Mekhoa e Metle ea Tlhahiso kapa GMP ke sistimi e nang le lits'ebetso, lits'ebetso le litokomane tse netefatsang hore lihlahisoa tsa tlhahiso, joalo ka lijo, litlolo le thepa ea meriana, li lula li hlahisoa le ho laoloa ho latela litekanyetso tse behiloeng tsa boleng.Ho kenya tšebetsong GMP ho ka thusa ho fokotsa tahlehelo le litšila, ho qoba ho hopola, ho ts'oaroa, likotlo le nako ea chankana.Ka kakaretso, e sireletsa lik'hamphani le bareki liketsahalong tse mpe tsa polokeho ea lijo.
Li-GMP li hlahloba le ho koahela karolo e 'ngoe le e 'ngoe ea ts'ebetso ea tlhahiso ho itebela khahlanong le likotsi tse ka bang kotsi bakeng sa lihlahisoa, joalo ka tšilafalo, bofokoli le ho ngola hampe.Libaka tse ling tse ka susumetsang polokeho le boleng ba lihlahisoa tseo tataiso ea GMP le aterese ea taolo ke tse latelang:
· Tsamaiso ea boleng
·Bohloeki le bohloeki
·Mohaho le lisebelisoa
·Thepa
·Lisebelisoa tse so fetoloe
·Basebetsi
·Tiisetso le mangolo a thuto
·Litletlebo
· Litokomane le ho boloka litlaleho
·Litlhahlobo le tlhahlobo ea boleng
Phapano ke efe lipakeng tsa GMP le cGMP?
Mekhoa e Metle ea Tlhahiso e Ntle (GMP) le Mekhoa e Metle ea Tlhahiso e Ntle (cGMP) hangata, lia fetoha.GMP ke molao oa mantlha o phatlalalitsoeng ke Tsamaiso ea Lijo le Lithethefatsi ea US (FDA) tlasa bolaoli ba Federal Food, Drug, and Cosmetic Act ho netefatsa hore bahlahisi ba nka mehato ea ho netefatsa hore lihlahisoa tsa bona li bolokehile ebile lia sebetsa.cGMP, ka lehlakoreng le leng, e ile ea kenngoa ts'ebetsong ke FDA ho netefatsa ntlafatso e tsoelang pele tseleng ea bahlahisi ho boleng ba sehlahisoa.E bolela boitlamo bo sa feleng ho litekanyetso tsa boleng bo phahameng ka ho fetisisa tse fumanehang ka tšebeliso ea litsamaiso le theknoloji ea morao-rao.
Likarolo tse 5 tsa mantlha tsa ts'ebetso e ntle ea tlhahiso ke life?
Ho bohlokoa ho indasteri ea tlhahiso ho laola GMP mosebetsing ho netefatsa boleng bo tsitsitseng le polokeho ea lihlahisoa.Ho tsepamisa maikutlo ho tse latelang tsa 5 P's tsa GMP ho thusa ho latela litekanyetso tse tiileng ts'ebetsong eohle ea tlhahiso.
Lintlha tse 5 tsa GMP
1. Batho
Basebetsi bohle ba lebelletsoe ho latela ka tieo lits'ebetso le melaoana ea tlhahiso.Koetliso ea hajoale ea GMP e tlameha ho etsoa ke basebetsi bohle ho utloisisa mesebetsi le boikarabello ba bona ka botlalo.Ho lekola ts'ebetso ea bona ho thusa ho eketsa tlhahiso ea bona, katleho le bokhoni ba bona.
2. Lihlahisoa
Lihlahisoa tsohle li tlameha ho lula li lekoa, papiso le netefatso ea boleng pele li abeloa ho bareki.Baetsi ba lokela ho etsa bonnete ba hore lisebelisoa tsa mantlha tse kenyelletsang lihlahisoa tse tala le likarolo tse ling li na le litlhaloso tse hlakileng mohatong o mong le o mong oa tlhahiso.Mokhoa o tloaelehileng o tlameha ho hlokomeloa bakeng sa ho paka, ho etsa liteko, le ho fana ka lihlahisoa tsa sampole.
3. Mekhoa
Ts'ebetso e tlameha ho ngoloa hantle, e hlake, e ts'oane, 'me e abeloe basebetsi bohle.Tlhahlobo ea kamehla e lokela ho etsoa ho netefatsa hore basebetsi bohle ba ikamahanya le lits'ebetso tsa hajoale mme ba fihlella maemo a hlokahalang a mokhatlo.
4. Mekhoa
Ts'ebetso ke lethathamo la litataiso tsa ho etsa ts'ebetso e mahlonoko kapa karolo ea ts'ebetso ho fihlela sephetho se ts'oanang.E tlameha ho fetisetsoa ho basebetsi bohle mme e lateloe kamehla.Phapang leha e le efe e tsoang ho mokhoa o tloaelehileng o lokela ho tlalehoa hang-hang le ho fuputsoa.
5. Libaka
Libaka li lokela ho khothaletsa bohloeki ka linako tsohle ho qoba tšoaetso, likotsi, esita le likotsi.Lisebelisoa tsohle li lokela ho behoa kapa ho bolokoa hantle le ho lekanyetsoa khafetsa ho netefatsa hore li lekane molemong oa ho hlahisa liphetho tse tsitsitseng ho thibela kotsi ea ho hloleha ha thepa.
Melao-motheo e 10 ea GMP ke efe?
1. Etsa Mekhoa e Tloaelehileng ea Ts'ebetso (SOPs)
2. Phethahatsa / Phethahatsa SOPs le litaelo tsa mosebetsi
3. Lits'ebetso tsa litokomane le mekhoa
4. Netefatsa katleho ea li-SOP
5. Rala le ho sebelisa mekhoa ea ho sebetsa
6. Boloka litsamaiso, lisebelisoa le lisebelisoa
7. Ntlafatsa bokhoni ba basebetsi
8. Thibela tšilafalo ka bohloeki
9. Beha boleng pele 'me u kenye letsoho mosebetsing
10.Etsa tlhahlobo ea GMP khafetsa
Mokhoa oa ho ikamahanya le GBoemo ba MP
Litaelo le melaoana ea GMP li bua ka litaba tse fapaneng tse ka amang polokeho le boleng ba sehlahisoa.Ho kopana le litekanyetso tsa GMP kapa cGMP ho thusa mokhatlo ho latela litaelo tsa molao, ho eketsa boleng ba lihlahisoa tsa bona, ho ntlafatsa khotsofalo ea bareki, ho eketsa thekiso, le ho fumana phaello e ntle ea matsete.
Ho etsa liphuputso tsa GMP ho bapala karolo e kholo ho lekola hore na mokhatlo o lumellana le liprothokholo le litataiso tsa tlhahiso.Ho etsa licheke khafetsa ho ka fokotsa kotsi ea bohlola le misbrand.Tlhahlobo ea GMP e thusa ho ntlafatsa ts'ebetso e akaretsang ea litsamaiso tse fapaneng ho kenyelletsa tse latelang:
·Mohaho le lisebelisoa
·Tsamaiso ea thepa
· Litsamaiso tsa taolo ea boleng
·Ho hlahisa
·Ho paka le ho ngola mangolo a boitsebiso
· Litsamaiso tsa tsamaiso ea boleng
· Koetliso ea basebetsi le ea GMP
·Ho reka
·Tšebeletso ea bareki
Nako ea poso: Mar-29-2023