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制藥常見詞匯英文對照
閱讀：1797 發(fā)布時間：2011-4-25
制藥常見詞匯英文對照
| 中文 | 英文 | 中文 | 英文 |
| 協(xié)調(diào)會議 | ICH | 顆粒 | granulation |
| 原料藥GMP | Q7A | 粒度 | particle size |
| 原料藥 | API | 磨粉 | milling |
| 指導(dǎo)原則 | guideline | 微粉 | micronizing |
| 符合要求 | Meet the requirements | GMP要求 | GMP requirements |
| 純度 | purity | 執(zhí)行v | implement |
| 物料接收 | receipt of materials | 組織機構(gòu) | organisational structure |
| 生產(chǎn) | production | 質(zhì)量相關(guān)事物 | quality related activities |
| 包裝 | packaging | 偏差 | deviation |
| 重包裝 | repackaging | 關(guān)鍵偏差 | Critical deviations |
| 貼標(biāo) | labelling | 評價 | evaluation |
| 重貼標(biāo) | relabelling | 藥政檢查 | regulatory inspections |
| 質(zhì)量控制 | quality control | 嚴(yán)重GMP缺陷 | serious GMP deficiencies |
| 放行 | release | 審核并批準(zhǔn) | review and approve |
| 儲存 | storage | 委派 | delegate |
| 銷售 | distribution | 拒收 | reject |
| 安全方面 | safety aspects | 包裝物和標(biāo)簽 | packaging and labelling materials |
| 環(huán)境保護 | protection of the environment | 實驗室控制記錄 | laboratory control record |
| 國家法律 | national laws | 標(biāo)準(zhǔn) | specifications |
| 注冊 | registration | 主生產(chǎn)文件 | master production instructions |
| 人用藥 | human drug | 自檢 | internal audits self-inspections |
| 無菌原料藥 | sterile APIs | 合同生產(chǎn)商 | contract manufacturers |
| 消毒 | sterilization | 驗證方案和報告 | validation protocols and reports |
| 當(dāng)?shù)厮幷块T | local authorities | 投訴 | complaints |
| 化學(xué)合成 | chemical synthesis | 維護 | maintaining |
| 提取 | extraction | 校正 | calibrating |
| 發(fā)酵 | fermentation | 穩(wěn)定性數(shù)據(jù) | stability data |
| 排除 | exclude | 復(fù)驗/失效日期 | retest or expiry dates |
| 臨床試驗 | clinical trials | 存儲條件 | storage conditions |
| 起始物料 | Starting Material | 產(chǎn)品質(zhì)量回顧 | product quality reviews |
| 結(jié)構(gòu)單元 | structural fragment | 批生產(chǎn)記錄 | production batch records |
| 供應(yīng)商 | supplier | 設(shè)施 | premises |
| 化學(xué)性質(zhì) | chemical properties | 設(shè)施變更 | modified facilities |
| 具體分析 | case-by-case | 證實 | verify |
| 關(guān)鍵步驟 | critical process | 糾偏措施 | corrective actions |
| 前面幾部 | early API steps | 工藝的穩(wěn)定性 | consistency of the process |
| zui后幾部 | final steps | 分析方法 | analytical methods |
| 純化 | purification | 穩(wěn)定性監(jiān)控計劃 | stability monitoring program |
| 分離 | Isolation | 人員資格 | Personnel Qualifications |
| 需要書面寫下 | should be specified in writing | 培訓(xùn)記錄 | Records of training |
| 人員衛(wèi)生 | Personnel Hygiene | 微生物總數(shù) | total microbial counts |
| 顧問 | Consultants | 控制菌 | objectionable organisms |
| 潛在污染 | potential contamination | 非無菌 | non-sterile |
| 微生物標(biāo)準(zhǔn) | microbiological specifications | 的 | Dedicated |
| 混淆 | mix-ups | 無水 | Sewage |
| 待驗 | quarantine | 垃圾 | Refuse |
| 洗滌劑 | detergent | 衛(wèi)生 | Sanitation |
| 手烘器 | air driers | 書面程序 | Written procedures |
| 反作用影響 | adversely affect | 設(shè)備維護 | Equipment Maintenance |
| 蒸汽 | steam | 預(yù)防性維護 | preventative maintenance |
| 通風(fēng) | ventilation | 集中生產(chǎn) | campaign production |
| 圖紙 | Drawings | 清洗媒介 | cleaning agents |
| 空氣過濾 | air filtration | 卸 | disassembling |
| 排氣 | exhaust | 連續(xù)批號 | successive batches |
| 交叉污染 | cross-contamination | 非設(shè)備 | Non-dedicated equipment |
| 空氣壓力 | air pressure | 可接受標(biāo)準(zhǔn) | Acceptance criteria |
| 塵埃 | dust | 殘留 | residues |
| 微生物 | microorganisms | 清潔程序 | cleaning procedures |
| 回風(fēng) | recirculate | 狀態(tài) | status |
| 管道 | pipework | 預(yù)先計劃 | established schedule |
| 中間體 | intermediate | 可追蹤的 | traceable |
| 排水溝 | Drains | 對 有影響 | had an impact on |
| 飲用水 | potable water | 計算機化系統(tǒng) | Computerized Systems |
| 文件系統(tǒng) | Documentation System | 電子格式 | electronic form |
| 修訂歷史 | revision histories | 電子簽名 | electronic signatures |
| 擴產(chǎn)報告 | scale-up reports | 中間控制 | in-process controls |
| 技術(shù)轉(zhuǎn)化 | technical transfer | 內(nèi)控檢測 | in-house testing |
| 開發(fā)歷程報告 | development history reports | 中試規(guī)模 | pilot scale |
| 保留期限 | retention periods | 歷史數(shù)據(jù) | historical data |
| 生產(chǎn)工藝規(guī)程 | Master Production Instructions | 不合格 | Out-of-specification |
| 工藝參數(shù) | process parameters | 混批 | Blending Batches |
| 批量 | batch size | 一級對照品 | primary standard |
| 時間限制 | time limits | 雜質(zhì)概況 | impurity profile |
| 預(yù)期產(chǎn)量 | expected yield | 微生物檢測 | microbiological tests |
| 實際產(chǎn)量 | Actual yield | 商業(yè)規(guī)模 | commercial scale |
| 關(guān)鍵物料 | critical materials | 留樣 | Retention Samples |
| 進廠物料 | incoming materials | 預(yù)驗證 | Prospective validation |
| 回顧性驗證 | retrospective validation | 結(jié)晶 | crystallization |
| 不少于 | not less than | 回收溶劑 | recovered solvents |
| 不大于 | not more than | 母液 | mother liquors |
| 攝氏度 | centigrade | 重新加工 | Reworking |
| 獸用 | Veterinary use | 保留時間 | retention time |
| 氫氧化鈉 | sodium hydroxide | 拆分溶液 | Resolution solution |
| 鹽酸 | hydrochloric acid | 水分 | water |
| 甲醇 | methanol | 重金屬 | Heavy metal |
| 殘留溶劑 | Residual solvents | 流動相 | phase |
| 熾灼殘渣 | Residue on ignition | 柱子 | column |
| 含量 | Assay | 容器 | Container |
| 作一個空白對照 | Perform a blank determination | 劑型 | dosage form |
| 鑒別 | Identification | 規(guī)格 | strength |
| 熔點 | Melting point | 適應(yīng)癥 | proposed indication |
| 熔程 | Melting range | 給藥途徑 | route of administration |
| 干燥失重 | Loss on drying | 輔料 | Excipient |
| 有關(guān)物質(zhì) | Related substance | 結(jié)構(gòu)式 | structural formula |
| 比旋度 | Specific rotation | 分子式 | molecular formula |
| 無水 | anhydrous | | |
| 靜態(tài) | at rest | | |
| 動態(tài) | in operation | | |
GMP車間房間名稱中英文對照
更衣室 Changing Room
一更 First Changing Room
手消室 Hands Disinfection Room
氣閘室 Airlock Room
潔具室 Cleaning Tools Room
清洗室 Cleaning Room
模具室 Dies Room
內(nèi)包裝室 Immediate Package Room
安全門 Emergency Door
外包清室Outer Package Removing Room
存料間Storage Room of Raw Materials
粉碎室 Pulverizing Room
更衣室 Changing Room
一更 First Changing Room
手消室 Hands Disinfection Room
氣閘室 Airlock Room
潔具室 Cleaning Tools Room
清洗室 Cleaning Room
模具室 Dies Room
內(nèi)包裝室 Immediate Package Room
安全門 Emergency Door
外包清室Outer Package Removing Room
存料間Storage Room of Raw Materials
粉碎室 Pulverizing Room