Mekhoa e metle ea tlhahiso kapa gmp ke sistimi e nang le lits'ebetso, e kang lijo, litlolo, li lula li laoloa le ho tsamaisoa ho latela maemo a boleng. Ho kenya tšebetsong gPP e ka thusa ho fokotsa tahlehelo le litšila, qoba ho hopola, ho ts'oaroa le teronkong le teronkong le chankaneng. Ka kakaretso, e sireletsa botsoalle le bareki liketsa tse mpe tsa lijo.
GPPS e hlahloba le ho akaretsa karolo e 'ngoe le e' ngoe ea ts'ebetso ea ho etsa lintho hore e itebeletse likotsi bakeng sa lihlahisoa tse tšelisang, tse felisang le ho etsa litšila. Libaka tse ling tse ka amang polokeho le boleng ba lihlahisoa tse tataisang le aterese tsa marang-rang ke tse latelang:
Bakhabane ba Mahlale
Bohloeki le Bohloeki
Ka meaho le lits'ebeletso
TLHOKOMELISO
·Lisebelisoa tse so fetoloe
Monna
Tutlalatso le Tloaelo
Molemo
Litemana le ho rekota ho boloka
Lipatlisiso tsa boleng bo holimo
Phapang ke efe lipakeng tsa GMP le CGP?
Mekhoa e metle ea tlhahiso (GMP) le tloaelo e ntle ea tlhahiso ea tlhahiso e ntle (CGP) ke, maemong a mangata, e hokahane. GMP ke tsamaiso ea mantlha ea lijo le tsamaiso ea lithethefatsi (FDA) tlasa bolaoli ba lijo tsa mmuso, lithethefatsi le ketso ea litlolo ho netefatsa hore lihlahisoa tsa bona li sireletsehile ebile li sebetsa hantle. Ka lehlakoreng le leng, CGP e sebelisitsoe ke FDA e tla boela e ntlafatsoe khafetsa mabapi le mokhoa o tsoelang pele ea bahlahisi ba sehlahisoa ho hlahisa boleng. E bolela boitlamo bo sa feleng ho litekanyetso tsa boleng bo phahameng ka ho fetisisa ka tšebeliso ea litsamaiso le mahlale a morao-rao.
Likarolo tse 5 tsa mantlha tsa ts'ebetso e ntle ea ho itlopanya ke Life?
E ea bohlokoa indastering ea ho etsa tlhahiso ea ho laola GMP ho netefatsa boleng bo sa fetoheng le polokeho ea lihlahisoa. Ho tsepamisa maikutlo ho tse latelang tse peli tsa GMP ho thusa ho latela melao e thata ts'ebetsong ea tlhahiso ea lihlahisoa.
Li-5 p tsa GMP
1. Batho
Basebetsi bohle ba lebelletsoe ho latela ka tieo lits'ebetsong tsa thepa le melaoana. Koetliso ea hona joale ea GMP e tlameha ho etsoa ke basebetsi bohle ho utloisisa likarolo le boikarabello ba bona feela. Ho lekola ts'ebetso ea bona ho thusa ho matlafatsa tlhahiso ea bona ea tlhahiso, katleho le bokhoni.
2. Lihlahisoa
Lihlahisoa tsohle li tlameha ho leka ho leka kamehla, ho bapisoa le tiiso ea boleng pele e tsamaisa bareki. Baetsi ba lokela ho netefatsa hore lisebelisoa tsa mantlha li kenyelletsa lihlahisoa tsa mantlha le likarolo tse ling li na le litlhaloso tse hlakileng ka mohato o mong le o mong oa tlhahiso. Mokhoa o tloaelehileng o tlameha ho bonoa bakeng sa ho paka, ho hlahlojoa le ho abela lihlahisoa tsa mohlala.
3. Ts'ebetso
Ts'ebetso e lokela ho tlalehoa hantle e hlakileng, e thata, e feto-fetohang, e feto-fetohang, e feto-fetohang, e fetotsoeng le ho abela basebetsi bohle. Tlhahlobo ea kamehla e lokela ho etsoa ho netefatsa hore basebetsi bohle ba latela mekhoa ea hajoale 'me ba khotsofatsa litekanyetso tse hlokahalang tsa mokhatlo.
4. Tsamaiso
Mokhoa ona ke lethathamo la litataiso tsa ho khetha ts'ebetso e nyarosang kapa karolo ea ts'ebetso ho fihlela sephetho se sa fetohe. E tlameha ho beoa ho basebetsi bohle 'me e latela nako e telele. Maikutlo afe kapa afe ts'ebetsong ea maemo a tloaelehileng ho lokela ho tlaleheloa hanghang 'me u hlahlojoe.
5. Memona
Mabaka a lokela ho khothaletsa bohloeki ka linako tsohle ho qoba tšilafalo, likotsi kapa esita le ho bolaea. Lisebelisoa tsohle li lokela ho beoa kapa li bolokiloe hantle le tse lekanyelitsoeng khafetsa ho netefatsa hore li loketse sepheo sa ho thibela litholoana tse sa atleheng.
Melao-motheo e 10 ea GMP ke efe?
1. Etsa lits'ebetso tsa lintho tse tloaelehileng (sops)
2. Enyelletsa / ho kenya tšebetsong lintlha le litaelo tsa mosebetsi
3. Ts'ebetso le lits'ebetso tsa tokomane
4. Netefatsa katleho ea SOPS
5. Moralo le sebelisa lits'ebetso tsa ho sebetsa
6. Boloka litsamaiso, lisebelisoa le lisebelisoa
7. Hlaolela bokhoni ba mosebetsi
8. Thibela litšila ka bohloeki
9. Pele ho boleng le ho hokahana ho ea ho workflow
10.Candud GMP Aututes khafetsa
Tsela ea ho Etsahala le GBoholo ba MP
Tataiso le litlhahiso tse arabang litaba tse fapaneng tse ka susumetsang polokeho le boleng ba sehlahisoa. Ho kopana le gPP kapa litekanyetso tsa CGP ho thusa mokhatlo ho latela melao ea maoto, ho ntlafatsa mokhoa oa bareki, ho eketsa thekiso, 'me u fumane chelete e ngata ea matsete.
Ho tsamaisa GPP Lekola ho bapala karolo e kholo ea ho lekola ho latela mokhatlo o hlophisitsoeng oa li-protocols le litataiso. Ho etsa tlhahlobo khafetsa ho ka fokotsa kotsi ea bofebe le tšebeliso e mpe. Tlhahlobo ea GPP e thusa ho ntlafatsa ho ntlafatsa ts'ebetso ea litsamaiso tse fapaneng ho kenyeletsa tse latelang:
Ka meaho le lits'ebeletso
Tsamaiso ea Masters
Litsamaiso tsa taolo ea boleng
Etsa tlhahiso
Ho nka karolo le ho ratoa ka tsela e tšoanang
Litsamaiso tsa Tsamaiso ea Lipalohi
Ho ikoetlisa le ho koetlisa
Ho reketsa
·Tšebeletso ea bareki
Nako ea poso: Mar-29-2023