CGMP ndi chiyani?
GMPO LA DMP idabadwira ku United States mu 1963. Pambuyo kukonzanso pang'ono komanso kukongoletsa kosalekeza ndi US FDA, CGMPS yabwino kwambiri yaukadaulo yaukadaulo Gawo, kusewera gawo lofunikira kwambiri pakugwiritsa ntchito mankhwala otetezeka padziko lonse lapansi. China Choyamba Cholinga Chambiri cha Chitetezo cha Chitetezo cha Mankhwala 1988, ndipo makamaka chakonzedwanso zitatu kuyambira 1992, 1998, ndipo 2010, yomwe ikufunabe kusinthanso. Pazaka zopitilira 20 zolimbikitsira GMP GPM Grant amagwira ntchito ku China, kuti afotokozere lingaliro la GMP kuti lithandizire GMP, zomwe zidakwaniritsidwa, zomwe zidakwaniritsidwa. Komabe, chifukwa cha kuyamba kwa gmp ku China, pakhala pali zinthu zambiri zomwe zakhala zikugwiritsa ntchito gmp, ndipo tanthauzo la GMP silinaphatikizidwe muzopangidwa zenizeni komanso kasamalidwe kabwino.
Kukula kwa CGMP
Zofunikira zamakono za gmp ku China zidakali "koyamba" ndipo ndizofunikira chabe. Pofuna mabizinesi aku China kuti mulowetse msika wapadziko lonse lapansi ndi zinthu zawo, ayenera kugwirizanitsa ntchito yawo yopanga ndi miyezo yapadziko lonse kuti apeze chithandizo pamsika. Ngakhale boma la China silinasungire makampani opangira mankhwala kuti akwaniritse CGMP, izi sizitanthauza kuti palibe chachangu ku China kuti ikhazikitse CGMP. M'malo mwake, kuthetsa njira yonse yopanga malingana ndi CGPP ndi gawo lofunikira polowera kusinthidwe. Mwamwayi, pakadali pano m'makampani opanga mankhwala omwe ali ndi njira zachitukuko amadziwira tanthauzo la malamulowa ndikuwagwiritsa ntchito.
Mbiri ya Chitukuko cha CGMPmp: Kaya ku United States kapena ku Europe, Kuyendera kwa CGM ku CGEP kwa ma cgmozation (Ich), imadziwikanso kuti ich Q7A . Izi zimachokera ku msonkhano wapadziko lonse wogwirizanitsa zinthu zopangira (yich ya api) ku Geneva, Switphoneland mu Seputembara 1998, kuphatikizidwa " M'dzinja la 1999, European Union ndi United States idafika pa pangano lozindikiridwa la CGMPE lomwe limadziwika kuti likuikidwa. Mgwirizanowu utayamba kugwira ntchito, onse awiriwa adagwirizana kuti azindikire kutsimikizika kwa CGM CGMP kwa ntchito yamalonda. Kwa makampani a API, malamulo a CGMP ndi omwe ali ndi Ich Q7a.
Kusiyana pakati pa CGMP ndi GMP
CGMP ndi rmp muyezo wokhazikitsidwa ndi maiko monga United States, Europe, ndi Japan, omwe amadziwikanso kuti "dziko lonse la GPS GRP". Miyezo ya CGMP siyofanana ndi miyezo ya GPM yomwe idakhazikitsidwa ku China.
Kukhazikitsa kwa GPM ku China ndi gawo la GMS GMS yomwe imagwiritsidwa ntchito ku mayiko omwe akutukuka kumene, omwe ali ndi chidwi kwambiri pazomwe zimapanga zida zopangira monga zida zopangira.
CGMP inkapangitsa mayiko ena monga United States, Europe, ndipo Japan amayang'ana mapulogalamu, monga kukonzanso zochita za ogwiritsa ntchito komanso momwe angathandizire zochitika zosayembekezeka pakupanga zosayembekezeka.
(1) Kuyerekeza zigawenga za Certification. Pazinthu zitatu zomwe amapanga mankhwala - Mapulogalamu a Zardware, ndi ogwira ntchito - CGMP ku United States ndi yosavuta ndipo ili ndi machaputala ochepa kuposa gmp ku China. Komabe, pali kusiyana kwakukulu pazomwe zimachitika pazomwe zitatuzi zimachitika. GMP GPA YA CHINA LINAKHALA ZOFUNIKA KWAMBIRI, pomwe United States 'CGMS' ili ndi zofunikira kwambiri pamapulogalamu ndi ogwira ntchito. Izi ndichifukwa choti kupanga kwa mankhwala osokoneza bongo mwachitsanzo zimadalira kugwira ntchito kwa wothandizirayo, motero udindo wa ogwira ntchito ku United States ndilofunika kwambiri kuposa mapangidwe a fakitale.
(2) Kuyerekeza ziyeneretso za ntchito. Mu gmp yaku China, pali malamulo atsatanetsatane pazoyenerera (gawo la maphunziro), koma pali zovuta zingapo pazinthu za ogwira ntchito; Munthawi ya CGMP ku United States, ziyeneretso (mulingo wophunzitsira) za ogwira ntchito ndi zachidule komanso zomveka, pomwe maudindo a anthu amafotokozedwa mwatsatanetsatane. Maudindo a udindowu amatsimikizira kuti kupanga mankhwala osokoneza bongo.
(3) Kufanizira kutolera ndi kuyendera. GMP ya China imangotulutsa njira zoyeserera, pomwe CGMNIST ku United States imafotokoza njira zambiri zowunikira, makamaka mu gawo la mankhwala osokoneza bongo, komanso kupereka chitsimikizo kuti mukonze bwino za mankhwala osokoneza bongo. Gwero.
Zovuta pakukhazikitsa CGMP
Kusandulika kwa GMP kwa GPMSECAChical Stangrical kwakhala kovuta. Komabe, pali zovuta zomwe zikuyenera kukhazikitsa CGMPM, makamaka zimawonekera muzodalirika ndi njira.
Mwachitsanzo, kampani yopanga mankhwala ku Europe akufuna kuti ilowetse msika wa US ndi wopatsa mphamvu mankhwala osokoneza bongo ndipo amapereka chinthu chotsimikizika ku US FDA. M'mbuyomu, panthawi yosiyanasiyana yophatikizika, panali kupatuka kolunjika kumodzi mu gawo limodzi la majini awiriwo. Ngakhale wothandizirayo adakonzekeretsa ndikupempha malangizo, sanajambule mwatsatanetsatane pa zojambula za batch. Zopangidwazo zitapangidwa, oyendera mtunduwo amangofufuzidwa zodetsa zodziwika bwino panthawi ya chromatographic, ndipo palibe mavuto omwe amapezeka. Chifukwa chake, lipoti loyeserera loyenerera linaperekedwa. Pa nthawi yoyang'aniridwa, akuluakulu a FDA adawona kuti kuwongolera kwa thermometer sikunakwaniritse zofunika, koma palibe zolemba zofananira zomwe zidapezeka muzojambula zopanga. Pakutsimikizira kwa lipoti laulimi, lidapezeka kuti Chromophic Persook sanachitike molingana ndi nthawi yofunikira. Zophwanya zonsezi za CGMP sizingathawe kuwunika kwa ozungulira, ndipo mankhwalawa adalephera kulowa pamsika wa US.
FDA yatsimikiza kuti kulephera kwake kutsatira malamulo a CGM kumavulaza anthu ogula aku America. Ngati pali kupatuka kolondola malinga ndi zomwe mukufuna ku CGMP Kuyeserera konse kwa mankhwalawa kumangokhala zodetsa zodziwika komanso zinthu zomwe zimadziwika, komanso zina zosadziwika kapena zosagwirizana, sizingadziwike momveka bwino kudzera m'njira zomwe zilipo.
Tikamaona mtundu wa mankhwala, nthawi zambiri timagwiritsa ntchito njira yoyendera kuti adziwe ngati mankhwalawo ali oyenera kapena kutengera zabwino komanso mawonekedwe a malonda. Komabe, ku CGMPEM, lingaliro la mtundu ndi njira yamakhalidwe yomwe imayendayenda yonse yopanga. Mankhwala oyenerera sangakwanitse kukwaniritsa zofunikira za CGMP, monga kuti pali mwayi wopatuka mu njira yake. Ngati palibe zofunika kwambiri pakukonzekera konse, zoopsa zomwe zingatheke sizingapezeke ndi malipoti abwino. Ichi ndichifukwa chake CGMP kuphedwa sikophweka monga choncho.
Post Nthawi: Jul-26-2023