Sefekitari yeGMP ine mabhenefiti makuru mukuchera zvidyarwa, kupatsanura uye synthesis, kutonga kwemhando yechigadzirwa kunokosha.Hande bioine madhipatimendi maviri mukutariswa kwemhando yechigadzirwa, anoti, Quality Assurance department (QA) uye Quality Control Dhipatimendi (QC).
Tevere, ngatidzidzei nezvemadhipatimendi edu maviri pamwe chete!
Chii chinonzi Quality Assurance?
Simbiso yemhando inoreva zvese zvakarongwa uye zvakarongeka zviitiko zvinoitwa mumhando yekutonga system uye yakasimbiswa sezvinodiwa kuti ive nechokwadi chekuti zvigadzirwa kana masevhisi anogona kuzadzisa zvinodiwa zvemhando.
Hunhu hwekusimbisa hurongwa ndeyekugadzirisa, kumisa uye kuisa hurongwa hwekuita zvemhando yepamusoro kuburikidza nemamwe masisitimu, mitemo, nzira, maitiro uye masangano.
Mukubatana nemamiriro ekugadzirwa kwekambani, takagadzira hurongwa hwehutongi hwemhando hunosanganisira mashandiro ekuita uye kutarisa kwemhando yechigadzirwa, matanho ekugadzirisa uye ekudzivirira, shanduko manejimendi uye manejimendi ongororo.Iyi yemhando yekusimbisa sisitimu yakavakirwa pane matanhatu makuru masisitimu eFDA, inosangana nezvinodiwa neChina, United States neEurope, uye inogona kuongororwa chero nguva.
Chii chinonzi Quality Control?
Kudzora kwehunhu kunoreva matanho ehunyanzvi uye manejimendi matanho anotorwa kuita kuti zvigadzirwa kana masevhisi asangane nezvinodiwa zvemhando.Chinangwa chekutonga kwemhando ndechekuona kuti mhando yezvigadzirwa kana masevhisi anogona kusangana nezvinodiwa (kusanganisira zvakajeka, zvechivanhu kana zvinosungirwa kupihwa).
Muchidimbu, basa guru redhipatimendi redu reQC nderekudzora kunaka kwemafekitari nezvigadzirwa zvedu, uye kuongorora kana zvigadzirwa zvatinogadzira zvichisangana nezvinodiwa maererano nehutachiona, zvirimo uye zvimwe zvinhu uye zvinogona kuzadzisa zvinodiwa nevatengi.
Nguva yekutumira: Aug-26-2022