Eduard Marty weCodols anotsanangura kuti michina yekuchenesa mishonga nelabhu ine madhizaini akasarudzika ayo vagadziri vanofanirwa kuziva kuti vatevedzere.
Vagadziri vezvishandiso vanotevedzera zvakaomesesa zviyero pakugadzira nekugadzira michina yekuchenesa yeindasitiri yemishonga. Iyi dhizaini yakakosha nekuti akasiyana maficha anopihwa kuti aenderane neGood Manufacturing Practice (GMP midziyo) uye Yakanaka Laboratory Dzidzira (GLP michina).
Sechikamu chevimbiso yemhando, GMP inoda kuve nechokwadi chekuti zvigadzirwa zvinogadzirwa nenzira yakafanana uye inodzorwa kune mhando yemhando yakakodzera kune yakarongwa kushandiswa kwechigadzirwa uye pasi pemamiriro anodiwa pakutengeserana. Mugadziri anofanira kudzora zvinhu zvese zvinogona kukanganisa hutano hwekupedzisira hwechigadzirwa chemishonga, nechinangwa chikuru chekudzikisa njodzi mukugadzirwa kwechigadzirwa chese chemishonga.
Mitemo yeGMP inosungirwa kune vese vagadziri vemishonga. Kune zvigadzirwa zveGMP, maitiro acho ane zvimwe zvinangwa chaizvo:
Kune marudzi akasiyana ekuchenesa maitiro: manual, in-place (CIP) uye yakakosha michina. Ichi chinyorwa chinofananidza kugeza maoko nekuchenesa nemidziyo yeGMP.
Kunyange zvazvo kugeza maoko kuine mukana wekuita zvakasiyana-siyana, pane zvakawanda zvinokanganisa zvakadai senguva refu yekugeza, mari yekugadzirisa zvakanyanya, uye kuoma kuedza zvakare.
Iyo GMP yekuwachisa muchina inoda kutanga kudyara, asi mukana wemidziyo ndeyekuti iri nyore kuyedza uye inzira inodhindwa uye inokodzera chero chishandiso, pasuru uye chikamu. Aya maficha anotendera iwe kukwenenzvera kuchenesa, kuchengetedza nguva nemari.
Otomatiki yekuchenesa masisitimu anoshandiswa mukutsvagisa uye mishonga yekugadzira mishonga kuchenesa nhamba huru yezvinhu. Michina yekuwachisa inoshandisa mvura, detergent uye mashandiro emuchina kuchenesa nzvimbo kubva kumarara emurabhoritari uye zvikamu zveindasitiri.
Iine akasiyana siyana emuchina wekuwachisa ekushandisa kwakasiyana pamusika, mibvunzo yakati wandei inomuka: Chii chinonzi GMP muchina wekugeza? Ndirini pandinoda kucheneswa nemaoko uye ini pandinoda kugeza GMP? Ndeupi musiyano uripo pakati peGMP neGLP gaskets?
Chinyorwa 21, Zvikamu 211 uye 212 zveCode of Federal Regulations (CFR) yeUS Chikafu neDrug Administration inotsanangura hurongwa hwekutonga hunoshanda kuGMP kutevedzera zvinodhaka. Chikamu D cheChikamu 211 chinosanganisira zvikamu zvishanu pamidziyo nemichina, kusanganisira gaskets.
21 CFR Chikamu 11 chinofanirwawo kutariswa sechine chekuita nekushandiswa kwemagetsi matekinoroji. Yakakamurwa kuita zvikamu zviviri zvikuru: kunyoreswa kwemagetsi uye siginecha yemagetsi.
Mitemo yeFDA yekugadzira nekugadzira michina inofanirwawo kutevedzera zvinotevera zvinongedzo:
Misiyano pakati peGMP neGLP yekuwachisa michina inogona kukamurwa kuita akati wandei, asi inonyanya kukosha ndeye dhizaini yavo yekugadzira, zvinyorwa, pamwe nesoftware, otomatiki uye maitiro ekugadzirisa. ona tafura.
Kuti ishandiswe nemazvo, GMP washers anofanirwa kutsanangurwa nenzira kwayo, kudzivirira zvakakwirira zvinodikanwa kana izvo zvisingaite zvimiro zvemitemo. Naizvozvo, zvakakosha kupa yakakodzera Mushandisi Inodiwa Kutsanangurwa (URS) kune yega yega chirongwa.
Tsanangudzo dzinofanirwa kutsanangura zviyero zvinofanirwa kusangana, dhizaini yekugadzira, maitiro ekudzora, software uye ekudzora masisitimu, uye zvinyorwa zvinodiwa. Nhungamiro dzeGMP dzinoda kuti makambani aite ongororo yenjodzi kubatsira kuona michina yekuwachisa inoenderana nezvinodiwa zvakatotaurwa.
GMP Gaskets: Yese masimbi anokodzera zvikamu ndeye FDA yakatenderwa uye ese pombi ari AISI 316L uye anogona kudonhedzwa. Ipa yakakwana chiridzwa wiring dhizaini uye chimiro zvinoenderana neGAMP5. Iwo matrolley emukati kana masheji eGMP washer akagadzirirwa marudzi ese ezvimiro zvemagadzirirwo, kureva midziyo, matangi, midziyo, mabhodhoro emutsara zvikamu, girazi, nezvimwe.
GPL Gaskets: Yakagadzirwa kubva musanganiswa wezvikamu zvakatenderwa zvishoma, yakaoma uye inochinjika pombi, shinda uye akasiyana marudzi egaskets. Haasi ese mapaipi anodonhedza uye dhizaini yavo haisi GAMP 5 inoenderana. Iyo GLP washer yemukati trolley yakagadzirirwa marudzi ese ezvigadzirwa zverabhoritari.
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