I-International Standard GMP: iimpawu kunye nezicelo

I-GMP esemgangathweni yamazwe ngamazwe ithathwa njengeyona nto ephambili emhlabeni, ichaza iimfuno zokuveliswa kwamachiza, izongezelelo zokutya kunye nezinto zokutya.

Yintoni umgangatho?

Igama elipheleleyo le setethi yeemfuno yiNkqubo yokuThengiswa kweeMveliso zoLwazi, oku kuthetha ukuba "Imithetho yokuveliswa kwemveliso yezobisi". I-GMP esemgangathweni yamazwe ngamazwe ineenjongo ezilandelayo:

1. Qinisekisa izinga eliphezulu lomgangatho wemveliso.
2. Qiniseka ukuba:

• Umhlathi weemveliso zonyango ezivelisiweyo zihambelana neentlawulo;
• Ukulungiselelwa akuququzekanga ukungcola kwamanye amazwe;
• Kukho ukumakisha okuhambelanayo;
• Ulungiso lufakwe ngokufanelekileyo;
• Ngeke ilahlekelwe iipropati zayo ngomhla wokuphela.

Imbali yokuvela

Umgangatho wawusetyenziswe kwi-USA ngo-1963, xa imithetho yokuqala yokukhupha nokukhupha imveliso yamachiza yazalwa. Ifom epheleleyo yexwebhu olusemthethweni, nangona kunjalo, bathatha kuphela ngo-1968. Ngonyaka kamva, iNhlangano yezeMpilo yehlabathi (i-WHO) icebisa ukuba onke amazwe asebenzise i-GMP esemgangathweni jikelele. Emva koko, le mithetho iphindwe ngokuphindaphindiweyo kwaye ihlengahlengiswe kwaneentlobo ezikhoyo zamkelwa.

Ukunyaniseka ngokunyanisekileyo kumgangatho wokuqala wokuphunyezwa kwayo, kuphela i-Soviet Union, uMphathiswa wezeMpilo oye wavelisa imimiselo yayo, ngokubandezela ngezinye izihlandlo ezingaphezu kwe-GMP. Inzala kwimigangatho yamazwe ngamazwe yaqala ukuvela kuphela ngo-1991, xa iinkqubo zokungenisa nokuthumela amayeza zaqala. Nangona kunjalo, ekuqaleni, kwakungenakwenzeka ukufezekisa ukuvisisana kwemithetho eyahlukileyo. Kuphela kwiminyaka engama-90 kwakukho inkqubela yangempela.

Standard Russian

Isikhokelo solawulo kwimimandla yelizwe le-CIS saqala ukuphuhliswa emva kokuwa kwe-USSR. Injongo ephambili yayikukwenza ukuba imigangatho emibini ifikelele kwimilinganiselo enokwenzeka, ngokukhawuleza ifikelele kwimithetho echazwe yi-GMP (umgangatho wehlabathi jikelele).

Inkqubo yayide. Kuphela ngo-2001, i-RF ibonakale isondele kumgangatho wamazwe ngamazwe. Ubonelela ukuba ukusuka ngomhla ka-01.07.2000 onke amabhizinisi amasha awakhiwa kunye nokuhlaziywa kwemveliso aza kufumana iilayisenisi zokuvelisa, ukugcinwa kunye nokuthengiswa kweemveliso kuphela xa zihambelana ne-Russian GMP.

Yayilungiswa yintlangano ebizwa ngokuba nguMbutho weeNjineli zoLawulo lweMicrosoft Control (ASINKOM). Imithetho yasekhaya yavunywa ngomhla we-10.04.2004 yi-Gosstandart yaseRussia Federation, ngenxa ye-GOST R 52249-2004 "Imigaqo yokuveliswa kunye nokulawulwa komgangatho wamachiza" yabonakala. Yayisetyenziswa ngomhla ka-01.01.2005, kwaye kwakukholelwa ukuba le miselo ifanelekile kunokwenzeka kwilizwe elizweni lonke. Nangona kunjalo, ukususela ngomhla we-01.01.2010 i-standard standard yaseRussia ye-GMP yaqala ukusebenza. Wathatha njengesiseko semithetho yaseYurophu, kwaye i-GOST yangaphambili yayingasasebenzi.

Apho eRashiya amabhizinisi asebenzisa umgangatho

Uninzi lwamashishini afumana izatifikethi eziphezulu ezihambelana nemithetho yezizwe ngezizwe ziseseMoscow, eSt. Petersburg nakwamanye amaziko amakhulu nakwizenzululwazi zelizwe.

Ukugqitywa ngokupheleleyo kwi-GMP (umgangatho wehlabathi jikelele) ucwangciselwe kuwo onke amabhizinisi. Ngaphezu koko, kwakufuneka kuphele ngo-2014, kodwa kwavela ubunzima obuninzi. Kwakukho ukuba zonke iinkampani zasemakhaya kwishishini lezobisi likwazi ukufumana isitifiketi esifanelekileyo somgangatho. Ingxaki ebalulekileyo kukuba akukho nabasebenzi abanolwazi olwaneleyo kwaye, yintoni ebaluleke ngakumbi, ukuqeqeshwa okusebenzayo ekuphunyezweni umgangatho kwiNgingqi yaseRussia.

Izinto eziphambili zomgangatho we-GMP

Umgangatho we-GMP (Umgangatho oPhezulu wokuThengiswa koMveliso) unikezela isethi seenqatswa abavelisi kufuneka bafanisane nazo. Kwaye amayeza eemfuno zeemoriyam, iimfuno nganye kwisigaba sokuvelisa zilawulwa ngokubanzi-ukusuka kwiinkcazo zebhaktheriya eziqulethwe kwi-cubic meter enye emoyeni ekumakishikeni kwemveliso.

Umzekelo ngumqathango wamachiza okuvelisa amafama kwiipilisi. Kwiimeko ezinje, i-GMP (umgangatho wamazwe ngamazwe) ifuna inhlangano "izitolo ezicocekileyo kakhulu", apho ukunyuka kwamanyathelo kwenkqubo kufezwa ngamasebe abasebenzi, indlela ekhethekileyo yokucoca umoya, njl. KwiRashiya kuphela i-silicon crystals kunye ne-microcircuits ezikhethekileyo zenziwe kwiivenkile ezinjalo.

Ziziphi iimeko ezifunekayo ukufudukela kwimigangatho?

Ukuguqulela amashishini aseRussia kwi-GMP yemigangatho yamazwe ngamazwe, zombini izimo zangaphandle ne zangaphakathi ziyimfuneko. Kwinqanaba likarhulumente, kufuneka:

• Yakha isakhelo somthetho, isisombululo kunye nesendlela, ongayilungisa ngayo ukubeka esweni ukuthotyelwa kule mithetho. Apha, abahloli abafanelekayo bayakufuneka, ngubani oza kuba neenkcukacha zeendlela zokwenza izinto ekuhloliseni kwamashishini ngaphambi kokukhupha izatifikethi, kunye nemithetho yokutshutshiswa kwabaphulaphuli.
• Yenza inkqubo yokubhaliswa kwamachiza eya kuhlangabezana neemfuno zanamhlanje. Oku kuyinyani ngokukhethekileyo kwinqanaba "lo mgangatho", njengoko iingcali ezikhoyo ngokulawula nokukhupha iimvume azifumaneki iziqinisekiso ezifanelekileyo. Ngaphezu koko, kwinethiwekhi yokuphunyezwa akukho kugxininiswa kumgangatho womveliso ogqityiweyo. Njengangaphambili, urhwebo lujolise ngakumbi kwixabiso lamayeza, ngamanye amaxesha ngeendleko zokusebenza kwazo.

Ukuze umgangatho we-GMP uzalisekiswe, i-GMP kwizinga loshishino kufuneka ifake izinto ezilandelayo:

• Izixhobo zanamhlanje kunye nezibonelelo ezineziseko ezihlangabezana neemfuno zomgangatho.
• Imithombo yezinto ezibonakalayo, apho unokufezekisa umgangatho ofunwayo wamayeza.
• Iingcali zezolimo ezifanelekileyo, kunye neengcali zobugcisa obuphezulu, ezilawula umgangatho weemveliso zokugqibela.
• Intlangano efanelekileyo yabasebenzi.
• Ukuhlaziywa kwamaphepha onke ezobuchwepheshe nokuyihambisa ngokuhambelana neemfuno zomgangatho.
• Inqanaba elaneleyo lenzuzo, ukuvumela ukuqinisekisa ukuphuhliswa kwemveliso kunye nokuveliswa kweentlobo ezintsha zamachiza.

Ngaba kukho imilinganiselo yokusetyenziswa kweziyobisi eRussia Federation?

Xa uphendula umbuzo malunga nokuba i-GMP (umgangatho wamazwe ngamazwe) iyadingeka eRashiya, iinkalo ezimbini zidlalwa ingqalelo.

1. Ngakolunye uhlangothi, ukuthotyelwa kwemithetho yayo eqinileyo kukuvumela ukuba uphakamise umgangatho wekhwalithi yamachiza kwizinga eliphezulu kakhulu. Inani labantu baseRashiya liya kufumana amayeza asebenzayo kwaye acocekileyo, okuya kwenza kube nzima kakhulu kwaye kufumaneke kwakhona.

2. Ngakolunye uhlangothi, amabhizinisi asekhaya asetyenziswa ngemali nje "akayikukhangela" utshintsho. Ukuba ishishini liyakwazi ukudluliselwa kwimilayezo yanamhlanje, ixabiso leendleko zamachiza liyakwandisa, kwaye ukuqonda kwabo kuba nzima.

Zombini ezi zinto e-Russia zihlala zixabana kwaye ziphazamise ukuphunyezwa komgangatho. Nangona kunjalo, ngokubhekisele kwizinto ezikhoyo ze-geopolitical kunye nesidingo sokungeniswa kwamanye amayeza endaweni, inkqubo kufuneka ihambe ngokukhawuleza.