1. Cov ntsiab lus thiab kev faib tawm
Cov khoom xyaw nruab nrab thiab cov khoom xyaw (APIs) Tsis muaj ib tus .
Cov khoom xyaw tshuaj (API) hais txog cov tshuaj lossis kev sib xyaw ua ke hauv cov khoom siv hauv cov tshuaj thiab kev tiv thaiv zoo li cov khoom siv tshuaj lom neeg ntawm kev siv hluav taws xob, thaum Intermediates sawv cev hauv nruab nrab theem hauv cov txheej txheem. Cov ntaub ntawv siv tau pab rau cov khoom siv hluav taws xob ntxiv nyob ntawm cov khoom siv hluav taws xob txuas ntxiv yog nyob ntawm cov intermediates {}}
2. kev sib txawv tseem ceeb
{. cov qauv thiab ua haujlwm:
Cov qauv siv tshuaj lom neeg ntawm cov intermediates txawv ntawm qhov kawg api . lawv lub luag haujlwm yog muab cov tshuaj reethesis, tsis yog ua haujlwm li tshuaj lawv tus kheej .
B . Kev Cai Tswj thiab Cov Qauv:
Cov Qauv Ntsuas: Tshuaj Tshuaj Kuaj Cov Qauv Kev Ntsuas Cov Qauv rau APIs tab sis tsis txhob them cov intermediates {}}
Daim ntawv pov thawj yuav tsum: FDA ua tiav kev sau npe rau cov ntawv pov thawj hauv nruab nrab (tsis yog lawv cov ntaub ntawv sib xyaw ua ke), thiab cov ntaub ntawv sib txawv yuav tsum tau ua cov ntawv pov thawj GMP li kev ua tiav GMP lifially.
3. toj roob hauv pes lag luam thiab yav tom ntej
Vim tias qhov kev nkag mus qis qis rau cov chaw tsim khoom siv hluav taws xob (piv rau APIs, uas xav tau kev loj hlob thiab kev loj hlob yog nyob ntawm peb lub peev xwm tseem ceeb:
{. Zoo Tswj: Ua kom muaj kev coj dawb huv thiab kev ruaj khov ntawm cov nruab nrab;
B . Nplog ua tau zoo: Txo chav tsev raug nqi los ntawm kev muaj peev xwm nthuav;
C {. Kev Ua Haujlwm Zoo Tshaj: Txhim Kho Cov Txheej Txheem Ntau Lawm thiab muab cov khoom sib txuas cov kev tswj hwm.
Raws li cov kev cai ib puag ncig ua kom nruj me ntsis, kev lag luam me me yog nce qib kev lag luam {}} yuav tsum ua tiav cov tswv yim hauv qab no:
{. product adapgrades: kev hloov pauv ntawm huab hwm coj muaj txiaj ntsig tsawg rau cov neeg feem ntau ntawm cov neeg feem coob hauv nruab siab;
B .}} Kev Pab Cuam Tshuam: Txuas mus muab cov kev pabcuam Cro / CDMO los muab cov kev pabcuam xaus-rau-D rau ntau lawm;
C {. ntsug kev sib xyaw ua ke: tsom rau cov qauv tsim txiaj, tsim kom muaj kev sib xyaw ua ke rau hauv API-API-qauv qauv "Lag luam qauv {3}