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

Ukususela ekuqaleni kwempucuko, abantu bebexhalabile malunga nomgangatho kunye nokukhuseleka kokutya kunye namayeza. Ngo-1202 kwenziwa umthetho wokuqala wokutya wesiNgesi. Kwakusemva kwexesha elikhulu, ngo-1902, ukuba kulandelwe umThetho woLawulo lweOrganic. Oku kwaziswa eUnited States ukulungiselela ukulawula iimveliso zezinto eziphilayo. Ezi mveliso zavavanywa ngokusemthethweni kubunyulu. UMthetho woKutya nokuThengiswa kwasekuqaleni, owasungulwa ngo-1906 kwaye wawenza akukho semthethweni ukuthengisa ukutya (okunesidima) okunesinxibo kwaye wafuna ukuba kufakwe iilebhile okuyinyani. Emva koko, yaqala ukusebenza eminye imithetho. Ngo-1938, kwaqaliswa umthetho wokutya, iziyobisi kunye ne-cosmetic. Umthetho ufuna ukuba iinkampani zinike ubungqina bokuba iimveliso zabo zazikhuselekile kwaye zazicocekile ngaphambi kokuba zibekwe emarikeni. I-FDA yaqhuba uphando lweetafile ezingcolisekileyo kwaye yaveza ukuba izinto ezitenxileyo kwimveliso zafunyanwa kumzi-mveliso kwaye akunakuphinda kulandelwe ukuba zingaphi ezinye iitafile ezingcolile. Esi siganeko sanyanzela i-FDA ukuba isebenze kule meko kwaye ithintele ukuphinda yenzeke ngokuzisa i-invovisic kunye nolawulo lomgangatho olusekwe kwimigangatho yokuphicothwa kwazo zonke iimveliso zamayeza. Oku kukhokelele kwinto ebizwa ngokuba yi-GMP kamva. Ibinzana elithi "Ukuziqhelanisa nokwenza izinto ezilungileyo" lavela ngonyaka ka-1962 njengesilungiso kuMthetho wokuTya, ukuChiza iziyobisi kunye noMthetho eMelika.

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 ngokuyintloko le mithetho inenjongo efanayo. I-GMP isetyenziswa ikakhulu kwishishini lamayeza kwaye yenzelwe ukuqinisekisa umgangatho wenkqubo yokuvelisa. Umgangatho wemveliso awunakuze ugqitywe ngokupheleleyo ngokuvavanya ukubekwa kwawo. Ayizizo zonke izinto ezingcolileyo ezinokufunyanwa kwaye ayizizo zonke iimveliso ezinokuhlaziywa. Umgangatho unokuqinisekiswa kuphela ukuba ngaba yonke inkqubo yokuqhutywa yenziwe ngendlela efanelekileyo kunye nolawulo. Yile ndlela kuphela inkqubo yokuvelisa eqinisekisa umgangatho weyeza. Le ndlela yokuvelisa, ebizwa ngokuba yiNgcaciso eMveliso yokuSebenza, 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 ngaphandle eMelika, imigaqo ye-GMP yi-United States yokutya kunye neziyobisi. Banyanzelisa imithetho phantsi kwesihloko 21 seKhowudi yeMigaqo ye Federal. Esi sikhokelo saziwa phaya phantsi kwegama elithi "iZinto eziQhelekileyo ngokuSebenza kakuhle (cGMP)".

iYurophu

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

Kwimveliso yamayeza enzelwe ukusetyenziswa ngabantu, eyona mithetho ibaluleke kakhulu ngummiselo we-1252/2014 kunye noMgaqo ka-2003/94 / EC. Kwiimveliso zamayeza ezenzelwe ukusetyenziswa kwezilwanyana ziyiDilesi 91/412 / EC iyasebenza. Kukho imithetho enxulumene ngakumbi nemigaqo elawula intengiso yamayeza. Iimfuneko ze-GMP ziyafana emntwini nakwicandelo lezonyango lwamayeza wezilwanyana.Ukucaciswa kwemigangatho ebekiweyo kulo mthetho, i-EudraLex inikezela isikhokelo. I-EudraLex yingqokelela yemithetho esebenza kumachiza ngaphakathi kwi-EU. Umthamo 4 we-EudraLex iqulethe imigaqo ye-GMP. Yincwadi esisikhokelo yokusebenzisa isikhokelo kunye nemigaqo-siseko ye-GMP. Le mithetho isebenza kumayeza omntu nawezilwanyana.

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 yokuqinisekiswa komgangatho. Ngokubanzi, esi siqinisekiso, ngaphandle kwe-GMP, sikwabandakanya iindawo ezinje ngemveliso yoyilo kunye nophuhliso lwemveliso. Ukuqinisekiswa komgangatho kukuphela kwemisebenzi ekufuneka iqinisekise ukuba imveliso okanye inkonzo iyahambelana neemfuno ezisemgangathweni. Ukuqinisekiswa komgangatho yenye yezinto ezisisiseko zolawulo lomgangatho. Ukubaluleka kolawulo lomgangatho kubalulekile. Ukuba ucinga okomzuzwana nje kuya kwenzeka ntoni ukuba iimpazamo zenziwe kwimveliso yamayeza kwaye kwafunyanwa kade. Ngaphandle kokubandezeleka kwabantu, ibiya kuba yintlekele igama elidume kakubi kwinkampani yamayeza. Ukuziqhelanisa nokulunga kugxila kwimingcipheko ebangelwa kukuveliswa kweziyobisi, njengokuchaphazela-ungcoliseko (ungcoliseko lwechiza elinye elinezinye izinto zelinye ichiza) kunye nokudityaniswa (iimpazamo) okubangelwa kukungahambelani kakuhle.

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 lweemfanelo kubasebenzi abaphambili, njengentloko yemveliso kunye / okanye ulawulo lomgangatho kunye nomntu ogunyazisiweyo. Umntu ogunyazisiweyo unoxanduva lokuqinisekisa ukuba zonke iinkqubo kunye neemveliso zonyango zenziwa kwaye ziphathwa ngokungqinelana nezikhokelo. Utyikitya (ngokoqobo) kwiqela ngalinye lamayeza avela kumzi-mveliso. Kukwakho nomphathi oyintloko, noxanduva lokuqinisekisa ukuba iimveliso ziyahlangabezana neemfuno ezisemthethweni zegunya lesizwe kwiimveliso zamayeza, ngaphandle kokubeka abaguli emngciphekweni ngenxa yokunqongophala, umgangatho okanye ukusebenza ngokufanelekileyo. Kufanele ukuba icace gca, kodwa ikwayimfuneko ukuba amayeza afanele injongo ayenzelwe 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).

Kwakhona ngesicelo seBhodi yokuVavanywa kweMithi, i-IGJ icebise abavelisi kwincwadi yokugunyazisa yokuthengisa (ukucaciswa kwesiza). Ukuba umenzi akasebenzi ngokungqinelana neemfuno zomgangatho we-GMP, iBhodi inokuthatha isigqibo sokuba lo menzi asuswe kwisaziso sesigunyaziso sentengiso. IBhodi le ikwenza oku ngokubonisana ne-IGJ kunye nabanye abasemagunyeni okuhlola abaseYurophu kunye nemibutho yaseYurophu efana neQela lokuLungelelanisa ukuqaphela izinto kunye neenkqubo ezinikezelweyo (i-CMDh) kunye ne-EMA. Ukuba oku kunokukhokelela kukunqongophala kwamayeza eNetherlands, umnini gunyaziso lokuthengisa kufuneka anike ingxelo oku kwi-Medicines Defenceriers kunye neDis Display Defence (i-Meldpunt geneesmiddelen tekort en -defecten).

I-cosmetics kunye ne-GMP

Kwizithambiso, kukho imigaqo eyahlukileyo yokuqinisekisa umgangatho wabo. Kwinqanaba laseYurophu kukho uMmiselo we-Cosmetics 1223/2009 / EC. Oku kwakhona kumisela ukuba izimonyo kufuneka zihambelane ne-GMP. Isikhokelo esisetyenziselwe oku yimigangatho ye-ISO 22916: 2007. Lo mgangatho uqukethe imigaqo esisiseko ye-GMP ejolise kwiinkampani ezivelisa izimonyo ezigqityiweyo. Lo ngumgangatho wamazwe aphesheya kwaye wamkelwe yiKomiti yaseYurophu yokuma ngokuBanzi (CEN). Eli liqumrhu lokumelana laseYurophu lenza imigangatho ekumgangatho ophezulu. Ukusetyenziswa kwale migangatho akanyanzelekanga, kodwa kubonisa kwilizwe langaphandle ukuba iimveliso okanye iinkonzo ziyahlangabezana nemigangatho esemgangathweni. Umzimba wokubekwa emgangathweni ukwakhula 'imigangatho elungelelanisiweyo' ngesicelo seManyano yaseYurophu.

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 zokuveliswa kweempahla. Ukufaka isicelo kumgangatho kuvumela umenzi ukuba alawule umgangatho kunye neemfuno zokhuseleko kwityathanga lokuhambisa kunye nokubeka iliso kwingozi kunye nemingcipheko yezithambiso. Imigaqo ye-GMP ihambelana nemithetho ebekhe yakhankanywa ngaphambili 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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