Eduard Marty wo muri Codols asobanura ko ibikoresho byo gukora imiti na laboratoire bifite ibikoresho byihariye byo gushushanya ababikora bakeneye kumenya kugirango byubahirizwe.
Abakora ibikoresho bakurikiza amahame akomeye mugihe cyo gutegura no gukora imashini zisukura inganda zimiti. Igishushanyo ni ngombwa kuko ibintu bitandukanye bitangwa kugirango hubahirizwe uburyo bwiza bwo gukora (ibikoresho bya GMP) hamwe na Laboratoire nziza (ibikoresho bya GLP).
Mu rwego rwo kwemeza ubuziranenge, GMP isaba ko ibicuruzwa byakorwa mu buryo bumwe kandi bugenzurwa ku bipimo by’ubuziranenge bijyanye no gukoresha ibicuruzwa kandi mu bihe bikenewe mu bucuruzi. Uruganda rugomba kugenzura ibintu byose bishobora kugira ingaruka kumiterere yanyuma yibicuruzwa bivura imiti, intego nyamukuru yo kugabanya ingaruka mugukora ibicuruzwa byose bivura.
Amategeko ya GMP ni itegeko kubakora imiti yose. Kubikoresho bya GMP, inzira ifite intego zinyongera:
Hariho uburyo butandukanye bwo gukora isuku: intoki, ahantu (CIP) nibikoresho bidasanzwe. Iyi ngingo igereranya gukaraba intoki nisuku nibikoresho bya GMP.
Mugihe gukaraba intoki bifite ibyiza byo guhinduka, haribintu byinshi bitameze nkigihe cyo gukaraba igihe kirekire, amafaranga menshi yo kubungabunga, hamwe nikibazo cyo kongera kwipimisha.
Imashini imesa GMP isaba ishoramari ryambere, ariko ibyiza byibikoresho nuko byoroshye kugerageza kandi ni inzira yororoka kandi yujuje ibyangombwa kubikoresho byose, paki nibigize. Ibiranga bigufasha guhitamo neza isuku, kuzigama igihe namafaranga.
Sisitemu yo gukora isuku ikoreshwa mubushakashatsi ninganda zikora imiti kugirango isukure ibintu byinshi. Imashini imesa ikoresha amazi, ibikoresho byo gukanika hamwe nubukanishi kugirango isukure hejuru yimyanda ya laboratoire nibice byinganda.
Hamwe nimashini zitandukanye zo kumesa kubikorwa bitandukanye kumasoko, havuka ibibazo byinshi: Imashini imesa GMP niki? Ni ryari nkeneye gusukura intoki kandi nkeneye gukaraba GMP ryari? Ni irihe tandukaniro riri hagati ya gasketi ya GMP na GLP?
Umutwe wa 21, Igice cya 211 na 212 by’igitabo cy’amategeko ngengamikorere (CFR) y’ikigo cy’Amerika gishinzwe ibiribwa n’ibiyobyabwenge gisobanura urwego ngenderwaho rukurikizwa mu kubahiriza GMP ku biyobyabwenge. Igice D cy'igice cya 211 gikubiyemo ibice bitanu ku bikoresho n'imashini, harimo gaseke.
21 CFR Igice cya 11 nacyo kigomba gusuzumwa kuko kijyanye no gukoresha ikoranabuhanga rya elegitoroniki. Igabanijwemo ibice bibiri by'ingenzi: kwiyandikisha kuri elegitoronike n'umukono wa elegitoronike.
Amabwiriza ya FDA yo gushushanya no gukora ibikoresho agomba kandi kubahiriza amabwiriza akurikira:
Itandukaniro riri hagati yimashini imesa GMP na GLP irashobora kugabanywamo ibice byinshi, ariko icyingenzi nigishushanyo mbonera cyabo, inyandiko, kimwe na software, automatike no kugenzura inzira. reba imbonerahamwe.
Kugirango ukoreshwe neza, abamesa GMP bagomba gutomorwa neza, birinda ibisabwa hejuru cyangwa bitujuje ubuziranenge. Kubwibyo, ni ngombwa gutanga umukoresha ukenewe (URS) kuri buri mushinga.
Ibisobanuro bigomba gusobanura ibipimo bigomba kubahirizwa, igishushanyo mbonera, kugenzura inzira, software na sisitemu yo kugenzura, hamwe nibisabwa. Amabwiriza ya GMP arasaba ibigo gukora isuzuma ryibyago kugirango bifashe kumenya imashini imesa ikwiye yujuje ibisabwa bimaze kugaragara.
GMP Gaskets: Ibice byose bikwiranye na FDA byemewe kandi imiyoboro yose ni AISI 316L kandi irashobora gutwarwa. Tanga ibikoresho byuzuye byerekana igishushanyo nuburyo ukurikije GAMP5. Imbere muri trolleys cyangwa rack yogeje ya GMP yagenewe ubwoko bwose bwibigize inzira, ni ukuvuga ibikoresho, tank, kontineri, ibice byacupa, ibirahure, nibindi.
GPL Gaskets: Yakozwe kuva murwego rwibice byemewe byemewe igice, umuyoboro ukomeye kandi woroshye, insinga nubwoko butandukanye bwa gasketi. Imiyoboro yose ntishobora gutwarwa kandi igishushanyo cyayo ntabwo GAMP 5 yujuje. GLP yogeje imbere trolley yagenewe ubwoko bwose bwibikoresho bya laboratoire.
Uru rubuga rubika amakuru nka kuki kumikorere yurubuga, harimo gusesengura no kwimenyekanisha. Ukoresheje uru rubuga, uhita wemera gukoresha kuki.