Page 48 - 2019食藥署年報(中文版)
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ɚe੶ʷᖹۜτΌ׌Ύ൙П


                       މ੶ʷᖹۜτΌۜሯd০࿁ՈϞτΌဲᅇᖹۜආБτΌ׌ʱؓ൙Пd107ϋ΍ҁ

                  ϓ47ධᖹۜτΌ׌Ύ൙ПdՉʕ০࿁16ධᖹۜમ՟ࡌҷͷఊeࠢᐵԴ͜ഃࠬᎈ၍છણ

                  ݄dԷνܵᚃੂБўCarbamazepineϓʱᖹۜࠬᎈ၍છࠇ೥ഃdԨ೯̺ᖹۜτΌ༟ৃ
                  ࠬᎈ๖ஷڌd੶ʷࠬᎈ၍છϓࣖd˸ᆽڭ͏଺͜ᖹτΌf


                  ɧeܔໄᖹۜݟ༔༟ৃ̻ၽ


                       107ϋܓ̻ၽԴ͜ඎ༺1ຬ3ɷɛϣdՉʕ˸ݟ༔ᖹۜԴ͜ኒඎeʔԄˀᏐʿᕿ̳

                  ࡬Ԫ͜ᖹܔᙄމ˴d̤ீཀ̏eʕeی௅3ఙႭ׼ึdᒗሗੂุᖹࢪᑺࠑʹʝЪ͜ݟ

                  ༔ၾሊ઺ఊੵ༶͜ʘː੻d຾͟Դ͜٫຾᜕ʱԮၾʹݴdၚආݟ༔Ҧ̷dᔟ˸੶ʷਿ

                  ᄴൢהၾٟਜᖹ҅ᖹԫɛࡰٙᖹԫ؂ਕඎঐf





                  ୋɧື   ҁഛГᖹᖹۜ༶ቖ஝ᇍɧື
                  ୋ


                  ݁ഄৎ
                  ݁ഄৎ๕๕

                       ྼ݄ᖹۜᎴԄ༶ቖ஝ᇍ€Good Distribution Practice, GDPٙͦٙd݊މᜫ͛

                  ପࠦୌΥᖹۜᎴԄႡி஝ᇍ€Good Manufacturing Practice, GMPʘᖹۜۜሯ၍ଣ

                  ַФЇᎷπၾ༶፩ཀ೻ୌΥGDPf

                       ਷ყගͦۃʊϞ஢εଡ଼ᔌʿ਷࢕ක֐ྼ݄ᖹۜGDPd̍ў˰ޢሊ͛ଡ଼ᔌeᆄ
                  ຑeอ̋սe৵ԸГԭeߵ਷eᅃ਷e๿ɻeߕ਷ၾዦݲഃd਷ყᔼᖹۜᇆݟ՘ߒ

                  ଡ଼ᔌ€Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-

                  operation Scheme, PIC/S͵׵103ϋ6˜͍όʮ̺ᖹۜᎴԄ༶ቖ஝ᇍdϤ஝ᇍʊϓ

                  މ਷ყᖹۜGDPྼ݄ᅺ๟dΪϤd͉໇ᔟ͟પਗၾ਷ყΝӉʘGDPՓܓdໝྼᖹۜ༶

                  ቖۜሯ၍ଣdڭღ਷ɛ͜ᖹτΌʿ౤ʺҢ਷ᖹۜ༶ቖۜሯԨ௴ி਷ყᘩنɢf











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