洁净工程专业英语概要1.docx

洁净厂房词汇中英文对照,大家补充.更衣室????Changing?Room一更??????First?Changing?Room手消室????Hands?Disinfection?Room气闸室????Airlock?Room洁具室????Cleaning?Tools?Room清洗室????Cleaning?Room模具室????Dies?Room内包装室??Immediate?Package?Room安全门????Emergency?Door外包清室Outer?Package?Removing?Room存料间Storage?Room?of?Raw?Materials粉碎室???Pulverizing?Room备料室???Materials?Preparing?Room硬胶室???Hard?Capsules?Filling?Room软胶室???Soft?Capsules?Room制粒干燥室Granulating?and?Drying?Room总混间???Blending?Room中间站???Intermediate?Station压片室Tablets?Room?Compression?Room包衣室??Coating?Room配浆间?Coating?Mixture?Preparing?Room铝塑包装间Packing?Room传递窗??Transferring?Window外包装室??Outer?Packing?Room蒸馏水室??Water?Purifying?Room质检室????Quality?Control?Room浓配室?Concentrated?Solution?Room稀配室?Diluted?Solution?Room灌封室Filling?and?Sealing?Room存瓶室?Ampul?Storage?Room洗瓶室?Ampul?Cleaning?Room灭菌间?Sterilizing?Room?灯检室?Light?Inspection?Room粉针室?Lyophilized?Sterile?Powder?Room冷冻干燥机?Lyophilizer?项目管理翻译词汇GMP英语?PIC/S的全称为：Pharmaceutical?Inspection?Convention/Pharmaceutical?Inspection?Cooperation?Scheme,?PIC/S(制药检查草案),?药品检查协会(PIC/S)?,也有人称PIC/S为医药审查会议/合作计划（PIC/S）?PIC的权威翻译：药品生产检查相互承认公约API(Active?Pharmaceutical?Ingredient)?原料药?又称：活性药物组分Air?Lock?气闸?Authorized?Person?授权人?Batch/Lot?批次?Batch?Number/Lot-Number?批号；Batch?Numbering?System?批次编码系统；Batch?Records?批记录；Bulk?Product?待包装品；Calibration?校正；Clean?area洁净区；Consignment（Delivery）托销药品。FDA（FOOD?AND?DRUG?ADMINISTRATION）：（美国）食品药品管理局IND（INVESTIGATIONAL?NEW?DRUG）：临床研究申请（指申报阶段,相对于NDA而言）；研究中的新药（指新药开发阶段，相对于新药而言，即临床前研究结束）?NDA（NEW?DRUG?APPLICATION）：新药申请?ANDA（ABBREVIATED?NEW?DRUG?APPLICATION）：简化新药申请?TREATMENT?IND：研究中的新药用于治疗?ABBREVIATED（NEW）DRUG：简化申请的新药?DMF（DRUG?MASTER?FILE）：药物主文件（持有者为谨慎起见而准备的保密资料，可以?包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物?品。只有在DMF持有者或授权代表以授权书的形式授权给FDA，FDA在审查IND、?NDA、ANDA时才能参考其内容）HOLDER：DMF持有者?CFR（CODE?OF?FEDERAL?REGULATION）：（美国）联邦法规?PANEL：专家小组?BATCH?PRODUCTION：批量生产；分批生产?BATCH?PRODUCTION?RECORDS：生产批号记录?POST-OR?PRE-?MARKET?SURVEILLANCE：销售前或销售后监督?INFORMED?CONSENT：知情同意（患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验）PREscriptION?DRUG：处方药?OTC?DRUG（OVER—THE—C