Ingamba zo kugenzura ubuziranenge bw’inganda za farumasi ya HPMC (hydroxypropyl methylcellulose) nuburyo bwingenzi kugirango habeho ubudahwema, isuku n’umutekano byibicuruzwa mugihe cyibikorwa.
1. Kugenzura ibikoresho
1.1 Igenzura ryibikoresho bitanga ibikoresho
Uruganda rwa farumasi rugomba guhitamo abatanga ibikoresho byemewe kandi rukabigenzura buri gihe kugirango hamenyekane neza ubwiza bwibikoresho fatizo.
1.2 Igenzura ryemewe ryibikoresho fatizo
Buri cyiciro cyibikoresho fatizo bigomba kugenzurwa cyane mbere yo kwinjira mubikorwa, nko kugenzura isura, gusesengura imiterere yimiti, kugena ibirimo ubuhehere, nibindi, kugirango byuzuze ubuziranenge.
1.3 Gukurikirana imiterere yububiko
Ububiko bwibikoresho fatizo bugenzurwa cyane, nkubushyuhe nubushuhe, kugirango birinde impinduka nziza mugihe cyo kubika.
2. Igenzura ry'umusaruro
2.1 Kwemeza inzira
Igikorwa cyo kubyaza umusaruro kigomba kwemezwa kugirango hemezwe ko gishobora gutanga ibicuruzwa byujuje ubuziranenge buteganijwe.Kwemeza bikubiyemo gushyiraho ibipimo ngenderwaho, kumenya no kugenzura ingingo zikomeye (CCP) mubikorwa byo gukora.
2.2 Gukurikirana kumurongo
Mugihe cyo gukora, ibikoresho bigezweho byo kugenzura kumurongo bikoreshwa mugukurikirana ibipimo byingenzi mugihe nyacyo, nkubushyuhe, umuvuduko, umuvuduko ukabije, nibindi, kugirango ibikorwa byumusaruro bikore mugihe cyagenwe.
2.3 Kugenzura ibicuruzwa hagati
Ibicuruzwa biciriritse byapimwe kandi bigenzurwa buri gihe kugirango harebwe niba ubuziranenge bwabyo buhoraho mu byiciro byose by’umusaruro.Iri genzura ririmo ibintu bifatika na chimique nkibigaragara, solubile, viscosity, pH agaciro, nibindi.
3. Kugenzura ubuziranenge bwibicuruzwa
3.1 Kugenzura ibicuruzwa byarangiye
Igicuruzwa cyanyuma gikorerwa ubugenzuzi bwuzuye, harimo isura, imiterere yumubiri nubumara, ubuziranenge, ibirimo umwanda, nibindi, kugirango ibicuruzwa byujuje farumasi cyangwa ibipimo byimbere.
3.2 Ikizamini gihamye
Igicuruzwa cyarangiye gipimwa kugirango gihamye kugirango harebwe impinduka nziza yibicuruzwa mugihe cyo kubika.Ibintu byikizamini birimo isura, ibirimo guhuza, kubyara umwanda, nibindi.
3.3 Kurekura Ubugenzuzi
Nyuma yo kugenzura ibicuruzwa byujuje ibyangombwa, birasabwa kandi kugenzurwa kugirango harebwe niba ibicuruzwa byujuje ibisabwa byose mbere yo kugurisha cyangwa gukoresha.
4. Ibikoresho no kugenzura ibidukikije
4.1 Kwemeza ibikoresho
Ibikoresho by’umusaruro bigomba guhanagurwa no kwanduzwa buri gihe, kandi ingaruka zogusukura zigomba kugenzurwa kugirango birinde kwanduza umusaraba.Kwemeza bikubiyemo gutahura ibisigisigi, gushiraho ibipimo byogusukura hamwe nibikorwa byogusukura.
4.2 Gukurikirana ibidukikije
Imiterere y’ibidukikije mu karere k’umusaruro irakurikiranwa cyane, harimo isuku y’ikirere, umutwaro wa mikorobe, ubushyuhe n’ubushuhe, kugira ngo ibidukikije bibe byujuje ibisabwa na GMP (Good Manufacturing Practice).
4.3 Kubungabunga ibikoresho no gusuzuma
Ibikoresho byo kubyaza umusaruro bigomba kubungabungwa no guhagarikwa buri gihe kugirango bikore neza kandi bipime neza, kandi birinde kunanirwa ibikoresho bigira ingaruka kumiterere yibicuruzwa.
5. Guhugura abakozi no kuyobora
5.1 Amahugurwa y'abakozi
Abakozi bashinzwe kugenzura no kugenzura ubuziranenge bakeneye guhabwa amahugurwa ahoraho kugirango bamenye uburyo bugezweho bwo gukora, uburyo bwo kugenzura ubuziranenge nibisabwa na GMP kugirango bongere ubumenyi bwabo bwumwuga no kumenya neza.
5.2 Sisitemu ishinzwe inshingano
Sisitemu ishinzwe inshingano zakazi zashyizwe mubikorwa, kandi buri murongo ufite umuntu witanze ushinzwe, asobanura inshingano zabo mugucunga ubuziranenge no kureba ko ingamba zo kugenzura ubuziranenge zishobora gushyirwa mubikorwa neza muri buri murongo.
5.3 Isuzuma ryimikorere
Gusuzuma buri gihe umurimo w'abakozi bashinzwe kugenzura ubuziranenge kugirango ubashishikarize kuzamura ireme ry'akazi no gukora neza, kandi uhite umenya kandi ukosore ibibazo mubikorwa.
6. Gucunga inyandiko
6.1 Inyandiko na raporo
Amakuru yose nibisubizo mubikorwa byo kugenzura ubuziranenge bigomba kwandikwa kandi hagomba gukorwa raporo yuzuye kugirango isuzumwe kandi ikurikiranwe.Izi nyandiko zirimo ibikoresho fatizo byemewe, ibipimo byerekana umusaruro, ibisubizo byo kugenzura ibicuruzwa byarangiye, nibindi.
6.2 Gusubiramo inyandiko
Buri gihe usubiremo kandi uvugurure inyandiko zijyanye no kugenzura ubuziranenge kugira ngo umenye neza niba igihe gikwiye kandi wirinde ibibazo by’ubuziranenge biterwa n’inyandiko zarangiye cyangwa zitari zo.
7. Ubugenzuzi bwimbere nubugenzuzi bwo hanze
7.1 Ubugenzuzi bwimbere
Uruganda rwa farumasi rugomba gukora igenzura ryimbere buri gihe kugirango rugenzure ishyirwa mubikorwa ryigenzura ryubuziranenge muri buri murongo, kumenya no gukosora ingaruka zishobora kuba nziza, kandi bikomeza kunoza imikorere yubuyobozi.
7.2 Igenzura ryo hanze
Emera ubugenzuzi buri gihe ninzego zishinzwe kugenzura ibikorwa bya leta hamwe n’ibindi bigo bishinzwe gutanga ibyemezo kugira ngo gahunda yo kugenzura ubuziranenge yubahirize amategeko, amabwiriza n’ibipimo nganda.
8. Kurega no kwibuka ubuyobozi
8.1 Gukemura ibibazo
Uruganda rwa farumasi rugomba gushyiraho uburyo bwihariye bwo gukemura ibibazo byo gukusanya no gusesengura ibitekerezo byabakiriya mugihe gikwiye, gukemura ibibazo byubuziranenge, no gufata ingamba zijyanye no kunoza.
8.2 Kwibutsa ibicuruzwa
Gutezimbere no gushyira mubikorwa uburyo bwo kwibuka ibicuruzwa, kandi mugihe ibibazo bikomeye byubwiza cyangwa ibyago byumutekano bibonetse mubicuruzwa, barashobora kwibuka byihuse ibicuruzwa bitera ibibazo bagafata ingamba zikwiye zo gukosora.
9. Gukomeza gutera imbere
9.1 Gucunga neza ingaruka
Koresha ibikoresho byiza byo gucunga ibyago (nka FMEA, HACCP) mugusuzuma no gucunga ibyago, kumenya no kugenzura ingaruka zishobora kuba nziza.
9.2 Gahunda yo kuzamura ireme
Gutegura gahunda yo kunoza ubuziranenge kugirango uhore utezimbere ibikorwa byumusaruro no kuzamura ubuziranenge bwibicuruzwa bishingiye kumibare yo kugenzura ubuziranenge nibisubizo byubugenzuzi.
9.3 Kuvugurura ikoranabuhanga
Kwinjiza tekinolojiya nibikoresho bishya, guhora uvugurura no kunoza umusaruro nuburyo bwo kugenzura ubuziranenge, no kunoza neza kumenya neza no gukora neza.
Izi ngamba zo kugenzura ubuziranenge zemeza ko uruganda rwa farumasi rwa HPMC rushobora guhora rukora ibicuruzwa byujuje ubuziranenge, byujuje ubuziranenge mu gihe cy’ibicuruzwa, bityo bikarinda umutekano n’ibiyobyabwenge.
Igihe cyo kohereza: Jul-03-2024