Isitifiketi se-GMP kanye nohlelo lokuphatha lwe-GMP

Iyini i-GMP?

I-GMP-Umkhuba Omuhle Wokukhiqiza

Ingase futhi ibizwe ngokuthi Umkhuba Wamanje Wokukhiqiza Okuhle(cGMP).

Imikhuba Emihle Yokukhiqiza ibhekisela emithethweni nasezimisweni zokukhiqiza kanye nokuphathwa kwekhwalithi yokudla, izidakamizwa kanye nemikhiqizo yezokwelapha. Kudinga ukuthi amabhizinisi ahlangabezane nezidingo zekhwalithi yenhlanzeko ngokuya ngezinto ezingavuthiwe, abasebenzi, izinsiza kanye nemishini, inqubo yokukhiqiza, ukupakisha nezokuthutha. ,ukulawula ikhwalithi,njll.ngokwemithetho kanye neziqondiso ezifanele zikazwelonke,ukwakha isethi yezicaciso zokusebenza ezisebenzayo ukusiza amabhizinisi ukuthuthukisa indawo yokuhlanzeka yamabhizinisi, kanye nokuthola izinkinga ohlelweni lokukhiqiza kusenesikhathi ukuze kuthuthukiswe.

Umehluko phakathi kweShayina namanye amazwe amaningi emhlabeni ukuthi ukusetshenziswa kwezidakamizwa kwabantu kanye nokusetshenziswa kwezidakamizwa zezilwane kuhlukile eShayina, okwamukela ukusetshenziswa kwezidakamizwa zabantu i-GMP kanye nesidakamizwa sezilwane i-GMP.Selokhu kwaqala ukusetshenziswa kwesitifiketi se-GMP somuthi e-China, iye yabuyekezwa. ngo-2010 futhi yaqalisa ngokusemthethweni inguqulo entsha ye-GMP ngo-2011.Inguqulo entsha yesitifiketi se-GMP ibeka phambili izidingo eziphezulu zokukhiqizwa kwamalungiselelo angenalutho nama-API.

Manje kungani izimboni eziningi zemithi zidinga ukuphasisa isitifiketi se-GMP?

Abakhiqizi noma amabhizinisi anezitifiketi ze-GMP athola ukugadwa okuqinile eminyangweni kazwelonke efanele ochungechungeni lwezinqubo ezifana nokukhiqizwa nokuhlolwa komkhiqizo. imikhiqizo inendinganiso yokulawula kangcono ikhwalithi yomkhiqizo.

Amabhizinisi anesitifiketi se-GMP adinga ukusungula uhlelo lokuphatha ikhwalithi ye-GMP ukuze aqinisekise ubuqotho nokulandeleka kwekhwalithi yebhizinisi, ngoba ibhizinisi libuye lithole njalo ukuhlolwa kwe-GMP ku-National Food and Drug Administration njalo eminyakeni emihlanu ukuze lihlole yonke imibhalo ye-GMP nokusebenza okufanelekile. amarekhodi omlando webhizinisi eminyakeni emihlanu edlule.

Njengemboni ye-GMP,Handeisebenzisa ukuphathwa kwekhwalithi ngokuhambisana ngokuqinile nezidingo ze-cGMP kanye nemibhalo yokuphatha ikhwalithi yamanje.UMnyango Wokuqinisekisa Ikhwalithi uqondisa ukuqaliswa komsebenzi wekhwalithi kuyo yonke iminyango, futhi uqhubeka uthuthukisa futhi uphelelisa uhlelo lokuphatha ikhwalithi yenkampani ngokuzihlola kwangaphakathi kwe-GMP kanye ne-GMP yangaphandle. ukucwaninga (ukucwaningwa kwamakhasimende, ukucwaningwa kwamabhuku okuvela eceleni kanye nokuhlolwa kwe-ejensi elawulayo).