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 ekuqaleni kwempucuko, abantu bebekhathazekile ngekhwalithi nokuphepha kokudla nemithi. Ngo-1202 umthetho wokuqala wokudla wamaNgisi wenziwa. Kamuva kakhulu, ngo-1902, lapho i-Organic Control Act yalandelwa. Lokhu kwethulwa e-United States ukulawula imikhiqizo yemvelo. Le mikhiqizo ihlolwe ngokusemthethweni ngobumsulwa. Umthetho woqobo wokudla nezidakamizwa, owasungulwa ngo-1906 wakwenza kwaba semthethweni ukuthengisa ukudla okungcolile (okukhohlisiwe) futhi wafuna ilebuli eneqiniso. Ngemuva kwalokho, eminye imithetho eminingi yaqala ukusebenza. Ngo-1938, Kwethulwa Umthetho Wokudla, Wezidakamizwa Nezimonyo. Umthetho wawudinga ukuthi izinkampani zinikeze ubufakazi bokuthi imikhiqizo yazo iphephile futhi imsulwa ngaphambi kokuba ifakwe emakethe. I-FDA yenze uphenyo lwamathebulethi angcolile yaveza ukuthi ukungahleleki kahle kwezinto ekukhiqizeni kwatholakala efemini nokuthi bekungasakwazi ukuthola ukuthi mangaki amanye amaphilisi asangcolisiwe. Lesi sigameko saphoqa i-FDA ukuthi isebenze ngalesi simo futhi ivimbele ukuphindeka ngokuletha ama-invoicing nezilawuli zekhwalithi ezisuselwa emazingeni wokucwaningwa kwayo yonke imikhiqizo yezemithi. Lokhu kwaholela kulokho okwabizwa kamuva ngokuthi yi-GMP. Isisho esithi "Umkhuba omuhle wokukhiqiza" savela ngeminyaka yo-1962 njengesichibiyelo soMthetho Wezokudla waseMelika, Wezidakamizwa Nezimonyo.
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 ukuthi "indlela enhle yokukhiqiza". Imithetho ye-GMP ifakiwe kuyo yonke inhlobo yemithetho, kepha empeleni le mithetho inenhloso efanayo. I-GMP isetshenziswa kakhulu embonini yezemithi futhi yenzelwe ukuqinisekisa ikhwalithi yenqubo yokukhiqiza. Ikhwalithi yomkhiqizo ayinakunqunywa ngokuphelele ngokuhlola ukwakheka kwayo. Akukhona konke ukungcola okungatholakala futhi akuwona wonke umkhiqizo ongahlaziywa. Ikhwalithi ingaqinisekiswa kuphela uma yonke inqubo yokukhiqiza yenziwa ngendlela enqunyiwe futhi elawulwayo. Ngale ndlela kuphela inqubo yokukhiqiza iqinisekisa ikhwalithi yomuthi. Le ndlela yokukhiqiza, ebizwa ngeNqubo Enhle Yokukhiqiza, ngakho-ke iyimfuneko ekukhiqizeni imithi.
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 ezithumela e-United States, imithetho ye-GMP eyenziwe yi-United States Food and Drug Administration (FDA) iyasebenza. Baphoqelela imithetho ngaphansi kwesihloko 21 sekhodi ye-Federal Regulations. Imihlahlandlela yaziwa lapho ngaphansi kwegama elithi "I-Current Good Manufacturing Practice (cGMP)".
Europe
Imihlahlandlela ye-GMP esebenza ngaphakathi kwe-EU ibekiwe emithethweni yase-Europe. Le mithetho isebenza kuyo yonke imikhiqizo edayiswa ngaphakathi kwe-European Union kungakhathalekile ukuthi umenzi wayo uzinze ngaphandle kwe-EU.
Ngemikhiqizo yokwelapha ehloselwe ukusetshenziswa ngabantu, imithetho ebaluleke kakhulu umthethonqubo 1252/2014 kanye ne-Directive 2003/94 / EC. Ngemikhiqizo yokwelapha ehloselwe ukusetshenziswa kwezilwane i-Directive 91/412 / EC iyasebenza. Kunemithetho nemithethonqubo ehlobene kakhulu elawula imakethe yezokwelapha. Izidingo ze-GMP ziyefana nezomuntu nezimboni zemithi yezilwane Ukuze kuchazwe izindinganiso ezibekwe kulo mthetho, i-EudraLex inikeza umhlahlandlela. I-EudraLex iqoqo lemithetho esebenza emithini engaphakathi kwe-EU. IVolumu 4 ye-EudraLex iqukethe imithetho ye-GMP. Empeleni kuyincwadi yokusebenzisa imigomo nezimiso ze-GMP. Le mithetho isebenza kumuthi womuntu nowesilwane.
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 nokuthuthukiswa komkhiqizo. Ukuqinisekiswa kwekhwalithi yikho konke okwenziwayo okumele kuqinisekiswe ukuthi umkhiqizo noma insizakalo iyahambisana nezidingo zekhwalithi. Ukuqinisekiswa kwekhwalithi kungenye yezinto eziyisisekelo zokuphathwa kwekhwalithi. Ukubaluleka kokuphathwa kwekhwalithi kubalulekile. Uma ucabanga umzuzwana nje bekungenzekani uma kunamaphutha enziwa ekukhiqizweni kwemithi bese etholwa sekwephuze kakhulu. Ngaphandle kokuhlupheka kwabantu, kungaba yinhlekelele ukuduma kwenkampani eyenza imithi. Umkhuba omuhle wokukhiqiza ugxila ezingcupheni ezitholakala ekukhiqizweni kwezidakamizwa, njengokungcola okuphambene (ukungcoliswa komuthi owodwa onezakhi zomunye umuthi) kanye nokuxuba (amaphutha) okubangelwa ukungahanjiswa kahle kwamagama.
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 uchungechunge lwezibopho kubasebenzi abalulekile, njengenhloko yezokukhiqiza kanye / noma ukulawula ikhwalithi kanye nomuntu ogunyaziwe. Umuntu ogunyaziwe unesibopho sokuqinisekisa ukuthi zonke izinqubo nemikhiqizo yokwelapha yenziwa futhi isingathwa ngokulandela imihlahlandlela. Usayina (ngokwezwi nezwi) iqoqo ngalinye lemithi evela efektri. Kukhona nemenenja enkulu, enesibopho sokuqinisekisa ukuthi imikhiqizo ihlangabezana nezimfuneko zomthetho zeziphathimandla zikazwelonke zemikhiqizo yokwelapha, ngaphandle kokubeka iziguli engcupheni ngenxa yokuntuleka kokuphepha, ikhwalithi noma ukusebenza kahle. Kufanele kube sobala, kepha futhi kuyimfuno yokuthi imithi ilungele inhloso ehloselwe 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 ngokwesicelo seBhodi Yezokuhlolwa Kwemithi, i-IGJ yeluleka abakhiqizi kudokhumende lokugunyazwa kwezokukhangisa (imvume yesiza). Uma umkhiqizi engasebenzi ngokuya ngezidingo zekhwalithi ye-GMP, Ibhodi lingathatha isinqumo sokuthi lo mkhiqizi asuswe embhalweni wokugunyazwa kokumaketha. Ibhodi likwenza lokhu ngokubonisana ne-IGJ kanye nezinye iziphathimandla zokuhlola zaseYurophu nezinhlangano zaseYurophu ezifana neCoordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) kanye ne-EMA. Uma lokhu kungaholela ekushodeni kwemithi eNetherlands, umnikazi wokugunyazwa kokumaketha kumele akubike lokhu kwi-Medicines Deficience and Defects Disclosure Office (Meldpunt geneesmiddelen tekort en -defecten).
Izimonyo kanye ne-GMP
Okwezimonyo kunemithetho ehlukile yokuqinisekisa ikhwalithi yazo. Ezingeni laseYurophu kuneCosmetics Regulation 1223/2009 / EC. Lokhu futhi kunquma ukuthi izimonyo kufanele zithobele i-GMP. Umhlahlandlela osetshenziselwe lokhu yizinga le-ISO 22916: 2007. Leli zinga liqukethe imigomo eyisisekelo ye-GMP egxile ezinkampanini ezikhiqiza izimonyo eseziqediwe. Leli yindinganiso yamazwe omhlaba futhi iphinde yamukelwa yiKomidi laseYurophu Lokumiswa Okujwayelekile (CEN). Lo ngumzimba wokulinganisa waseYurophu odala amazinga adingeka kakhulu. Ukusetshenziswa kwalawa mazinga akuphoqelekile, kepha kukhombisa umhlaba wangaphandle ukuthi imikhiqizo noma izinsizakalo ziyahlangabezana nezindinganiso zekhwalithi. Umzimba wokwenziwa kwamazinga nawo athuthukisa 'amazinga ahambisanayo' ngokucela kwe-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 aliqinisekisi kuphela ukusetshenziswa kwezinqubo zomkhiqizo nezidingo zokukhiqizwa kwempahla. Ukusebenzisa indinganiso kuvumela umenzi ukuthi aphathe izidingo zekhwalithi nezokuphepha kochungechunge lokuphakelwa kanye nokuqapha izingozi nezingozi zezimonyo. Imithethonqubo ye-GMP iyahambisana nemithetho eyayishiwo phambilini ngokuningiliziwe esigabeni "Izidingo ze-GMP".
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