GMP常见英文缩写
AQAI(Automated Quality Assurance Inspection Equipment):在线自动质量保证检查设备
API(Active Pharmaceutical Ingredient):活性药物物质,即原料药
低血糖昏迷ANDA (Abbreviated New Drug Application):简化新药申请
中国海关电话
ADR(Adver Drug Reaction):不良反应
昨日种种BSE(Bovine Spongiform Encephalopathy):疯牛病
BPCS(Business Planning and Control System):业务计划及控制系统
BIA(Business impact asssment): 商业影响评估
cGMP(current Good Manufacturing Practice):现行药品生产质量管理规范
CCCD(China Certification Committee for Drugs):中国药品认证委员会
CIP(Cleaning In Place):在线清洁
CV(Concurrent Validation):同步验证
CDER( Center for Drug Evaluation and Rearch): 药品研究与评价中心
COA(Certificate Of Analysis):分析报告单
CFR(Code of Federal Regulation):(美国)联邦法规
CDC(Centers for Dia Control and Prevention):疾病预防控制中心
COS/ CEP( Certificate of Suitability for European Pharmacopeia ):欧洲药典适用性证书
营销部是做什么的CCD (Certification Committee for Drugs):药品认证管理中心
CPMP(Committee for Proprietary Medicinal Products): 欧洲专利药品委员会
CTD(Common Technical Document):通用技术文件
CDC( Centers for Dia Control and Prevention): 疾病预防控制中心
GMP(Good Manufacturing Practice):药品生产质量管理规范
ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human U):人用药品注册技术要求国际协调会
EU(European Union):欧洲联盟
EFPIA(European Federation of Pharmaceutical Industries Associations):欧洲制药工业协会联合会
MHW(Ministry of Health and Welfare,Japan):日本厚生省
JPMA(Japan Pharmaceutical Manufacturers Association):日本制药工业协会
FDA(US Food and Drug Adminiistration):美国食品与药品管理局
PRMA(Pharmaceutical Rearch and Manufacturers of America):美国药物研究和生产联合会
WHO(World Health Organization):世界卫生组织
IFPMA(International Federation of Pharmaceutical Manufacturers Associations):
国际制药工业协会联合会
TQC(Total Quality Control),TQM(Total Quality Management): 全面质量管理
PDCA(Plan,Do,Check,Action):计划,执行,检查,处理
QA(Quality Assurance):质量保证
钓鲫鱼最好的饵料QC (Quality Control):质量控制
QS(Quality System):质量体系
QM(Quality Management): 质量管理
SOP(Standard Operating Procedure): 标准操作规程
SMP(Standard Management Procedure):标准管理程序
SOR(Standard Operating Record): 标准操作记录
GEP(Good Engineering Practice):工程设计规范
HVAC(Heating Ventilation and Air Conditioning):空调净化系统
DQ(Design Qualification):设计确认
IQ(Installation Qualification):安装确认
OQ(Operational Qualification):运行确认
PQ(Performance Qualification):性能确认
OOS(Out-Of-Specification):检验不合格;超标
PFDS(Process Flow Diagrams):工艺流程图
MRA(cMutual Reognition Agreements): 现场检查多边认同协议
DMF( Drug Master File):
怎么用烤箱烤鱼EDMF(European Drug Master File）欧盟药物主文件
EDQM（European Directorate for Quality Medicines）: 欧洲药品质量管理局
ORA(Office of Regulatory Affairs):药政事务办公室
GGPs( Good Guidance Practices): 优良指南规范
MOA(Method Of Analysis):分析方法
VMP(Validation Master Plan):验证主计划
VP(Validation Protocol):验证方案
MSDS(Material Safety Data Sheet):物料安全技术说明书
NDA (New Drug Application):新药申请
OTC(Over-the-counter):非处方
INN(International Nonproprietary Name)国际非专有名称
lol无法连接USP(the united state pharmacopeia): 美国药典
NF(National Formulary):(美国)国家药品集
GAP(Good Agricultural Practice):中药材种植管理规范
GCP(Good Clinical Practice):药物临床试验质量管理规范
GLP(Good Laboratory Practice):药物实验室管理规范
GSP(Good Supply Practice):药品经营质量管理规范
GUP(Good U Practice):药品使用质量管理规范
SM(Starting Material):起始物料
PMF(Plant Master File); SMF(Site Master File):工厂主文件
EDL(List of Esntial Drugs ) : 基本药物目录
PI(Package Inrt):说明书
PCT( Patent Cooperation Treaty): 专利合作条约
抗疫英雄手抄报PPAC(Patent Protection Association of China):中国专利保护协会
PIC( Person In Charge) :负责人
PDS(Pharmaceutical Development Services): 整体新药研发机构
SPC(Summary of Product Characteristics):产品特性摘要
