/v2\/pages\/708\/revisions"}],"predecessor-version":[{"id":1438,"href":"https:\/\/jsqa.com\/wp2\/wp-json\/wp\/v2\/pages\/708\/revisions\/1438"}],"up":[{"embeddable":true,"href":"https:\/\/jsqa.com\/wp2\/wp-json\/wp\/v2\/pages\/643"}],"wp:attachment":[{"href":"https:\/\/jsqa.com\/wp2\/wp-json\/wp\/v2\/media?parent=708"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}