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质量管理 QM(Quality Management)
质量保证 QA(Quality Assurance)
质量控制 QC(Quality Control)
生产管理 PM(Production Management)
工程设备管理 EM (Engineer Equipment Managemant)
销售管理 MS (Management Of Sales)
行政人员管理AP (Administration and Personael Management)
工艺验证 PV (Process Validation)
设备验证 EV (Equipment Validation)
工艺规程 PP (Process Procedure)
质量标准 QS (Quality Management)
物料管理 MM (Material Management)
原料管理 RM (Raw Material Management)
辅料管理 EM (Excipient Management)
质量标准 QS (Quality Standard)
在线清洁CIP
在线消毒 SIP
安装确认IQ
运行确认OQ
性能确认PQ
增补和修订A.A.A Addition and Amendments
空调器AC Air Conditioner
药物不良反应ADR Adverse Drug Reaction
食品与药品官员协会(美国)AFDO Association of Food and Drug Officials
接受ACC Accept
合格质量标准AQL Acceptable Quality Level
简化的新药申请ADNA Abbreviated New Drug Application
物料清单BOM Bill of Material
原料药BPC Bulk pharmaceutical Chemicals
生物制品评价与研究中心CBER Center for Biologics Evaluation Research
菌落形成单位CFU Colony Forming Unit
药品管理档案DMF Drug Master File
药物评价与研究中心CDER Cemter for Drug Evaluation amd Research
企业识别(形象)CI Corporate Identity (Image)
在线清洗CIP Cleaning in Place
消费者安全调查员CSI Consumer Safety Insepctor
在线清洗程序CLP Cleaning Line Procedure
缺陷作用水平DAL Defect Action Level
管制药品管理DEA Drug Enforcement Adminestration
文件系统DS Documentation Systim
食品与药品管理局(美国)FDA Food and Drug Administration
关贸总协会GATT General Agreemernt on Tariffs and Trade
药品生质量管理规范GMP Good Manufacturing Practice Gvp
药品临床实验管理规范GCP Good Clinical Practice
实验室管理规范GLP Good Laboratory Practice
药品商业质量规范GSP Good Supply Practice
药品零业质量管理规范GRP Gook RaTAIL Practice
药材生产管理规范GAP Good Agriculture Practice
验证管理规范GVP Gook Validation Prctice
药品重用规范GUP Gook Use Practice
空调净化系统HVAC Heating Ventilation Air Conditioning
国际标准化组织ISO Intematonal Organization for Standardization
谅解备忘录MOU Memorandum of Understanding
生产记录用表格PF Porduction File
非处方药品OTC Over the Counter (Drug)
产品许可申请PLA Product License Application
质量保证QA Quality Assurance
质量控制QC Quality Control
质量管理程序QMP Quality Management Procedure
国家药品监督管理局SDA State Drug Administration
标准管理程序SMP Standard Managmert Procedure
标准操作程序SOP Standard Operating Procedure
全面质量管理TQC Tatal Quality Control
美国药典USA Uneted States Pharmacopeia
