2014食藥署中文年報電子書

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ୋɚືcᖹۜ๕᎘၍ଣ
ତر
މ౤ʺᖹۜႡிۜሯʿୌΥ਷ყᅺ๟dҢ਷࿁ᖹۜႡኒᅀʘ၍ଣ˚ᒈᘌᔫԨၾ਷ყ
ટ ࠐ d੽71ϋપਗྼ݄ᎴԄᖹۜႡி஝ᇍ€ Good Manufacturing Practice, GMPd84
ϋྼ݄ᆽࣖЪุ€current Good Manufacturing Practice, cGMPdԨΝӉ೯࢝ୌΥ˰ޢ
ᆓ ݴ ٙcGMPਗ࿒၍ଣᅼόi96ϋʮѓྼ݄˜਷ყᔼᖹۜᇆݟ ՘ ߒ ଡ଼ᔌ€ Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, PIC/S™
ʘ GMPᅺ๟dԨ஝֛͊ԸІ104ϋ 1˜ 1˚ৎΌࠦҁϓྼ݄dԴၽᝄႡᖹุ˥๟ၾ਷ყટ
ࠐ d͂කΌଢ׌̹ఙdҢ਷ྼ݄GMP ዝ೻νྡ3-5f
ၝᝈҢ਷ᖹۜGMPՓ ܓʘ၍ଣᇍᖚd੽ГᖹႡኒᅀ஼Ӊਗ਼ᖹۜݴيᅀeᔼ͜ं᜗
ᅀʿࡡࣘᖹᅀഃѩॶɝ၍ଣd͊Ըਗ਼ܵᚃપਗྼ݄ᖹۜᎴԄ༶ቖ஝ᇍ€Good Distribution
Practice, GDPd˸଄ႊᖹۜΌԶᏐᗡʘۜሯ၍ଣfᔟ͟ໝྼГᖹႡிᅀΌࠦྼ݄PIC/S
GMPd౤ʺᖹۜႡி၌ʘۜሯ၍ଣd੶ʷᖹᅀlz̮௅္ຖdΝࣛੂБ፩ɝᖹۜᗙྤݟ ᜕d
ӁഒʔԄପۜ׵ྤ̮d˸੶ʷᖹۜ๕᎘၍ଣdᜫ͏଺͜ᖹһτːf
݁ഄၾϓ؈
ɓeໝྼГᖹᖹۜႡிᅀΌࠦྼ݄PIC/S GMP
€ɓ PIC/S GMP ʘપБ
1. މ əᆽڭ ᖹۜGMPՓܓ ܵᚃੂБdપБGMPᖹᅀܝ ᚃ ݟࣨ၍ଣd ܔͭӊ2-4 ϋɓ
ϣ ܝᚃ׌ݟ ᅀٙዚՓd˸̋੶ᖹۜۜሯʘ္ຖၾ၍ଣf
2. મ͜਷ყGMPᅺ๟ʊމ Όଢᖹ̹ۜఙٙᒈැdҢ਷஝֛͊ԸІ 104 ϋ1˜ 1˚ৎה
ϞГᖹႡኒᅀᏐΌࠦҁϓྼ݄ PIC/S GMPᅺ๟d֣ࣛ͊ஷཀ൙ᛠʘᖹᅀdԱ஝֛
ʔ੻Ύ͛ପf
3. ܵᚃપБᖹۜᎴԄGMPႡி஝ᇍdԨપਗΌࠦྼ݄PIC/S GMPᅺ๟dЇ 102ϋ 12
˜ֵd਷lzGMPГᖹႡኒᅀࠇ Ϟ140 ࢕d57࢕ʊஷཀ൙ᛠf፩ɝᖹۜʘ਷̮Ⴁி
ᅀ ࠇϞ 820΁ஷཀݟ ࣨi̤dІ91ϋЇ102ϋֵމ˟d਷̮ГᖹႡኒᅀϞ 213 ࢕ஷ
ཀྼή ݟ ࣨdՉྼ݄ഐ؈ ዆ଣνڌ 3-2f
4. Ї 102ϋ 12˜ֵd਷lzஷཀ PIC/S GMP൙ᛠ57࢕ᖹᅀdʊϓމ ᆄeߕe˚ᖹᅀഃ
਷ᙑఊٙ࿁൥d௔ᚃʊϞᖹᅀટա਷ყɽᖹᅀ։ৄႡிdԨϞᖹᅀ͍ၾߕ eᆄe
˚ʿ؇ی ԭ਷࢕ݻሔΥЪක೯א ̮ቖࠇ೥fл͜˾ʈΥЪၾਖ਼ࣩ˙όdਗ਼Չᖹᅀ
ᓒ࢝ϓމ ਷ყ׌ᖹۜԶᏐʕːdԨጐ฽ᓒɽ̮ቖ̈ɹ਷࢕eήਜၾ܄˒fڐ ̬
ϋԸҢ਷ГᖹႡኒ̈ɹ ࠽ ʊϓڗ ɓ ࠴ ˸ɪdཫ ࠇҢ਷͛ҦႡᖹ೯࢝ਗঐਗ਼ܵᚃ
ᄣ੶d̮ቖϓڥ؈଻f€І 71ϋપਗGMPЇʦdᖹۜ̈ɹପ࠽ ϓ ڗᒈැྡνྡ
3-6