A H U 空调机组 A ir handing unit
AOAC 美国公职化学家协会Association of Official Analytical Chemists
A M V 分析方法验证 Analytical method validation
API 药物活性成分 Active pharmaceutical ingredient
ASME 美国机械工程学会 American Society of Mechanical Engineers
ASME BPE 美国机械工程 -生物工程设备学会 American Society of Mechanical Engineers Bioprocessing Equipment
ASTM 美国材料与试验协会 American Society for Testing and Materials
BMS 楼宇控制系统 Building management system
BI 生物指示剂 Biological indicator
CAPA 纠正和预防措施 Corrective and preventative action
CCA 部件关键性评估Component criticality assessment
CCP 关键控制点Critical control point
CD 程序开发Cycle development
CEHT 干净设备保留时间Clean equipment hold time
CFR 美国联邦法规Code of Federal Regulations
CFU 菌落形成单位Colony forming unit
cGMP 现行药品生产质量管理规范Current good manufacturing practice
CHO 中国仓鼠卵巢细胞Chinese hamster ovary
CIP 在线清洗Clean in place
ChP 《中华人民 共和国药典》Chinese Pharmacopeia
Cp/Cpk 工序能力指数Process capability index
CPP 关键工艺参数Critical process parameter
CQA 关键质量属性Critical quality attribute
CSV 计算机化系统验证Computer system validation
CVP 清洁验证计划Cleaning validation plan
DCS 分布式控制系统Distributed control system
DDS 详细设计说明Detailed design specification
D EHT 脏设备保留时间D irty equipment hold time
DNA 脱氧核糖核酸Deoxyribonucleic acid
DOE 实验设计Design of experiment
D〇P 邻苯二甲酸二辛酯Dioctyl phthalate
DQ 设计确认Design qualification
DS 设计说明Design specification
ED50 半数有效量50% effective dose
EDI 电极 法去离 子（美国 滤 材Electrodeionization deionization (US Filter)）
EHS 环境健康安全Environment health safety
ELISA 酶联免疫吸附测定Enzyme-linked immuno sorbent assay
EM A 欧洲药品管理局European Medicines Agenc
EMS 环境监测系统Environmental monitoring system
EP 《欧洲药典 》European Pharmacopoeia
EPA 美国环境保护署Environmental Protection Agency
ERP 企业资源计划Enterprise resource planning
ETOP 工程交付包Engineering turnover packages
EU 欧盟European Union
FAT 工厂验收测试Factory acceptance testing
FDA 美国食品与药品管理局Food and Drug Administration
FDS 功能设计说明Functional design specification
FM EA 失效模式影响分析Failure mode effects analysis
FS 功能说明Function specification
FTA 故障树分析Fault tree analysis
FQCP 现场质量控制计划Field quality control plan
GAMP 良好自动化生产实践指南Good automated manufacturing practice
GDP 良好文件管理规范Good document practice
GEP 良好工程管理规范Good engineering practice
GLP 良好实验室管理规范Good laboratory practice
GMP 良好药品生产管理规范Good manufacturing practice
GxP 药品质量管理规范Good x practice
HACCP 危害分析和关键控制点Hazard analysis and critical control points
HAZOP 危害操作分析Hazard operability analysis
HDS 硬件设计说明Hardware design specification
HEPA 高效空气过滤器High efficiency particulate air
HBV 乙型肝炎病毒Hepatitis B virus
H IV 人类免疫缺陷病毒Human immunodeficiency virus
H M I 人机界面Human machine interface
HPLC 高效液相色谱High performance liquid chromatography
HVAC 采 暖 、通风和空调系统Heating, ventilation, and air conditioning
I/O 输人 / 输出Input and output
IC50 半抑制浓度The half maximal inhibitory concentration
ICH 人用药品注册技术要求国际协调会International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
IEC 国际电工委员会International Electro Technical Commission
IQ 安装确认Installation qualification
ISO 国际标准化组织International Standards Organization
ISPE 国际制药工程协会International Society for Pharmaceutical Engineering
IUPAC 国际理论 (化学)与应用化学联合会International Union of Pure and Applied Chemistry
LIM S 实验室信息管理系统Laboratory information management system
LOD 检测限度Lim it of detection
LOQ 含量限度Lim it of quantizatity
M B /L 亚甲蓝光敏法Methyleneblue
MCB 主细胞库Master cell bank
MES 生产执行系统Manufacturing execution system
MTDD 最低日治疗剂量Minimum treatment daily dosage
00S 超标结果调查Out of specification
0Q 运行确认Operational qualification
OSD 口服固体制剂Oral solid dosage
P&JD 管道和仪表图Piping and instrumentation diagrams
PAO 聚 a-烯烃Poly-alpha-olefin
PAT 过程分析技术Process analytical technology
PBS 磷酸缓冲液Phosphate- buffered saline
PCB 原始细胞库Primary cell bank
PCR 聚合酶链反应Polymerase chain reaction
PDA 美国注射剂协会Parenteral Drug Association
PDI 发货前检查Pre-delivery inspection
PEP 项目执行计划Project execution plan
PFD 工艺流程图Process flow diagrams
PHA 初步危害分析Preliminary hazard analysis
PIC/S 国际药品检查协会组织Pharmaceutical Inspiration Convention And Pharmaceutical Inspection Co-Operation Scheme
PLC 可编程逻辑控制器Programmable logic controller
PM 项目管理Project management
PP 聚丙烯Polypropylene
PPE 人员保护装备Personal protective equipment
PPQ 工艺性能确认Process performance qualification
PQ 性能确认Performance qualification
PS 纯蒸汽Pure steam
PTFE 聚四氟乙烯Polytetrafluoroethylene
PURs 工艺用户需求Process user requirements
PV 工艺验证Process validation
PVC 聚氯乙烯Polyvinyl chloride
PVP 工艺验证计划Process validation plan
PW 纯化水Purified water
QA 质量保证Quality assurance
QbD 质量源于设计Quality by design
QC 质量控制Quality control
QMS 质量管理体系Quality management system
QPP 质量及项目计划Quality and project plan
QRM 质量风险管理Quality risk management
R A 风险评估Risk assessment
RABS 限制进出隔离系统Restricted access barrier system
RH 相对湿度Relative humidity
RNA 核糖核酸Ribonucleic acid
RO 反渗透Reverse osmosis
RSD 相对标准偏差Relative standard deviation
RTM 需求追溯性矩阵Requirements traceability matrix
RTP 快速运转接口Rapid transfer port
SAL 无菌保证水平Sterility assurance level
SAT 现场验收测试Site acceptance testing
SCADA 检测控制和数据收集Supervisory control and data acquisition
SCR 源代码审核Source code review
SDA-PAGE 十二烷基硫酸钠 -聚丙烯酰胺凝胶Sodium dodecyl sulfate-polyacrylamide gel
SDI 淤泥指数Silt density index
SDS 软件设计说明Software design specification
SFDA 国家食品药品监督管理局State Food and Drug Administration
SIA 系统影响性评估System impact assessment
SIP 在线灭菌Sterilize in place
SME 主题专家Subject matter expert
SMS 软件模块说明Software module specifications
s m t 软件模块测试Software module test
SOP 标准操作规程Standard operating procedure
SV 辛德毕斯病毒Sindbis virus
TM 可追溯矩阵Traceability matrix
TOC 总有机碳Total organic carbon
TR 技术报告Technical report
UAF 单向气流Unidirectional airflow
UCL 置信上限Upper confidence lim it
UPS 不间断电源Uninterruptable power supply
URB 用户需求简介User requirements brief
URS 用户需求说明User requirements specification
USP 《美 国 药 典 》United States Pharmacopoeia
u v 紫外灯Ultraviolet light
VMP 验证主计划 / 验证总计划Validation master plan
VP 验证计划Validation plan
VSR 验证总结报告Validation summary report
VSV 水疱性口炎病毒Vesicular stomatitis virus
WCB 工作细胞库Working cell bank
WFI 注射用水Water for injection
WHO 世界卫生组织World Health Organization
WIP 在线加湿Wetting in place
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发表于 2022-11-23 10:42:31
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