Niki capsule & tablet kumurongo ukurikirana kugenzura kugenzura kubice CVS?
Capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro byahujwe nubwoko bwose bwimashini zuzuza capsule hamwe nimashini itanga imashini ya tablet, kandi binyuze kumurongo wo hejuru wikigereranyo cyo gupima no gupima, ihora ikurikirana itandukaniro ryuburemere bwa capsule na tablet kimwe nuburyo imikorere ya capsule yuzuza imashini hamwe na tablet imashini.Iyo uburemere bwibinyampeke bubonetse burenze ibisanzwe, hita uhita utabaza hanyuma uhite ubika ingero zujuje ibyangombwa bitandukanye.
Muri icyo gihe, capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro byikora byikora bitanga amakuru atandukanye yamakuru, imibare, inyandiko hamwe nimbonerahamwe igenzura isabwa gucunga neza, hamwe nibibazo byanditse hamwe nibikorwa byo gucapa byikora.Ku bijyanye no gucunga amakuru, yujuje byuzuye ibisabwa cyane muri EU cGMP na GMAP5, yubahiriza byimazeyo ibivugwa muri Amerika FDA 21CFR-PART11, kandi ifite imirimo ya sisitemu yo kwinjira mu nzego eshatu, umukono wa elegitoroniki umukono wa elegitoronike, gukurikirana ubugenzuzi , nibindi kugirango tumenye neza uburinganire bwamakuru yimikorere yibiyobyabwenge.
Kugaragaza ibyiciro no gupfa umwobo wa capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro ni imikorere ikomeye, hamwe nubushobozi bwo guca imanza.Iyo habonetse uburemere bukabije bwibinyampeke, gutahura ibyiciro bya CVS birashobora guhita bitandukanya ibyiciro byibicuruzwa bifite ibyago byuburemere bwibinyampeke, kugirango harebwe niba ibyiciro byujuje ibyangombwa bigomba kuba byujuje ibyangombwa, kandi abafite uburemere bwibinyampeke bidasanzwe bazigunga muri ibyiciro byibicuruzwa;ibikorwa byo gupima umwobo wa capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro, birashobora no kwerekana buri capsule ikabije cyangwa ibinini byerekana na CVS kandi biva aho bipfa kuzuza capsule cyangwa imashini itanga imashini, imikorere yayo ya SPD (kwisuzumisha gukumira imibare) , gutanga inyungu zuzuye kurenza uburyo bwo gukemura ikibazo cyo gutandukana ibiro.
Capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro bituma uburemere bwibinyampeke bwa capsules na tableti hamwe nuburyo imikorere yimashini yuzuza capsule hamwe na mashini ya tablet yamashini ihora munsi ya monitor ikaze kandi ikora neza, ntishobora gusa kuvumbura ikibazo cyuburemere bwibinyampeke, guhita gutabaza, kwigunga. ibicuruzwa bishobora guterwa mugihe gikwiye, ndetse no muburyo butaziguye kugirango umenye inkomoko yikibazo, mugihe kimwe capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro bishobora kubona igenzura rya kure kumurima wibyakozwe, birashobora gusobanukirwa nigihe imiterere yikibanza cyakorewe ahantu hose umwanya uwariwo wose. , niryo jisho ryibumba hamwe nu gutwi guherekeza umuyaga wumusaruro n'abakozi bashinzwe ubuziranenge.
Nuburyo bwo kugenzura ubuziranenge, CMC checkweigher nigisubizo cyo kugenzura capsules na tableti nziza, itandukaniro, capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro ni inzira yo kugenzura ubuziranenge, nigikoresho gikomeye cyo kuvumbura ikibazo no kubona ikibazo, ni ishyirwaho ya sisitemu ikomeye yo gucunga neza, nigikoresho cyiza cyubutaka bwa SPC imicungire yubuziranenge, ariko kandi nuburyo bwiza bwubuziranenge bwibicuruzwa.
Mugihe kimwe, capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro birashobora kandi gukoreshwa mugukora capsules ya hollow kugirango ikurikirane uburemere bwibinyampeke bya capsules kumurongo cyangwa kumurongo mugihe nyacyo.Ubwoko bwose bwa capsules burasanzwe, kandi nta mpamvu yo guhindura ifumbire.Ariko ntigikorwa cyo gutahura ibyiciro no gupfa umwobo.
Nibihe bikorwa bya capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro?
- Kwihuza na capsule yuzuza hamwe na tablet imashini
2. Urwego rwibanga 3 kugirango winjire muri sisitemu y'imikorere
3. Amateka yibipimo byibicuruzwa byitwa byoroshye
4. Igihe cyateganijwe kugenzura neza impagarike ya electromagnetic
5. Kugenzura inshuro nyinshi kugenzura mugihe cyagenwe cyagenwe
6. Fata umubare wateganijwe mbere hanyuma upime umwe umwe
7. Gupima neza kandi uhita wandika amakuru ya buri ngano
8. Shushanya ingano yo kugenzura uburemere bwibihe muri dinamike nyayo - igihe
9. Kurikirana neza ukurikije ibihe byateganijwe
10. Shira ahagaragara raporo yubugenzuzi bwerekana uburemere bwibinyampeke igihe icyo aricyo cyose
11. Ako kanya gutabaza niba uburemere burenze ibisanzwe
12. Niba ibintu bikomeye, noneho uhagarike gukanda tablet hanyuma wuzuze
13. Bika ibicuruzwa byiza nibibi bitandukanye
14. Igice cyikora kandi gitandukanya neza ibicuruzwa bishobora guteza ingaruka
15. Gukurikiranira hafi igihe cyakorewe ahakorerwa
16. Kubaka amahugurwa adafite abadereva kugirango bamenye inganda 4.0
17. Gusuzuma SPD itabishaka
18. Erekana mu buryo butaziguye umwobo wihariye wo gutandukanya ibiro
19. Gutunga amakuru akomeye yamakuru yimibare
20. CPK yabazwe gushushanya ikwirakwizwa risanzwe ryuburemere
21. Amakuru yazigamye burundu kubibazo byo gutabaza
22. Ibyuma bya elegitoronike umukono wa elegitoronike ya 21CFR-11
23. Byoroheye gusubira inyuma, hamwe n'inzira zubugenzuzi
24. Kurikiza byimazeyo ubunyangamugayo bwa FDA
25. Hindura ibisabwa hejuru ya cGMP GAMP5
26. Irashobora gutsinda sisitemu ya mudasobwa neza
Nuwuhe gaciro kubakoresha kuri capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro?
- Capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro byahujwe na mashini yuzuza capsule hamwe na mashini yandika imashini ya tablet, gutoranya ubudahwema ukurikije igihe cyagenwe, birashobora gukurikiranwa amasaha 24 kumunsi, uburemere bwa capsule na tablet ntibizagaragara nkibidasanzwe, kuko nibimara kugaragara nkibidasanzwe. , bizahita biboneka ako kanya, capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro bizajya bibutsa kwibutsa, kandi mugihe kimwe, harikibazo cyibice byibicuruzwa byahise byigunga, bityo bikurikiranirwa hafi capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro mumasaha 24, niba ubuziranenge bwibicuruzwa, cyangwa ibikoresho byumusaruro bikora, byose muburyo bugenzurwa, ntabwo ari ikibazo.
- Ibipimo byuburemere bwibinyampeke nukuri kandi byizewe, kandi amakuru yibarurishamibare arambuye kandi yandikwa burundu, arashobora kubaza arashobora gusohora, icyitegererezo cyibipimo byerekana uburemere bwibinyampeke byanditse ku mpapuro bifite amakuru yuzuye hamwe namakuru arambuye, birashobora kuba nkibyanditswe byerekana umusaruro. , ibibi byo gupima intoki gupima no gufata amajwi birasonerwa, bigabanya cyane ubukana bwabakozi, bigatuma igenzura ryibiyobyabwenge rirushaho gutera intambwe nshya.
- Kubijyanye nigihe gikwiye nuburyo bwo gucunga ibyago no kugenzura, kugenzura ibyiciro nibikorwa byo kwigunga bya CVS ntibishobora kugerwaho nintoki;imikorere yo gupima umwobo wapfuye SPD inzira y'ibarurishamibare ituma ikibazo kivumburwa kugeza kumuzi yikibazo flash, ikiza rwose umwanya munini, imbaraga noguta ibikoresho mugihe imashini igomba gukoreshwa kugirango ikemure ikibazo mubitabo uburyo.
- Kubyerekeranye no kubahiriza, capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro byujuje ibyangombwa bisabwa cyane bya cGMP na GMAP5, byubahiriza cyane amategeko yose yo muri Amerika FDA 21CFR-PART11, byujuje ibisabwa byose mubusugire bwamakuru, kandi amakuru ya elegitoronike aroroha mugushakisha ubuziranenge no kugenzura gukurikirana.
- Imikorere ikomeye no kugenzura kure ya capsule & tablet kumurongo ukurikirana kugenzura kugenzura ibyiciro bituma umusaruro nubuyobozi bwiza byoroha kandi byiza.Capsule & tablet monitor ikurikirana igenzura ryerekana ibyiciro ntabwo ari igikoresho gifatika cyo kuzamura ubuziranenge no kumenya uburyo bw’ibarurishamibare rya SPC kugenzura ubuziranenge bw’ibiyobyabwenge, ahubwo ni ibikoresho by’ibikoresho bikenewe kugira ngo inganda zizamure inganda kandi zimenyekanishe amahugurwa y’ubukorikori kandi adafite abadereva.
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Igihe cyo kohereza: Ukwakira-29-2020