Ọdịiche dị n'etiti American CGMP na Old Chinese GMP (Nkebi nke Mbụ)

GMP (Ezi Nrụpụta Omume) bụ ntụzịaka ezubere iji chịkwaa na ilekọta ọrụ nrụpụta ọgwụ n'ụwa niile.Ọ bụkwa ikike dị mkpa maka ndị na-emepụta ọgwụ iji banye n'ọhịa nke ahia mba ụwa.

GMP gụnyere: akụrụngwa, ndị mmadụ, saịtị, ịdị ọcha, nkwado, akwụkwọ, mmepụta, ịdị mma, ire ere, ojiji na nyocha wdg. ọgwụ ndị ọzọ, mgbanwe na ntụgharị site na ngwakọta nke akụkụ dị iche iche, ihe mberede nke nzọụkwụ na-efu efu nke nyocha, ọrụ na-ezighị ezi na usoro ndị ọzọ na-ekwesịghị ekwesị.

Ewepụtara echiche nke GMP na 80s nke China wee kwupụta n'ihu ọha dị ka iwu zuru oke na nke iwu na July 1.^st, 1999. Na USA, cGMP (obere maka Omume Nrụpụta Dị Mma ugbu a) ka ewepụtara na CFR akụkụ 210 na akụkụ 211 na 90s.

N'ozuzu, ebumnuche, ụkpụrụ, isiokwu na ihe achọrọ nke Chinese GMP fọrọ nke nta ka ọ bụrụ otu nke American cGMP mana enwere ọtụtụ ọdịiche dị ka ndị a.

Usoro nnabata

Asambodo GMP nke China bụ naanị asambodo maka ikike nrụpụta ọgwụ, ewezuga ndebanye aha ngwaahịa.Mgbe akwadochara onye nrụpụta maka ngwaahịa ọhụrụ yana nọmba ndebanye aha, ọ ga-enwe ike ịga n'ihu na ntinye asambodo GMP.Ọzọkwa, data nke mmepụta ihe atọ na data nke nkwụsi ike n'ime opekata mpe ọnwa isii ka achọrọ nrubeisi maka ndebanye aha ngwaahịa ma ọ bụ asambodo GMP.

Asambodo nke American cGMP nwere akụkụ abụọ: Mmepe ngwaahịa na njikwa nrụpụta kemịkalụ.Nke ahụ pụtara ndebanye aha mmepụta na ikike nrụpụta na-aga n'ihu n'otu oge ahụ.Enwere ụdị ndebanye aha ngwaahịa abụọ na USA: Ngwa Ọgwụ Ọhụrụ (NDA) na Ngwa Ọgwụ Ọhụrụ Abbreviated (ANDA).NDA chọrọ data nke mmepụta ihe atọ na data nke nkwụsi ike n'ime ọnwa isii.ANDA chọrọ data nke ngwungwu mmepụta na data nke nkwụsi ike n'ime ọnwa atọ.A ga-echekwa data nke nyocha na nkwado na-aga n'ihu site n'aka onye nrụpụta wee kwupụta ya na mkpesa kwa afọ nye FDA.

• [cf7ic]