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[?Ϻ?????????]??????????Ƽ?????

  1. ????ʱ?䣺2020-10-14
  2. ?????ص㣺?Ϻ? ????
  3. ְλ???ͣ?ȫְ
  4. ??Դ?????ݴ?ѧ?о???Ժ
  5. ְλ??2021У԰??Ƹ
רҵ??ǩ???????ѧ

CBMG??Ƹ????

ʱ?䣺2020-10-14

??˾??????

??????????Ƽ????ţ?һ?????ٴ??о?Ϊ????????????ҩ??˾???????ڿ??????ư?֢??????ϸ?????Ʋ?Ʒ???????????Լ????ĸ?ϸ?????Ʋ?Ʒ?;???????֪ʶ??Ȩ??ϸ???Ʒ??????Dz??þ?????֤??GMP?????????IJ?Ʒ???й???չ????????ѧ????ϸ???ٴ????顣???????й???GMP???亭??12????????ϸ???????ߣ???ȫ???????й?????????GMP??׼??????ƺ͹?????

 

???и?λ??

1)      ϸ??????Ա???Ϻ?????????????????????

?  ??????GMP??SOP??Ҫ??????Լ?????????????????ݼ?¼???쳣????????????????????ؼ??豸???????ά????????

?  ????????????׼?????????Ͽ?Ĺ?????

?  ????Э??????豸??????SOP???޸ġ?

 

2)      ????????Ա???Ϻ?????????

?  ??????GMP??SOP??Ҫ??????Լ?????????????????ݼ?¼???쳣????????????????????ؼ??豸???????ά????????

?  ????????????׼?????????Ͽ?Ĺ?????

?  Э????????????ɽྻ???豸??ʩ??ά?????Ա?֤?ྻ?ҵ????????С?

 

3)      QAרԱ???Ϻ???

?  Э???????ŵIJ??????????Ϸ??桢ISO9001??GMP??????׼??Ҫ??

?  ????ά????˾?????Ϲ????̣??????????????????ƻ?????????????????

?  ????ʵʩ??˾??????ϵ????߷???ķ????Ե??ж???

?  ???ά??????????ƻ???Э??????????ƻ???????????ʵʩ ??

?  ??????ƾ????;????ж???

?  ????Э??ISO??֤???ⲿGMP??ƣ?

?  ????˾GMP??ѵ??????ϵ?Ľ?????ά??????????ѵ??????ϵ??

?  ????˾ʵ???ҵĺϹ??Լ?飬????½???ʵ???ҵ??????????ļ???

 

4)      QC????Ա???Ϻ?????????????????????

?  ????GMP??????ճ????????豸?ļ?⣻

?  ?????ٴ?CARTϸ????ص??????ʼ죻

?  ????QC????????Լ??IJġ??????豸?IJɹ????ճ?ʹ??ά???ȣ?

?  ????sopִ?ж?????ԭ?ϡ??м??塢??Ʒ?ļ?⹤??????ʱ?????????????ܽ????

?  ????ִ??QC?Լ췽???Ŀ???????֤??׫д????Ч??sop???????֤???棻

?  ????ִ??QC??췽?????????ճ??ͼ죬???ܼ?????ȡ?

 

5)      CRA-????ϸ???????Ϻ???

?  Э???߼??ٴ????Ա???ճ???鹤????        

?  Э???߼??ٴ????Ա???о????Ľ??з??????о???ص???ѵ?????о????Ľ??ж??ڹ?ͨ??Э????????Ŀ?????е?Ҫ??????⡣

?  Э???߼??ٴ????Ա???????IJ?????ɸѡ&???顢???????????CRF??????Լ????????ʲ????ͽ?????????Э?????????????о????ĵĽ?չ??

?  Э???߼??ٴ????Ա??????ά?????о????Ĺ??????????ӵķ????Լ??ж??ƻ???ص??ļ????ݽ????ӱ?????????????о??ļ???

 

6)      CRA-??ϸ???????Ϻ???

?  Э???߼??ٴ????Ա???ճ???鹤????        

?  Э???߼??ٴ????Ա???о????Ľ??з??????о???ص???ѵ?????о????Ľ??ж??ڹ?ͨ??Э????????Ŀ?????е?Ҫ??????⡣

?  Э???߼??ٴ????Ա???????IJ?????ɸѡ&???顢???????????CRF??????Լ????????ʲ????ͽ?????????Э?????????????о????ĵĽ?չ??

?  Э???߼??ٴ????Ա??????ά?????о????Ĺ??????????ӵķ????Լ??ж??ƻ???ص??ļ????ݽ????ӱ?????????????о??ļ???

 

7)      ?з?????-????ϸ???????Ϻ???

?  ??????һ??Ƕ?Ͽ?ԭ????(CARs)?Ŀ????????????ѧ?о???????

?  ?Ż?CARTϸ??????????????

?  ֧??ת??ҽѧ?о???

?  ????SOPִ???ٴ??????ļ?⹤??????ʱ?????????????㱨???????

?  ????TM?????ٴ?????????????Լ????IJġ??????豸?IJɹ???

?  ?????ٴ???????????ԤԼ?????????ա????????ȣ?

?  ?????ٴ??????ɼ??????Ѫ?Լ??еĴ???????ͼ?????ʵ?????ʵĽ??ӵȣ?

?  Э??ʵ???ҹ?????????

 

8)      ?з?????-??ϸ???????Ϻ???

?  ??????????ϸ????????ԭ??ϸ????ϸ??ϵ??

?  ?????Ż???ϸ???????????Ĺؼ?ָ?꣬?????µĸ?ϸ??????????

?  ?????µ?ϸ???????????о?ģ?ͣ????Ը?ϸ??ҩ???????Ч?????????µ????????Ʊ?׼??

?  ???ö???ϸ??????ѧ?ͷ???????ѧ?????о???ϸ??ҩ?????????յĸĽ?????

?  ?ڹ?˾?Ĺ淶???ռ????????????????ݣ???ʵ??????ʱ׫д??ʵ?鱨?棬????ʱ?????????㱨??

?  ???ϸ?????????????Ŷ?Э????????ʵ???????Ľ?ʵ????ƣ??????桢??ʵִ??ʵ???????

?  ????ʵ???ҹ?????????ά?????????????豸??ά?????Լ?ʵ???ҵ???????

?  Э??ϸ?????????ϸ????????⹤????

 

????Ȥ??ͬѧҲ????ͨ??????Ͷ?ݼ?????????͸????ļ??????ԡ?ѧУ ??ҵ??? ???? ӦƸ??λ???ķ?ʽ???????? hr@cellbiomedgroup.com?????ǻᾡ?????ȡ????ϵ??


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