Intshayelelo

Kwishishini lamayeza, apho ukhuseleko lwamayeza lunxulumene ngqo nobomi kunye nempilo yezigulane, naziphi na iziphene zokupakisha okanye ukuphazamiseka okubonwayo kunokukhokelela kwimiphumo emibi. Kwiminyaka yakutshanje, ngenxa yokuvela rhoqo kweengxaki ezifana nokusasazeka kwamayeza obuxoki kunye nokungcola kwamayeza,Ukupakisha okumelana nokuphazanyiswa kube yinxalenye ebalulekileyo yothungelwano lobonelelo lwamayezaPhakathi kwazo, iibhotile zeglasi ezibonakala ngathi azinazo izinto ezisetyenzisiweyo ziye zaba sisisombululo esithandwayo sokupakisha amayeza anobungozi obukhulu afana neenaliti, ii-vaccine, kunye ne-biologics ngenxa yokhuseleko lwazo, ukuzinza kunye nokulandeleka kwazo.

Iingozi Zokuphazamisa Amayeza Kwishishini Lamayeza

Ukuxhaphaza iziyobisi kuyingozi enkulu kukhuseleko lwezigulane, udumo lwenkampani, kunye nokuthembeka kwenkqubo yezempilo yoluntu.

1. Iindlela zokuphamba (ezinobungozi okanye ezingezizo ezengozi)

• Ukutshintshwa kweziyobisi: ukutshintshwa kwamayeza okwenyani endaweni yamayeza obuxoki okanye angaphantsi, ngokuqhelekileyo kwiindawo ezibuthathaka kwikhonkco lokubonelela. Amayeza obuxoki asenokungabi nazo kwaphela izithako ezisebenzayo okanye abe nezinto eziyingozi.
• Ungcoliseko okanye ukungcoliswaumz., ukujova kungcoliswe ziintsholongwane xa kufikwa kwinqanaba lokuzalisa okanye lokupakisha; amalungiselelo omlomo anokungcoliswa zizinto zangaphandle, izongezo ezingekho mthethweni okanye ukungcola.
• Ukuphazamiseka kweMetrological: Ukuphathwa kakubi okanye ngendlela engafanelekanga okukhokelela ekwandeni okanye ekwehleni kobungakanani bezithako ezisebenzayo kwiyeza kunokubangela ukuba idosi ingasetyenziswa ngokwaneleyo (ingasebenzi kakuhle kwezonyango) okanye idosi igqithisile (iziphumo ebezingalindelekanga ezinobungozi).

2. Iziphumo ezinokubakho

• Iingozi zempilo yesigulana: iimpembelelo ezinobuthi, iimpembelelo ze-allergy, ukungaphumeleli konyango, ukwanda kokunganyangeki ngamayeza, kwanokufa. Iyingozi ngakumbi ebantwaneni, kubantu abadala okanye kwizigulane ezinesifo esinganyangekiyo.
• Ukonakala kwegama lophawu kunye noxanduva olusemthethweni: Xa kuthe kwaphazamiseka, iinkampani ziya kujongana nengxaki yokuthembana. Ukuzithemba kwabathengi kuyawa, isabelo semarike siyawohloka, kwaye zikwajongene namatyala ezenzo zamaqela.
• Izohlwayo ezilawulwayo: Abalawuli behlabathi banemithetho engqongqo ngomgangatho wamayeza. Nje ukuba kufunyanwe ukuphambuka kwemveliso, iinkampani zinokujongana nokurhoxiswa kwayo, ukuvalwa kokuthengisa, isohlwayo esinzima kunye nokurhoxiswa kweelayisenisi.

Iingenelo Eziphambili ZeeVili Zeglasi Ezibonakalayo Eziphazamisayo

Ngenxa yemeko yokulawula engqongqo ngakumbi kwishishini lamayeza kunye nokukhathazeka okukhulayo koluntu malunga nokhuseleko lwamayeza, ukwamkelwa kokupakisha okumelana nokuphazanyiswa kuye kwaba ngundoqo kuyilo lokupakisha amayeza. Ingakumbi kwiinaliti kunye namayeza anexabiso eliphezulu, iibhotile zeglasi ezibonakalayo eziphazanyiswayo zinokuphucula ngempumelelo ukhuseleko lwemveliso kunye nokuthenjwa.

1. Iimpawu zokhuseleko ezibonakalayo eziqondakalayo

• Indandatho yokuphumla: isiciko sebhotile okanye iseti yesixhobo sokutywina isakhiwo seringi yokuqhekeza, ayinakubuyiselwa emva kokuvulwa, kukho iimpawu ezicacileyo zokuvulwa.
• Ileyibhile yokutshintsha umbala: Iilebhile zezinto ezikhethekileyo zitshintsha umbala xa isiciko sivuliwe, nto leyo ebonisa ngokubonakalayo ukuba iphakheji ivuliwe na.
• Uyilo Lokutshabalalisa Olungenakuguqulwa: Izivalo zeebhotile kunye nezivalo zealuminiyam azinakubuyiselwa emva kokuba zivuliwe, nto leyo ephelisa ukwenziwa kwezinto zomgunyathi kunye nokuphinda zipakishwe.

Zonke ezi zakhiwo zinceda abasebenzisi bokugqibela, oosokhemesti kunye nabalawuli ukuba bagqibe ngokukhawuleza ukuthembeka kwephakheji kwaye balumkise ngokufanelekileyo ngeengozi ezinokubakho zokuphazamiseka.

2. Ithintela ukuvalelwa kwesibini kwaye iqinisekisa ukuba amayeza awavulwa ngokungekho mthethweni emva kokuphuma kwifektri

Iindlela ezinganyangekiyo zithintela ukuvulwa, ukutshintshwa okanye ukungcoliswa okungekho mthethweni kwimigodi yokuhambisa. Nje ukuba ivulwe okokuqala, isakhiwo sephakheji sonakele ngokungenakulungiseka kwaye asinakuphinda sipakishwe, nto leyo ekhusela ukuthembeka kwesiyobisi ukusuka kumzi-mveliso ukuya kwinqanaba lokusetyenziswa.

3. Ukuthobela ii-arhente zehlabathi ezilawula iziyobisi

Ukupakishwa okumelana nokuphazanyiswa yinxalenye ebalulekileyo yenkqubo yokuqinisekisa umgangatho weemveliso zamayeza ziiarhente ezininzi zamazwe ngamazwe ezilawula amayeza. Ukusetyenziswa kweebhotile zeglasi ezibonakaliswa ngokuphazanyiswa okuqhelekileyo kunokuhlangabezana neemfuno zokuthobela ukupakishwa kwe-GMP kunye nemvume yokuthengisa, kwaye kuphucule amandla enkampani okufikelela kwimarike yehlabathi.

4. Ukuphucula ukuthembana kwabathengi kunye nokuthembeka kophawu

Iindlela zokuhambisa ulwazi olukhuselekileyo nolucacileyo zinokwandisa ukuzithemba kwesigulana kunye nomboneleli wezempilo kukhuseleko lwamayeza. Kwangaxeshanye, ukusetyenziswa kweebhotile zeglasi ezibonakala ngathi azinazo iimpawu kungasetyenziswa njengenxalenye yokwahluka kophawu, ukuqinisa umfanekiso wenkampani ngokubhekiselele kulawulo lomgangatho kunye nokhathalelo lwezigulane, kunye nokunceda ukuphucula ukhuphiswano lwemarike.

Imizekelo ebalulekileyo yokusetyenziswa kweeVili zeGlasi ezibonakala ngathi ziphazamisekile

Iibhotile zeglasi ezibonakalayo eziphazamisekileyo zibaluleke kakhulu kwiindawo ezininzi eziphambili zamayeza, azincedi nje kuphela ekuphuculeni umgangatho wolawulo lokhuseleko lwamayeza, kodwa zikwanxulumene ngokuthe ngqo nokhuseleko lwamayeza ezigulana, ukuthotyelwa kwedatha kunye nokhuseleko loluntu.

1. Iinaliti kunye neegonyo

• Inqaku lesicelo: Izinto zokugonya nezitofu zifuna amanqanaba aphezulu okungabi nazintsholongwane, uzinzo kunye nokuthembeka kwephakheji.
• Injongo ephambili: Ukuthintela ukusasazeka kwamayeza obuxoki ngokungenelela okungekho mthethweni kwikhonkco elibandayo kunye nokukhusela impilo yoluntu.

2. Amayeza ebhayoloji kunye nonyango lwezakhi zofuzo axabisa kakhulu

• Inqaku lesicelo: La mayeza abiza kakhulu. Uzinzo lunobuthathaka kwaye iimfuno zokuthembeka kwephakheji kunye nokumelana nokuphazanyiswa ziphezulu kakhulu.
• Izinto ezinobungoziNgenxa yexabiso lazo eliphezulu, kulula kakhulu ukuba zisetyenziswe ngokungekho mthethweni xa kuthelekiswa nezinye izinto ezisetyenzisiweyo.
• Injongo ephambili: Gcina ixabiso lemveliso kunye nokuqinisekiswa kokusebenza kwayo ngokuqinisekisa ukuba amayeza ayafikeleleka kubasebenzi abangagunyaziswanga ngokusebenzisa iibhotile zeglasi ezibonakala ngathi ziphazamisekile.

3. Iziyobisi ezidakisayo kunye nezinto ezilawulwayo

• Inqaku lesiceloIziyobisi ezineempawu zokulutha kunye nomngcipheko wokusetyenziswa gwenxa zizinto ezilawulwa ngokungqongqo.
• Iimfuneko zoLawulo: Ayizibambi iimfuno zomthetho La mayeza kufuneka abe neendlela zokhuseleko ezicacileyo nezingqinisisekayo zokupakishwa.
• Injongo ephambili: Ukuthintela ukuvulwa okungagunyaziswanga, ukusetyenziswa gwenxa okanye ukutshintshwa kwephakheji, kunye nokunciphisa ngokufanelekileyo ukusetyenziswa gwenxa kweziyobisi kunye nokusasazwa kwemarike emnyama.

4. Iisampulu zovavanyo lweklinikhi

• Inkcazo yesicelo: Ulawulo lwesampulu kwinqanaba lovavanyo lweklinikhi lubalulekile, kwaye ukuphazamisa kuya kuchaphazela ngokuthe ngqo ubunyani bedatha kunye nokuthembeka kweziphumo zovavanyo.
• Injongo ephambili: Ukukhusela ukulandeleka kwayo yonke inkqubo yamayeza ovavanyo ukususela ekuvelisweni, ukusasazwa ukuze kusetyenziswe ngokusebenzisa ukupakisha okungenakuguqulwa, ukuhlangabezana neemfuno ze-GCP (i-Good Clinical Practice), kunye nokuthintela idatha yovavanyo ukuba ingabuzwa okanye ingamkelwa.

Iinkampani zamayeza zinokukhetha njani iiVili zeglasi ezibonakala ngathi ziphazamisekile

Iibhotile zeglasi ezibonakala ngathi azikho nje kuphela kwiphakheji yamayeza, ziyinxalenye ebalulekileyo yokuqinisekisa ukhuseleko lwamayeza, ukuthobela imithetho kunye nokuthembeka kwimarike. Iinkampani zamayeza kufuneka ziqwalasele ukusebenza kwezinto eziphathekayo, iteknoloji yokutywina, imigangatho yolawulo kunye nokuguquguquka kwekhonkco lokubonelela xa zikhetha ibhotile ukuqinisekisa ukuba isisombululo sokupakisha sisesayensi, sinokwenzeka kwaye sisebenza kakuhle.

1. Ukukhetha izinto

• Iglasi yeBorosilicate: ngokuqina okugqwesileyo kweekhemikhali, inokuthintela ukuba izinto zamayeza zingasabelani nesikhongozeli; ngokumelana nobushushu obuphezulu kunye namandla oomatshini, isetyenziswa kakhulu kwiinaliti, kwiigonyo nakwezinye iimveliso ezifunwa kakhulu. Ifanelekile ngokukodwa kwiibhotile zeglasi ezingathathi cala zeClass I kwaye ihlangabezana neemfuno zeNational Pharmacopoeia zokupakisha amalungiselelo angenazintsholongwane.
• Unyango olukhethekileyo lokugquma: ulwelo lwangaphandle oluchasene nokukrweleka luthintela ukukrweleka nokuqhekeka ngexesha lokuthuthwa.

2. Itekhnoloji yokutywina

• Isiciko sokudibanisa i-aluminium-plastiki: isetyenziswa kakhulu kulwimi lokupakisha ibhotile, idibene nenkqubo yokuqhobosha, kunye nokutywinwa okuhle kunye nesakhiwo sokuvula esingaguqukiyo. Ingaxhotyiswa ngeringi yekrazula engaguqukiyo ukuze ifezekise umsebenzi wokukhumbuza ngokubonakalayo "wokubonakala ekuqaleni kokuvula".
• Ifilimu encitshiswayo ngobushushu kunye nokukrola nge-laser: Ifilimu encitshiswa bubushushu ingasetyenziswa kwindawo yokutywina isiciko sebhotile, esiqhekekayo xa sivulwa kwaye asinakufunyanwa. Ukukrola nge-laser kungasetyenziselwa ukuphawula ibhotile okanye isiciko ngekhowudi ye-serial, inombolo yelothi okanye ipateni yokulwa nobuxoki, okunzima ukuyiphazamisa.

Iindlela kunye nophuhliso lwexesha elizayo

Ubuchwepheshe kunye nokusetyenziswa kweebhotile zeglasi ezibonakala ngathi azinazo izinto ezisetyenzisiweyo kungena kwinqanaba elitsha njengoko iimfuno zehlabathi zokhuseleko lwamayeza, ukucaca kwekhonkco lokubonelela kunye nokuzinza ziqhubeka nokukhula.

1. Izisombululo ezizinzileyo zokulwa nokuphazamiseka

• Izikhongozeli zeglasi ezinokuphinda zisetyenziswe: Khuthaza iibhotile zeglasi ze-borosilicate okanye zeglasi ezikhaphukhaphu ezihlangabezana nemigangatho yokusingqongileyo ukunciphisa izinto eziluhlaza kunye nokukhutshwa kwekhabhoni. Khuthaza ukusetyenziswa kwezakhiwo zezikhongozeli ezizisebenzela zodwa nezingasetyenziswa kwakhona ukunciphisa umthwalo wokusingqongileyo.
• Izinto zokutywina ezinobuhlobo nokusingqongileyo: Sebenzisa izinto zokupakisha eziluhlaza ezifana nefilimu yeplastiki ebolayo kunye nezinto eziphinda zisetyenziswe ze-aluminium-plastic hybrid, ucinge ngokusebenza okunganyangekiyo kunye nokuzinza.
• Ukuhlanganiswa koVavanyo loMjikelo woBomi: Kwiinyanga ezimbini emva kweenyanga iinkampani ezininzi ziza kwazisa uhlalutyo lwe-LCA kwinqanaba lophuhliso lwemveliso ukuqinisekisa ukuba uyilo olumelana nokuphazanyiswa lulungelelanisa ukhuseleko lokusingqongileyo kunye noqoqosho kulo lonke ixesha lobomi.

2. Ukuqinisa imithetho yehlabathi kuqhuba ukubekwa emgangathweni kweshishini

• Imeko yokulawula engqongqo ngakumbi: Abalawuli bayaqhubeka nokuqinisa ukuthembeka nokulandeleka kokupakisha amayeza, kwaye ukupakisha okungenakuphazamiseka kube yenye yezinto eziphambili ekufuneka zilandelwe.
• Ukukhuthaza ukwenziwa komgangatho kunye nokwamkelwa kwamanye amazwe: Uyilo lokupakisha olunganyangekiyo luhambela phambili ekuguquleni izinto, ukumisela umgangatho, kunye nokuqinisekiswa ukuze kuvumeleke iinkampani zamazwe ngamazwe ukuba zilawule uthungelwano lwazo lokubonelela kulo lonke eli candelo. Kwixesha elizayo, kuya kwenzeka ukwenza indlela yokuvavanya ukusebenza enganyangekiyo kunye nenkqubo yokuvavanya amanqanaba enxibelelana nehlabathi liphela.

Isiphelo

Iibhotile zeglasi ezibonakala ngathi ziphazamisekile ziba sesinye sezisombululo ezibalulekileyo kwishishini lamayeza njengesixhobo esibalulekileyo sokuqinisekisa umjikelo wobomi bamayeza. Ayithinteli nje kuphela ukwenziwa kwezinto ezingeyonyani, ungcoliseko kunye nokuguqulwa kwezinto ngokungekho mthethweni, kodwa ikwadlala indima ephambili ekuphuculeni udumo lwebhrendi, ukuhlangabezana neemfuno zokuthobela imithetho kunye nokukhusela ukhuseleko lwezigulane.

Iinkampani zamayeza ekukhetheni izisombululo zokupakisha ezichasene nokuphazamiseka, apho kuqwalaselwa khona ngokupheleleyo iimpawu zamachiza, inqanaba lomngcipheko, iimarike ekujoliswe kuzo kunye nemigangatho yokulawula, ngokweemeko zasekuhlaleni, ngokweziyobisi ukuze kusetyenziswe izixhobo ezifanelekileyo, izakhiwo kunye nobuchwepheshe bokulwa nobuxoki. Kwangaxeshanye, kufuneka kuqwalaselwe ukuguquguquka kobuchwepheshe ukuze buvumelane nomkhwa wophuhliso lwexesha elizayo lwemigaqo yehlabathi kunye nokupakisha okukrelekrele.