GMP international ejwayelekile: Izici and zokusebenza

GMP international ejwayelekile ubhekwa omunye ezinkulu emhlabeni, ichaza nezidingo zokukhiqiza kwemikhiqizo yasekhemisi, Izithako zokudla ngisho ukudla.

Iyini indinganiso?

Igama eligcwele le iqoqo nezimfuneko - ". Imithetho zokukhiqiza yezokwelapha" Good Ukukhiqiza Practice for Imithi Imikhiqizo, okuyinto uhumusha njengoba GMP international ejwayelekile linemigomo ezilandelayo:

1. Nikeza ezingeni lelisetulu izinga umkhiqizo.
2. Qiniseka ukuthi:

• Umkhiqizo amafomula imithi leso sicelo;
• ekwakhiweni ayiqukethe ukungcola;
• ube kophawu ezifanele;
• nefanele ezipakishiwe ukulungiselela;
• ke akaphelelwa impahla yayo phezu okungapheli.

Umlando nesenzakalo

Qala ejwayelekile seluqaliwe e-US ngo-1963, lapho kwaba khona Umthetho wokuqala ephephile futhi eliphezulu yokukhiqiza kwemithi. Nokho, Ifomu esezingeni nencwadi engokomthetho, azamukela kuphela ngo-1968. Ngemva konyaka, i-World Health Organization (WHO) Kunconywa ukuthi wonke amazwe ukusebenzisa international GMP ejwayelekile. Ngemva kwalokho, le mithetho ngokuphindaphindiwe kulekelelwa futhi isilungisiwe, asizange okwamanje yokutholwa ukubukeka kwayo kwamanje.

Ngokusobala indiva indinganiso lapho besanda kuqala kokusebenza yayo kodwa eSoviet Union, lapho uMnyango wezeMpilo isungule kwezinkambiso ayo, ngezinye izikhathi esingeqile austerity GMP. Isithakazelo namazinga omhlaba baqala ukuvela kuphela ngo-1991, lapho inqubo waqala ngokuveza ungenisa noma uthumela izidakamizwa. Nokho, ukuze sifinyelele ukuvumelana okunjalo imithetho ehlukene bahluleka ekuqaleni. Kuphela kusukela 90s kwakukhona abanye intuthuko yangempela.

standard Russian

I zokulawula nohlaka olubhekele emazweni CIS waqala ukuba esavela ngemva kokuwa USSR. Injongo eyinhloko kwaba - ngesisekelo amazinga eyedlule ngangokunokwenzeka ukuvumelanisa amazinga ezimbili, kancane kancane esondela imithetho echaziwe GMP (international izinga ejwayelekile).

Inqubo kwaba eside omunye. Kuphela 2001 wabonakala eduze namazinga omhlaba kule Russian Federation. Itjho bona nge 01.07.2000 wonke amabhizinisi wadala futhi kabusha ukwenziwa izidakamizwa uzothola ilayisense womshini, isitoreji nokudayiswa kwemikhiqizo kungaphansi ekuhambisaneni okulingana Russian of GMP kuphela.

Kwakuthinta wahlanganyela ukuthuthukiswa inhlangano ebizwa ngokuthi yi-Association of Engineers ukulawula micropollutants (ASINKOM). iziqondiso Domestic abangu evunywe Standard State of the Russian Federation 10.04.2004, ngokuletha uvele GOST R 52249-2004 "Imithetho zokukhiqiza nokulawula izinga izidakamizwa." Yena owaphasiswa 01.01.2005 futhi kwakucatshangwa ukuthi le ndinganiso ngangokunokwenzeka ndawonye yamazwe ngamazwe. Nokho, kusukela 01.01.2010 bajoyine Russian kazwelonke GMP ejwayelekile. Wathatha njengesisekelo imithetho European, izinto zakuqala GOST elahlekile ngokuhlathulula ukusebenza kwawo.

Lapho eRussia zitholakala ekusebenziseni ibhizinisi ejwayelekile

Iningi amabhizinisi Uthole izitifiketi izinga, ngokuhambisana nemithetho yamazwe ngamazwe, ngesikhathi eMoscow, eSt Petersburg kanye nezinye izikhungo ezinkulu ezimbonini kanye ngokwesayensi yezwe.

It is kuhlelwe ukuqedela ukuhumusha GMP (standard international) ka wonke amabhizinisi. Ngaphezu kwalokho, kwakufanele bonyana enze ukuqeda kudala njengoba 2014, kodwa kube khona eziningi nobunzima. Kwavela ukuthi akuzona zonke ibhizinisi ezifuywayo abekho embonini yokwenziwa kwemithi uyakwazi ukuthola isitifiketi izinga elifanele. Inkinga eyinhloko - akukho abasebenzi nge theory eyanele futhi, okubaluleke kakhulu, izandla-on ukuqeqeshwa ukuqaliswa namazinga endaweni Russian.

izakhi eziyisisekelo GMP ejwayelekile

Standard GMP (Good Ukukhiqiza Practice) ihlinzeka iqoqo izinkomba okufanele zifinyelelwe abakhiqizi yemikhiqizo. Ngaphezu kwalokho, i-kunodokotela ngokuningiliziwe ezilungisiwe izimfuneko esigabeni ngasinye zokukhiqiza - lokuhlushwa amagciwane eziqukethwe eyodwa imitha cubic umoya, ngaphambi kophawu.

Njengoba isibonelo, imfuneko izinkampani esikhiqiza amaphilisi imithi. Ezimweni ezinjalo, GMP (standard international) kudinga inhlangano "ultrapure izitolo" lapho lenyuka inqubo inzalo ifinyelela Indlela umfula kubasebenzi mode ekhethekile ye-filtration emoyeni futhi m. N. ERussia izitolo ezinjalo ekhiqizwa kuphela Silicon zinhlayiya kanye chip ekhethekile.

Yiziphi izimo ezidingekayo ukuze kwathatha ejwayelekile?

Ukuze izinkampani Russian ngawo ohlelweni lwamazwe ngamazwe GMP ejwayelekile, futhi kudingeka izimo zangaphakathi nezangaphandle. Ezingeni lombuso iyadingeka:

• Ukwakha uhlaka lomthetho, zokulawula kanye methodological engasetshenziswa ukuhlela ukuqapha nokulandela mithetho. Kube abahloli kwakudingeka afanelekayo nginazo uzobe ezinemininingwane izinto methodological ukuze ihlolwe wamabhizinisi Ukukhishwa izitifiketi, kanye nemithetho ngokuletha abenzi bokubi ukuba ubulungisa.
• Sungula uhlelo sokubhalisa kwemikhiqizo zokwelapha okwakuyoholela nezimfuneko yesimanje. Lokhu kuyiqiniso ikakhulukazi esigabeni "izinga ', ngoba ochwepheshe lanamuhla ukulawula nokugunyazwa akuyona ziqu okwanele. Ngaphezu kwalokho, e realizable net kungekho Ukugcizelelwa izinga umkhiqizo osuphelile. Namanje ukuhweba izogxila kakhulu intengo izidakamizwa, ngezinye izikhathi, bese lokho kulimaza ukusebenza kwabo.

Ukuze enze GMP ejwayelekile, GMP iziqondiso ezingeni kwamabhizinisi kuzomele sifake izinto ezilandelayo:

• imishini yesimanje kanye nezindawo ingqalasizinda ekhona, izidingo ezifanele ejwayelekile.
• Imithombo izinto zokusetshenziswa engasetshenziswa ukuze kuzuzwe izinga oyifunayo kwemithi.
• izisebenzi ezinekhono ukukhiqizwa, ongoti, kanye ochwepheshe upscale, ukuqapha izinga umkhiqizo wokugcina.
• Kahle inhlangano zomsebenzi.
• Kubuyeketa yonke imibhalo lobuchwepheshe futhi umngenisa ku kuhambisana nezidingo standard.
• Esanele isilinganiso sokubuyisela, ezizohlinzeka sokuthuthukiswa ukukhiqizwa futhi ukwenziwa kwemithi emisha.

Ingabe ngidinga nendinganiso nokusetshenziswa kwezidakamizwa kule Russian Federation?

Ekuphenduleni umbuzo ngabe kunesidingo GMP (standard international) eRussia ubhekwa izici ezimbili.

1. Ngakolunye uhlangothi, ngokuvumelana nemithetho yayo elawula ivumela ukukhulisa ibha izidakamizwa izinga ezingeni eliphezulu kakhulu. Inani labantu base-Russia ke uthole imithi kakhulu esebenza kahle futhi enobungane ezivumela kancane ogulayo futhi basemathubeni amaningi okuthi alulame.

2. Ngakolunye uhlangothi, amabhizinisi yasekhaya akuzona ngokwezimali nje, "ukudonsa" ukuguqulwa. Uma inkampani yehluleka nokuhumushela olimini amathrekhi yesimanje, izindleko nemithi luyanda kakhulu, kanye nokuqaliswa yabo luyindida.

Zombili lezi zici ERussia kukhona njalo okushayisanayo futhi kuvimbela kwetfulwa kwetinchubomgomo standard. Nokho, ngenxa yalezi zinto ezintsha geopolitical kanye nesidingo yokungenisa esikhundleni yenqubo imithi kufanele ukusheshisa esikhathini esizayo esiseduze.