09

1
09??????????(????)
??

• NPO-QA????
• 2009.5.147.23

2
? ?
??????
?1? ?????????
1)??????????2)CMC????3)????
?2? GQP????????
4)??????(S?)????????GQPGMP?????
?3? ????????????????
5)???????????????????????????
?4? ??????????
6)?????????? (?????????) 7)?????????
????????? ??????????
?5? ?????????????????
8)???? ????????????? ?????
(??????) 9)???MF????
?6? GMP????????
10)GMP?????? GMP Matter ???????
3
? ?
??
?1? ?????????
???????GQPGMP????? ?????????
?2? GQP????????
??????(S?)???????? GQPGMP?????
ECO???????????? ?????????????
?3? ????????? ???????
?4? ??????????
??????????(????? ????) ??????????????????
??????????
?5? ????????? ????????
????????????? ????? (??????)
?6? GMP????????
GMP Matter ???????
4
?1??????????
DRUG LAG
????????????????????????????????????(???????????
????)?????????????????????????????????????(??)????
????????????????? ????????????????????????200006
????????????????????104?????????97?????????
?????????????????????30.7????????33.0?????????????
????30???????????? ??????????3?????????? ??????(n
58??)?????68.0??????53.0??????63.5??????????????1
5.0????????4.5?????????????????3????????????????(n
76??)????????19.9??????12.3??????13.0???????????7
.6????????6.9??????? ???????????????????????????
???????????????????
CMC?????? CMCChemistry,Manufacturing and
Controls
????????????????????? ????????????????????? ??????
??????????????? ????????????????????? ????????????
?
???? 1)???????(???????????) 2)???????????????????
??? 3)???????????????? 4)????????????????????????
5)???????????? (Validation,?????etc.
) 6)?????????????????????
ManufacturingProduction Quality control(QC)
???????
??????????????(2008.4) ????CEO????
5
?2?GQP????????
??
?????????
????????????
??????????????????????????????????? ???????????(S?
)???? S??????????????? ???????(A?)??????? ????????
A???????????? ????????????????????????????????????
??? ??????????????????????F.W.??????????????????A?
??????????????????????? ???????????F????????? ????
???????????????????????????S?????? ???????????????
? ??????A??????????????????????.??????????????S???
??????????????????
1.?????????
????????
2.??????????
???(holos -on)?????
3.???????
????????????????
4.?????
WHAT,Objective,Goal
5.?????????
MUST,Want?Is,Is not
6.????????????
????????????CAPA
7.??????
??????????????? ????? ?????????? ?????(?????)
????????
6
??
?3???????-??????????
??????????????????. ?????????????????.
????????????????? 1)???? ??????????????????
????????(H14.??151?) ??????????????????
???????????????? (H16??149?e-???) ?????????????
??? (H12??102?) CTD??????(????)????
(H16.5.27??????0527001?) ??????????????????
?????????????? (H17.4.1????0401022?)
????????1)e-???(H16??149?) 1)??????
????????????????????. ?????????SOP???????
??????????? 2)?????? ??????????????
??????????? 3)?????? ??????SOP?
????????????SOP 4)????????? ???????????????????
??? ???? 5)???????? ???????????
(??????????????????)
???????(H12??102?) 1)???????????.???????. 2)?????
?? ?????????? ??(????????)? ????
??????(???)
7
?? ????????ISO9000????? GQP/GMP????????????
GQP?GMP??????????? ????????????????
???? PL?????.State of the Arts EU?GMP???????????
? ???GQP/GMP??(??)?? ????????????????? ????????
???????? ????????????(VMP) ?????
????????????? ?????????????
?4???????????
???????????????ISO9000 ?????????
ISO9000?????(2006)
1)?????????
1)Qualification process
Qualification process????????? ?????????????????
????? ???????.(Pre Validation)
1
2)??????
2)Validation
Validation?????? ????????????????????.
2
3)??
3)Verification

• ??3-4-2????????????
• ?????????????????
• ????????????
• ??????????
• (?????????)

Verification?? ??????????????????? ??????.
8
??
?5???????????????
??????????????????? ????????????
??????? ????????????MF?? ????(CTD)????
???? 1)????????? 2)?????? 3)???????? 4)????????
(??) 5)???????(???) 6)?????????? 7)???????? 8)???
?????? 9)????
????? ????????? 1)??? 2)????? ???? 3)?????
(??????)
MBR??????? EUGMP ???????????????? ???????????? (?
??????)??????? ??????????? ?????? c-GMP ??????
?????????? ??? ICHQ7a ???????????????? ??????????
?????? ???????????????? ?.
???? 1)???????????? 2)????? 3)?????????? 4)?????
? 5)???????? 6)???????(???????) 7)????????????? 8
)??????? 9)??????????
?????????????????????
9
??
?6?GMP????????
?????????
OECD1)????,Audit?,??????? ????????,???????????? ??
????????? (objective assurance activity)????
Audit?????????????????? ??????,????????????? ????
??(assess)?,??????? ??,??????????????, ????(Intern
al Auditing)?,???? ???????????????????? ??(Interna
l Controls)???????? ?????????,???? (External
Auditing)?????????? ????????????
????????(??)GMP?? (H18.10.13 ????)

• GMP????????(?????????)
• H3?????????????
• (??????????)
• 2. H3?????????(????????)
• 3. H4WHOGMP????(????????)
• 4. H13?????????????
• (??????????)
• 5. H13??????????(NIHS?????)
• 6. H14?????????
• (NIHS?????????)
• 7. H15???????(NIHS????)
• 8. H15??????????(???? ????)
• 9. H17??????????????????
• (???? ????)
• 10. H18???????GQP/GVP??????
• (?????? ????)
• 11. H19CSV???????(???? ????)

1)Glossary of Key Terms in Evaluation and
Result-Based Management
???????? ????????? ???? ?? ???????? ????????
?