Amanyathelo okulawula umgangatho we-HPMC (i-hydroxypropyl methylcellulose) iifektri zamachiza ziyindlela ebalulekileyo yokuqinisekisa ukuhambelana, ukucoceka kunye nokhuseleko lweemveliso ngexesha lenkqubo yokuvelisa.
1. Ulawulo lwempahla ekrwada
1.1 Uphicotho lwababoneleli ngezixhobo zokusebenza
Iifektri zamachiza kufuneka zikhethe abathengisi bezinto ezikrwada abaqinisekisiweyo kwaye zibaphicothe kwaye zibavavanye rhoqo ukuqinisekisa ukuzinza komgangatho wemathiriyeli ekrwada.
1.2 Ukwamkelwa kokuhlolwa kwemathiriyeli ekrwada
Ibhetshi nganye yemathiriyeli ekrwada kufuneka ijongwe ngokungqongqo phambi kokuba ingene kwinkqubo yokuvelisa, njengokuhlolwa kwenkangeleko, uhlalutyo lwemichiza, ukuzimisela komxholo wokufuma, njl.njl., ukuqinisekisa ukuba ziyahlangabezana nemigangatho yomgangatho.
1.3 Ukubekwa esweni kwemeko yogcino
Indawo yokugcina izinto eziluhlaza ilawulwa ngokungqongqo, njengokushisa kunye nomswakama, ukukhusela utshintsho lwekhwalithi ngexesha lokugcinwa.
2. Ulawulo lwenkqubo yokuvelisa
2.1 Ukuqinisekiswa kwenkqubo
Inkqubo yemveliso kufuneka iqinisekiswe ukuqinisekisa ukuba inokuvelisa ngokuzinzileyo iimveliso ezihlangabezana nemigangatho yomgangatho olindelekileyo. Ukuqinisekiswa kubandakanya ukusetwa kweeparamitha zenkqubo, ukuchongwa kunye nokubeka iliso kumanqaku olawulo abalulekileyo (CCP) kwinkqubo yokuvelisa.
2.2 Ukubeka iliso kwi-Intanethi
Ngexesha lenkqubo yokuvelisa, izixhobo zokubeka iliso eziphambili kwi-intanethi zisetyenziselwa ukubeka iliso kwiiparitha eziphambili ngexesha langempela, njengokushisa, uxinzelelo, isantya esishukumisayo, njl., Ukuqinisekisa ukuba inkqubo yokuvelisa isebenza ngaphakathi koluhlu olumiselweyo.
2.3 Ukuhlolwa kweMveliso ePhakathi
Iimveliso eziphakathi zithathwa iisampulu kwaye zihlolwe rhoqo ukuqinisekisa ukuba umgangatho wazo uhlala ungaguquguquki kuwo onke amanqanaba emveliso. Olu hlolo lubandakanya iimpawu ezibonakalayo kunye neekhemikhali ezifana nokubonakala, ukunyibilika, i-viscosity, ixabiso le-pH, njl.
3. Ukulawulwa koMgangatho weMveliso egqityiweyo
3.1 Ukuhlolwa kweMveliso egqityiweyo
Imveliso yokugqibela iphantsi kokuhlolwa komgangatho obanzi, kubandakanywa ukubonakala, iimpawu zomzimba kunye neekhemikhali, ukucoceka, umxholo wokungcola, njl., Ukuqinisekisa ukuba umkhiqizo udibana ne-pharmacopoeia okanye imigangatho yangaphakathi.
3.2 Uvavanyo loZinzo
Imveliso egqityiweyo ivavanywa ukuzinza ukuvavanya utshintsho lwekhwalithi yemveliso ngexesha lokugcinwa. Izinto zovavanyo ziquka ukubonakala, ukufana komxholo, ukuveliswa kokungcola, njl.
3.3 Ukukhutshwa koHlolo
Emva kokuba ukuhlolwa kwemveliso egqityiweyo kufanelekileyo, kuyafuneka kwakhona ukuba kuhlolwe ukukhululwa ukuze kuqinisekiswe ukuba umkhiqizo uhlangabezana nazo zonke iimfuno zomgangatho ngaphambi kokuthengisa okanye ukusetyenziswa.
4. Izixhobo kunye noLawulo lokusiNgqongileyo
4.1 Ukuqinisekisa ukuCocwa kweZixhobo
Izixhobo zokuvelisa kufuneka zicocwe kwaye zibulawe iintsholongwane rhoqo, kwaye umphumo wokucoca kufuneka uqinisekiswe ukuthintela ukungcoliswa komnqamlezo. Ukuqinisekiswa kubandakanya ukufunyanwa kwentsalela, ukusetwa kweparamitha yokucoca kunye neerekhodi zenkqubo yokucoca.
4.2 Ukubeka iliso kokusiNgqongileyo
Iimeko zokusingqongileyo kwindawo yokuvelisa zibekwe esweni ngokungqongqo, kubandakanywa ukucoceka komoya, umthwalo we-microbial, ubushushu kunye nomswakama, ukuqinisekisa ukuba indawo yokuvelisa ihlangabezana neemfuno ze-GMP (i-Good Manufacturing Practice).
4.3 ULondolozo lweZixhobo kunye noHlengahlengiso
Izixhobo zokuvelisa kufuneka zigcinwe kwaye zilinganiswe rhoqo ukuze kuqinisekiswe ukusebenza kwayo okuqhelekileyo kunye nokuchaneka komlinganiselo, kunye nokuphepha ukusilela kwezixhobo ezichaphazela umgangatho wemveliso.
5. UQeqesho noLawulo lwaBasebenzi
5.1 Uqeqesho lwaBasebenzi
Abasebenzi bemveliso kunye nolawulo lomgangatho kufuneka bafumane uqeqesho rhoqo ukuze balawule iinkqubo zokusebenza zamva nje, iindlela zokulawula umgangatho kunye neemfuno ze-GMP zokuphucula izakhono zabo zobungcali kunye nokuqonda umgangatho.
5.2 Inkqubo yokuJonga uXanduva lweMisebenzi
Inkqubo yoxanduva lomsebenzi iphunyeziwe, kwaye ikhonkco nganye inomntu ozinikeleyo ophetheyo, ecacisa uxanduva lwabo ekulawuleni umgangatho kunye nokuqinisekisa ukuba amanyathelo okulawula umgangatho anokuphunyezwa ngokufanelekileyo kwikhonkco ngalinye.
5.3 Uvandlakanyo lwentsebenzo
Ukuvavanya rhoqo umsebenzi wabasebenzi bokulawula umgangatho ukubakhuthaza ukuba baphucule umgangatho womsebenzi kunye nokusebenza kakuhle, kwaye bachonge ngokukhawuleza kwaye balungise iingxaki ekusebenzeni.
6. Ulawulo lwamaxwebhu
6.1 Iirekhodi kunye neengxelo
Zonke iinkcukacha kunye neziphumo kwinkqubo yokulawula umgangatho kufuneka zirekhodwe kwaye ingxelo epheleleyo kufuneka yenziwe ukuba ihlaziywe kwaye ilandelelwe. Ezi rekhodi ziquka ukwamkelwa kwezinto eziluhlaza, iiparamitha zenkqubo yokuvelisa, iziphumo zokuhlolwa kwemveliso egqityiweyo, njl.
6.2 Uphononongo lwamaxwebhu
Ukuphonononga rhoqo kunye nokuhlaziya amaxwebhu anxulumene nokulawulwa komgangatho ukuqinisekisa ukuchaneka kunye nexesha elifanelekileyo lomxholo wabo kwaye ugweme iingxaki ezisemgangathweni ezibangelwa ngamaxwebhu aphelelwe lixesha okanye angachanekanga.
7. Uphicotho lwangaphakathi nohlolo lwangaphandle
7.1 Uphicotho lwangaphakathi
Iifektri zamachiza kufuneka zenze uphicotho lwangaphakathi rhoqo ukujonga ukuphunyezwa kolawulo lomgangatho kwikhonkco ngalinye, zichonge kwaye zilungise imingcipheko enokubakho yobulunga, kwaye ngokuqhubekayo iphucula inkqubo yolawulo lomgangatho.
7.2 Uhlolo lwangaphandle
Yamkela ukuhlolwa rhoqo ngamagunya karhulumente alawulayo kunye nee-arhente zezatifiketi zomntu wesithathu ukuqinisekisa ukuba inkqubo yokulawula umgangatho iyahambelana nemithetho efanelekileyo, imimiselo kunye nemigangatho yoshishino.
8. Isikhalazo kunye nokukhumbula ulawulo
8.1 Ukuphathwa kwezikhalazo
Iifektri zamachiza kufuneka ziseke indlela ekhethekileyo yokusingatha isikhalazo ukuqokelela nokuhlalutya ingxelo yabathengi ngexesha elifanelekileyo, ukucombulula iingxaki zomgangatho, kunye nokuthatha amanyathelo okuphucula ahambelanayo.
8.2 Ukukhunjuzwa kwemveliso
Ukuphuhlisa nokuphumeza iinkqubo zokukhumbula imveliso, kwaye xa iingxaki ezinzulu zomgangatho okanye iingozi zokhuseleko zifumaneka kwiimveliso, zinokukhumbula ngokukhawuleza iimveliso ezinengxaki kwaye zithathe amanyathelo okulungisa ahambelanayo.
9. Uphuculo oluqhubekayo
9.1 Umgangatho wolawulo lomngcipheko
Sebenzisa izixhobo zokulawula umngcipheko (ezifana ne-FMEA, i-HACCP) yokuvavanya umngcipheko kunye nokulawula, ukuchonga nokulawula ubungozi obunokubakho.
9.2 Isicwangciso sokuphucula umgangatho
Phuhlisa isicwangciso sokuphucula umgangatho wokuphucula ngokuqhubekayo iinkqubo zemveliso kunye nokuphucula umgangatho wemveliso ngokusekelwe kwidatha yokulawula umgangatho kunye neziphumo zophicotho.
9.3 Uhlaziyo lwetekhnoloji
Yazisa ubuchwephesha obutsha kunye nezixhobo, ngokuqhubekayo uhlaziywa kwaye uphucule imveliso kunye neendlela zokulawula umgangatho, kunye nokuphucula ukuchaneka kokuchongwa kunye nokusebenza kakuhle kwemveliso.
La manyathelo okulawula umgangatho aqinisekisa ukuba iifektri ze-HPMC zamachiza zinokuqhubeka zivelisa umgangatho ophezulu, iimveliso ezihambelana nomgangatho ngexesha lenkqubo yokuvelisa, ngaloo ndlela ziqinisekisa ukhuseleko kunye nokusebenza kwamachiza.
Ixesha lokuposa: Jul-03-2024