制藥行業(yè)GMP英文詞匯.doc

Approve 批準(zhǔn)Artwork 藥品標(biāo)簽Authorized Person，AQ WHO關(guān)于質(zhì)量受權(quán)人Bacteriostatic Water for Injection 抑菌注射用水Batch-based production 按批次生產(chǎn)Blending 混合Blending batches 混批Calibration 校驗(yàn)Calibration 校準(zhǔn)Campaign-based production 階段性生產(chǎn)Checked 校驗(yàn)Cleanance or site cleaning 清場(chǎng)Cleaning 清潔Cleaning Validation 清潔驗(yàn)證Clinical Trials 臨床研究Contamination 污染Contamination Control 污染控制Continuous production 連續(xù)生產(chǎn)Contract manufacturing 委托生產(chǎn)Contract Analysis 委托檢驗(yàn)Cool Storage 陰涼儲(chǔ)存Critical Deviation 關(guān)鍵偏差Critical Process Parameter 關(guān)鍵工藝參數(shù)Critical Processing Step 關(guān)鍵操作步驟Cross contamination 交叉污染Design qualification, DQ 設(shè)計(jì)確認(rèn)Deviation 偏差Drinking Water 飲用水Dry Place 干燥儲(chǔ)存education 個(gè)人學(xué)歷Equipment logbook 設(shè)備使用日志Excessive heat 過(guò)熱Expected Yield, expected 預(yù)期收率experience 工作經(jīng)驗(yàn)Expiry Date 有效期Factory Acceptance Test，F(xiàn)AT 供應(yīng)商工廠(chǎng)的驗(yàn)收測(cè)試Freezer Storage 冷凍儲(chǔ)存Holding Time 貯存期I：Implemente 執(zhí)行Impurity profile 雜質(zhì)概況In-process Controls 過(guò)程控制In-process Sampling 過(guò)程取樣Installation qualification, IQ 安裝確認(rèn)Intermediate 中間體Logbook 使用日志Maintenance Basic Practice 維護(hù)基本實(shí)踐Maintenance Best Practice 維護(hù)最佳實(shí)踐Maintenance Good Practice 維護(hù)良好實(shí)踐Maintenance Plan 維護(hù)計(jì)劃M(mǎn)aintenance Program 維護(hù)管理程序Manufacture 制造Master Cell Bank , MCB 主細(xì)胞庫(kù)mix-ups 混淆Non-conformance 不合格Operation qualification, OQ 運(yùn)行確認(rèn)Out of Specification , OOS 超標(biāo)Performance qualification, PQ 性能確認(rèn)Preliminary Cell Bank ,PCB 原始細(xì)胞庫(kù)Preventive Maintenance 預(yù)防性維護(hù)Production 生產(chǎn)Production Operations 生產(chǎn)操作Purified Water 純化水Qaultiy Assurance，QA 質(zhì)量保證Qualification 確認(rèn)Qualified Person，QP 質(zhì)量受權(quán)人Quality Agreement 質(zhì)量協(xié)議Quality Control，QC 質(zhì)量控制Quality Management，QM 質(zhì)量管理Quality review 質(zhì)量審核Quality Unit，QU/Quality Operations，QO質(zhì)量管理部門(mén)Responsible 負(fù)責(zé)Rechecked 復(fù)驗(yàn)Reconciliation 物料平衡Refrigerator Storage 冷藏儲(chǔ)存Reject 拒收Retest dates 復(fù)驗(yàn)期Risk Assessment 風(fēng)險(xiǎn)評(píng)估Room Temperature Storage 室溫儲(chǔ)存Safety Environment Health, EHS 環(huán)境、健康及安全Semi-continuous production 半連續(xù)生產(chǎn)Site Acceptance Test，SAT 用戶(hù)工廠(chǎng)的驗(yàn)收測(cè)試Specification 質(zhì)量標(biāo)準(zhǔn)Stability 穩(wěn)定性Sterile Purified Water 滅菌純化水Sterile Water for Inhalation 滅菌吸入用水Sterile Water for Injection 滅菌注射用水Sterile Water for Irrigation 滅菌沖洗用水Subdividing Operation 分裝操作Tamper Evidence 防篡改封簽Time Limits 生產(chǎn)時(shí)限training 培訓(xùn)Update Batch Production Record, BPR 批記錄User Requirement Specification, URS 用戶(hù)需求標(biāo)準(zhǔn)Validation 驗(yàn)證Validation master plan 驗(yàn)證主計(jì)劃Verification 復(fù)核Verification 檢定Water for Injection 注射用水Working