47
ɚeՓ
ܓ
ʷ၍ଣ˾݄
ݟ
ࣨዚ
ͦ
ۃ
Ңᔼᐕኜҿ
GMP
˾݄
ݟ
ࣨዚdܼ̍ʈ৫ඎʕːeཥɿᏨ᜕ʕːe
᙮ږ
ʈุӺ೯࢝ʕːʿ෧ᇭʈุҦஔ೯࢝ʕːഃ
4
d͉࿁˾݄
ݟ
ࣨዚʘ༟
ࣸϞᆽʘᇍ
ࠅ
Ӌd
މ
Դᔼᐕኜҿ
GMP
ݟ
ࣨՓ
ܓ
ၾყટ
ࠐ
d
102
ϋᔼᐕኜҿ
᜕ᗇዚୌΥ൙ᛠਖ਼ࣩ
ࠇ
dੂБ࿁˾݄
ݟ
ࣨዚʘᐼ൙ПʿԈᗇ൙
Пd˸ᆽ
ڭ
ᇆ
ݟ
ۜሯf
ɧeᔼᐕኜҿႡிᅀႩ̙೮၍ଣ
፩ɝᔼᐕኜҿɪ̹
ۃ
dՉᔼᐕኜҿႡிุ٫ʘۜሯӻ୕̀ୌΥҢᔼᐕኜҿ
GMP
fᔼᐕኜҿ፩ɝุ٫̙͡ሗୌΥҢᔼᐕኜҿۜሯӻ୕˖
Quality System
Documentation, QSD
dପႡிุ٫˸ྼή
ݟ
ࣨ
މ
˴d፩ɝุ٫̙͡ሗ
ࠌ
ऎ̮ʈᅀ
ྼή
ݟ
ࣨd࿚Ї
102
ϋֵdϞࣖପᔼᐕኜҿ
GMP
Ⴉ̙೮ᅰ
މ
568
ੵd፩ɝᔼᐕኜ
ҿ
QSD
Ⴉ̙೮ᅰ
މ
3,231
ੵ
ڌ
4-2
f
ୋɧືcᔼᐕኜҿۜሯᗡ္
ତ
ر
ӊϋீཀࠬᎈ൙ПዚՓ፯त֛ۜධdԨΥή˙ጤ̹ሊ͛҅༟๕dੂБᖹ
ي
ʷ
㛭ۜۜሯ္
ࠇ
d͟ɽᖹ
ג
eᖹ҅eᔼᐕኜҿБʿႡிᅀ
א
˾ଣਠഃආБ̹ਯ
ପۜʘۜሯ
פ
Ꮸd္છɪ̹
ܝ
ᔼᐕኜҿʘۜሯf
݁ഄၾϓ
؈
ɓe̹ਯᔼᐕኜҿۜሯሜ
ݟ
္
ɓۜሯሜ
ݟ
ۜධࠬᎈ൙П
ৣΥᔼᐕኜҿ၍ଣ݁ഄdԨԱኽ͉ዝϋ̹ਯۜۜሯሜ
ࠇݟ
ʔΥࣸଟ༰৷ʘ
ۜධeಀ೯͛ᔼᐕኜҿʔԄˀᏐ
א
ʔԄۜஷజ٫ഃࠬᎈ൙ПΪɿdආБΌ
פ
ᅵd
Չ
ࠇ
Ꮸ᜕ഐ
؈
d̙Զҁʘۜሯ൙Пd͵̙Ъ
މ
ʔΥࣸପۜஈໄʿ
ࠅ
ӋႡிᅀҷ
ڌ
4-2
cᔼᐕኜҿ
GMP/QSD
ϞࣖႩ̙೮ᅰ
ᔼᐕኜҿ
GMP
ā
QSD
ϞࣖႩᗇ̙೮Ռᅰ
ϋй
GMP
ϞࣖႩᗇ̙೮Ռ
QSD
ϞࣖႩᗇ̙೮Ռ
99
ϋ
236
1,340
100
ϋ
486
2,777
101
ϋ
531
3,065
102
ϋ
568
3,213