Kusiyana Pakati pa American CGMP ndi Old Chinese GMP (Gawo I)

GMP (Good Manufacturing Practice) ndi chitsogozo chomwe cholinga chake ndi kuyang'anira ndi kuyang'anira ntchito zopanga mankhwala padziko lonse lapansi.Ndilonso chilolezo chofunikira kwa opanga mankhwala kuti alowe mu gawo la malonda apadziko lonse.

GMP imaphatikizapo: malo, anthu, malo, ukhondo, kutsimikizira, zolemba, kupanga, khalidwe, kugulitsa, kugwiritsiranso ntchito ndi kuyang'anitsitsa etc. Ili ndi malamulo okhwima a teknoloji, kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe kake. mankhwala ena, kusiyanasiyana ndi kupatuka kuchokera ku kusakaniza kwa zigawo zosiyanasiyana, ngozi za kusowa masitepe oyendera, opaleshoni yolakwika ndi njira zina zosayenera.

Lingaliro la GMP lidaleredwa m'ma 80s ku China ndipo adalengezedwa mwalamulo ngati lamulo lokwanira komanso lovomerezeka pa Julayi 1.^st, 1999. Ku USA, cGMP (yachidule ya Current Good Manufacture Practices) inatulutsidwa mu CFR gawo 210 ndi gawo 211 mu 90s.

Ponseponse, cholinga, mfundo, phunziro ndi zofunikira za Chinese GMP ndizofanana ndi za American cGMP koma palidi zosiyana zambiri motere.

Njira Yovomerezeka

Chitsimikizo cha Chinese GMP ndi chiphaso cha chilolezo chopanga mankhwala, kupatula kulembetsa kwazinthu.Wopangayo atavomerezedwa kuti apange chinthu chatsopanocho ndi nambala yolembetsa, amatha kupitiliza kugwiritsa ntchito chiphaso cha GMP.Kuphatikiza apo, zidziwitso zamagulu atatu opanga ndi kuwunika kokhazikika m'miyezi isanu ndi umodzi zimafunikira kutumizidwa kuti kalembetse katundu kapena chiphaso cha GMP.

Chitsimikizo cha American cGMP chili ndi magawo awiri: Kukula Kwazinthu ndi Chemical Manufacture Control.Izi zikutanthauza kuti chilolezo cholembetsa ndi kupanga chikuchitika nthawi yomweyo.Pali mitundu iwiri yolembetsa ku USA: New Drug Application (NDA) ndi Abbreviated New Drug Application (ANDA).NDA imafuna deta yamagulu atatu opangira ndi kuwunika kwa kukhazikika m'miyezi isanu ndi umodzi.ANDA imafuna zambiri zamagulu opanga komanso kuwunika kokhazikika m'miyezi itatu.Zambiri zakuwunika kosalekeza ndi kutsimikizika zidzasungidwa ndi wopanga ndikulengezedwa mu lipoti lapachaka ku FDA.

• [cf7ic]