I-Good Manufacturing Practice (GMP)

Ngaphakathi kumashishini athile, abavelisi baphantsi kwemigangatho yemveliso engqongqo. Injalo imeko kumzi-mveliso wamachiza (wezilwanyana nowabantu), ishishini lezithambiso kunye nemveliso yokutya. Ukuziqhelanisa noMsebenzi oLungileyo (GMP) ligama elaziwa kakuhle kolu shishino. I-GMP yinkqubo yokuqinisekisa esemgangathweni eqinisekisa ukuba inkqubo yokubhaliswa ibhalisiwe ngokufanelekileyo kwaye ke umgangatho uqinisekisiwe. Ngenxa yendima ephambili kumzi-mveliso wezamayeza nezokunyanga, yi-GMP kuphela kula macandelo eza kuxutyushwa apha ngezantsi.

imbali

Ukusukela oko yaqala impucuko, abantu bebekhathazekile malunga nomgangatho kunye nokhuseleko lokutya kunye namayeza. Kwi-1202 umthetho wokuqala wokutya waseNgesi wenziwa. Kwakusekuhambeni kwexesha, ngo-1902, apho kwalandelwa iOrganic Control Act. Oku kwaziswa e-United States ukulawula iimveliso zendalo. Ezi mveliso zavavanywa ngokusemthethweni ngokucoceka. Umthetho wasekuqaleni wokutya kunye neziyobisi, owasungulwa ngo-1906 kwaye wenza ukuba kungabikho mthethweni ukuthengisa ukutya okungcolileyo (falsified) kunye nokufuna iilebheli eziyinyani. Emva koko, eminye imithetho yaqala ukusebenza. Ngo-1938, kwaziswa umthetho wokutya, iziyobisi kunye nezithambiso. Umthetho ufuna iinkampani ukuba zibonelele ngobungqina bokuba iimveliso zabo zikhuselekile kwaye zicocekile phambi kokuba zibekwe emarikeni. I-FDA yenze uphando ngamacwecwe angcolileyo kwaye yaveza ukuba izitenxo ezibi kakhulu kwimveliso zafunyanwa kumzi-mveliso kwaye kwakungasekho mkhondo ukulandelela ukuba zingaphi ezinye iipilisi ezazisengcolisiwe. Esi siganeko sanyanzela i-FDA ukuba isebenze kule meko kwaye ikhusele ukuphindaphinda ngokuzisa i-invoicing kunye nolawulo lomgangatho ngokusekwe kwimigangatho yokuphicothwa kwazo zonke iimveliso zamayeza. Oku kukhokelele kwinto eyabizwa ngokuba yi-GMP. Ibinzana elithi "Indlela elungileyo yokuvelisa" lavela ngeminyaka yoo-1962 njengesilungiso kuMthetho wokutya waseMelika, iziyobisi kunye neCosmetic Act.

I-Good Manufacturing Practice (GMP)

Imigaqo ye-GMP yangoku yaphuhliswa eYurophu naseMelika.

Ekugqibeleni amazwe aseYurophu aqala ukusebenzisana kwaye enza izikhokelo eziqhelekileyo ze-GMP ezazamkelwe yi-European Union.

Ukongeza, okwangoku kukho eminye imithetho emininzi yamazwe kunye nemigaqo ebandakanyiwe kwimigaqo ye-GMP.

Yintoni i-GMP?

I-GMP ithetha "indlela elungileyo yokuvelisa". Imigaqo ye-GMP ibandakanyiwe kuzo zonke iintlobo zemithetho, kodwa ke le mithetho inenjongo efanayo. I-GMP isetyenziswa ngokukodwa kumzi mveliso wamayeza kwaye yenzelwe ukuqinisekisa umgangatho wenkqubo yemveliso. Umgangatho wemveliso awunakuze ugqitywe ngokupheleleyo ngokuvavanya ukwakheka kwawo. Ayizizo zonke izinto ezingcolileyo ezinokufunyanwa kwaye ayizizo zonke iimveliso ezinokuhlaziywa. Umgangatho ke unokuqinisekiswa kuphela ukuba yonke inkqubo yemveliso yenziwa ngendlela emiselweyo nelawulwa ngokuchanekileyo. Ngale ndlela kuphela inkqubo yokuvelisa iqinisekisa umgangatho wamayeza. Le ndlela yokuvelisa, ibizwa ngokuba yiNkqubo elungileyo yokuThengisa, ke iyimfuneko kwimveliso yamayeza.

I-GMP ikwabaluleke kakhulu kubambiswano lwamanye amazwe. Uninzi lwamazwe luye lwamkela ukungeniswa nokuthengiswa kwamayeza aveliswe ngokungqinelana ne-GMP eyamkelwe kwilizwe liphela. Oorhulumente abafuna ukukhuthaza ukuthunyelwa kwamayeza kwamanye amazwe banokukwenza oku ngokwenza u-GMP ngokunyanzelekileyo kuyo yonke imveliso yamayeza nangokuqeqesha abahloli babo kwizikhokelo ze-GMP.

I-GMP ichaza ukuba phantsi kwesi sifo kwenziwa njani na. Ngexesha lokuveliswa kwazo zonke izinto, izithako, iimveliso eziphakathi kunye nemveliso yokuphela konyaka ihlolwe kwaye inkqubo ibhalisiwe ngokuchanekileyo kwiprotocol yokulungiselela oko. Ukuba emva koko kwenzeka into engalunganga ngebhendi ethile yeemveliso, kusoloko kunokwenzeka ukufumana ukuba yenziwa njani, ngubani okuvavanyeyo kwaye kwasetyenziswa phi Kuyenzeka ukuba ulandele ezona ndawo zihambe kakubi.

Ngelixa ulawulo olulungileyo luyimfuneko ukuqinisekisa umgangatho weemveliso zamachiza, kufuneka iqondwe ukuba eyona njongo iphambili yolawulo lomgangatho kukufezekisa inkqubo yemveliso. Ulawulo lomgangatho lwenziwa ukuqinisekisa umthengi ukuba imveliso iyahlangabezana nemigangatho esemgangathweni, ukulebhelisha ngokuchanekileyo nazo zonke iimfuno ezisemthethweni. Nangona kunjalo, ukulawulwa komgangatho kukodwa akwanelanga ukufezekisa zonke iinjongo. Kufuneka kubekho ukuzibophelela ekufezekiseni umgangatho kunye nokuthembeka kuyo yonke imveliso, yonke ibatch. Oku kuzinikela kunokuchazwa kakuhle njenge-GMP.

Imithetho nemigaqo

Isikhokelo se-GMP sibekwe phantsi kwimithetho eyahlukeneyo kunye nemigaqo yamashishini ohlukeneyo. Kukho imithetho nemigaqo yezizwe ngezizwe, kodwa kukwakhona nemigaqo kwinqanaba laseYurophu nelikazwelonke.

yezizwe ngezizwe

Kwiinkampani ezithumela kwelinye ilizwe eUnited States, imigaqo ye-GMP yi-United States yokutya kunye noLawulo lweeDrug (FDA) iyasebenza. Banyanzelisa imigaqo phantsi kwesihloko 21 seKhowudi yeMigaqo yeSigqeba. Izikhokelo zaziwa phaya phantsi kwegama "UkuziQhelanisa neMveliso ngoku eyiNgcono (cGMP)".

iYurophu

Izikhokelo ze-GMP ezisebenza ngaphakathi kwe-EU zibekiwe kwimigaqo yaseYurophu. Le migaqo isebenza kuzo zonke iimveliso ezithengiswa kwi-European Union ngaphandle kokuba umenzi wazo usekwe ngaphandle kwe-EU.

Kwimveliso yamayeza elungiselelwe ukusetyenziswa ngabantu, eyona mithetho ibalulekileyo yimigaqo 1252/2014 kunye noMyalelo 2003/94 / EC. Kwiimveliso zamayeza ezilungiselelwe ukusetyenziswa kwezilwanyana nguMgaqo 91/412 / EC osebenzayo. Kukho eminye imithetho ehambelana nayo kunye nemigaqo elawula intengiso yamayeza. Iimfuno ze-GMP ziyafana emntwini nakwishishini lamayeza ezonyango lwezilwanyana Ukutolikwa kwemigangatho ebekwe kulo mthetho, i-EudraLex ibonelela ngesikhokelo. I-EudraLex yingqokelela yemithetho esebenza kumayeza akwi-EU. IVolumu 4 ye-EudraLex iqulethe imigaqo ye-GMP. Ngokwenyani sisikhokelo sokusebenzisa izikhokelo kunye nemigaqo ye-GMP. Le migaqo isebenza kumayeza abantu kunye nezilwanyana. 

KaZwelonke

ICandelo loMphathiswa Wezempilo, elezeNtlalontle kunye lezeMidlalo lithatha isigqibo malunga nenqanaba likazwelonke lokuba kungeniswe elizweni ukhathalelo lwamayeza phantsi kweemeko ezithile. Umthetho wamayeza uchaza iimeko zokwenziwa kweyeza, ukuthengisa kunye nokusasaza isigulana. Umzekelo umThetho we-Opium uyakwalela ukubanjwa kwamachiza athile adweliswe kuluhlu lll kunye nomthetho we-Opium Act. Kukho nommiselo kwizinto ezandulelayo. Ngokwale migaqo, oosokhemisi banokugcina kuphela kunye / okanye urhwebo lweekhemikhali ezinokusetyenziswa ukwenza iziyobisi okanye iziqhushumbisi (zangaphambili) phantsi kwemeko ezithile. Kukho imigaqo kunye nezikhokelo ezinje ngommiselo we-FMD (umda ngokuchasene nokwenziwa kwamanani

I-Arhente yeMithi yaseYurophu (i-EMA) inoxanduva lokuvavanya isayensi, ukubeka esweni nokulawula ukhuseleko lwamayeza e-EU. UMthetho weeMveliso zeCosmetic umisela iimfuno zokwenza izinto zokuthambisa.

Iimfuno ze-GMP

I-GMP yinxalenye yoqinisekiso lomgangatho. Ngokubanzi, esi siqinisekiso, ngaphandle kwe-GMP, sikwabandakanya indawo ezinje ngokuyilwa kwemveliso kunye nophuhliso lwemveliso. Uqinisekiso lomgangatho zizonke izinto ekufuneka ziqinisekisile ukuba imveliso okanye inkonzo iyahambelana neemfuno zomgangatho. Uqinisekiso lomgangatho yenye yezinto ezisisiseko kulawulo lomgangatho. Ukubaluleka kolawulo lomgangatho kubalulekile. Ukuba ucinga okomzuzwana nje ukuba kuya kwenzeka ntoni ukuba kwenziwe iimpazamo kwimveliso yamayeza kwaye zafunyanwa sele kusemva kwexesha. Ngaphandle kokubandezeleka komntu, kuya kuba yintlekele kwigama lenkampani eyenza amayeza. Inkqubo elungileyo yokuvelisa ijolise kumngcipheko okhoyo kwimveliso yeziyobisi, ezinje ngokungcoliseka (ukungcoliseka kwelinye ichiza elinento yokwenza nelinye ichiza) kunye nokudityaniswa (iimpazamo) ezibangelwa kukunga gunyaziswa gwenxa.

Iimfuno ezimiselwa yi-GMP yokwenza imveliso zivunyelwe kwilizwe liphela. Le blog ichaza iimfuno ezivela kwimigaqo enxulumene nomzi mveliso wamachiza. Ngokubanzi, imigaqo-nkqubo esisiseko efanayo isebenza kuyo yonke imveliso. Le migaqo isisiseko iyayeka kwilizwe jikelele.

Umthetho waseYurophu ufuna iimveliso zonyango ukuba zenziwe ngokuhambelana nemigaqo kunye nezikhokelo zendlela elungileyo yokusebenza. Imiba egutyungelwe zizikhokelo lulawulo lomgangatho, abasebenzi, izakhiwo kunye nezixhobo, amaxwebhu, ukuveliswa, ukulawulwa komgangatho, ukuthotywa, izikhalazo nokukhumbula imveliso kunye nokuzihlola. Umthetho unyanzelisa umenzi ukuba aqalise kwaye asebenzise inkqubo yokuqinisekisa umgangatho wamachiza. Le mithetho ikwasebenza kwiimveliso zamayeza ezenzelwe ukuthunyelwa kwelinye ilizwe.

Ezi zikhokelo zilandelayo ze-GMP kufuneka zithathelwe ingqalelo:

  • Abasebenzi abaqeqeshiweyo, abanobuchule,
  • Ucoceko lugcinwa ngokungqongqo. Ukuba umntu, umzekelo ngenxa yesifo esosulelayo okanye inxeba elivulekileyo, kukho isibophelelo sokwazisa kunye nokulandela umgaqo.
  • Iimviwo zonyango rhoqo zabasebenzi
  • Kubaqeshwa abaqhuba uhlolo lokubonakalayo, kukwakhona ukuhlola okongeziweyo,
  • Isixhobo esifanelekileyo,
  • Izinto ezilungileyo, izikhongozelo kunye neelebheli,
  • Imiyalelo yomsebenzi evunyiweyo,
  • Indawo yokugcina efanelekileyo kunye nezothutho,
  • Abasebenzi aboneleyo, iilabhoratri kunye nezixhobo zolawulo lomgangatho lwangaphakathi,
  • Imiyalelo yomsebenzi (IiNkqubo eziSebenzayo); imiyalelo yomsebenzi ibhaliwe ngolwimi olucacileyo kwaye igxile kwimeko yendawo,
  • Uqeqesho; abasebenzi abasebenzayo baqeqeshelwe ukwenza imiyalelo yomsebenzi,
  • Amaxwebhu; Yonke into kufuneka ibe ngokucacileyo ephepheni kunye nokufaneleka kwabasebenzi
  • Ulwazi malunga nelebheli kunye nendlela yokulebhelisha kwezinto ezingavuthi, eziphakathi kunye nemveliso ezigqityiweyo,
  • Kukho iindlela ezichazwe ngokucacileyo, ezingqiniweyo, ezithembakeleyo zenkqubo yokwenza,
  • Uvavanyo kunye nokuqinisekiswa kuyenziwa,
  • Ngexesha lokuvelisa (incwadana yemiyalezo okanye ezenzekelayo) irekhodwa ukuba onke amanyathelo enziwe ngokuchanekileyo,
  • Ukuphambuka kwimiyalelo kuyarekhodwa kwaye kuphandwe ngokweenkcukacha,
  • Imbali epheleleyo yebatch nganye (ukusuka kwizinto ezingafunekiyo ukuya kubathengi) igcinwe ngendlela yokuba ilandeke ngokulula,
  • Iimveliso zigcinwe kwaye zihanjiswe ngokuchanekileyo,
  • Kukho indlela yokususa iibatch kwintengiso ukuba kunyanzelekile,
  • Izikhalazo malunga neengxaki ezisemgangathweni ziyaqwalaselwa kwaye ziphandwa ngokufanelekileyo. Ukuba kukho imfuneko, amanyathelo athathiweyo ukuthintela ukuphinda. 

uxanduva

I-GMP inikezela uthotho loxanduva kubasebenzi abaphambili, njengentloko yemveliso kunye / okanye ulawulo lomgangatho kunye nomntu ogunyazisiweyo. Umntu ogunyazisiweyo unoxanduva lokuqinisekisa ukuba zonke iinkqubo kunye namayeza ayenziwa kwaye aphathwe ngokuhambelana nezikhokelo. Utyikitya (ngokoqobo) kwibhetshi nganye yamayeza avela kumzi-mveliso. Kukwakho nomphathi oyintloko, onoxanduva lokuqinisekisa ukuba iimveliso ziyahlangabezana neemfuno zomthetho wegunya lesizwe kwiimveliso zamayeza, ngaphandle kokubeka abaguli emngciphekweni ngenxa yokunqongophala kokhuseleko, umgangatho okanye ukusebenza. Kufanele ukuba icace gca, kodwa ikwayimfuneko yokuba amayeza afanelekile ukulungiselela injongo eyenzelwe yona. 

Ukongamela kunye nesatifikethi se-GMP

Kwinqanaba laseYurophu nelikazwelonke, kukho abaqhubi abamele umsebenzi wokongamela. Ezi ziiArhente zeMedicine yeYurophu (i-EMA) kunye neMpilo kunye noPhononongo lolutsha (IGJ). ENetherlands, i-IGJ inika isatifikethi se-GMP kumenzi wamayeza ukuba uyahambelana nezikhokelo ze-GMP. Ukwenza oku kwenzeke, i-IGJ yenza uhlolo lwamaxesha ngamaxesha kubavelisi eNetherlands ukuphanda ukuba bayayithobela na imithetho ye-GMP. Ukuba imigaqo ye-GMP ayifezekiswanga, umenzi ayizukubanjwa kuphela kwisatifikethi se-GMP, kodwa nakwimvume yokuvelisa. IGJ ikwavavanya abavelisi kumazwe angaphandle kwe-European Union. Oku kwenziwa ngokomyalelo we-EMA kunye neBhodi yokuVavanywa kweMithi (i-CBG).

Kwisicelo seBhodi yoVavanyo lwaMayeza, i-IGJ icebisa abavelisi kwigunya lokuthengisa eligunyazisiweyo (imvume yendawo). Ukuba umenzi akasebenzi ngokungqinelana neemfuno ezisemgangathweni ze-GMP, iBhodi inokuthatha isigqibo sokuba lo mvelisi asuswe kwidosisier yesigunyaziso sentengiso. IBhodi ikwenza oku ngokubonisana ne-IGJ kunye namanye amagunya okuhlola aseYurophu kunye nemibutho yaseYurophu enje ngeQela lokuLungelelanisa ukuThathelwa kweMvisiswano kunye neNkqubo eziMiselweyo- uLuntu (i-CMDh) kunye ne-EMA. Ukuba oku kungakhokelela ekunqongophaleni kwamayeza eNetherlands, umnini ogunyazisiweyo wentengiso kufuneka axele oku kwi-Medicines Deficiencies and Defects Disclosure Office (Meldpunt geneesmiddelen tekort en -defecten).

I-cosmetics kunye ne-GMP

Kwizinto zokuthambisa, kukho imigaqo eyahlukileyo yokuqinisekisa umgangatho wayo. Kwinqanaba laseYurophu kukho uMmiselo weCosmetics 1223/2009 / EC. Oku kugqiba ukuba izinto zokuthambisa kufuneka zithobele i-GMP. Isikhokelo esisetyenziselwe oku ngumgangatho we-ISO 22916: 2007. Lo mgangatho unemigaqo esisiseko ye-GMP egxile kwiinkampani ezivelisa izinto zokuthambisa ezigqityiweyo. Lo ngumgangatho wamazwe aphesheya kwaye uye wamkelwa yiKomiti yaseYurophu yokuBekwa emgangathweni (i-CEN). Lo ngumbutho wokumiselwa komgangatho waseYurophu odala imigangatho ebangwayo kakhulu. Ukusetyenziswa kwale migangatho akunyanzelekanga, kodwa kubonisa umhlaba ongaphandle ukuba iimveliso okanye iinkonzo ziyahlangabezana nemigangatho esemgangathweni. Umbutho wokumiswa komgangatho ukwaphuhlisa 'imigangatho engqinelanayo' ngokwesicelo se-European Union.

Le migaqo ye-GMP ecaciswe kumgangatho ngokusisiseko ineenjongo ezifanayo nezo zeshishini lamayeza: ukuqinisekisa umgangatho kunye nokhuseleko lwemveliso. Lo mgangatho ugxile kuphela kushishino lwezinto zokuthambisa. Ibandakanya kwaye ihlanganisa:

  • mveliso,
  • ukugcinwa,
  • ukupakisha,
  • iinkqubo zokuvavanya kunye nezothutho
  • uphando nophuhliso
  • ukuhanjiswa kwezinto zokuthambisa ezigqityiweyo
  • ukhuseleko lwabasebenzi bemveliso
  • ukukhuselwa kwendalo esingqongileyo.

Umgangatho awuqinisekisi kuphela ukusetyenziswa kweenqobo zemveliso kunye neemfuno zemveliso yeempahla. Ukusetyenziswa komgangatho kuvumela umenzi ukuba alawule umgangatho kunye neemfuno zokhuseleko kwityathanga lonikezelo kunye nokubeka iliso kwiingozi kunye nobungozi bezinto zokuthambisa. Imigaqo yeGMP iyahambelana nemithetho ebikhankanywe ngaphambili ngokweenkcukacha kwicandelo "iimfuno ze-GMP".

Ngaba ufuna ingcebiso okanye inkxaso kumthetho wamachiza okanye kwimithetho yezithambiso? Okanye ngaba unemibuzo malunga nale bhlog? Nceda unxibelelane nabameli apha Law & More. Siza kuphendula imibuzo yakho kwaye sinike uncedo lwezomthetho apho kufanelekileyo

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