1. Dab tsi yog qhov yuav tsum tau ua ntawm ib puag ncig thaum kuaj cov khoom siv thiab cov khoom ntim khoom?
A: Warehouse cheeb tsam tuaj yeem teeb tsa chav kuaj, huab cua huv chav ntawm cov qauv ib puag ncig yuav tsum ua raws li qhov yuav tsum tau ua. Yog tias tsis kuaj hauv chav kuaj, yuav tsum muaj kev ntsuas kom tsis txhob muaj kuab paug thiab hla - paug (piv txwv li: tsheb sampling nrog kev ua kom huv si tuaj yeem siv tau)
2. Dab tsi yog qhov yuav tsum tau muaj nyob rau hauv cov txheej txheem ntawm kev khaws cov ntaub ntawv?
A: Cov khoom siv, cov khoom nruab nrab thiab cov khoom tiav nrog cov kev cai tshwj xeeb rau qhov kub, av noo lossis lwm yam kev mob yuav tsum tau muab cia rau hauv cov xwm txheej tshwj xeeb. Cov ntaub ntawv nyoos thiab kua yuav tsum tau muab cais tawm; Cov khoom siv hluav taws xob tsis txhob ua paug rau lwm cov ntaub ntawv. Npaj, xaiv, thiab cov khoom siv tshuaj pretreated yuav tsum tau ntim rau hauv cov thawv huv lossis pob khoom thiab cais nruj me ntsis ntawm cov khoom siv tshuaj tsis hnav thiab tsis tau ua tiav. Cov ntaub ntawv yuav tsum tau khaws cia raws li lub sijhawm teev tseg ntawm kev siv. Yog tias tsis muaj lub sijhawm siv tau teev tseg, qhov khaws cia feem ntau tsis tuaj yeem tshaj peb xyoos. Re- kev tshuaj xyuas yuav ua tom qab hnub tas sij hawm. Yuav tsum muaj ib ntus rov-kev tshuaj xyuas hauv lub sijhawm khaws khoom, yog tias muaj xwm txheej tshwj xeeb, rov- tshuaj xyuas lub sijhawm. Cov khoom tawg, tawg, tshuaj lom thiab corrosive yuav tsum tau muab khaws cia rau hauv cov khoom lag luam txaus ntshai uas ua tau raws li qhov yuav tsum tau muaj kev tiv thaiv hluav taws, thiab muaj cov chaw tiv thaiv hluav taws.
3. Dab tsi yog qhov yuav tsum tau ua rau kev khaws cia thiab siv cov ntawv sau tshuaj thiab cov lus qhia ua haujlwm?
A: Cov ntawv sau tshuaj thiab cov lus qhia ua haujlwm yuav tsum khaws cia thiab sau los ntawm cov neeg ua haujlwm tshwj xeeb, Cov kev cai yog raws li hauv qab no:
(1) Cov ntawv sau tshuaj thiab cov lus qhia ua haujlwm yuav tsum khaws cia rau hauv ntau hom lossis cov lus qhia tshwj xeeb, lossis muab khaws cia rau hauv lub txee tshwj xeeb lossis lub tsev khaws khoom. Lawv raug faib raws li cov lus qhia ntim thiab tau txais raws li qhov xav tau tiag tiag;
(2) Cov ntawv sau yuav tsum tau muab rau hauv kev suav, tus neeg thov kev kuaj xyuas seb puas kos npe, tus naj npawb ntawm kev siv, tus naj npawb ntawm kev puas tsuaj thiab tus lej seem yog raws li tus lej ntawm kev thov. Cov ntawv tseem ceeb lossis cov ntawv puas nrog cov lej yuav tsum yog lub luag haujlwm rau ib tus neeg, thiab raug rhuav tshem hauv kev suav thiab saib xyuas los ntawm QA.
4. Dab tsi yuav tsum tau qhia rau ntawm daim ntawv lo thiab phau ntawv qhia? Cov kev cai luam tawm, kev faib tawm thiab siv yog dab tsi?
A: The contents of drugs' labels and instruction must comply with the related terms in Administrative Regulations for Drug Packaging, Labeling and Instruction, and must same as the content, style and text approved by the drug supervision and administration department.
Cov ntawv sau thiab phau ntawv qhia yuav tsum tau muab luam tawm, faib, thiab siv tom qab raug txheeb xyuas los ntawm lub tuam tsev tswj xyuas kev ua haujlwm zoo.
The specific requirements for labels, can reference the related regulations of the detailed rules (provisional) of drug packaging and labeling specifications in the Notice of Detailed Rules for Pharmaceutical Packaging and Labeling (Interim)" which NMPA(2001) printed and distributed.
5. Muaj pes tsawg lub cim qhia txog kev tswj cov ntaub ntawv hauv tsev rau khoom?
A: Kev tswj cov khoom tuaj yeem muab faib ua: a. tos rau kev tshuaj xyuas, kos npe daj; b.txog tus qauv, kos npe ntsuab; c.hauv qab qauv, kos npe liab; d. muag rov qab, xiav kos npe.
6. Yuav ua li cas nrog cov ntaub ntawv tsis tsim nyog?
A: Cov ntaub ntawv luam tawm tag nrho yog cov tshuaj ntim tshwj xeeb. Cov pob ntawv luam tawm tsis tsim nyog yuav tsum raug rhuav tshem hauv qhov chaw, txwv tsis pub qhov tshwm sim loj yuav tshwm sim vim cov khoom poob. Tab sis rau cov pob ntawv tsis tsim nyog, yog tias lawv yuav tsum tau ua rau hauv cov ntaub so ntswg, lawv yuav tsum tau muab txiav thiab txav mus rau hauv lub thawv ntim khoom raws li kev saib xyuas ntawm lub tuam tsev saib xyuas zoo.
7. Vim li cas hais tias kev tswj cov khoom muag yog ib qho tseem ceeb ntawm GMP?
A: Original and auxiliary package material as the starting materials of drug production, its quality will directly affect the final quality of drugs. There are many incidents of unqualified drugs produced due to the errors or confusion of the original and auxiliary package materials in the supplier's production process. Therefore, it is necessary to strengthen the management of suppliers, control the quality at the source, and then control and manage the acceptance and use process, so as to ultimately ensure the quality of the drugs produced.
8. Yuav tsum ntsuas dab tsi hauv tsev rau khoom?
A: Tsib ntsuas yog nas, noog thiab lwm yam tsiaj tiv thaiv, insets tiv thaiv, mycete thiab moist tiv thaiv, tiv thaiv hluav taws, tiv thaiv burglary.
9. Kev ntim tshuaj sab hauv yog dab tsi?
A: Lub ntim ntim tshuaj yog cov ntim uas ncaj qha rau cov tshuaj (xws li ampoule, lub qhov ncauj kua lub raj mis, aluminium ntawv ci rau ntim blister, zaj duab xis sib xyaw rau cov ntim tshuaj ntsiav lossis tshuaj ntsiav)
10. What's categories of drug packaging materials divide into?
A: Classification of drug packaging materials: drug packaging materials are divided into three categories: Ⅰ, Ⅱ, and Ⅲ.
Cov ntaub ntawv ntim tshuaj Class I xa mus rau cov ntaub ntawv ntim tshuaj thiab cov thawv ntim khoom uas raug cuam tshuam nrog cov tshuaj thiab siv ncaj qha.
ClassⅡdrug packaging materials refer to drug packaging materials and containers that are directly contact with drugs but easy to clean, can and need to sterilize after cleaning in actual using process.
ClassⅢdrug packaging materials refer to drug packaging materials and containers that may affect drug quality directly except classⅡand classⅢ.