制藥行業(yè)GMP英文詞匯.doc

Approve 批準Artwork 藥品標簽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Calibration 校準Campaign-based production 階段性生產(chǎn)Checked 校驗Cleanance or site cleaning 清場Cleaning 清潔Cleaning Validation 清潔驗證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Cool Storage 陰涼儲存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 設計確認Deviation 偏差Drinking Water 飲用水Dry Place 干燥儲存education 個人學歷Equipment logbook 設備使用日志Excessive heat 過熱Expected Yield, expected 預期收率experience 工作經(jīng)驗Expiry Date 有效期Factory Acceptance Test，F(xiàn)AT 供應商工廠的驗收測試Freezer Storage 冷凍儲存Holding Time 貯存期I：Implemente 執(zhí)行Impurity profile 雜質(zhì)概況In-process Controls 過程控制In-process Sampling 過程取樣Installation qualification, IQ 安裝確認Intermediate 中間體Logbook 使用日志Maintenance Basic Practice 維護基本實踐Maintenance Best Practice 維護最佳實踐Maintenance Good Practice 維護良好實踐Maintenance Plan 維護計劃Maintenance Program 維護管理程序Manufacture 制造Master Cell Bank , MCB 主細胞庫mix-ups 混淆Non-conformance 不合格Operation qualification, OQ 運行確認Out of Specification , OOS 超標Performance qualification, PQ 性能確認Preliminary Cell Bank ,PCB 原始細胞庫Preventive Maintenance 預防性維護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Responsible 負責Rechecked 復驗Reconciliation 物料平衡Refrigerator Storage 冷藏儲存Reject 拒收Retest dates 復驗期Risk Assessment 風險評估Room Temperature Storage 室溫儲存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 用戶工廠的驗收測試Specification 質(zhì)量標準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)時限training 培訓Update Batch Production Record, BPR 批記錄User Requirement Specification, URS 用戶需求標準Validation 驗證Validation master plan 驗證主計劃Verification 復核Verification 檢定Water for Injection 注射用水Working