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AMO

????. FDA(cGMP):21CFR-PARTS 210

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AMO

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    1. ????????? ???

    2. ?? ???? ???? ???? ?????? ?????? ?????? AMO????????? ?? ??

    3. ???? FDA(cGMP):21CFR-PARTS 210 & 211 211.67??????? ????????????????????????,????????????????????????????????

    4. ???? EU GMP: 336 ?????????????????,?????????????????????????????? 337 ?????????????,?????????????

    5. ???? ??GMP: ???????:??????? ??????? ????????????

    6. ???? ??:??????????????????? ??????? ??? ???

    7. ????—????? ???? ???????? ?? ??? ??? ??? ??? ?????? ????????????? ?????????

    8. ????—?? ???? ????????????????? ???? ??????????? ????? ???????????

    9. ????—?? ?? ?? ?? ??

    10. ????—?? ??????:??????????????????????? ???????????????? ????:CIP???????? ???????????????? ??????? ?????????????

    11. ????—??? ????????? ??????????? ????????? ???????? ???????? ?????????

    12. ????—????? ?? ?????????????????????????????????????? ?? ??????????????? ??????????????

    13. ????—???? ???????????????? ???????? ???????????????????????? ????????????? ????????? ????????????????????? ???????????????????????? ??????SOP

    14. ????—???? FDA: ????????????????????????,?????????????????

    15. ????—?? FDA?????? ???????CV Master Plan ??????????SOP ???????????? ????????????????????????????????? ?????? ???????

    16. ????—??????? ????????? ????????? ?????? ?????????SOP???? ???????,?????? ??????

    17. ????—??????? ????????????? ????????????SOP ??SOP?????? ?????? ???????????? ???????????

    18. ????—??????? ??? QC??? ???????? ????? ?????????? ??? ???????? ????????? QA ???????? ?????????

    19. ????—???? ???????? ??SOP??? ????????? ?????????? ????????????????? ???????

    20. ????—???? ????????: ?? ?? ??????? ????? ???SOP ?????? ????????? ????? ??

    21. ????—???? ??? ??????????? ????,?????? ???? ???? ???? ??????????? ??????? ?????????

    22. ????—???? ?? ????????????,?????????,?“????”????? ?????:???? ?????:???? ?????????? ??????????????

    23. ????—???? ???? ???? ??????????????? ???? ????????????,?????????????? ???? ????????????,????? ?????????

    24. ????—???? ??????? ???????????????? ????????,?????????? ????????????????

    25. ????—???? ??????????????? ?????(DTC) ?? ????:?????????????????? ????:?????CIP??????????? ????

    26. ????—???? ???? ??3?????? ?????????????????????????????????? ???????????,??????????????

    27. ????—???? ??? ??:??????? ?????? ?????????? ?????????? ?????

    28. ????—???? ??????? ?????? ???? ??????? ????????? ??????? ????? ??????

    30. ????—???? ???????????: ?? ???? ????? ??????Holding Time ???????????????Dirty holding time ???????????????Cleaning holding time ??????????Campaigning

    31. ????—???? ???? ?? ???? ???? Rodac????? ????:25CM2 ???????? ??????? ???????? ???

    32. ????—???? ???? ???? ???? ??????? ????? ???? ???????

    33. ????—???? ??????? ????: ?????? ????????? ??????(HPLC?GC) ????????? LOD LOQ ??? ??? ???

    34. ????—???? ??????? ??? ???Rodac?????,?????(15-20%) ?????:?????????

    35. ????—???? ????? ????????? ???? ?????????? ??????(????????????????) ?????????

    36. ????—???? ?? ???????? ??????????? ??????

    37. ????—???? ?????? ??????? ???TOC(<=10 ppm) ??????? L1=???????????NOEL(No observable effect level) L2=?????????????????? =L1xLDR(BS??????/HDD???????) L3=??????????? =L2x(SS????/SES????????)xSR???? L1*(LDR)*SS*SR ????: --------------------------------=ug/?? SES ?????:<100ug/??

    38. ????—???? ????? ?? ??????????????????????????????????????????????????????????????????? ????:100CFU/25cm2 ?????:10CFU/25cm2 ??????? ???(???):0.25EU/ml ??? 100 CFU/ml ????? 10 CFU/100ml ???WFI??

    39. ????—???? ?????? ???????????????? ????????? ?????????

    40. ????—???? ???? ?????? CIP:5? ????:3? ???????? ????? ????????? ????? ???????

    41. ????—AMO?????? CIP:????????? ??????:Bulk??? ???? ???TOC?????? ???TOC?????? (Spec.: TOC<500ppb,???<2.1us/cm) ????????????

    42. ??????? ???????? Filling machine and product transfer pipe 1. Take a swab sample by swab all outer surface of filling nozzles 2. Take a rinse from the total outlet of filling machine

    43. ??????? ???????? Product inlet pipe 1. Take a rinse sample from the outlet of product inlet pipe

    44. ??????? ????????

    45. ??????? Total Organic Carbon Analyzer

    46. ???Conductivity Meter

    47. ????—AMO??????? ??????? ???:??????????????????? ??????????????? ???????????????? ????????? ??????????

    48. ???? ??????????? ???????????

    49. ????—??

    50. ?????

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