Mekhoa e Metle ea Tlhahiso kapa GMP ke sistimi e nang le lits'ebetso, mekhoa le litokomane tse netefatsang hore lihlahisoa tsa tlhahiso, tse kang lijo, litlolo le thepa ea meriana, li hlahisoa le ho laoloa ka mokhoa o tsitsitseng ho latela maemo a boleng bo behiloeng. Ho kenya tšebetsong GMP ho ka thusa ho fokotsa tahlehelo le tšenyo, ho qoba ho hopoloa, ho tšoaroa ka mahahapa, likotlo le nako ea chankana. Ka kakaretso, e sireletsa k'hamphani le moreki liketsahalong tse mpe tsa polokeho ea lijo.
Li-GMP li hlahloba le ho akaretsa karolo e 'ngoe le e 'ngoe ea ts'ebetso ea tlhahiso ho itšireletsa khahlanong le likotsi life kapa life tse ka bang kotsi bakeng sa lihlahisoa, joalo ka tšilafalo e fapaneng, ho senyeha le ho ngoloa hampe ha mabitso. Libaka tse ling tse ka susumetsang polokeho le boleng ba lihlahisoa tseo tataiso le melaoana ea GMP li sebetsanang le tsona ke tse latelang:
·Tsamaiso ea boleng
·Bohloeki le bohloeki
·Meaho le mehaho
·Lisebelisoa
·Lisebelisoa tse so fetoloe
·Basebetsi
·Netefatso le mangolo a thuto
·Litletlebo
·Litokomane le ho boloka lirekoto
·Litlhahlobo le litlhahlobo tsa boleng
Phapang ke efe pakeng tsa GMP le cGMP?
Mekhoa e Metle ea Tlhahiso (GMP) le Mekhoa ea hona joale ea Tlhahiso e Metle (cGMP) lia fapanyetsana maemong a mangata. GMP ke molaoana oa motheo o phatlalalitsoeng ke US Food and Drug Administration (FDA) tlas'a taolo ea Federal Food, Drug, and Cosmetic Act ho netefatsa hore bahlahisi ba nka mehato e potlakileng ho netefatsa hore lihlahisoa tsa bona li bolokehile ebile lia sebetsa. Ka lehlakoreng le leng, cGMP e kentsoe tšebetsong ke FDA ho netefatsa ntlafatso e tsoelang pele mokhoeng oa bahlahisi oa ho fihlela boleng ba sehlahisoa. E bolela boitlamo bo sa khaotseng ho latela maemo a boleng a holimo ka ho fetisisa a fumanehang ka ho sebelisa litsamaiso le mahlale a morao-rao.
Likarolo tse 5 tsa Sehlooho tsa Mokhoa o Motle oa Tlhahiso ke Life?
Ho bohlokoa haholo indastering ea tlhahiso ho laola GMP mosebetsing ho netefatsa boleng le polokeho e tsitsitseng ea lihlahisoa. Ho tsepamisa maikutlo ho 5 P tse latelang tsa GMP ho thusa ho latela maemo a thata nakong eohle ea ts'ebetso ea tlhahiso.
Li-P tse 5 tsa GMP
1. Batho
Basebetsi bohle ba lebeletsoe ho latela ka tieo mekhoa le melawana 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, bokhoni le bokhoni.
2. Lihlahisoa
Lihlahisoa tsohle li tlameha ho feta litekong tse sa khaotseng, papisong le netefatsong ea boleng pele li abeloa bareki. Bahlahisi ba lokela ho netefatsa hore thepa ea mantlha ho kenyeletsoa 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 leka le ho aba lihlahisoa tsa sampole.
3. Mekhoa
Mekhoa e lokela ho ngoloa hantle, ho hlaka, ho tsitsisa, le ho abeloa basebetsi bohle. Tlhahlobo ea kamehla e lokela ho etsoa ho netefatsa hore basebetsi bohle ba latela mekhoa ea hona joale 'me ba fihlela maemo a hlokahalang a mokhatlo.
4. Mekhoa ea Ts'ebetso
Mokhoa ke sete ea litataiso tsa ho etsa ts'ebetso ea bohlokoa kapa karolo ea ts'ebetso ho fihlela sephetho se tsitsitseng. E tlameha ho hlalosetsoa basebetsi bohle le ho lateloa ka mokhoa o tsitsitseng. Ho kheloha leha e le hofe ho tsoa ts'ebetsong e tloaelehileng ho lokela ho tlalehoa hang-hang le ho hlahlojoa.
5. Sebaka
Libaka li lokela ho khothaletsa bohloeki ka linako tsohle ho qoba tšilafalo e fapaneng, likotsi, kapa esita le mafu. Lisebelisoa tsohle li lokela ho beoa kapa ho bolokoa hantle le ho hlahlojoa khafetsa ho netefatsa hore li loketse morero oa ho hlahisa liphetho tse tsitsitseng ho thibela kotsi ea ho hloleha ha lisebelisoa.
Melao-motheo e 10 ea GMP ke efe?
1. Theha Mekhoa e Tloaelehileng ea Ts'ebetso (li-SOP)
2. Phethahatsa / Kenya tšebetsong li-SOP le litaelo tsa mosebetsi
3. Ngola mekhoa le lits'ebetso
4. Netefatsa katleho ea li-SOP
5. Rala le ho sebelisa litsamaiso tsa ho sebetsa
6. Ho hlokomela litsamaiso, mehaho le lisebelisoa
7. Ntlafatsa bokgoni ba mosebetsi ba basebetsi
8. Thibela tšilafalo ka bohloeki
9. Beha boleng pele 'me u bo kenye mosebetsing oa mosebetsi
10. Etsa tlhahlobo ea GMP khafetsa
Mokhoa oa ho Latela GTekanyetso ea MP
Tataiso le melawana ya GMP e sebetsana le ditaba tse fapaneng tse ka susumetsang polokeho le boleng ba sehlahiswa. Ho fihlella maemo a GMP kapa cGMP ho thusa mokgatlo ho latela ditaelo tsa molao, ho eketsa boleng ba dihlahiswa tsa bona, ho ntlafatsa kgotsofalo ya bareki, ho eketsa thekiso, le ho fumana phaello e ntle ya matsete.
Ho etsa ditlhahlobo tsa GMP ho bapala karolo e kgolo ho lekoleng ho latela melaoana le ditataiso tsa tlhahiso ya mokgatlo. Ho etsa diteko tse tlwaelehileng ho ka fokotsa kotsi ya ho senyeha le ho se be le lebitso le lebe. Tlhahlobo ya GMP e thusa ho ntlafatsa tshebetso yohle ya ditsamaiso tse fapaneng ho kenyeletswa tse latelang:
·Meaho le mehaho
·Tsamaiso ea thepa
·Litsamaiso tsa taolo ea boleng
·Tlhahiso
· Ho paka le ho ngola mabitso a boitsebiso
·Mekhoa ea taolo ea boleng
·Thupelo ea basebetsi le ea GMP
·Ho reka
·Tšebeletso ea bareki
Nako ea poso: Hlakubele-29-2023