Njengoba siqala omunye unyaka, ngifuna ukugxila kokuthile okuzosungula ngethemba umbono omusha mayelana nokukhucululwa kwendle: “Isimo sengqondo” empeleni “siwukuphakama.”
Uma sinesimo sengqondo esibi noma sokudebesela mayelana nokukhucululwa kwendle futhi sixhumane, sidlula nje, maduzane amakhasimende ethu azoshintsha isimo sethu sengqondo futhi aqale ukungakhululeki. Okulandelayo, bakhathazeka ngokuthi ukuphepha noma izinga lokudla kungase kube sengozini futhi ekugcineni banqume ukuthi ingozi yokutheleleka inkulu kakhulu futhi bahambe baye emadlelweni aphephile. Kodwa, uma sinombono omuhle mayelana nokukhucululwa kwendle, engikubiza ngokuthi, “Ngaphezulu Kokungcono Kakhulu,” futhi silwela ukweqa izimfuneko zokulawula, siyohlala sifunwa ngamakhasimende. Isithunzi sethu sizosandulela, futhi lelo sithunzi sizoba sezingeni eliphakeme kakhulu.
Kufanele ubheke uhlelo lwakho lokukhucululwa kwendle njengembuyiselo ekutshalweni kwezimali; iyisikhungo senzuzo kanye nenqubomgomo yomshwalense evikela ukutshalwa kwezimali kwakho kwesikhathi, umsebenzi, imali namandla owachithwa ekukhiqizeni umkhiqizo osezingeni eliphezulu emakethe yomhlaba wonke enokuncintisana.
Ngibona imithethonqubo, efana nama-GMP, njengophawu lwebhentshi. Yizona “ezingcono kakhulu” mayelana nalokho okufanele kwenziwe ukuze kuvikelwe ukuphepha kokudla. Kodwa, ngikubekela inselelo yokuthi ubheke ngale kwebhentshimakhi.
Isimo sengqondo esijwayelekile mayelana nohlelo lokukhucululwa kwendle ukuthi kuthatha isikhathi kude nokukhiqizwa, kuhlanganisa ithimba lokuthuthwa kwendle, amakhemikhali athile kanye nemishini; ukuthi kubiza kakhulu futhi akulethi inzuzo.
Ukubuka Okuhlukile
Umbono wami ngohlelo lokukhucululwa kwendle wehluke kancane. Ngikholelwa ukuthi kufanele kuqale ngomongameli wenkampani futhi kusebenze indlela yayo kuze kufike kubasebenzi bemikhumbi nabamukelayo—kusuka kumphathi olawula ikhwalithi kuye kubantu abaseqenjini lezokukhucululwa kwendle, kusukela kumqaphi kuya kowamukelayo oletha izinto zokusetshenziswa. . Ngaphandle uma ubheka ukukhucululwa kwendle kwesitshalo sakho njengombono ophelele, awusoze waba nohlelo lokukhucululwa kwendle “Olungaphezu Kokungcono Kakhulu.”
Kule makethe yomhlaba, leso simo sengqondo sizobeka ikhono lakho lokuncintisana engozini. Kungani? ngoba asisesona isizwe esizimele kodwa sesiyisizwe esisemhlabeni wonke. Sine-NAFTA, ibhulokhi yokuhweba yaseYurophu, ibhulokhi yokuhweba yase-Asia, njll. Uma ucabanga ukuthi ukuncintisana komhlaba kusekelwe nje enanini, unephutha. Akekho umthengi eYurophu noma kwenye indawo ozothenga umkhiqizo esitshalweni esinombono ongemuhle ngekhwalithi noma ongenalo uhlelo oluphelele lokukhucululwa kwendle.
21CFR .110 uphawu lwebhentshi. Lawa ama-GMP abekwe yi-FDA. Zavela ngenxa yokuthi abanye abacubungula ukudla bengenandaba noma befisa ukucabangela ukuphepha kokudla emisebenzini yabo yokucubungula. Ama-GMP amahhala futhi atholakala nge-FDA noma esitolo sezincwadi sikahulumeni. Zimfushane, zicacile, ziyaqondakala futhi zilula. Ake sibheke i-GMP eyodwa futhi sibone ukuthi singaya kanjani “Ngaphezulu Kokungcono Kakhulu.”
21 CFR 110.35 (D): “Ukukhucululwa kwendle ezindaweni ezithinta ukudla. Zonke izindawo ezithinta ukudla, okuhlanganisa izitsha nezinto ezithinta ukudla zemishini, zizohlanzwa kaningi ngangokunokwenzeka ukuze kuvikelwe ekungcolisweni kokudla.”
Isicelo esilula, kodwa wenzani ukuze weqe okuhle kakhulu?
Bhala phansi ukuhlanza kwakho lezi zindawo ezithinta ukudla. Yiba nesimiso sokuhlanza esicacisayo ukuthi ubani ohlanze ini, nini, kanjani futhi ngani.
Hlola izindawo ezithinta ukudla ukuthi azingcoli yini ngokwenza i-Bac T's, i-ATP ngeyunithi yokuhlola ye-ATP (ngithumele i-imeyili uma udinga ulwazi ngalokhu) kanye nokuhlola okubonakalayo kwefilimu ye-bio. Indawo othinta kuyo ukudla kufanele ihlanzeke kunomkhiqizo wokudla owubeka kuwo!
Thola ikhophi yama-GMP futhi ubuyekeze into ngayinye, bheka izindlela ongaya ngazo “Ngaphezulu Kokungcono Kakhulu” ukuze udlule izimfuneko zokulawula futhi uhlangabezane noma weqe izimfuno zamakhasimende akho.
Amandla Okushayela
Amandla agqugquzela uhlelo olukhulu lokukhucululwa kwendle akuwona umthetho. Ikhasimende lakho.
Ukudlulela ngalé kokungcono kakhulu, ibhentshimark okuyi-GMPs, ihilela ukusungula ukuqeqeshwa kokukhucululwa kwendle okuklanyelwe ukuhlangabezana nezidingo zomnyango ngamunye wesikhungo sakho.
Okokuqala, abaphathi badinga ukuqeqeshwa kwezokukhucululwa kwendle ukuze bakhe ubuholi obungcono kanye nesimo sengqondo esihle okufanele bonke abasebenzi basilandele. Isimo sengqondo esihle ngabaphathi mayelana nokukhucululwa kwendle kwezitshalo kungasebenza ukuze kuqedwe ukulahlekelwa kwezimali ngenxa yokukhumbula, ukungcoliswa komkhiqizo noma ukunganeliseki kwamakhasimende. Okulandelayo, abasebenzi be-QC banezidingo ezengeziwe zokuqeqeshwa kanye nezinsizakalo ezibalulekile abangazihlinzeka ukuze basize ithimba lokuthuthwa kwendle. Ithimba lezokuthuthwa kwendle linezidingo zokuqeqeshwa kwezobuchwepheshe bokuthuthwa kwendle kanye nesidingo sokuqonda phakathi kweminyango ngokubaluleka kokuthuthwa kwendle.
I-OJT (ukuqeqeshwa emsebenzini) ayinqamuli. Ukuqasha nje umuntu ngomholo ophansi futhi ubatshele ukuthi "bahlanze imishini" ngaphandle kokunikeza ukuqeqeshwa okudingekayo kuyisethi yokwehluleka. Omunye umprosesa wangitshela, “Kwenzekani uma ngikuqasha ukuthi uqeqeshe abantu bami bese behamba?” Impendulo yami yaba ukuthi, “Kwenzekani uma ngingabaqeqeshi futhi bahlale?”
I-turnover iyizaba ezimbi zokungaqeqesheki. Ukuze unciphise inzuzo, tshala imali ohlelweni lwakho lokukhucululwa kwendle. Uma wenza lokho ubeka inani kumuntu, isikhundla kanye nohlelo oluphelele.
Uma uzokwenza konke esikhulume ngakho lapha, ngokuqinisekile uzoba nohlelo lokukhucululwa kwendle “Olungaphezu Kokungcono Kakhulu” ngempela.