Njengefekthri ye-GMP enezinzuzo ezinhle ekukhishweni kwezitshalo, ukuhlukaniswa kanye nokuhlanganiswa, ukulawulwa kwekhwalithi yomkhiqizo kubalulekile.Hande bioineminyango emibili yokuqondisa izinga lomkhiqizo, okunguMnyango Wokuqinisekisa Ikhwalithi (QA) noMnyango Wokulawula Ikhwalithi (QC).
Okulandelayo, masifunde ngeminyango yethu emibili ndawonye!
Kuyini Ukuqinisekiswa Kwekhwalithi?
Ukuqinisekiswa kwekhwalithi kusho yonke imisebenzi ehleliwe nehlelekile eyenziwa ohlelweni lokuphatha ikhwalithi futhi yaqinisekiswa njengoba kudingeka ukuze kuqinisekiswe ukuthi imikhiqizo noma amasevisi angakwazi ukuhlangabezana nezidingo zekhwalithi.
Uhlelo lokuqinisekisa ikhwalithi wukuhlela kahle, ukulinganisa kanye nokwenza imisebenzi yokuqinisekisa ikhwalithi ibe yisikhungo ngokusebenzisa izinhlelo ezithile, imithetho, izindlela, izinqubo kanye nezikhungo.
Ngokuhambisana nesimo sokukhiqiza senkampani, sisungule uhlelo lokuphatha ikhwalithi oluhlanganisa ukusebenza kwenqubo kanye nokuqapha izinga lomkhiqizo, izinyathelo zokulungisa nokuvimbela, ukuphathwa koshintsho nokubuyekezwa kokuphatha.Lolu hlelo lokuqinisekisa ikhwalithi lusekelwe ezinhlelweni eziyisithupha ezinkulu ze-FDA, luhlangabezana nezimfuneko ze-China, United States kanye ne-Europe, futhi lungaphansi kokuhlolwa kwamabhuku noma nini.
Kuyini Ukulawulwa Kwekhwalithi?
Ukulawulwa kwekhwalithi kubhekisela ezinyathelweni zobuchwepheshe kanye nezinyathelo zokuphatha ezithathwayo ukuze kwenziwe imikhiqizo noma amasevisi ahlangabezane nezidingo zekhwalithi.Inhloso yokulawula ikhwalithi ukuqinisekisa ukuthi ikhwalithi yemikhiqizo noma amasevisi angahlangabezana nezidingo (okuhlanganisa nemibandela ecacile, eshiwo ngokwezifiso noma eyisibopho).
Ngamafuphi, umsebenzi oyinhloko womnyango wethu we-QC ukulawula izinga lezimboni nemikhiqizo yethu, futhi sihlole ukuthi imikhiqizo esiyikhiqizayo iyahlangabezana yini nezindinganiso maqondana nama-microorganisms, okuqukethwe nezinye izinto futhi ingahlangabezana nezidingo zamakhasimende.
Isikhathi sokuthumela: Aug-26-2022