Isingeniso

Embonini yezemithi, lapho ukuphepha kwemithi kuhlobene ngqo nokuphila kanye nempilo yeziguli, noma yikuphi ukukhubazeka kokupakishwa noma ukuphazamiseka okubonwayo kungaholela emiphumeleni emibi kakhulu. Eminyakeni yamuva nje, njengoba kuvela njalo izinkinga ezifana nokusakazwa kwemithi mbumbulu kanye nokungcola kwemithi,ukupakishwa okumelana nokuphazanyiswa sekuyingxenye ebalulekile yochungechunge lokuhlinzekwa kwemithiPhakathi kwazo, amabhodlela engilazi abonakala sengathi ayaphazamiseka abe yisisombululo esithandwayo sokupakisha imithi enobungozi obukhulu njengemijovo, imijovo, kanye ne-biologics ngenxa yokuphepha kwawo, ukuzinza kanye nokulandeleka kwawo.

Izingozi Zokuphazamisa Izidakamizwa Embonini Yezemithi

Umkhuba wokushintshashintsha izidakamizwa uyingozi enkulu ekuphepheni kweziguli, idumela lenkampani, kanye nokwethenjwa kohlelo lwezempilo yomphakathi.

1. Izindlela zokuphamba (ezinonya noma ezingengozi)

• Ukushintshaniswa kwezidakamizwa: ukufaka esikhundleni semithi yangempela kunemithi mbumbulu noma ephansi, ngokuvamile ezindaweni ezibuthakathaka ochungechungeni lokuhlinzeka. Imithi mbumbulu ingase ingabi nazithako ezisebenzayo noma iqukathe izinto eziyingozi.
• Ukungcola noma ukungcoliswa: isib. imijovo ingcoliswe yizilokazane ezincane ngesikhathi sokugcwalisa noma sokupakisha; amalungiselelo omlomo angase axutshwe nezinto zakwamanye amazwe, izithasiselo ezingekho emthethweni noma ukungcola.
• Ukuphazamiseka kwesimo sezulu: Ukuphathwa kabi noma okungalungile okuholela ekwandeni noma ekwehleni kwenani lezithako ezisebenzayo emthini kungabangela ukunqunywa okungaphansi komthamo (okungasebenzi kahle kwezokwelapha) noma ukunqunywa ngokweqile (imiphumela emibi enobuthi).

2. Imiphumela engaba khona

• Izingozi zempilo yesiguli: ukusabela okunobuthi, ukusabela kokungezwani komzimba, ukwehluleka kokwelashwa, ukwanda kokumelana nemithi, ngisho nokufa. Kuyingozi kakhulu ezinganeni, asebekhulile noma iziguli ezinesifo esingamahlalakhona.
• Ukulimala kwedumela lomkhiqizo kanye nesibopho esisemthethweni: Uma kwenzeka kuphazanyiswa, izinkampani zizobhekana nenkinga yokuthembana. Ukuzethemba kwabathengi kuyehla, isabelo semakethe siyalimala, futhi zibhekane ngisho namacala ezenzo zesigaba.
• Izinhlawulo zomthetho: Abalawuli bomhlaba wonke banemithetho eqinile ngekhwalithi yemithi. Uma ukuphambuka sekutholakale, izinkampani zingase zibhekane nokuhoxiswa kwemikhiqizo, ukuvinjelwa kokuthengisa, izinhlawulo ezinkulu ngisho nokuhoxiswa kwelayisensi.

Izinzuzo Eziyinhloko Zamabhodlela Engilazi Abonakala Engathinti

Ngenxa yesimo sendawo yokulawula eqinile embonini yezemithi kanye nokukhathazeka komphakathi okwandayo ngokuphepha kwemithi, ukwamukelwa kokupakisha okumelana nokuphazanyiswa sekuyisihluthulelo sokwakhiwa kokupakisha kwemithi. Ikakhulukazi ngemithi ejovwayo kanye nemithi enenani eliphezulu, amabhodlela engilazi abonakalayo angathuthukisa ngempumelelo ukuphepha komkhiqizo kanye nokwethenjwa.

1. Izimpawu zokuphepha ezibonakalayo eziqondakala kalula

• Indandatho yokuphumula: isivalo sebhodlela noma iseti yedivayisi yokuvala isakhiwo sendandatho yokuphuka, ayikwazi ukubuyiselwa ngemva kokuvulwa, kunezimpawu ezisobala zokuvulwa.
• Ilebula Lokushintsha Umbala: Amalebula ezinto ezikhethekile ashintsha umbala lapho isivalo sivulwa, okubonisa ngokubonakalayo ukuthi iphakheji livuliwe yini.
• Umklamo Wokubhujiswa Okungenakuguqulwa: Izivalo zamabhodlela nezivalo ze-aluminium azikwazi ukubuyiselwa uma sezivuliwe, okususa ukwenziwa komgunyathi kanye nokupakishwa kabusha.

Zonke lezi zakhiwo zisiza abasebenzisi bokugcina, osokhemisi kanye nabalawuli ukuthi banqume ngokushesha ubuqotho bephakheji futhi baxwayise ngempumelelo ngezingozi ezingase ziphazamiseke.

2. Kuvimbela ukuvalelwa kwesibili futhi kuqinisekisa ukuthi izidakamizwa azivulwa ngokungemthetho ngemva kokuphuma efektri

Izindlela ezingavimbeli ukuphazamiseka zivimba ukuvulwa, ukufakwa esikhundleni noma ukungcoliswa okungekho emthethweni emigodini yochungechunge lokuhlinzeka. Uma selivuliwe okokuqala, isakhiwo sephakheji sonakaliswa ngokungenakulungiseka futhi asinakupakishwa kabusha, okuvikela ubuqotho bomuthi kusukela efektri kuze kube yilapho usetshenziswa khona.

3. Ukuthobela imithetho yezikhungo zokulawula izidakamizwa zomhlaba wonke

Ukupakishwa okumelana nokuphazamiseka kuyingxenye ebalulekile yesistimu yokuqinisekisa ikhwalithi yemikhiqizo yemithi yizinhlangano eziningana zomhlaba wonke ezilawula imithi. Ukusetshenziswa kwamabhodlela engilazi ajwayelekile angaphazanyiswa kungahlangabezana nezidingo zokuhambisana nokupakisha ze-GMP kanye nokugunyazwa kokumaketha, futhi kuthuthukise ikhono lenkampani lokufinyelela emakethe yomhlaba wonke.

4. Thuthukisa ukwethenjwa kwabathengi kanye nokuthembeka komkhiqizo

Izindlela zokulethwa kolwazi lokupakisha eziphephile nezisobala zingakhulisa ukuzethemba kwesiguli kanye nomhlinzeki wezempilo ngokuphepha kwemithi. Ngesikhathi esifanayo, ukusetshenziswa kwamabhodlela engilazi abonakalayo aphazamisekile kungasetshenziswa njengengxenye yokwehlukanisa uhlobo, kuqiniswe isithombe senkampani maqondana nokulawulwa kwekhwalithi kanye nokunakekelwa kwesiguli, futhi kusize ekuthuthukiseni ukuncintisana emakethe.

Izimo Ezibalulekile Zokusetshenziswa Kwamabhodlela Engilazi Abonakalayo Aphazamisayo

Amabhodlela engilazi abonakalayo abaluleke kakhulu ezindaweni eziningi ezibalulekile zemithi, hhayi nje kuphela ekusizeni ukuthuthukisa izinga lokuphathwa kokuphepha kwemithi, kodwa futhi ahlobene ngqo nokuphepha kwemithi yeziguli, ukuthobela idatha kanye nokuphepha komphakathi.

1. Imijovo kanye nemithi yokugoma

• Inothi Lokusebenza: Imijovo nemijovo yokugoma idinga amazinga aphezulu okungabi namagciwane, ukuzinza kanye nobuqotho bephakheji.
• Inhloso Eyinhloko: Ukuvimbela ukusakazwa kwezidakamizwa mbumbulu ngokungenelela okungekho emthethweni ochungechungeni olubandayo kanye nokuvikela impilo yomphakathi.

2. Imithi ye-biologics kanye neyokwelapha izakhi zofuzo enenani eliphezulu

• Inothi Lokusebenza: Le mithi ibiza kakhulu. Ukuzinza kuyazwela futhi izidingo zokuqina kwephakheji kanye nokumelana nokuphazanyiswa ziphakeme kakhulu.
• Izici zengoziNgenxa yentengo yazo ephezulu, zilula kakhulu ukuhlasela izinto mbumbulu kanye nokushintshana ngokungemthetho.
• Inhloso Eyinhloko: Gcina inani lomkhiqizo kanye nokuqinisekiswa kokusebenza kahle ngokuqinisekisa ukuthi imithi iyatholakala kubasebenzi abangagunyaziwe ngamabhodlela engilazi abonakalayo aphazamisekile.

3. Izidakamizwa ezidakayo kanye nezinto ezilawulwayo

• Inothi LokusebenzaIzidakamizwa ezinezimpawu zokulutha kanye nengozi yokusebenzisa kabi ziyizidakamizwa ezilawulwa ngokuqinile.
• Izidingo Zokulawula: Igwema izidingo zomthetho Le mithi kumele ibe nezindlela zokuphepha zokupakisha ezicacile neziqinisekisiwe.
• Inhloso Eyinhloko: Vimbela ukuvulwa okungagunyaziwe, ukusetshenziswa kabi noma ukushintshaniswa kwamaphakheji, futhi unciphise ngempumelelo ukusetshenziswa kabi kwezidakamizwa kanye nokusatshalaliswa kwemakethe emnyama.

4. Amasampula esivivinyo somtholampilo

• Incazelo Yesicelo: Ukuphathwa kwesampula esigabeni sesivivinyo somtholampilo kubalulekile, futhi ukuphambuka kuzothinta ngqo ubuqiniso bedatha kanye nokuthembeka kwemiphumela yesivivinyo.
• Inhloso Eyinhloko: Ukuvikela ukulandeleka kwayo yonke inqubo yemithi yokuhlola kusukela ekukhiqizweni, ukusatshalaliswa kokusetshenziswa ngokusebenzisa ukupakishwa okungenakuguqulwa, ukuhlangabezana nezidingo ze-GCP (Umkhuba Omuhle Wezokwelapha), kanye nokugwema ukuthi idatha yokuhlola ingabuzwa noma yenqatshwe.

Indlela Izinkampani Zemithi Ezingakhetha Ngayo Amabhodlela Engilazi Abonakala Ephazamisekile Afanele

Ama-vial engilazi abonakalayo awona nje ingxenye yokupakisha imithi, kodwa futhi ayingxenye ebalulekile yokuqinisekisa ukuphepha kwemithi, ukuthobela imithetho kanye nokwethembeka emakethe. Izinkampani zemithi kufanele zicabangele ukusebenza kwezinto ezibonakalayo, ubuchwepheshe bokuvala, amazinga okulawula kanye nokuzivumelanisa nezimo kochungechunge lokuhlinzeka lapho zikhetha i-vial ukuqinisekisa ukuthi ikhambi lokupakisha lingokwesayensi, liyasebenza futhi lisebenza kahle.

1. Ukukhetha izinto

• Ingilazi ye-borosilicate: ngokuqina kwamakhemikhali okuhle kakhulu, ingavimbela izingxenye zemithi ukuthi zingasabelani nesitsha; ngokumelana nokushisa okuphezulu kanye namandla omshini, isetshenziswa kabanzi ekujovweni, ekugonyeni kanye neminye imikhiqizo efunwa kakhulu. Ifaneleka kakhulu emabhodleleni engilazi angathathi hlangothi ekilasini I futhi ihlangabezana nezidingo ze-National Pharmacopoeia zokupakisha amalungiselelo angenamagciwane.
• Ukwelashwa okukhethekile kokumboza: ukugqoka kwangaphandle okulwa nokuklwebheka kuvimbela ukuklwebheka nokuphuka ngesikhathi sokuthuthwa.

2. Ubuchwepheshe bokuvala

• Isivalo esihlanganisiwe se-aluminium-plastic: ivame ukusetshenziswa olimini lokupakisha i-vial, kuhlanganiswe nenqubo yokugoqa, nokuvala okuhle kanye nesakhiwo sokuvula esingenakuguqulwa. Ingafakwa indandatho yezinyembezi elwa nokukhwabanisa ukuze kufezwe umsebenzi wokukhumbuza obonakalayo wokuthi "kubonakala ekuqaleni kokuvulwa".
• Ifilimu encibilika ngokushisa kanye nokuqoshwa nge-laser: Ifilimu encibilika ngokushisa ingasetshenziswa endaweni yokuvala isivalo sebhodlela, esiqhekeka lapho sivuleka futhi singakwazi ukutholwa. Ukuqoshwa nge-laser kungasetshenziswa ukumaka ibhodlela noma isivalo ngekhodi yochungechunge, inombolo yelothi noma iphethini yokulwa nokukhwabanisa, okunzima ukuphazanyiswa.

Izitayela Nentuthuko Yesikhathi Esizayo

Ubuchwepheshe kanye nokusetshenziswa kwamabhodlela engilazi abonakala sengathi awasebenzi kahle kungena esigabeni esisha njengoba izidingo zomhlaba wonke zokuphepha kwemithi, ukucaca kochungechunge lokuhlinzekwa kanye nokusimama kuqhubeka nokukhula.

1. Izixazululo eziqhubekayo zokulwa nokuphazanyiswa

• Izitsha zeglasi ezingaphinde zisetshenziswe: Khuthaza amabhodlela engilazi e-borosilicate noma engilazi alula ahlangabezana nezindinganiso zemvelo ukuze kuncishiswe izinto zokusetshenziswa kanye nokukhishwa kwekhabhoni. Khuthaza ukusetshenziswa kwezakhiwo zezitsha ezizisebenzela zodwa nezingasetshenziswa kabusha ukuze kuncishiswe umthwalo wemvelo.
• Izinto zokuvala ezinobungani nemvelo: Sebenzisa izinto zokupakisha eziluhlaza njengefilimu yepulasitiki ebolayo kanye nezinto eziphinde zisetshenziswe ezixubile ze-aluminium-plastic, ucabangela ukusebenza okungenakuphazamiseka kanye nokusimama.
• Ukuhlanganiswa Kokuhlolwa Komjikelezo Wempilo: Ezinyangeni ezimbili izinkampani ezengeziwe zizokwethula ukuhlaziywa kwe-LCA esigabeni sokuthuthukiswa komkhiqizo ukuqinisekisa ukuthi imiklamo engaphazanyiswa ilinganisela ukuvikelwa kwemvelo kanye nezomnotho kulo lonke umjikelezo wokuphila.

2. Ukuqinisa imithethonqubo yomhlaba wonke kuqhuba ukwenziwa kwezimboni zibe yizinga elifanayo

• Indawo yokulawula eqinile kakhulu: Abalawuli bayaqhubeka nokuqinisa ubuqotho nokulandeleka kokupakisha kwemithi, kanti ukupakisha okungenakuphazamiseka kuba ngenye yezinto eziza kuqala ekuhambisaneni nomthetho.
• Ukukhuthaza ukwenziwa kwezindinganiso kanye nokuqashelwa kwamazwe ngamazwe: Umklamo wokupakisha omelana nokuphazamiseka uhambela ekuguqukeni kwesimo, ukulinganisa, kanye nokuqinisekiswa ukuze kuvunyelwe izinkampani zamazwe ngamazwe ukuphatha izintambo zazo zokuhlinzeka kulo lonke isifunda. Esikhathini esizayo, kuzokwazi ukwakha indlela yokuhlola ukusebenza emelana nokuphazamiseka kanye nohlelo lokuhlola amazinga olusetshenziswa emhlabeni wonke.

Isiphetho

Amabhodlela engilazi abonakalayo aphazamisekile aseba ngesinye sezixazululo ezibalulekile embonini yezemithi njengemoto ebalulekile yokuqinisekisa umjikelezo wokuphila wemithi. Akugcini nje ngokuvimbela ukwenziwa mbumbulu, ukungcola kanye nokuphambuka okungekho emthethweni, kodwa futhi kudlala indima ebalulekile ekuthuthukiseni idumela lomkhiqizo, ukuhlangabezana nezidingo zokuthobela imithetho kanye nokuvikela ukuphepha kweziguli.

Izinkampani zemithi ekukhetheni izixazululo zokupakisha ezilwa nokuphazamiseka, lapho kucatshangelwa khona izici zemithi, izinga lobungozi, izimakethe eziqondiwe kanye nemigomo yokulawula, ngokuya ngezimo zendawo, ngokuya ngemithi ukuze kusetshenziswe izinto ezifanele, izakhiwo kanye nobuchwepheshe bokulwa nokukhwabanisa. Ngesikhathi esifanayo, kufanele kuqashelwe ukusabalala kobuchwepheshe ukuze kuvumelane nomkhuba wentuthuko yesikhathi esizayo yemithetho yomhlaba kanye nokupakisha okuhlakaniphile.