精心整理批準(zhǔn)Artwork藥品標(biāo)簽，AQWHO關(guān)于質(zhì)量受權(quán)人菌注射用水批次生產(chǎn)Blending合混批校驗(yàn)校準(zhǔn)Campaign-basedproduction階段性生產(chǎn)校驗(yàn)清場(chǎng)清潔CleaningValidation清潔驗(yàn)證ClinicalTrials臨床研究染污染控Continuousproduction連續(xù)生產(chǎn)托生產(chǎn)ContractAnalysis委托檢驗(yàn)陰涼儲(chǔ)存關(guān)鍵偏差鍵工藝參數(shù)關(guān)鍵操作步驟Crosscontamination交叉污染Designqualification,DQ設(shè)計(jì)確認(rèn)Deviation偏差DrinkingWater飲用水干燥儲(chǔ)存?zhèn)€人學(xué)歷Equipmentlogbook備使用日志過(guò)熱期收率experience工作經(jīng)驗(yàn)ExpiryDate有效期FactoryAcceptanceTest，F(xiàn)AT供應(yīng)商工廠的驗(yàn)收測(cè)試?yán)鋬鰞?chǔ)存HoldingTime存期I：Implemente執(zhí)行質(zhì)概況程控制過(guò)程取樣

精心整理安裝確認(rèn)Intermediate中間體使用日志MaintenanceBasicPractice維護(hù)基本實(shí)踐維護(hù)最佳實(shí)踐MaintenanceGoodPractice維良好實(shí)踐MaintenancePlan維護(hù)計(jì)劃MaintenanceProgram維護(hù)管理程序Manufacture制造主細(xì)胞庫(kù)混淆Non-conformance不合格Operationqualification,OQ運(yùn)行確認(rèn)OutofSpecification,OOS超標(biāo)性能確認(rèn)原始細(xì)胞庫(kù)PreventiveMaintenance預(yù)防性維護(hù)Production生產(chǎn)生產(chǎn)操作化水QaultiyAssurance，QA質(zhì)量保證Qualification確認(rèn)，QP質(zhì)量受權(quán)人QualityAgreement質(zhì)量協(xié)議QualityControl，質(zhì)量控制，QM質(zhì)管理質(zhì)量審核QualityUnit，質(zhì)量管理部門(mén)Responsible負(fù)責(zé)復(fù)驗(yàn)Reconciliation物料平衡冷藏儲(chǔ)存拒收Retestdates復(fù)驗(yàn)期RiskAssessment風(fēng)險(xiǎn)評(píng)估RoomTemperatureStorage室溫儲(chǔ)存SafetyEnvironmentHealth,EHS環(huán)境、健康及全半連續(xù)生產(chǎn)，SAT用戶工廠的驗(yàn)收測(cè)試質(zhì)量標(biāo)準(zhǔn)穩(wěn)定性菌純化水滅菌吸入用水SterileWaterforInjection滅菌注射用水菌沖洗用水

精心整理SubdividingOperation分裝操作防篡改封簽生產(chǎn)時(shí)限培訓(xùn)批記錄戶需求標(biāo)準(zhǔn)Validation驗(yàn)證Validationmasterplan驗(yàn)證主計(jì)劃Verification核Verification定注射用水工作細(xì)胞庫(kù)WorstCase最差