Indlela Yokukhiqiza Enhle (GMP)

Ezimboni ezithile, abakhiqizi bangaphansi kwezindinganiso eziqinile zokukhiqiza. Lokhu kunjalo embonini yezemithi (yabantu ney yezilwane), embonini yezimonyo nasemkhakheni wokudla. IGreat Production Practice (GMP) yigama elaziwa kahle kulezi zimboni. I-GMP uhlelo lokuqinisekisa ikhwalithi oluqinisekisa ukuthi inqubo yokukhiqiza ibhalisiwe kahle yingakho ikhwalithi iqinisekisiwe. Ngenxa yendima enkulu embonini yezemithi nasezimonyo, yi-GMP kuphela kule mikhakha ezoxoxwa ngayo ngezansi.

Umlando

Kusukela kuqale impucuko, abantu bebelokhu bekhathazekile ngekhwalithi nokuphepha kokudla nemithi. Ngo-1202 kwenziwa umthetho wokuqala wokudla wamaNgisi. Kwaba kamuva kakhulu, ngo-1902, lapho kulandelwa umthetho we-Organic Control Act. Lokhu kwethulwe e-United States ukulawula imikhiqizo ye-organic. Le mikhiqizo yahlolwa ngokomthetho kobu msulwa. Umthetho wokudla kanye nezidakamizwa wasekuqaleni, owasungulwa ngonyaka we-1906 futhi wakwenza kwaba semthethweni ukuthengisa ukudla okungcolisiwe (kwaqanjwa ngamanga) nokufuna ukufakwa ilebula okuyikho. Ngemuva kwalokho, eminye imithetho eminingi yaqala ukusebenza. Ngo-1938, kwethulwa umthetho wokudla, izidakamizwa kanye ne-cosmetic Act. Umthetho wawudinga ukuthi izinkampani zinikeze ubufakazi bokuthi imikhiqizo yazo iphephile futhi ihlanzekile ngaphambi kokuthi ifakwe emakethe. I-FDA yenze uphenyo ngamathebhulethi angcolisiwe futhi iveze ukuthi kuqubuke okungahambi kahle ekukhiqizweni okutholakele efemini nokuthi akusekho ukuthi kulandele umkhondo wokuthi mangaki amanye amaphilisi asengcolisiwe. Lesi sehlakalo siphoqe i-FDA ukuthi isebenze ngalesi simo futhi ivikele ukuphinda yenzeke ngokungenisa ama-invovis kanye nokulawulwa kwekhwalithi okusekelwe kumazinga wokucwaninga kwemikhiqizo yonke yemithi. Lokhu kuholele kulokho okwabizwa ngokuthi yi-GMP kamuva. Inkulumo ethi "Ukwenza kahle izinto" yavela ngonyaka we-1962 njengesichibiyelo se-American Food, Drug and cosmetic Act.

Indlela Yokukhiqiza Enhle (GMP)

Imithetho ye-European GMP yamanje yathuthukiswa eYurophu nase-United States.

Ekugcineni amazwe aseYurophu nawo aqala ukusebenzisana futhi futhi enza izeluleko ezijwayelekile ze-GMP ezazamukelwa yi-European Union.

Ngaphezu kwalokho, njengamanje kuneminye imithetho eminingi nemithetho yamazwe omhlaba lapho kufakwe khona imithetho ye-GMP.

Yini i-GMP?

I-GMP isho "indlela enhle yokukhiqiza". Imithetho ye-GMP ifakiwe kuzo zonke izinhlobo zemithetho, kepha empeleni le mithetho inenhloso efanayo. I-GMP isetshenziswa ikakhulukazi embonini yezemithi futhi ihloselwe ukuqinisekisa ikhwalithi yenqubo yokukhiqiza. Izinga lomkhiqizo alisoze lanqunywa ngokuphelele ngokuhlola ukwakheka kwalo. Akusikho konke ukungcola okungatholakala futhi akuwona wonke umkhiqizo ongahlaziywa. Ikhwalithi ngakho-ke ingaqinisekiswa kuphela uma yonke inqubo yokukhiqiza yenziwa ngendlela enqunyelwe futhi elawulwa ngendlela efanele. Ngale ndlela kuphela inqubo yokukhiqiza iqinisekisa ikhwalithi yomuthi. Le ndlela yokukhiqiza, ebizwa ngokuthi yi-Good Production Practice, ngenxa yalokho iyimfuneko ekwenziweni kwemithi.

I-GMP nayo ibaluleke kakhulu ekubambisaneni kwamanye amazwe. Amazwe amaningi amukela ukungenisa nokuthengisa kuphela kwemithi ekhiqizwa ngokuya nge-GMP eyaziwa emazweni onke. Ohulumeni abafuna ukukhuthaza ukuthunyelwa kwemithi kwamanye amazwe bangenza lokhu ngokwenza igunya le-GMP lokuthola konke ukukhiqizwa kwemithi nangokuqeqesha abahloli babo imihlahlandlela ye-GMP.

I-GMP icacisa ukuthi umuthi wenziwa kanjani futhi ngaphansi kwaziphi izimo. Ngesikhathi sokukhiqiza zonke izinto zokwakha, izithako, imikhiqizo ephakathi nendawo kanye nomkhiqizo wokugcina kuyahlolwa futhi inqubo ibhalisiwe ngokuqondile kuphrothokholi ebizwa ngokuthi yokulungiselela. Uma emuva kwalokho kuvela okuthile okungahambi kahle ngeqoqo elithile lemikhiqizo, kuhlale kwenzeka ukuthola ukuthi kwenziwa kanjani, ngubani okuvivinyile nokuthi kusetshenziswe kuphi futhi kusetshenziswe kuphi. Kungenzeka ukulandelela kahle lapho kuhambe khona okungalungile.

Ngenkathi ukulawula okuhle kudingekile ukuqinisekisa ikhwalithi yemikhiqizo yemithi, kufanele kuqashelwe ukuthi inhloso yokugcina yokulawulwa kwekhwalithi ukufezekisa inqubo yokukhiqiza. Ukulawulwa kwekhwalithi kudalelwe ukuqinisekisa umthengi ukuthi umkhiqizo uhlangabezana namazinga wekhwalithi, ukulebula okufanelekile nazo zonke izidingo zomthetho. Kodwa-ke, ukulawulwa kwekhwalithi kukodwa akwanele ukufeza yonke imigomo. Kufanele kube nokuzibophezela ekufezeni ikhwalithi nokwethembeka kuwo wonke umkhiqizo, yonke i-batch. Lokhu kuzinikela kungachazwa kangcono njenge-GMP.

Imithetho nemigomo

Imihlahlandlela ye-GMP ibekwe emithethweni nasezimisweni ezahlukahlukene zezimboni ezahlukahlukene. Kunemithetho nemithetho yamazwe omhlaba, kepha kunemithetho ezingeni laseYurophu kanye nelikazwelonke.

International

Ezinkampanini ezikhipha emazweni aseMelika, imithetho ye-GMP eyenziwa yi-United States Food and Drug Administration (FDA) iyasebenza. Baphoqa imithetho engaphansi kwesihloko 21 seKhodi Yemithetho Yezimali. Imihlahlandlela yaziwa lapho ngaphansi kwegama elithi "yamanje Good Production Practice (cGMP)".

Europe

Imihlahlandlela ye-GMP esebenza ngaphakathi kwe-EU ibekwe phansi emithethweni yaseYurophu. Le mithetho isebenza kuyo yonke imikhiqizo ethengiswa ngaphakathi kwe-European Union noma ngabe umenzi wayo usekelwe ngaphandle kwe-EU.

Emikhiqizweni yokwelapha ehloselwe ukusetshenziswa kwabantu, imithetho ebaluleke kakhulu yomthetho ngu-1252/2014 kanye ne-Directive 2003/94 / EC. Emikhiqizweni yokwelapha ehloselwe ukusetshenziswa kwezilwane i-Directive 91/412 / EC iyasebenza. Kukhona imithetho ehlobene neminye imithetho elawula imakethe yezokwelapha. Izidingo ze-GMP ziyefana kumuntu nakwezimboni zemithi yezilwane.Ngokuba ukuhunyushwa kwezindinganiso ezibekwe kulo mthetho, i-EudraLex inikeza umhlahlandlela. I-EudraLex iqoqo lemithetho elisebenza emithini ngaphakathi kwe-EU. IVolumu 4 ye-EudraLex iqukethe imithetho ye-GMP. Eqinisweni liyincwadi yokusebenzisa izinkombandlela nemigomo ye-GMP. Le mithetho isebenza kubo bobabili emithini yabantu nasezilwaneni.

National

UMnyango Wezempilo, Wezenhlalo Nezemidlalo unquma ezingeni likazwelonke ukuthi ukunakekelwa kwemithi kungangeniswa ngaphansi kwaziphi izimo nokuthi yiziphi izinkomba zokwelashwa. Umthetho Wezemithi uchaza imibandela yokwenziwa kwalo muthi, ukumaketha kwawo kanye nokwabela isiguli. Isibonelo Umthetho we-Opium ukwenqabela ukutholakala kwezidakamizwa ezithile ezisohlwini ll lll of the Opium Act. Kukhona futhi umthethonqubo on preursors. Ngokwale mithetho, osokhemisi bangase bahlise kuphela amakhemikhali kanye / noma ukuhweba amakhemikhali angasetshenziswa ukwenza izidakamizwa noma iziqhumane (izimbangi) ngaphansi kwezimo ezithile. Kukhona futhi imihlahlandlela nemihlahlandlela efana nommiselo we-FMD (isilinganiso uma kuqhathaniswa nokwenziwa kwezinombolo ezilandelanayo) kanye nemihlahlandlela ye-KNMP yokunakekelwa kwemithi kanye neDashi Lokhemisi elijwayelekile.

I-European Medicines Agency (i-EMA) inesibopho sokuhlola isayensi, ukuphatha kanye nokulawula ukuphepha kwemithi e-EU. Umthetho weCosmetic Products Actree ubeka izidingo zokwenza izimonyo.

Izidingo ze-GMP

I-GMP iyingxenye yokuqinisekiswa kwekhwalithi. Ngokuvamile, lesi siqinisekiso, ngaphandle kwe-GMP, sifaka nezindawo ezinjengokwakhiwa komkhiqizo nentuthuko yomkhiqizo. Ukuqinisekiswa kwekhwalithi kungukuphela kwemisebenzi okufanele iqinisekise ukuthi umkhiqizo noma insiza ihambisana nezidingo zekhwalithi. Ukuqinisekiswa kwekhwalithi kungenye yezinto eziyisisekelo zokuphathwa kwekhwalithi. Ukubaluleka kokuphathwa kwekhwalithi kubalulekile. Uma ungacabanga umzuzwana nje ngabe kwenzekani uma kwenziwa amaphutha ekukhiqizweni kwemithi futhi kutholakale sekwephuze kakhulu. Ngaphandle kokuhlupheka kwabantu, kungaba inhlekelele yedumela lenkampani ekhiqiza imithi. Ukwenza okuhle kokukhiqiza kugxila ezingozini ezitholakala ekukhiqizweni kwezidakamizwa, ezinjengokuphambana (ukungcoliswa kwesidakamizwa esisodwa sinezakhi zomunye umuthi) kanye nokuxubana (amaphutha) okubangelwa ukuguquguquka.

Izidingo ezibekwe yi-GMP zokwenziwa kwemikhiqizo zivunyelwe emhlabeni jikelele. Le bhulogi ichaza izidingo ezivela emithethweni ephathelene nomkhakha wezemithi. Ngokuvamile, izimiso ezifanayo eziyisisekelo ziyasebenza kuyo yonke imboni. Lezi zimiso eziyisisekelo ziyeka okufanayo emhlabeni jikelele.

Umthetho wase-Europe udinga ukuthi kwenziwe imikhiqizo yokwelapha ngokuya ngemigomo nemihlahlandlela yokusebenza okuhle. Izici ezembozwe imihlahlandlela ukuphathwa kwekhwalithi, abasebenzi, izakhiwo nemishini, imibhalo, ukukhiqizwa, ukulawulwa kwekhwalithi, ukukhipha, ukukhononda nokukhumbula umkhiqizo kanye nokuzihlola. Umthetho uphoqa umenzi ukuthi asungule futhi aqalise uhlelo lokuqinisekisa ikhwalithi yemithi. Le mithetho iyasebenza nasemikhiqizweni yokwelapha ehloselwe ukuthekelisa.

Imihlahlandlela elandelayo ye-GMP kumele icatshangwe:

  • Abasebenzi abaqeqeshiwe, abaqeqeshiwe,
  • Ukuhlanzeka kugcinwa ngokuqinile. Uma umuntu, ngokwesibonelo ngenxa yesifo esithathelwanayo noma isilonda esivulekile, kukhona isibopho sokwazisa nokulandela inqubo.
  • Ukuhlolwa okujwayelekile kwabasebenzi
  • Okwabasebenzi abahlola okubonakalayo, kukhona nokuhlola okubukwayo okwengeziwe,
  • Imishini efanelekile,
  • Izinto ezinhle, iziqukathi namalebula,
  • Imiyalo yokusebenza evunyelwe,
  • Isitoreji esifanelekile
  • Abasebenzi abenele, indawo yokusebenzela kanye nezinsimbi zokulawula ikhwalithi yangaphakathi,
  • Imiyalo yomsebenzi (Izinqubo Zokusebenza Ezijwayelekile); Imiyalo yomsebenzi ibhaliwe ngolimi olucacile futhi igxile esimweni sendawo,
  • Ukuqeqeshwa; abasebenzi abasebenzayo baqeqeshelwe ukwenza imiyalo yomsebenzi,
  • Imibhalo; yonke into kumele ibe semthethweni ephepheni nasekufanelekeni kwabasebenzi
  • Imininingwane emalebula nakwindlela yokulebhelanisa izinto zokusetshenziswa, imikhiqizo ephakathi nendawo neyiphelile,
  • Kunezinqubo ezichaziwe ngokucacile, ezifakazelwe, ezethembekile zokwenziwa endaweni,
  • Ukuhlolwa nokuqinisekiswa kuyenziwa,
  • Ngesikhathi sokukhiqiza (okwenziwa ngesandla noma okuzenzakalelayo) kubhalwe ukuthi zonke izinyathelo zenziwe kahle,
  • Ukuphambuka emiyalweni kuyaqoshwa futhi kuphenywe kabanzi,
  • Umlando ophelele we-batch ngayinye (kusuka kokuqukethwe kuya kwekhasimende) ligcinwa ngendlela yokuthi lingalandelelwa kalula,
  • Imikhiqizo igcinwa futhi ihanjiswe kahle,
  • Kukhona indlela yokususa amabhathi ekuthengisweni uma kunesidingo,
  • Izikhalazo ngezinkinga zekhwalithi ziyadingidwa futhi ziphenywa ngokwanele. Uma kunesidingo, kuthathwa izinyathelo zokuvimbela ukuphindeka.

Izibopho

I-GMP inikezela uhide lwezibopho kubasebenzi ababalulekile, njengekhanda lokukhiqiza kanye / noma ukulawulwa kwekhwalithi nomuntu ogunyaziwe. Umuntu ogunyaziwe unesibopho sokuqinisekisa ukuthi zonke izinqubo nemikhiqizo yezokwelapha iyenziwa futhi iphathwe ngokuhambisana nemihlahlandlela. Ubuye asayine (ngokoqobo) ngeqoqo ngalinye lemithi eqhamuka efemini. Kukhona futhi umphathi omkhulu, obhekene nokuqinisekisa ukuthi imikhiqizo iyahlangabezana nezidingo ezingokomthetho zeziphathimandla zikazwelonke ngemikhiqizo yezokwelapha, ngaphandle kokubeka iziguli engcupheni ngenxa yokuntuleka kokuphepha, ikhwalithi noma ukusebenza kahle. Kufanele kube sobala, kepha futhi kuyisidingo sokuthi imithi ilungele inhloso eyenzelwe yona.

Isitifiketi sokugada kanye ne-GMP

Kuzo zombili izigaba zase-Europe kanye nakuzwelonke, kukhona abasebenza ophethe umsebenzi wokugada. Lezi yi-European Medicines Agency (i-EMA) ne-Health Care and Youth Inspectorate (IGJ). ENetherlands, i-IGJ inikeza isitifiketi se-GMP isitifiketi kumenzi wemithi uma ethobela imihlahlandlela ye-GMP. Ukwenza lokhu kwenzeke, i-IGJ yenza ukuhlolwa ngezikhathi ezithile kwabakhiqizi eNetherlands ukuphenya ukuthi bayayilandela yini imithetho ye-GMP. Uma imitheshwana ye-GMP ingahlangatshezwanga, umenzi ngeke anqatshelwe isitifiketi se-GMP kuphela, kodwa futhi nemvume yokukhiqiza. IGJ ibuye ihlole abakhiqizi emazweni angaphandle kwe-European Union. Lokhu kwenziwa ngoku-oda kwe-EMA ne-Medicines Evaluation Board (CBG).

Futhi ngesicelo se-Medicines Evaluation Board, i-IGJ yeluleka abakhiqizi kukokugunyazwa kokugunyazwa kokuthengisa (ukuvunyelwa kwendawo). Uma umenzi engasebenzi ngokuhambisana nezidingo zekhwalithi ye-GMP, iBhodi linganquma ukuthi lo mkhiqizi asuswe kokubhaliwe kokugunyazwa kokuthengisa. Ibhodi lenza lokhu ngokubonisana ne-IGJ nezinye iziphathimandla zokuhlola zaseYurophu kanye nemizimba yaseYurophu njengeCoordination Group for Mutual Recognition and Proentralised Proc inqubo - Human (CMDh) ne-EMA. Uma lokhu kungaholela ekushwabeni komuthi eNetherlands, umnikazi wokugunyazwa wokuthengisa kufanele abike lokhu eHhovisi Lama-Medicines Deficiencies and Defects Disclosure Office (Meldpunt geneesmiddelen tekort en -defecten).

Izimonyo kanye ne-GMP

Kwezimonyo, kunemithetho ehlukile yokuqinisekisa ikhwalithi yabo. Ezingeni laseYurophu kuneCosmetics Regulation 1223/2009 / EC. Lokhu futhi kunquma ukuthi izimonyo kumele zihambisane ne-GMP. Inkombandlela esetshenziselwe lokhu yikhambi le-ISO 22916: 2007. Leli zinga liqukethe izimiso eziyisisekelo ze-GMP ezigxile ezinkampanini ezikhiqiza izimonyo eziqediwe. Lokhu kusezingeni lomhlaba jikelele futhi kuvunyelwe futhi yiKomidi laseYurophu (i-CEN). Lokhu kungumzimba wokumisa waseYurophu odala amazinga afuneka kakhulu. Ukusetshenziswa kwalezi zindinganiso akuphoqelekile, kodwa kukhombisa umhlaba ongaphandle ukuthi imikhiqizo noma izinsiza zihlangabezana namazinga asezingeni elifanele. Indikimba yokumisa nayo ithuthukisa 'amazinga avumelanayo' ngesicelo se-European Union.

Le mithethonqubo ye-GMP echazwe kujwayelekile inenhloso efanayo naleyo yomkhakha wezemithi: ukuqinisekisa ikhwalithi nokuphepha komkhiqizo. Leli zinga ligxile kuphela embonini yezimonyo. Kufaka futhi ihlanganisa:

  • ukukhiqizwa,
  • isitoreji,
  • ukupakisha,
  • izinqubo zokuhlola nokuhamba
  • ucwaningo nentuthuko
  • ukusatshalaliswa kwezimonyo eziqediwe
  • ukuphepha kwabasebenzi bokukhiqiza
  • ukuvikela imvelo.

Izinga aligcini ngokuqinisekisa ukusetshenziswa kwezimpawu zomkhiqizo nezimfuneko zokukhiqizwa kwempahla. Ukusebenzisa okujwayelekile kuvumela umenzi ukuthi aphathe izidingo zekhwalithi nezokuphepha kwephakeji lokuhlinzekela futhi aqaphele izingozi nobungozi bezimonyo. Imithetho ye-GMP ihambelana nemithetho ebikade ikhonjwe ngokuningiliziwe esigabeni "Izidingo ze-GMP".

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