Kev Ua Tau Zoo & Ua Raws Li Kev Nyab Xeeb Kev Nyab Xeeb Ntiaj Teb thiab CMC Kev Xeem
Zoo-tsav biosafety thiab CMC kuaj kev txhawb nqa rau biologics, tshuaj tiv thaiv, kab mob vectors, thiab cov kev pab cuam ntawm tes thiab noob caj noob ces txav mus thoob ntiaj teb txoj kev loj hlob.
Cov txheej txheem zoo uas txhawb kev tswj hwm - ntsib cov ntaub ntawv biosafety
Quality Management System (QMS)
Kev tswj cov txheej txheem, kev cob qhia, cov khoom siv lub neej, kev tswj cov khoom siv, kev siv tau / kev pov thawj, kev sib txawv, CAPA, kev hloov pauv, kev tshuaj xyuas sab hauv, thiab kev tswj xyuas kev tswj xyuas.
Kev tswj hwm kev tswj hwm & cov lus qhia
Kev sim cov tswv yim qhia rau ICH, LEEJ TWG, FDA, EMA, NMPA/CDE, PMDA, MHRA, TGA, Health Canada, MFDS, CDSCO, thiab HSA cov kev cia siab uas cuam tshuam.
Daim ntawv pov thawj & Kev lees paub
Daim ntawv pov thawj thiab cov ntaub ntawv qhia txog kev tsim nyog rau tus neeg muag khoom. Hnub tim, cov peev txheej, lub logo, thiab cov ntawv thov yuav tsum ua raws QA- cov ntaub ntawv pov thawj pom zoo ua ntej tshaj tawm.
Data Integrity & Digital Systems
ALCOA+ cov hauv paus ntsiab lus, LIMS/EMS/e- kev tswj kos npe, CSV, kev tshawb xyuas txoj hauv kev, kev tswj xyuas, thaub qab / rov qab, thiab QA tshuaj xyuas rau kev tswj hwm- ntsib cov ntaub ntawv.
HyQure kev pabcuam tsom
Cell line characterization, viral clearance, RCL/RCR/rcAAV testing, adventitious agent testing, mycoplasma and sterility, lot release and stability, residual DNA/RNA/HCP/process residue testing, and GMP/GLP{0}} txhawb kev tshaj tawm.
Vim li cas qhov no yog kev sib tw thoob ntiaj teb
Cov neeg siv khoom thoob ntiaj teb tsim nyog rau kev sib tw nrog cov pov thawj, tsis yog kho kom zoo nkauj. HyQure yuav tsum nthuav qhia cov ntaub ntawv pov thawj zoo, kev sib txuas ncaj qha, kev tswj hwm- paub lus, thiab cov ntaub ntawv raug cai kom QA/QC, CMC, kev tswj hwm, thiab pab pawg neeg yuav khoom tuaj yeem ntsuas HyQure sai.
Cov kev pabcuam HyQure ntsig txog
Npaj ib qho kev ua tau zoo - tau tsav pob kuaj
Qhia cov khoom lag luam, theem kev loj hlob, lub hom phiaj kev lag luam, hom qauv, txheej txheem txheej txheem, thiab xav tau daim ntawv tshaj tawm. HyQure tuaj yeem pab txhim kho cov peev txheej, cov ntaub ntawv, thiab ncua sij hawm ua ntej pib qhov project.
Txoj cai tswjfwm kev sib txuas
- FDA 21 CFR Tshooj 58
- FDA 21 CFR Tshooj 210
- FDA 21 CFR Tshooj 211
- FDA 21 CFR Part 11
- EU GMP Annex 11
- LEEJ TWG GMP Cov Lus Qhia
- ICH Cov Lus Qhia Zoo
- ISO / IEC 17025: 2017 Txuj
- ISO 9001: 2015 Txuj