32
ୋɚືcᖹۜ๕᎘၍ଣ
ତ
ر
މ
ʺᖹۜႡிۜሯʿୌΥყᅺdҢ࿁ᖹۜႡኒᅀʘ၍ଣ˚ᒈᘌᔫԨၾყ
ટ
ࠐ
d
71
ϋપਗྼ݄ᎴԄᖹۜႡிᇍ
Good Manufacturing Practice, GMP
d
84
ϋྼ݄ᆽࣖЪุ
current Good Manufacturing Practice, cGMP
dԨΝӉ೯࢝ୌΥ˰
ޢ
ᆓ
ݴ
ٙ
cGMP
ਗ࿒၍ଣᅼόi
96
ϋʮѓྼ݄ყᔼᖹۜᇆ
ݟ
ߒ
ଡ଼ᔌ
Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, PIC/S
ʘ
GMP
ᅺdԨ֛͊ԸІ
104
ϋ
1
˜
1
˚ৎΌࠦҁϓྼ݄dԴၽᝄႡᖹุ˥ၾყટ
ࠐ
d͂කΌଢ̹ఙdҢྼ݄
GMP
ዝνྡ
3-5
f
ၝᝈҢᖹۜ
GMP
Փ
ܓ
ʘ၍ଣᇍᖚdГᖹႡኒᅀӉਗ਼ᖹۜ
ݴي
ᅀeᔼ͜ं
ᅀʿࡡࣘᖹᅀഃѩॶɝ၍ଣd͊Ըਗ਼ܵᚃપਗྼ݄ᖹۜᎴԄ༶ቖᇍ
Good Distribution
Practice, GDP
d˸ႊᖹۜΌԶᏐᗡʘۜሯ၍ଣfᔟ͟ໝྼГᖹႡிᅀΌࠦྼ݄
PIC/S
GMP
dʺᖹۜႡி၌ʘۜሯ၍ଣd੶ʷᖹᅀlz္̮ຖdΝࣛੂБ፩ɝᖹۜᗙྤ
ݟ
᜕d
ӁഒʔԄପۜྤ̮d˸੶ʷᖹۜ๕᎘၍ଣdᜫ͏͜ᖹһτːf
݁ഄၾϓ
؈
ɓeໝྼГᖹᖹۜႡிᅀΌࠦྼ݄
PIC/S GMP
ɓ
PIC/S GMP
ʘપБ
1.
މ
əᆽ
ڭ
ᖹۜ
GMP
Փ
ܓ
ܵᚃੂБdપБ
GMP
ᖹᅀ
ܝ
ᚃ
ݟ
ࣨ၍ଣd
ܔ
ͭӊ
2-4
ϋɓ
ϣ
ܝ
ᚃ
ݟ
ᅀٙዚՓd˸̋੶ᖹۜۜሯʘ္ຖၾ၍ଣf
2.
મ͜ყ
GMP
ᅺʊ
މ
Όଢᖹ̹ۜఙٙᒈැdҢ֛͊ԸІ
104
ϋ
1
˜
1
˚ৎ
ה
ϞГᖹႡኒᅀᏐΌࠦҁϓྼ݄
PIC/S GMP
ᅺd֣ࣛ͊ஷཀ൙ᛠʘᖹᅀdԱ֛
ʔΎ͛ପf
3.
ܵᚃપБᖹۜᎴԄ
GMP
ႡிᇍdԨપਗΌࠦྼ݄
PIC/S GMP
ᅺdЇ
102
ϋ
12
˜ֵdlz
GMP
ГᖹႡኒᅀ
ࠇ
Ϟ
140
d
57
ʊஷཀ൙ᛠf፩ɝᖹۜʘ̮Ⴁி
ᅀ
ࠇ
Ϟ
820
ஷཀ
ݟ
ࣨi̤dІ
91
ϋЇ
102
ϋֵ
މ
˟d̮ГᖹႡኒᅀϞ
213
ஷ
ཀྼή
ݟ
ࣨdՉྼ݄ഐ
؈
ଣν
ڌ
3-2
f
4.
Ї
102
ϋ
12
˜ֵdlzஷཀ
PIC/S GMP
൙ᛠ
57
ᖹᅀdʊϓ
މ
ᆄe
ߕ
e˚ᖹᅀഃ
ᙑఊٙ࿁dᚃʊϞᖹᅀટաყɽᖹᅀ։ৄႡிdԨϞᖹᅀ͍ၾ
ߕ
eᆄe
˚ʿ؇
ی
ԭ
ݻ
ሔΥЪක೯
א
̮ቖ
ࠇ
fл͜˾ʈΥЪၾਖ਼ࣩ˙όdਗ਼Չᖹᅀ
ᓒ࢝ϓ
މ
ყᖹۜԶᏐʕːdԨጐᓒɽ̮ቖ̈ɹeήਜၾ܄˒f
ڐ
̬
ϋԸҢГᖹႡኒ̈ɹ
࠽
ʊϓ
ڗ
ɓ
࠴
˸ɪdཫ
ࠇ
Ң͛ҦႡᖹ೯࢝ਗঐਗ਼ܵᚃ
ᄣ੶d̮ቖϓ
ڥ؈
fІ
71
ϋપਗ
GMP
Їʦdᖹۜ̈ɹପ
࠽
ϓ
ڗ
ᒈැྡνྡ
3-6