Eduard Marty wo muri Codols asobanura ko ibikoresho byo gusukura imiti n’ibikoresho byo muri laboratwari bifite imiterere yihariye abakora bagomba kumenya kugira ngo barebe ko byubahirizwa.
Abakora ibikoresho bakurikiza amahame akomeye mu gihe bashushanya kandi bakora imashini zisukura zakora mu nganda zikora imiti. Iyi miterere ni ingenzi kuko hari ibintu bitandukanye bitangwa kugira ngo bihuze n'amabwiriza agenga imikorere myiza (ibikoresho bya GMP) n'amabwiriza agenga imikorere myiza ya laboratwari (ibikoresho bya GLP).
Mu rwego rwo kugenzura ubuziranenge, GMP isaba kugenzura ko ibicuruzwa bikorwa mu buryo bumwe kandi bugenzurwa hakurikijwe amahame y’ubuziranenge ajyanye n’ikoreshwa ry’umuti ndetse no mu buryo bukenewe mu bucuruzi. Ukora agomba kugenzura ibintu byose bishobora kugira ingaruka ku buziranenge bw’umuti, intego nyamukuru ikaba ari ukugabanya ibyago mu gukora umuti wose.
Amategeko ya GMP ni itegeko ku nganda zose zikora imiti. Ku bikoresho bya GMP, iyi gahunda ifite intego zihariye:
Hari ubwoko butandukanye bw'ibikorwa byo gusukura: ibikoresho by'intoki, ibikoresho biri aho biri (CIP) n'ibikoresho byihariye. Iyi nkuru igereranya gukaraba intoki no gusukura hakoreshejwe ibikoresho bya GMP.
Nubwo gukaraba intoki bifite akamaro ko gukora ibintu bitandukanye, hari ibintu byinshi bibangamira nko gukaraba igihe kirekire, ikiguzi cyo kubungabunga kiri hejuru, ndetse no kugorwa no kongera gupimwa.
Imashini imesa ya GMP isaba ishoramari rya mbere, ariko inyungu y'ibikoresho ni uko byoroshye kubigerageza kandi bikaba ari uburyo bworoshye bwo kubikoresha ku gikoresho icyo ari cyo cyose, ipaki n'ibice byacyo. Ibi bigufasha kunoza isuku, kuzigama igihe n'amafaranga.
Uburyo bwo gusukura bwikora bukoreshwa mu bushakashatsi no mu nganda zikora imiti kugira ngo hasukurwe ibintu byinshi. Imashini zimesa zikoresha amazi, isabune n'ibikoresho bya mashini kugira ngo zisukure ahantu hava imyanda yo muri laboratwari n'ibice by'inganda.
Kubera ubwoko bwinshi bw'imashini zo kumesa zikoreshwa mu buryo butandukanye ku isoko, hari ibibazo byinshi bibaza: Imashini yo kumesa ya GMP ni iki? Ni ryari nkeneye gusukurwa n'intoki kandi ni ryari nkeneye gukaraba GMP? Ni irihe tandukaniro riri hagati ya gasket za GMP na GLP?
Umutwe wa 21, Ibice bya 211 na 212 by'amategeko agenga imikorere ya Leta Zunze Ubumwe za Amerika (CFR) asobanura urwego rw'amategeko agenga iyubahirizwa rya GMP ku miti. Igice cya D cy'Igice cya 211 gikubiyemo ibice bitanu bivuga ku bikoresho n'imashini, harimo na gasket.
Igice cya 11 cya CFR nacyo kigomba gusuzumwa kuko kijyanye n'ikoreshwa ry'ikoranabuhanga. Gigabanyijemo ibice bibiri by'ingenzi: kwiyandikisha hakoreshejwe ikoranabuhanga n'umukono w'ikoranabuhanga.
Amabwiriza ya FDA yerekeye igishushanyo mbonera n'ikorwa ry'ibikoresho agomba kandi kubahiriza amabwiriza akurikira:
Itandukaniro riri hagati y’imashini zimesa GMP na GLP rishobora kugabanywamo ibice byinshi, ariko icy’ingenzi ni imiterere yazo ya mekanike, inyandiko, ndetse na porogaramu, ikoranabuhanga n’igenzura ry’imikorere. Reba imbonerahamwe.
Kugira ngo ikoreshwe neza, imashini zoza za GMP zigomba kugaragazwa neza, hirindwa ibisabwa byo hejuru cyangwa ibitujuje ibisabwa n'amategeko. Kubwibyo, ni ngombwa gutanga ibisobanuro bikwiye ku bisabwa n'umukoresha (URS) kuri buri mushinga.
Ibisobanuro bigomba gusobanura amahame agomba kubahirizwa, imiterere y’imashini, igenzura ry’imikorere, porogaramu n’uburyo bwo kugenzura, hamwe n’inyandiko zisabwa. Amabwiriza ya GMP asaba amasosiyete gukora isuzuma ry’ingaruka kugira ngo afashe mu kumenya imashini zimesa zikwiye kandi zujuje ibisabwa byavuzwe.
Gasket za GMP: Ibice byose bifatanya clamp byemewe na FDA kandi imiyoboro yose ni AISI 316L kandi ishobora gukurwamo amazi. Tanga igishushanyo mbonera cyuzuye cy'insinga z'ibikoresho n'imiterere yabyo hakurikijwe GAMP5. Amagare cyangwa udukingirizo tw'imbere tw'imashini yoza GMP byagenewe ubwoko bwose bw'ibice bikoreshwa mu gutunganya, ni ukuvuga ibikoresho, amatangi, amacupa, ibice by'imiyoboro y'amacupa, ikirahure, nibindi.
Gasket za GPL: Zikozwe mu buryo bw’ibice bisanzwe byemewe igice, imiyoboro ikomeye kandi yoroshye, imigozi n’ubwoko butandukanye bwa gasket. Si imiyoboro yose ishobora gusohoka kandi imiterere yayo ntiyujuje ibisabwa na GAMP 5. Igare ry’imbere rya GLP rikoreshwa mu kumesa ibikoresho byose bya laboratwari.
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