Imithethonqubo Yokungenisa Izinto Ezingavuthiwe Zemithi
Ukungeniswa kwezinto zokusetshenziswa kwemithi kudlala indima ebalulekile ekugcineni ukukhiqizwa kwemithi yasekhaya kuqhubeka. Izimboni eziningi zemithi zisathembele ezithakweni zemithi ezisebenzayo (ama-API) ezivela kwamanye amazwe kanye nezinto ezisizayo ngenxa yomthamo olinganiselwe wokukhiqiza ekhaya, isidingo semininingwane ethile, noma ukucatshangelwa kokusebenza kahle kwezindleko. Kodwa-ke, ngenxa yokuthi izinto zokusetshenziswa kwemithi zizoba yingxenye yemikhiqizo esetshenziswa umphakathi, inqubo yokungenisa ilawulwa ngokuqinile. Imithethonqubo yokungenisa ayihlanganisi nje kuphela izici zokuhweba kodwa futhi nekhwalithi, ukuphepha, ukulandeleka, kanye nokuvimbela ukungena kwezinto ezingekho emthethweni noma ezingaphansi kwezindinganiso.
Kungani ukungeniswa kwezinto zokusetshenziswa kwemithi kulawulwa ngokuqinile?
Izinto zokusetshenziswa zemithi ziyisisekelo sekhwalithi yemithi. Uma izinto zokusetshenziswa zingcolisiwe, zibhalwe ngendlela engafanele, noma zingahlangabezani nezimfuneko, umthelela ungaba mkhulu: ukwehla kokusebenza kahle kwemithi, ukuvela kwemiphumela emibi eyingozi, ngisho nokukhushulwa komkhiqizo okuphazamisa izinsizakalo zokunakekelwa kwempilo. Ngakho-ke, imithethonqubo yokungenisa ihlose ukuqinisekisa ukuthi zonke izinto zokungenisa zihlangabezana nezidingo ze-Good Manufacturing Practices (GMP), amazinga e-pharmacopoeial, kanye nezidingo zeziphathimandla ezilawula ukudla nezidakamizwa.
Ngakolunye uhlangothi, imithethonqubo nayo idlala indima ekuvikeleni imakethe emikhubeni yokuhweba engafanele, njengokufaka imali engaphansi kwe-invoyisi, ukushushumbisa, ukuqamba amanga ngamadokhumenti, noma ukungenisa okuvela kubaphakeli abangenazo izinhlelo zekhwalithi ezanele. Ngohlaka olucacile lokulawula, uhulumeni angalinganisa isidingo semboni sempahla eluhlaza kanye nesibopho sikahulumeni sokuqinisekisa ukuphepha komphakathi.
Ukuhlukaniswa kwezinto zokusetshenziswa kwemithi ngokwesimo sokungeniswa kwamanye amazwe
Ngokuvamile, izinto zokusetshenziswa kwemithi ezingenisiwe zingahlukaniswa zibe:
1. Isithako esisebenzayo (i-API): isithako esisebenzayo esinikeza umphumela wokwelapha womuthi. Ama-API ngokuvamile anezidingo eziqinile kakhulu ngoba athinta ngqo ukusebenza kahle nokuphepha.
2. Izinto ezisizayo: izinto ezengeziwe ezifana nezigcwalisi, izihlanganisi, izithako zokugcina, izinyibilikisi, izimbozo, njalo njalo. Nakuba zingezona izithako ezisebenzayo, izinto ezisizayo kumele zisahlangabezane nezindinganiso zekhwalithi ngoba zingathinta ukuzinza nokuphepha komkhiqizo.
3. Izinsiza zenqubo: isibonelo izinyibilikisi ezithile noma izinto ezisetshenziswa ngesikhathi sokukhiqiza, ezingase zingahlali emkhiqizweni wokugcina kodwa zisalawulwa ngenxa yengozi yokungcola.
4. Izinto ezikhethekile: kufaka phakathi izinto ezihlukaniswe njengezibikezelo, izidakamizwa ezingokwengqondo noma izidakamizwa, ngokuvamile ezinezigaba eziningi zokuqapha.
Lo mehluko wezigaba uvame ukuthinta izinga lezidingo zedokhumenti, izindlela zokunikeza amalayisense, kanye nokuqapha.
Ilayisensi kanye neziphathimandla
Empeleni, ukungenisa izinto zokusetshenziswa kwemithi kuhilela abathintekayo abaningana: ongqongqoshe/ama-ejensi alawula ukuhweba, iziphathimandla ezilawula izidakamizwa, kanye neziphathimandla zentela. Izinkampani ezingenisa imithi—ngokuvamile izimboni zemithi, abathengisi bemithi ngobuningi, noma izinkampani ezinezimvume zomthetho—kumele ziqinisekise ukuba semthethweni kwebhizinisi lazo, ukufaneleka kwezinhlelo zazo zekhwalithi, kanye nokulungela kwezindawo zazo zokugcina impahla.
Ngaphezu kwezimvume zebhizinisi, izinkampani kumele futhi zilandele imithethonqubo ephathelene nokubhaliswa/ukuhlolwa kwabaphakeli, ukuvunyelwa kokungeniswa kwempahla, kanye nemibhalo ephelele yekhwalithi. Ukuhlolwa kungenziwa ngaphambi kokuthunyelwa, lapho kufika, noma ngemva kokuba izimpahla zingene endaweni yokugcina impahla (ngemuva komngcele), kuye ngokuthi uhlelo lokuqapha lusetshenziswa kanjani.
Imibhalo eyinhloko yokungenisa izinto zokusetshenziswa kwemithi
Ukuze izinto zokusetshenziswa zamukelwe ukuze zisetshenziswe ekukhiqizeni, amadokhumenti avame ukudingeka afaka:
– Isitifiketi Sokuhlaziya (CoA): idokhumenti yokuhlaziya ikhwalithi evela kumenzi echaza imiphumela yokuhlolwa kanye nokuhambisana nemininingwane.
– Ishidi Ledatha Lokuphepha Kwezinto (MSDS/SDS): ulwazi mayelana nokuphepha kwezinto, izingozi, ukuphathwa, kanye nokugcinwa kwazo.
– Amadokhumenti okuqala kanye nochungechunge lokuhlinzeka: kufaka phakathi ama-invoyisi, uhlu lokupakisha, ama-bill of ladding/airway bills, kanye nezitifiketi zokuqala uma kudingeka.
– Imininingwane yezinto ezibonakalayo: bheka i-pharmacopoeias noma izindinganiso zangaphakathi eziqinisekisiwe.
– Imibhalo ye-GMP: ubufakazi bokuthi umenzi we-API/excipient usebenzisa i-Good Manufacturing Practice (GMP). Kwezinye izimo, imibhalo yokuhlola abahlinzeki kanye nemibiko yeziqu nayo iyacelwa.
– Imibhalo eyengeziwe yezinto ezithile: isibonelo, izitatimende ezingenayo i-BSE/TSE zezinto ezivela ezilwaneni, izitifiketi ze-halal uma zifanele, noma izimvume ezikhethekile zezinto ezihlukaniswe njengeziyingozi.
Ukuphelela kwale mibhalo akuyona nje into ehlelekile; imboni yezemithi kudingeka ukuthi iwaqinisekise ngoba azothonya isinqumo sokukhipha izinto zokusetshenziswa ukuze zikhiqizwe.
Inqubo yokuqapha emngceleni kanye nangemva kokungena (ngemuva komngcele)
Ukuqapha ukungeniswa kwezinto zokusetshenziswa kwemithi kungenziwa ngezindlela ezimbili. Okokuqala, ukulawulwa kwemingcele, okuhlanganisa ukuhlola izimpahla lapho zifika echwebeni noma esikhumulweni sezindiza. Lokhu kuhlanganisa ukuhlolwa kwamadokhumenti, ukuhlolwa ngokomzimba uma kudingeka, kanye nokuhlolwa kwelabhorethri kwezimpahla ezithile ezibhekwa njengeziyingozi.
Okwesibili, ukuqapha ngemva komngcele, lapho izimpahla zingangena khona ngokushesha, kodwa izinkampani kudingeka zihambisane nezidingo zokubika, zokugcina, kanye nokulungela ukuhlolwa. Le ndlela igcizelela umthwalo wemfanelo webhizinisi osekelwe ekulandeleni imithetho kanye nokuphoqelelwa komthetho ngokuhlola, ukuhlolwa, kanye nezijeziso uma kutholakala ukwephulwa kwemithetho.
Kuwo womabili amamodeli, izici ezinquma izinga lokuhlolwa ngokuvamile ziyiphrofayili yengozi: umlando wokuthobela imithetho womthumeli, uhlobo lwezinto ezibonakalayo, izwe avela kulo, idumela lomhlinzeki, kanye nerekhodi lekhwalithi langaphambilini.
Izidingo zekhwalithi kanye nezinhlelo zokuphatha ikhwalithi
Ngale kokuphathwa kokungeniswa kwempahla kwamanye amazwe, isici esibaluleke kakhulu ukuqinisekisa ikhwalithi. Izimboni zemithi ezisebenzisa izinto ezingenisiwe kudingeka zibe nohlelo lokufaneleka lwabaphakeli, okuhlanganisa:
– ukuhlolwa kokuqala komhlinzeki (uhlu lwemibuzo, imibhalo ye-GMP, ukuhlolwa kwamabhuku),
- isivumelwano sekhwalithi,
– uhlelo lokuhlola izinto zokusetshenziswa ezisekelwe engcupheni (ukuhlolwa okungenayo),
– ukulandeleka kwenqwaba/iqembu kanye nohlelo lokuphatha izikhalazo noma ukuphambuka.
Uma izinto ezingavuthiwe zingahlangabezani nezimfuneko, izinqubo zokuhlukaniswa, uphenyo, ngisho nokubhujiswa noma ukubuyiselwa kumele kwenziwe ngokuhambisana nemithethonqubo. Ngaphezu kwalokho, izinto ezizwela izinga lokushisa kanye nomswakama kumele ziphathwe kusetshenziswa uchungechunge olubandayo noma izilawuli zemvelo ezanele, zigcwele ama-data logger kanye namarekhodi okuthuthwa.
Imithethonqubo yezinto eziyingozi kakhulu
Ezinye izinto zokusetshenziswa zidinga ukugadwa okwengeziwe, isibonelo:
- izandulela zemithi ezingasetshenziswa kabi ekukhiqizeni izidakamizwa ezingekho emthethweni,
– imithi ethile yokulwa namagciwane ngenxa yengozi yokumelana nezinkinga zokungcola,
- izinyibilikisi namakhemikhali ayingozi anezinhlinzeko zokuphepha kwezokuthutha,
– izinto eziphilayo noma lezo ezingaba yingozi yokuphepha kwezinto eziphilayo.
Kuleli qembu, izidingo zingase zihlanganise izimvume ezikhethekile, izilinganiso, ukubika ngezikhathi ezithile, kanye nemikhawulo kubathumeli abathile. Umgomo ukuvimbela ukuxhashazwa ngenkathi kuqinisekiswa ukuphathwa okuphephile.
Izinselele ezivame ukuvela ekungeniseni izinto zokusetshenziswa kwemithi kwamanye amazwe
Nakuba imithethonqubo yenzelwe ukuvikela umphakathi, ukusetshenziswa kwayo kungabhekana nezinselele, okuhlanganisa:
1. Ukungafani kwedokhumenti: I-CoA ayikho kwifomethi efanele, imininingwane ayicacile, noma kukhona umehluko egameni lezinto ezibonakalayo kanye nekhodi ye-HS.
2. Ukwehluka kwezindinganiso phakathi kwamazwe: umehluko kuma-pharmacopoeias, izindlela zokuhlola, noma izindlela zokwamukela.
3. Isikhathi eside sokuhola: izinqubo zokunikeza amalayisense nokuhlola zingandisa isikhathi sokulethwa, zithinte isitoko sokukhiqiza.
4. Izinguquko zomthetho: izinqubomgomo zokungenisa zingashintsha kuye ngezimo zenqubomgomo yezomnotho, yezempilo, noma yezimboni.
5. Abahlinzeki bomgunyathi nabangathembekile: izingozi ziyanda ezintweni ezidingeka kakhulu futhi ezitholakalayo zincane.
Ukuze kuxazululwe lokhu, izinkampani zidinga ukwakha umsebenzi oqinile wokuthobela imithetho, zisebenzisane nabaphakeli abathembekile, futhi zilondoloze ukuxhumana okujulile neziphathimandla ezifanele.
Amasu okuthobela imithetho embonini
Ukuqinisekisa inqubo yokungenisa ebushelelezi futhi ehambisanayo, amanye amasu avame ukusetshenziswa yile:
– lungiselela uhlu lokuhlola lwemibhalo yokungenisa kanye nekhwalithi yohlobo ngalunye lwezinto,
– ukwenza ukuhlolwa kwabahlinzeki njalo,
– sebenzisa ukuphathwa kwengozi ukuze kunqunywe izinga lokuhlolwa okuzayo,
– qinisekisa ukuthi izindawo zokugcina impahla ziyahlangabezana nezidingo zokugcina (kufaka phakathi ukuqapha izinga lokushisa/umswakama),
– lungiselela izinhlelo zokulandelela kanye nokulungiselela ukukhumbula,
– ukusebenzisa izinsizakalo zokuthutha ezinolwazi ekuphatheni imikhiqizo yemithi.
Ukuthobela imithetho njalo akugcini nje ngokunciphisa ingozi yezijeziso, kodwa futhi kuthuthukisa ukwethembeka kokuhlinzekwa kanye nedumela lenkampani kubalingani bebhizinisi.
I-Penutup
Ukulawulwa kokungeniswa kwezinto zokusetshenziswa kwemithi kuyithuluzi elibalulekile lokuqinisekisa ikhwalithi nokuphepha kwemithi esakazwa emphakathini. Ngokusebenzisa amalungiselelo okuthola amalayisense, imibhalo ephelele, ukuqapha okusekelwe engcupheni, kanye nokusetshenziswa kwezinhlelo zekhwalithi embonini yonke, ingozi yezinto ezingaphansi kwekhwalithi engena emakethe ingancishiswa. Phakathi kwesidingo esikhulayo sokuhlinzekwa kanye nokuguquguquka kokuhweba komhlaba wonke, ukuthobela imithetho yokungenisa akuyona nje isibopho sokuphatha kodwa yingxenye ebalulekile yesibopho semboni yemithi empilweni yomphakathi.
Uma ufisa, ngingaguqula lesi sihloko ukuze siqonde ngqo umongo wase-Indonesia (ngikhuluma ngama-ejensi nezinqubo zokunikeza amalayisense), noma ngidale inguqulo yobuchwepheshe enezinyathelo zenqubo yokungenisa kusukela ekuthunyelweni kusengaphambili kuya ekukhishweni kwezinto ezigcinweni.
