制藥常見(jiàn)詞匯英文對照
中文 | 英文 | 中文 | 英文 |
國際協(xié)調會(huì )議 | ICH | 顆粒 | granulation |
原料藥GMP | Q7A | 粒度 | particle size |
原料藥 | API | 磨粉 | milling |
指導原則 | guideline | 微粉 | micronizing |
符合要求 | Meet the requirements | GMP要求 | GMP requirements |
純度 | purity | 執行v | implement |
物料接收 | receipt of materials | 組織機構 | 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 | labelling | 評價(jià) | evaluation |
重貼標 | relabelling | 藥政檢查 | regulatory inspections |
質(zhì)量控制 | quality control | 嚴重GMP缺陷 | serious GMP deficiencies |
放行 | release | 審核并批準 | review and approve |
儲存 | storage | 委派 | delegate |
銷(xiāo)售 | distribution | 拒收 | reject |
安全方面 | safety aspects | 包裝物和標簽 | packaging and labelling materials |
環(huán)境保護 | protection of the environment | 實(shí)驗室控制記錄 | laboratory control record |
國家法律 | national laws | 標準 | 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(wú)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 |
當地藥政部門(mén) | 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 | 穩定性數據 | stability data |
排除 | exclude | 復驗/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 |
結構單元 | structural fragment | 批生產(chǎn)記錄 | production batch records |
供應商 | supplier | 設施 | premises |
化學(xué)性質(zhì) | chemical properties | 設施變更 | modified facilities |
具體分析 | case-by-case | 證實(shí) | verify |
關(guān)鍵步驟 | critical process | 糾偏措施 | corrective actions |
前面幾部 | early API steps | 工藝的穩定性 | consistency of the process |
最后幾部 | final steps | 分析方法 | analytical methods |
純化 | purification | 穩定性監控計劃 | stability monitoring program |
分離 | Isolation | 人員資格 | Personnel Qualifications |
需要書(shū)面寫(xiě)下 | should be specified in writing | 培訓記錄 | Records of training |
人員衛生 | Personnel Hygiene | 微生物總數 | total microbial counts |
顧問(wèn) | Consultants | 控制菌 | objectionable organisms |
潛在污染 | potential contamination | 非無(wú)菌 | non-sterile |
微生物標準 | microbiological specifications | 專(zhuān)用的 | Dedicated |
混淆 | mix-ups | 無(wú)水 | Sewage |
待驗 | quarantine | 垃圾 | Refuse |
洗滌劑 | detergent | 衛生 | Sanitation |
手烘器 | air driers | 書(shū)面程序 | Written procedures |
反作用影響 | adversely affect | 設備維護 | Equipment Maintenance |
蒸汽 | steam | 預防性維護 | 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(guò)濾 | air filtration | 卸 | disassembling |
排氣 | exhaust | 連續批號 | successive batches |
交叉污染 | cross-contamination | 非專(zhuān)用設備 | Non-dedicated equipment |
空氣壓力 | air pressure | 可接受標準 | 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 | Computerized Systems |
文件系統 | 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)轉化 | technical transfer | 內控檢測 | in-house testing |
開(kāi)發(fā)歷程報告 | development history reports | 中試規模 | pilot scale |
保留期限 | retention periods | 歷史數據 | historical data |
生產(chǎn)工藝規程 | Master Production Instructions | 不合格 | Out-of-specification |
工藝參數 | process parameters | 混批 | Blending Batches |
批量 | batch size | 一級對照品 | primary standard |
時(shí)間限制 | time limits | 雜質(zhì)概況 | impurity profile |
預期產(chǎn)量 | expected yield | 微生物檢測 | microbiological tests |
實(shí)際產(chǎn)量 | Actual yield | 商業(yè)規模 | commercial scale |
關(guān)鍵物料 | critical materials | 留樣 | Retention Samples |
進(jìn)廠(chǎng)物料 | incoming materials | 預驗證 | Prospective validation |
回顧性驗證 | retrospective validation | 結晶 | 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(shí)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(dòng)相 | Mobile phase |
熾灼殘渣 | Residue on ignition | 柱子 | column |
含量 | Assay | 容器 | Container |
作一個(gè)空白對照 | Perform a blank determination | 劑型 | dosage form |
鑒別 | Identification | 規格 | strength |
熔點(diǎn) | Melting point | 適應癥 | 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 | 結構式 | structural formula |
比旋度 | Specific rotation | 分子式 | molecular formula |
無(wú)水 | anhydrous | ||
靜態(tài) | at rest | ||
動(dòng)態(tài) | in operation |
GMP車(chē)間房間名稱(chēng)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
內包裝室 Immediate Package Room
安全門(mén) Emergency Door
外包清室Outer Package Removing Room
存料間Storage Room of Raw Materials
粉碎室 Pulverizing Room
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