Imashini ikora ya Tablet ikora neza Kumurongo wo kugenzura imashini igenzura ibice bya TVS

Amakuru y'ibicuruzwa

Gukurikirana imashini itahura ibyiciro TVS ituma ibipimo byerekana ubuziranenge bwa tablet ndetse nigikorwa cyimashini itanga imashini igenzurwa neza kandi neza mugihe cyose, kugirango ikemure ibibazo mugihe, ihite imenyesha kandi itandukanya ibice byibicuruzwa bishobora guteza akaga.Gukurikirana imashini itahura ibyiciro TVS ituma hakurikiranwa kure ahakorerwa ibicuruzwa, gusobanukirwa nigihe nyacyo kubibera ahakorerwa ibicuruzwa, hamwe na clairance-vision hamwe n'amatwi yumuyaga wumuyaga kubakozi n'abakozi bashinzwe ubuziranenge.

Nka seti ya sisitemu ikomeye yo kugenzura ubuziranenge, kugenzura imashini itahura ibyiciro TVS nigikorwa cyo kugenzura ubwiza bwibicuruzwa bya tablet, igikoresho gikomeye cyo gushakisha ibibazo mbere na mbere no gufasha abakozi bakora ibicuruzwa kubona ibibazo vuba, igikoresho cyiza cyo gushyira mubikorwa ubuziranenge bwa SPC imiyoborere, hamwe ningwate ifatika yubwiza bwibicuruzwa.

Agaciro kubakoresha

1. Gukurikirana imashini itahura ibyiciro TVS ihujwe na mashini yuzuza capsule hamwe na mashini ya tablet ya tablet, gutoranya ubudahwema ukurikije igihe cyagenwe, birashobora gukurikiranwa amasaha 24 kumunsi, uburemere bwa capsule na tablet ntibizagaragara nkibisanzwe, kuko bimaze kugaragara bidasanzwe, bizahita biboneka ako kanya, CVS izahita yibutsa kwibutsa, kandi mugihe kimwe, harikibazo cyibicuruzwa byahise byigunga, bityo ukurikiranira hafi CVS mumasaha 24, yaba ubwiza bwibicuruzwa, cyangwa ibikoresho byumusaruro bikora, byose muburyo bugenzurwa, ntabwo ari ikibazo.

2. Ibyerekeye uburemere bwibinyampeke byibinini ni ukuri kandi byizewe, kandi amakuru y'ibarurishamibare arambuye kandi yandikwa burundu, arashobora kubaza ikibazo, icyitegererezo cyibipimo byerekana uburemere bwibinyampeke byanditse ku mpapuro bifite amakuru yuzuye hamwe namakuru arambuye, birashobora kuba nkibyo icyiciro cyibikorwa byakozwe, ibibi byo gupima intoki gupima no gufata amajwi birasonerwa, bigabanya cyane ubukana bwabakozi, bigatuma igenzura ryibiyobyabwenge rirushaho gutera intambwe nshya.

3. Kubijyanye nigihe no gukora neza mugucunga no kugenzura ingaruka, gutahura ibyiciro nibikorwa byo kwigunga byo kugenzura imashini itahura ibyiciro TVS, birashobora kugabanya ibyago byurwego kugeza kurwego rwo hasi, birashobora kumanura imyanda yibikoresho kugeza kurwego rwo hasi.

4. Kubijyanye no kubahiriza, kugenzura imashini itahura ibyiciro TVS yujuje ibyangombwa bisabwa cyane bya cGMP na GMAP5, yubahiriza byimazeyo amabwiriza yose yo muri Amerika FDA 21CFR-PART11, yujuje ibisabwa byose kugirango uburinganire bwamakuru, kandi amakuru ya elegitoronike aroroha mugushakisha ubuziranenge kandi kugenzura.

5. Gukurikirana imashini itahura ibyiciro ibikorwa bikomeye bya TVS hamwe no kugenzura kure bituma umusaruro nubuyobozi bwiza byoroha kandi neza.CVS ntabwo ari igikoresho gifatika cyo kuzamura ireme no kumenya uburyo SPC igenzura uburyo bwo kugenzura ubuziranenge bw’ibiyobyabwenge, ariko kandi ni ibikoresho nkenerwa by’ibikoresho bigamije kuzamura inganda no kumenya amahugurwa y’ubukorikori kandi adafite abadereva.

• [cf7ic]