Page 46 - 2020食藥署年報(中文版)

ୋɧື cҁഛГᖹᖹۜ༶ቖ஝ᇍ

݁ഄৎ๕๕
݁ഄৎ

ГᖹᎴԄ༶ቖ஝ᇍ€Good Distribution Practice, GDPމַᚃᖹۜᎴԄႡி஝
ᇍ€Good Manufacturing Practice, GMPᘌᔫٙۜሯ၍ଣၚग़dਗ਼၍ଣ଄ႊЇ዆ࡈ

ᖹۜԶᏐᗡd˸ᆽڭᖹۜᕎකᖹᅀܝ༶৔Їᖹਠeᔼᐕ৫הʿᖹ҅ಂගdঐ੄ၪܵۜ

ሯʿҁ዆׌f

਷ყගʊϞ஢εଡ଼ᔌʿ਷࢕ක֐ྼ݄ᖹۜGDPd਷ყᔼᖹۜᇆݟ՘ߒଡ଼ᔌ

€Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-

operation Scheme, PIC/S͵׵103ϋ6˜͍όʮ̺ᖹۜᎴԄ༶ቖ஝ᇍd͉໇͵஼ϋપ

ਗၾ਷ყΝӉʘGDPՓܓdໝྼᖹۜ༶ቖۜሯ၍ଣdڭღ਷ɛ͜ᖹτΌd౤ʺ਷ყᘩ
نɢf

ੂБഄଫБഄଫ
ੂ

ɓeࡌࠈ(%1޴ᗫج஝

͉໇ጐ฽ҁ௪ج๕d׵106ϋ6˜14˚຾ᐼ୕˿ʮ̺ࡌ͍ᖹԫجୋ53-1ૢd஝֛຾

ᐄГᖹҭ೯e፩ɝʿ፩̈ʘุ٫dՉГᖹ༶ቖ޴ᗫЪุdᏐୌΥГᖹᎴԄ༶ቖ๟ۆd

Ԩ຾ʕ̯ሊ͛˴၍ዚᗫᏨݟΥࣸd՟੻Гᖹ༶ቖ஢̙ܝd֐੻މʘf

ৣΥᖹԫجࡌ͍d׵106ϋ12˜28˚೯̺˜ГᖹᎴԄ༶ቖ๟ۆ™dЪމГᖹனር

ุ٫ྼ݄GDPʘᅺ๟d׵107ϋ5˜28˚ࠈ֛೯̺˜Гᖹ༶ቖ஢̙ʿᗇ׼˖΁ࣨ೯၍

ଣ፬ج™d׼֛͡ሗᏨݟʿࣨ೯஢̙ഃ၍ଣ஝֛f

ɚeપਗ(%1ྼ݄ࣛ೻

ሊ͛၅л௅׵105ϋ2˜18˚ʮѓГᖹႡிุ٫ʿჯϞГᖹႡኒᖹۜ஢̙ᗇʘனር

ุᖹਠdᏐІ108ϋ1˜1˚ৎୌΥГᖹᎴԄ༶ቖ๟ۆʘ஝֛dϤމႡኒୋɓචݬGDP

ࣛ೻f

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