Ngwakọta ọgwụ na-ezo aka na ọgwụ ọgwụ eji eme ihe dị iche iche nkwadebe. Ọ bụ ihe dị irè na nkwadebe. Ọ bụ ntụ ntụ, kristal, wepụ, wdg nke a kwadebere site na njikọ kemịkalụ, mmịpụta osisi ma ọ bụ biotechnology ma jiri ya mee ihe dị ka ọgwụ, ma ndị ọrịa agaghị ewere ya ozugbo. Nkọwa zuru oke nke API na ICH Q7A: ihe ọ bụla ma ọ bụ ngwakọta nke ihe a chọrọ iji mee ihe na mmepụta ọgwụ ma ghọọ ihe na-arụ ọrụ nke ọgwụ ọjọọ mgbe ejiri ya na ọgwụ. Ihe a nwere ọrụ ọgwụ ma ọ bụ mmetụta ndị ọzọ kpọmkwem na nchoputa, ọgwụgwọ, enyemaka mgbaàmà, ọgwụgwọ ma ọ bụ mgbochi ọrịa nke ọrịa, ma ọ bụ nwere ike imetụta ọrụ ma ọ bụ nhazi nke ahụ.
Ihe nke etiti ọgwụ pụtara bụ na ihe abụọ ma ọ bụ karịa dị iche iche nwere ihe pụrụ iche nke ngwaahịa site na mmeghachi omume kemịkalụ na usoro kwesịrị ekwesị. Ọ na-ejigide nrụpụta pụrụ iche nke akụrụngwa nke ya, na-emeri ntụpọ nke iji otu akụrụngwa na-emeziwanye arụmọrụ na nchekwa nke ọgwụ.
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