{"id":106009,"date":"2019-03-26T00:00:50","date_gmt":"2019-05-17T09:07:38","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/106009\/"},"modified":"2019-05-17T17:07:42","modified_gmt":"2019-05-17T09:07:42","slug":"64711816b6","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/106009\/","title":{"rendered":"\u57fa\u4e8eFDA \u5de5\u827a\u9a8c\u8bc1\u6307\u5357&PDA TR60\u7684\u5168\u751f\u547d\u5468\u671f\u5de5\u827a\u9a8c\u8bc1"},"content":{"rendered":"
\n


<\/p>\n

\n
\n

\u81eaICH Q10\u9881\u5e03\uff0cFDA\u4e8e2011\u5e74\u53d1\u5e03\u300a\u5de5\u827a\u9a8c\u8bc1\uff1a\u4e00\u822c\u539f\u5219\u4e0e\u89c4\u8303\u300b\u4ee5\u6765\uff0c\u5c06\u5bf9\u5de5\u827a\u9a8c\u8bc1\u7684\u8981\u6c42\uff0c\u4ece\u539f\u5148\u76843\u6279\uff0c\u53d8\u5316\u4e3a\u4e86\u751f\u547d\u5468\u671f\u7684\u65b9\u6cd5\uff0c\u8fd9\u4e9b\u53d8\u5316\u5bf9\u6574\u4e2a\u5236\u836f\u4f01\u4e1a\u5728\u5de5\u827a\u4ece\u7814\u7a76\u5f00\u53d1\u5230\u786e\u8ba4\uff0c\u518d\u5230\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u90fd\u5e26\u6765\u7684\u5de8\u5927\u7684\u6311\u6218\uff0c\u4f7f\u5f97\u4f01\u4e1a\u5728\u5de5\u827a\u63a7\u5236\u65b9\u9762\uff0c\u4e0d\u518d\u662f\u751f\u4ea7\u4f01\u4e1a\u72ec\u81ea\u627f\u62c5\u7684\u5de5\u4f5c\uff0c\u800c\u662f\u6269\u589e\u5230\u4e86\u6574\u4e2a\u7814\u53d1\u3001\u751f\u4ea7\u3001\u8d28\u91cf\u4f53\u7cfb\u4e2d\u3002<\/span><\/p>\n

\u672c\u6b21\u8bfe\u7a0b\u5c06\u5bf9\u57fa\u4e8e\u751f\u547d\u5468\u671f\u65b9\u6cd5\u7684\u5de5\u827a\u9a8c\u8bc1\u7684\u6cd5\u89c4\u8981\u6c42\uff0c\u7ed3\u5408NMPA\u3001FDA\u3001EMA\u3001PDA\u7b49\u7ec4\u7ec7\u53d1\u5e03\u7684\u5de5\u827a\u9a8c\u8bc1\u7684\u8981\u6c42\uff0c\u9762\u5411\u5236\u836f\u4f01\u4e1a\u8fdb\u884c\u4e3a\u671f2\u5929\u7684\u8be6\u7ec6\u4ecb\u7ecd\uff0c\u7cfb\u7edf\u6027\u7684\u628a\u6cd5\u89c4\u8981\u6c42\u3001\u5e38\u89c1\u7f3a\u9677\u3001\u5de5\u827a\u5f00\u53d1\u3001\u5de5\u827a\u786e\u8ba4\u3001\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u3001\u7edf\u8ba1\u65b9\u6cd5\u7684\u4f7f\u7528\u8fdb\u884c\u4e86\u5168\u9762\u3001\u8be6\u7ec6\u7684\u4ecb\u7ecd\uff0c\u529b\u56fe\u4f7f\u5236\u836f\u4f01\u4e1a\u80fd\u591f\u5bf9\u57fa\u4e8e\u751f\u547d\u5468\u671f\u7684\u5de5\u827a\u9a8c\u8bc1\u7684\u8981\u6c42\u6709\u5177\u6709\u53ef\u64cd\u4f5c\u6027\u7684\u4e86\u89e3\u548c\u638c\u63e1\uff0c\u5bf9\u9762\u5411\u672a\u6765\u836f\u76d1\u3001\u9762\u5411\u6b27\u7f8e\u5e02\u573a\u589e\u52a0\u4ece\u653f\u7b56\u5230\u6280\u672f\u7684\u5168\u9762\u7684\u6b66\u88c5\u3002<\/span><\/p>\n

\u8bfe\u7a0b\u5c06\u7ed3\u5408\u4e30\u5bcc\u7684\u6848\u4f8b\u5c55\u793a\u5458\u5de5\u65e5\u5e38\u5de5\u4f5c\u7ecf\u5e38\u9047\u5230\u7684\u5b9e\u9645\u60c5\u51b5\u548c\u6709\u6548\u7684\u89e3\u51b3\u65b9\u6cd5 \u3002<\/span><\/p>\n

\n
\n
\"\u57fa\u4e8eFDA<\/section>\n<\/section>\n<\/section>\n
\n


<\/p>\n

\n
\"\u57fa\u4e8eFDA<\/section>\n<\/section>\n
\n
\n

\u9ad8\u7ea7\u7814\u4fee\u73ed<\/span><\/p>\n

\u57fa\u4e8eFDA \u5de5\u827a\u9a8c\u8bc1\u6307\u5357&PDA TR60\u7684\u5168\u751f\u547d\u5468\u671f\u5de5\u827a\u9a8c\u8bc1<\/span><\/strong><\/p>\n

2019\u5e744\u670825-26\u65e5 \u91cd\u5e86<\/span><\/p>\n<\/section>\n<\/section>\n

\n
\"\u57fa\u4e8eFDA<\/section>\n<\/section>\n<\/section>\n
\n
\n

<\/section>\n
\u8bfe\u7a0b\u76ee<\/span><\/strong><\/section>\n<\/section>\n<\/section>\n
\n
\n
\n
\n
\n
\u9002\u7528\u5bf9\u8c61<\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
    \n
  • \n

    \u5de5\u827a\u5f00\u53d1\u4eba\u5458<\/span><\/strong><\/p>\n<\/li>\n<\/ul>\n

    \u4e86\u89e3\u6cd5\u89c4\u5728\u4e09\u4e2a\u9636\u6bb5\u7684\u8981\u6c42\uff0c\u540c\u65f6\u4e86\u89e3\u5728\u5de5\u827a\u5f00\u53d1\u3001\u6280\u672f\u8f6c\u79fb\u3001\u5546\u4e1a\u5316\u751f\u4ea7\u4e2d\u9700\u8981\u6ce8\u610f\u7684\u4e8b\u9879\uff0c\u907f\u514d\u5f00\u53d1\u540e\u7684\u4ea7\u54c1\u548c\u5de5\u827a\u5728\u6ce8\u518c\u62a5\u6279\u3001\u5546\u4e1a\u5316\u751f\u4ea7\u4e2d\u51fa\u73b0\u7f3a\u9677\uff1b\u4e86\u89e3PAT\u5728\u5de5\u827a\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u7684\u8981\u6c42\u3002<\/span><\/p>\n

      \n
    • \n

      \u4f01\u4e1a\u7ba1\u7406\u5c42\u548c\u8d28\u91cf\u7ba1\u7406\u9ad8\u5c42\u9886\u5bfc<\/span><\/strong><\/p>\n<\/li>\n<\/ul>\n

      \u63d0\u9ad8\u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d\u5bf9\u5de5\u827a\u9a8c\u8bc1\u3001\u5de5\u827a\u63a7\u5236\u7684\u7ba1\u7406\u601d\u8def\uff0c\u5f3a\u5316\u5de5\u827a\u63a7\u5236\u8981\u6c42\uff0c\u6e05\u695a\u5728\u63a5\u6536\u5de5\u827a\u65f6\u9700\u8981\u8fdb\u884c\u7684\u5de5\u4f5c\uff1b\u5f3a\u5316\u5bf9\u6301\u7eed\u5de5\u827a\u63a7\u5236\u7684\u9700\u6c42\u3002<\/span><\/p>\n

        \n
      • \n

         QA\u4eba\u5458<\/span><\/strong><\/p>\n<\/li>\n<\/ul>\n

        \u638c\u63e1\u57fa\u4e8e\u751f\u547d\u5468\u671f\u7684\u5de5\u827a\u9a8c\u8bc1\u7684\u9700\u6c42\uff0c\u638c\u63e1CQA\u3001CPP\u8bc4\u4f30\u3001\u638c\u63e1\u5de5\u827a\u98ce\u9669\u8bc4\u4f30\u53ca\u5728\u5de5\u827a\u786e\u8ba4\u548c\u6301\u7eed\u5de5\u827a\u9a8c\u8bc1\u8fc7\u7a0b\u4e2d\u7684\u8fd0\u7528\uff0c\u4e86\u89e3\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u8fc7\u7a0b\u4e2d\u7684\u5de5\u4f5c\u5f00\u5c55\u65b9\u5f0f\u548c\u7edf\u8ba1\u65b9\u6cd5\uff0c\u638c\u63e1\u5de5\u827a\u9a8c\u8bc1\u4e3b\u8ba1\u5212\u3001\u5de5\u827a\u9a8c\u8bc1\u65b9\u6848\u7684\u7f16\u5199\uff0c\u5168\u9762\u638c\u63e1\u5de5\u827a\u9a8c\u8bc1\u7ba1\u7406\u3002<\/span><\/span><\/p>\n

          \n
        • \n

          \u751f\u4ea7\u4eba\u5458<\/span><\/strong><\/p>\n<\/li>\n<\/ul>\n

          \u638c\u63e1\u5de5\u827a\u9a8c\u8bc1\u603b\u4f53\u8981\u6c42\uff0c\u638c\u63e1\u5de5\u827a\u786e\u8ba4\u3001\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u7684\u5de5\u4f5c\u65b9\u5f0f\u548c\u7edf\u8ba1\u65b9\u6cd5\uff0c\u4e3a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u5de5\u827a\u63a7\u5236\u63d0\u4f9b\u5fc5\u8981\u6280\u672f\u652f\u6301\u3002<\/span><\/span><\/p>\n


          <\/p>\n

          \n
          \n
          \n
          \n
          \u8bfe\u7a0b\u7279\u8272<\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
          \n
            \n
          • \n

            \u7cfb\u7edf\u6027\u8bfe\u7a0b\uff0c\u6db5\u76d6\u5de5\u827a\u9a8c\u8bc1\u5168\u751f\u547d\u5468\u671f\u5b9e\u65bd\u65b9\u6cd5\u548c\u5de5\u5177<\/span><\/p>\n<\/li>\n

          • \n

            \u6a21\u62df\u5b9e\u9645\u6848\u4f8b\uff0c\u4e30\u5bcc\u4e92\u52a8\u4ea4\u6d41<\/span><\/p>\n<\/li>\n

          • \n

            \u73b0\u573a\u7b54\u7591\uff0c\u652f\u6301\u6311\u6218\u6743\u5a01<\/span><\/p>\n<\/li>\n

          • \n

            \u6765\u4e4b\u5fc5\u6709\u6240\u83b7\uff0c\u83b7\u4e4b\u5fc5\u6709\u6240\u7528<\/span><\/p>\n<\/li>\n<\/ul>\n<\/section>\n


            <\/p>\n<\/section>\n

            \n
            \n
            \n
            \n
            \u5b66\u5458\u83b7\u76ca<\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
            \n
              \n
            • \n

              \u4e86\u89e3\u8fd1\u5e74\u6765\u56fd\u5185\u3001\u56fd\u9645\u5728\u5de5\u827a\u9a8c\u8bc1\u65b9\u9762\u7684\u7f3a\u9677\u8d8b\u52bf\u548c\u6cd5\u89c4\u8fdb\u5c55<\/span><\/span><\/p>\n<\/li>\n

            • \n

              \u4e86\u89e3\u5168\u751f\u547d\u5468\u671f\u7684\u5de5\u827a\u9a8c\u8bc1\u7684\u8981\u6c42\u548c\u6574\u4f53\u601d\u8def\u3002<\/span><\/span><\/p>\n<\/li>\n

            • \n

              \u4e86\u89e3\u4e09\u4e2a\u9636\u6bb5\u4e2d\u5bf9\u5de5\u827a\u9a8c\u8bc1\u7684\u4e0d\u540c\u8981\u6c42\uff0c\u4ee5\u53ca\u5de5\u4f5c\u5f00\u5c55\u7684\u6d41\u7a0b\u3002<\/span><\/span><\/p>\n<\/li>\n

            • \n

              \u4e86\u89e3\u5de5\u827a\u98ce\u9669\u8bc4\u4f30\u3002<\/span><\/span><\/p>\n<\/li>\n

            • \n

              \u4e86\u89e3\u5de5\u827a\u9a8c\u8bc1\u4e3b\u8ba1\u5212\u3001\u5de5\u827a\u9a8c\u8bc1\u65b9\u6848\u62a5\u544a\u7684\u6574\u4f53\u8981\u6c42\u3002<\/span><\/span><\/p>\n<\/li>\n

            • \n

              \u4e86\u89e3\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u4e2d\u7684\u8981\u6c42\u4ee5\u53ca\u7edf\u8ba1\u65b9\u6cd5\u7684\u8fd0\u7528\u3002<\/span><\/span><\/p>\n<\/li>\n<\/ul>\n


              <\/p>\n

              \n
              \n
              \n
              \n
              \u589e\u503c\u670d\u52a1<\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
              \n
                \n
              • \n

                \u5404\u4e2a\u56fd\u5bb6\u548c\u7ec4\u7ec7\u7684\u76f8\u5173\u6cd5\u89c4\u548c\u6307\u5357\u76ee\u5f55<\/span><\/p>\n<\/li>\n<\/ul>\n


                <\/p>\n


                <\/p>\n<\/section>\n<\/section>\n

                \n
                \n
                \n
                \u8bfe\u7a0b\u5e08\u8d44<\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n
                \n
                \n
                \n


                <\/p>\n<\/section>\n<\/section>\n

                \n
                \n
                \n
                \n
                \"\u57fa\u4e8eFDA<\/section>\n
                \n

                \u9a6c\u4e49\u5cad<\/span><\/strong><\/span><\/p>\n

                \n

                \u9a8c\u8bc1\u4e0e\u98ce\u9669\u7ba1\u7406\u4e13\u5bb6\u3001ISPE\u7279\u7ea6\u8bb2\u5e08\u3001\u5317\u4eac\u5316\u5de5\u5927\u5b66&\u6c88\u9633\u836f\u79d1\u5927\u5b66 \u987e\u95ee\u6559\u6388<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


                <\/p>\n<\/section>\n

                \n


                <\/p>\n<\/section>\n

                \n
                \n
                \n
                \"\u57fa\u4e8eFDA<\/section>\n
                \n

                \u674e \u57fa<\/span><\/strong><\/span><\/p>\n

                \n

                \u8d44\u6df1\u54a8\u8be2\u987e\u95ee\uff0c\u53c2\u4e0e\u7f16\u5199\u591a\u90e8\u5236\u836f\u7c7b\u4e66\u7c4d<\/span><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


                <\/p>\n<\/section>\n<\/section>\n

                \n
                \n
                \n
                \n
                \u8bfe\u7a0b\u5b89\u6392<\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
                \n

                2019\u5e744\u670825\u65e5\uff08\u5468\u56db\uff09<\/span><\/strong><\/span><\/p>\n

                Part1 <\/strong><\/span><\/strong><\/span> \u5de5\u827a\u9a8c\u8bc1\u5bfc\u8bba<\/strong><\/span><\/strong><\/span><\/p>\n

                  \n
                • \n

                  \u4ec0\u4e48\u662f\u5de5\u827a\u9a8c\u8bc1<\/span><\/p>\n<\/li>\n

                • \n

                  \u4e3a\u4ec0\u4e48\u8981\u505a\u5de5\u827a\u9a8c\u8bc1<\/span><\/p>\n<\/li>\n

                • \n

                  \u5de5\u827a\u9a8c\u8bc1\u4e0e\u54ea\u4e9b\u4eba\u6709\u5173<\/span><\/p>\n<\/li>\n

                • \n

                  \u4ec0\u4e48\u65f6\u5019\u505a\u5de5\u827a\u9a8c\u8bc1<\/span><\/p>\n<\/li>\n

                • \n

                  \u5de5\u827a\u9a8c\u8bc1\u5728\u54ea\u91cc\u505a<\/span><\/p>\n<\/li>\n

                • \n

                  \u600e\u4e48\u505a\u5de5\u827a\u9a8c\u8bc1<\/span><\/p>\n<\/li>\n<\/ul>\n


                  <\/p>\n

                  Part2 <\/strong><\/span><\/strong><\/span> <\/strong><\/span><\/strong><\/span>\u6cd5\u89c4\u6307\u5357\u7b80\u4ecb<\/strong><\/span><\/strong><\/p>\n

                    \n
                  • \n

                    \u56fd\u9645\u4e3b\u8981\u5de5\u827a\u9a8c\u8bc1\u6cd5\u89c4\u6307\u5357\u603b\u89c8<\/span><\/p>\n<\/li>\n

                  • \n

                    \u4e2d\u56fdGMP\u5173\u4e8e\u5de5\u827a\u9a8c\u8bc1\u7684\u8981\u6c42<\/span><\/p>\n<\/li>\n

                  • \n

                    FDA\u5de5\u827a\u9a8c\u8bc1\u6307\u5357\uff082011\uff09\u6982\u8ff0<\/span><\/p>\n<\/li>\n

                  • \n

                    EMA\u5236\u5242\u5de5\u827a\u9a8c\u8bc1\u6307\u5357\u6982\u8ff0<\/span><\/p>\n<\/li>\n

                  • \n

                    EMA\u751f\u7269\u6280\u672f\u884d\u751f\u7269\u5de5\u827a\u9a8c\u8bc1\u6307\u5357\u6982\u8ff0<\/span><\/p>\n<\/li>\n

                  • \n

                    \u5176\u4ed6\u6307\u5357\u6982\u8ff0<\/span><\/p>\n<\/li>\n<\/ul>\n


                    <\/p>\n

                    Part3 <\/strong><\/span><\/strong> <\/strong><\/span><\/strong><\/span>\u7f3a\u9677\u5206\u6790<\/span><\/strong><\/p>\n

                      \n
                    • \n

                      \u4e2d\u56fd GMP\u68c0\u67e5\u76f8\u5173\u7f3a\u9677\u9879<\/span><\/p>\n<\/li>\n

                    • \n

                      FDA cGMP\u68c0\u67e5\u76f8\u5173\u7f3a\u9677\u9879<\/span><\/p>\n<\/li>\n

                    • \n

                      \u6b27\u76df GMP\u68c0\u67e5\u76f8\u5173\u7f3a\u9677\u9879<\/span><\/p>\n<\/li>\n

                    • \n

                      WHO GMP\u68c0\u67e5\u76f8\u5173\u7f3a\u9677\u9879<\/span><\/p>\n<\/li>\n

                    • \n

                      GMP\u68c0\u67e5\u5de5\u827a\u76f8\u5173\u7f3a\u9677\u9879\u603b\u7ed3\u5206\u6790<\/span><\/p>\n


                      <\/p>\n<\/li>\n<\/ul>\n

                      Part4 <\/strong><\/span><\/strong><\/span> <\/strong><\/span><\/strong><\/span>\u5de5\u827a\u98ce\u9669\u8bc4\u4f30\u6982\u8ff0<\/strong><\/span><\/strong><\/span><\/p>\n

                        \n
                      • \n

                        \u98ce\u9669\u8bc4\u4f30\u6982\u8ff0<\/span><\/p>\n<\/li>\n

                      • \n

                        CQA&CPP\u8bc4\u4f30<\/span><\/p>\n<\/li>\n

                      • \n

                        FMEA\u5728\u5de5\u827a\u98ce\u9669\u8bc4\u4f30\u4e2d\u7684\u5e94\u7528<\/span><\/p>\n<\/li>\n

                      • \n

                        HACCP\u5728\u5de5\u827a\u98ce\u9669\u8bc4\u4f30\u4e2d\u7684\u5e94\u7528<\/span><\/p>\n<\/li>\n<\/ul>\n


                        <\/p>\n

                        Part5 <\/strong><\/span><\/strong><\/span> <\/strong><\/span><\/strong><\/span>\u6280\u672f\u8f6c\u79fb<\/strong><\/span><\/strong><\/span><\/p>\n

                          \n
                        • \n

                          \u6280\u672f\u8f6c\u79fb\u6982\u8ff0<\/span><\/p>\n<\/li>\n

                        • \n

                          \u6280\u672f\u8f6c\u79fb\u76f8\u5173\u6cd5\u89c4\u6307\u5357\u4ecb\u7ecd<\/span><\/p>\n<\/li>\n

                        • \n

                          \u6280\u672f\u8f6c\u79fb\u98ce\u9669\u8bc4\u4f30\u53ca\u6267\u884c\u8bf4\u660e<\/span><\/p>\n<\/li>\n

                        • \n

                          \u6280\u672f\u8f6c\u79fb\u6848\u4f8b\u5206\u6790<\/span><\/p>\n<\/li>\n<\/ul>\n


                          <\/p>\n


                          <\/p>\n


                          <\/p>\n

                          2019\u5e744\u670826\u65e5\uff08\u5468\u4e94\uff09<\/span><\/strong><\/span><\/p>\n


                          <\/p>\n

                          Part1 <\/strong><\/span><\/strong><\/span> \u7b2c\u4e00\u9636\u6bb5\uff1a\u5de5\u827a\u8bbe\u8ba1\u9636\u6bb5<\/strong><\/span><\/strong><\/span><\/p>\n

                            \n
                          • \n

                            \u7b2c\u4e00\u9636\u6bb5\uff1a\u5de5\u827a\u8bbe\u8ba1\u6982\u8ff0<\/span><\/p>\n<\/li>\n

                          • \n

                            TPP\u3001QTPP\u548c\u77e5\u8bc6\u7ba1\u7406<\/span><\/p>\n<\/li>\n

                          • \n

                            \u7b2c\u4e00\u9636\u6bb5\u98ce\u9669\u8bc4\u4f30\uff1aCQA\u3001CPP\u3001CMA<\/span><\/p>\n<\/li>\n

                          • \n

                            \u53d8\u91cf\u7814\u7a76\u548cDoE\u3001\u6a21\u578b\u3001\u5de5\u827a\u7279\u6027<\/span><\/p>\n<\/li>\n

                          • \n

                            \u7b2c\u4e00\u9636\u6bb5\u91c7\u7528PAT\u65b9\u6cd5\u7b80\u4ecb<\/span><\/p>\n<\/li>\n

                          • \n

                            \u63a7\u5236\u7b56\u7565\u53ca\u7b2c\u4e00\u9636\u6bb5\u8f93\u51fa\u6210\u679c<\/span><\/p>\n<\/li>\n<\/ul>\n


                            <\/p>\n

                            Part2 <\/strong><\/span><\/strong><\/span> <\/strong><\/span><\/strong><\/span>\u7b2c\u4e8c\u9636\u6bb5\uff1a\u5de5\u827a\u6027\u80fd\u786e\u8ba4<\/strong><\/span><\/strong><\/span><\/p>\n

                              \n
                            • \n

                              \u7b2c\u4e8c\u9636\u6bb5\uff1a\u5de5\u827a\u6027\u80fd\u786e\u8ba4\u6982\u8ff0<\/span><\/p>\n<\/li>\n

                            • \n

                              \u6279\u6b21\u6570\u91cf\u786e\u5b9a\u7684\u4e09\u79cd\u65b9\u6cd5<\/span><\/p>\n<\/li>\n

                            • \n

                              PPQ\u4e2d\u7684\u53d6\u6837\u7b56\u7565<\/span><\/p>\n<\/li>\n

                            • \n

                              \u5de5\u827a\u9a8c\u8bc1\u4e3b\u8ba1\u5212<\/span><\/p>\n<\/li>\n

                            • \n

                              PPQ\u65b9\u6848\u4e00\u822c\u5185\u5bb9<\/span><\/p>\n<\/li>\n

                            • \n

                              PPQ\u62a5\u544a<\/span><\/p>\n<\/li>\n

                            • \n

                              PAT\u5de5\u827a\u7684PPQ\u7b56\u7565<\/span><\/p>\n<\/li>\n


                              <\/ul>\n

                              Part3 <\/strong><\/span><\/strong> <\/strong><\/span><\/strong><\/span>\u7b2c\u4e09\u9636\u6bb5\uff1a\u5de5\u827a\u6301\u7eed\u6838\u5b9e<\/strong><\/span><\/strong><\/span><\/p>\n

                                \n
                              • \n

                                \u7b2c\u4e09\u9636\u6bb5\uff1a\u6301\u7eed\u5de5\u827a\u786e\u8ba4\u603b\u8ff0<\/span><\/p>\n<\/li>\n

                              • \n

                                \u6301\u7eed\u5de5\u827a\u786e\u8ba4\u5e38\u89c1\u7edf\u8ba1\u5de5\u5177\u548c\u5e94\u7528\u6848\u4f8b<\/span><\/p>\n<\/li>\n

                              • \n

                                \u5e38\u89c1\u95ee\u9898<\/span><\/p>\n<\/li>\n<\/ul>\n


                                <\/p>\n

                                Part4 <\/strong><\/span><\/strong><\/span> <\/strong><\/span><\/strong><\/span>\u5de5\u827a\u53d8\u66f4\u548c\u5de5\u827a\u518d\u9a8c\u8bc1<\/strong><\/span><\/strong><\/span><\/p>\n

                                  \n
                                • \n

                                  \u5de5\u827a\u53d8\u66f4\u5206\u7ea7<\/span><\/p>\n<\/li>\n

                                • \n

                                  \u5de5\u827a\u53d8\u66f4\u6d41\u7a0b<\/span><\/p>\n<\/li>\n

                                • \n

                                  \u573a\u5730\u53d8\u66f4\u6307\u5bfc\u539f\u5219\u7b80\u4ecb<\/span><\/p>\n<\/li>\n

                                • \n

                                  \u5de5\u827a\u518d\u9a8c\u8bc1<\/span><\/p>\n<\/li>\n<\/ul>\n<\/section>\n

                                  \n


                                  <\/p>\n

                                  \n
                                  \n
                                  \n
                                  \n
                                  \u7533\u8bf7\u4fe1\u606f<\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
                                  \n
                                  \n

                                  \u8bfe\u7a0b\u8d39\u7528<\/strong><\/span><\/p>\n

                                  2800\u5143\/\u4eba\uff08\u542b\u8bae\u671f\u95f4\u4e2d\u9910\u8d39\u3001\u8bb2\u4e49\u8d39\u3001\u8bc1\u4e66\u8d39\u3001\u589e\u503c\u670d\u52a1<\/span>\u8d44\u6599\u8d39\uff09<\/span><\/span><\/p>\n

                                    \n
                                  • \n

                                    \u98df\u5bbf\u8d39\u7528<\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                                    \u57f9\u8bad\u671f\u95f4\u665a\u9910\u53ca\u4f4f\u5bbf\u53ef\u7531\u4f1a\u52a1\u7ec4\u7edf\u4e00\u5b89\u6392\uff0c\u8d39\u7528\u81ea\u7406<\/span><\/p>\n

                                      \n
                                    • \n

                                      \u8d39\u7528\u4f18\u60e0\u529e\u6cd5<\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n

                                      1.\u540c\u4e00\u96c6\u56e2\u6216\u516c\u53f8<\/span>5\u540d\uff08\u5305\u62ec5\u540d<\/span>\uff09\u4ee5\u4e0a\u62a5\u540d\u53ef\u4eab<\/span>8\u6298<\/span>\u4f18\u60e0\uff0c\u9f13\u52b1\u5404\u96c6\u56e2\u516c\u53f8\u3001\u5b50\u516c\u53f8\u7edf\u4e00\u62a5\u540d\u4eab\u53d7\u4f18\u60e0\u653f\u7b56<\/span><\/p>\n

                                      2.\u8bf7\u5728<\/span>04\u670818\u65e5<\/span>\u4e4b\u524d\u7f34\u8d39\uff0c\u53ef\u4eab\u53d7<\/span>9\u6298<\/span>\u4f18\u60e0<\/span><\/p>\n

                                      \u7533\u8bf7\u65b9\u5f0f<\/strong><\/span><\/p>\n

                                        \n
                                      • \n

                                        \u626b\u63cf\u4e0b\u65b9\u4e8c\u7ef4\u7801<\/strong>\u6216\u70b9\u51fb\u4e0b\u65b9\u9605\u8bfb\u539f\u6587<\/strong>\u5373\u523b\u62a5\u540d\uff0c\u9501\u5b9a\u5e2d\u4f4d<\/span><\/p>\n<\/li>\n

                                      • \n

                                        \u7535\u8bdd\u54a8\u8be2\uff1a15342234370\uff08\u540c\u5fae\u4fe1\u53f7\uff09<\/span><\/p>\n<\/li>\n<\/ul>\n

                                        \n
                                        \n
                                        \n
                                        \n
                                        \n

                                        \u626b\u63cf\u4e8c\u7ef4\u7801<\/p>\n

                                        \u5373\u523b\u62a5\u540d<\/p>\n<\/section>\n

                                        \n
                                        <\/section>\n
                                        <\/section>\n
                                        <\/section>\n<\/section>\n<\/section>\n
                                        <\/section>\n
                                        \n
                                        <\/section>\n
                                        <\/section>\n
                                        <\/section>\n<\/section>\n<\/section>\n<\/section>\n

                                        \"\u57fa\u4e8eFDA<\/p>\n<\/section>\n<\/section>\n<\/section>\n


                                        <\/p>\n

                                        \n
                                        \n
                                        \"\u57fa\u4e8eFDA<\/section>\n<\/section>\n<\/section>\n


                                        <\/p>\n

                                        \u5e2d\u4f4d\u6709\u9650\uff0c\u70b9\u51fb\u201c\u9605\u8bfb\u539f\u6587<\/span>\u201d\uff0c\u5373\u523b\u62a5\u540d\uff01<\/strong><\/span><\/p>\n


                                        <\/p>\n

                                        \n
                                        \n
                                        \n
                                        \n
                                        \u4f1a\u8bae\u8d5e\u52a9\u5546\u54c1\u724c\u62db\u52dfing<\/span><\/strong><\/span><\/strong><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
                                        \n
                                        \n
                                        \n
                                        \n
                                        \n


                                        <\/p>\n

                                        \u4f9d\u6258\u4e8e\u5141\u54a8\u57f9\u8bad\u5e73\u53f0\uff0c\u6211\u4eec\u4e3a\u5236\u836f\u4f01\u4e1a\u4e0a\u4e0b\u6e38\u4f9b\u5e94\u5546\u63d0\u4f9b\u5b66\u672f\u63a8\u5e7f\u7efc\u5408\u670d\u52a1\u65b9\u6848\u3002<\/strong><\/span><\/p>\n


                                        <\/p>\n

                                        \u63a8\u5e7f\u7279\u8272\uff1a<\/span><\/strong>\u6211\u516c\u53f8\u4e3b\u8981\u4e3a\u4f9b\u5e94\u5546\u63d0\u4f9b\u4ee5\u201cGMP\u6cd5\u89c4\u7b26\u5408\u6027\u201d\u4e3a\u7279\u70b9\u7684\u201c\u5b66\u672f\u63a8\u5e7f\u201d\u670d\u52a1\u6a21\u5f0f\uff0c\u8bfe\u4ef6\u8bbe\u8ba1\u4e2d\uff0c\u5c06\u4e0e\u4ea7\u54c1\u76f8\u5173\u7684\u6cd5\u89c4\u8981\u6c42\u548c\u4f9b\u5e94\u5546\u7684\u4ea7\u54c1\u7279\u70b9\u3001\u6280\u672f\u53c2\u6570\u7b49\u8fdb\u884c\u878d\u5408\uff0c\u4ee5\u201c\u6da6\u7269\u7ec6\u65e0\u58f0\u201d\u7684\u65b9\u5f0f\u8ba9\u5ba2\u6237\u89c9\u5f97\u60a8\u7684\u4ea7\u54c1\u662f\u201c\u5b89\u5168\u7684\u201d\u7684\uff0c\u662f\u7b26\u5408GMP\u6cd5\u89c4\u8981\u6c42\u7684\uff0c\u5728\u8ba4\u8bc1\u8fc7\u7a0b\u4e2d\u662f\u53ef\u4ee5\u88ab\u68c0\u5bdf\u5b98\u63a5\u53d7\u7684\u3002<\/span><\/p>\n


                                        <\/p>\n

                                        \u63a8\u5e7f\u9014\u5f84\uff1a<\/span><\/strong><\/p>\n

                                          \n
                                        • \n

                                          \u5b66\u672f\u690d\u5165   <\/span><\/p>\n<\/li>\n

                                        • \n

                                          \u54c1\u724c\u5f15\u8350  <\/span><\/p>\n<\/li>\n

                                        • \n

                                          \u5c55\u4f4d\u6446\u653e<\/span> <\/span><\/p>\n


                                          <\/p>\n<\/li>\n

                                        • \n

                                          \u63d2\u9875\u5ba3\u4f20<\/span>  <\/span><\/p>\n<\/li>\n

                                        • \n

                                          \u5546\u673a\u63a8\u9001<\/span><\/p>\n<\/li>\n<\/ul>\n

                                          \u4eba\u7fa4\u7279\u70b9\uff1a<\/span><\/strong>60%\u4ee5\u4e0a\u4e3a<\/span>\u4e2d\u9ad8\u7aef\u6280\u672f\u53ca\u7ba1\u7406\u4eba\u5458\uff0c\u65b0\u5efa\u9879\u76ee\u6216\u6b63\u5728\u5b9e\u65bd\u6539\u6269\u5efa\u9879\u76ee\u4f01\u4e1a\u4eba\u5458\u3002<\/span><\/p>\n

                                          \u589e\u503c\u670d\u52a1\uff1a<\/span><\/strong>
                                          <\/p>\n

                                            \n
                                          • \n

                                            \u514d\u8d39\u57f9\u8bad\u540d\u989d\u4e00\u540d<\/span><\/p>\n<\/li>\n

                                          • \n

                                            \u63a8\u8350\u5ba2\u6237\u53c2\u8bad8\u6298\u4f18\u60e0<\/span><\/p>\n<\/li>\n

                                          • \n

                                            \u91c7\u8d2d\u5546\u673a\u4f18\u5148\u63a8\u8350<\/span><\/p>\n<\/li>\n

                                          • \n

                                            \u516c\u4f17\u53f7\u54c1\u724c\u63a8\u5e7f\u5ba3\u4f20<\/span><\/p>\n<\/li>\n

                                          • \n

                                            \u5fc5\u8981\u7684\u7b7e\u5355\u652f\u6301<\/span><\/p>\n<\/li>\n<\/ul>\n


                                            <\/p>\n

                                            \u90e8\u5206\u5f80\u671f\u53c2\u5c55\u7167\u7247<\/span><\/strong><\/p>\n


                                            <\/p>\n

                                            \"\u57fa\u4e8eFDA<\/span><\/strong><\/span><\/strong><\/span><\/strong>\"\u57fa\u4e8eFDA<\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/span><\/strong><\/p>\n


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

                                            \u81eaICH Q10\u9881\u5e03\uff0cFDA\u4e8e2011\u5e74\u53d1\u5e03\u300a\u5de5\u827a\u9a8c\u8bc1\uff1a\u4e00\u822c\u539f\u5219\u4e0e\u89c4\u8303\u300b\u4ee5\u6765\uff0c\u5c06\u5bf9\u5de5\u827a\u9a8c\u8bc1\u7684\u8981\u6c42\uff0c\u4ece […]<\/p>\n","protected":false},"author":1,"featured_media":106010,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/106009"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=106009"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/106009\/revisions"}],"predecessor-version":[{"id":106023,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/106009\/revisions\/106023"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/106010"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=106009"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=106009"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=106009"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}