GLOSSARY术语
Definitions given below apply to the words as ud in this guide. They may have different meanings in other contexts.
以下所列定义适用于本指南中所用词汇，在其他上下文中同一术语的涵义可能不同。
AIR-LOCK气锁
An enclod space with two or more doors, and which is interpod between two or more rooms, e.g. of differing class of cleanliness, for the purpo of controlling the
air-flow between tho rooms when they need to be entered. An air-lock is designed for and ud by either people or goods.
设置于两个或数个房间之间(如不同洁净级别的房间之间)的具有两扇或多扇门的隔离空间。设置气锁的目的是在人员或物料出入其间时，对气流进行控制。气锁有人员气锁和物料气锁之分。
天堂一
BATCH (OR LOT)批
A defined quantity of starting material, packaging material or product procesd in one process or ries of process so that it could be expected to be homogeneous.
由一个或若干加工过程生产的具有预期均一质量和特性的一定数量的原辅料、包装材料或药品。
Note
To complete certain stages of manufacture, it may be necessary to divide a batch into a number of sub batches, which are later brought together to form a final homogeneous batch. In the ca of continuous manufacture, the batch must correspond to a defined fraction of the production, characterid by its intended homogeneity.
注：为完成某些生产操作步骤，可能有必要将一批分成若干亚批，然后再合起来成为一个最终均一的批。在连续生产工艺情况下，批必须相应于生产中具有预期均一特性的确定数量的产品。
For control of the finished product, the following definition has been given in Annex 1 of Directive 2001/83/EC as amended by Directive 2003/63/EC: ‘For the control of the finished product, a batch of a proprietary medicinal product compris all the units of a pharmaceutical form which are made from the same initial mass of material and have undergone a single ries of manufacturing operatio
ns or a single sterilisation operation or, in the ca of a continuous production process, all the units manufactured in a given period of time’.
就成品控制而言，法令2001/83/EC的增补法令2003/63/EC附录1有如下定义：“就成品控制而言，一个有产权药品的批系指由同一种起始物料经同一个连续生产操作或一次灭菌获得的所有产品。在连续生产情况下，指在规定时间段内生产的产品。
BATCH NUMBER (OR LOT NUMBER)批号
A distinctive combination of numbers and/or letters which specifically identifies a batch.
用于识别一个特定批的具有专一性的数字/字母的组合。
BIOGENERATOR生物反应器
A contained system, such as a fermenter, into which biological agents are introduced along with other materials so as to effect their multiplication or their production of other substances by reaction with the other materials. Biogenerators are generally fitted with devices for regulation, control, connection, material addition and material withdrawal.
如发酵罐那样的封闭系统，将菌种和其他物料加其中，此系统能控制增殖或与其他物料作用获得生成物的过程。生物反应器通常配有调节、控制、连接、添加物料和收集收获液的装置。
BIOLOGICAL AGENTS生物载体
Micro-organisms, including genetically engineered micro-organisms, cell cultures and endoparasites, whether pathogenic or not.
微生物，包括转基因微生物，细胞和寄生体(病原或非病原)。
BULK PRODUCT待包装产品
Any product which has completed all processing stages up to, but not including, final packaging.
尚未进行最终包装但已完成所有其他加工工序的任何产品。
CALIBRATION校准
The t of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, or values reprented by a material measure, and the corresponding known values of a reference standard.
在规定条件下，为确定一个测量仪器或系统所指示的量值(尤指称量)，或实物量具所代表的量值，与对应的由参照标准所复现的量值之间关系的一系列活动。
CELL BANK细胞库
Cell bank system: A cell bank system is a system whereby successive batches of a product are manufactured by culture in cells derived from the same master cell bank.
A number of containers from the master cell bank are ud to prepare a working cell bank. The cell bank system is validated for a passage level or number of population doublings beyond that achieved during routine production.
细胞库系统：用相同主细胞库中的细胞制备并以细胞培养的方式生产连续批次产品的系统。工作细胞库由主细胞库中的数瓶细胞制备而得。常规生产时，细胞库系统是为了控制所用细胞的传代次数不超过经验证确定的范围。
Master cell bank: A culture of [fully characterid] cells distributed into containers in a single operation, procesd together in such a manner as to ensure uniformity and stored in such a manner as to ensure stability. A master cell bank is usually stored at - 70°C or lower.
主细胞库：通过一次培养并分装到容器中经全面鉴定的细胞培养物，其处理方式和保存可确
保细胞培养物的一致性及稳定性。主细胞库通常保存在-70℃或更低的温度下。
Working cell bank: A culture of cells derived from the master cell bank and intended for u in the preparation of production cell cultures. The working cell bank is usually stored at - 70°C or lower.
工作细胞库：由主细胞库制备并用于正常生产的细胞培养物。工作细胞库通常保存在-70℃或更低的温度下。
CELL CULTURE细胞培养物
The result from the in-vitro growth of cells isolated from multicellular organisms.
由多细胞组织中分离得到的细胞株在体外生长的培养物。
CLEAN AREA洁净区
An area with defined environmental control of particulate and microbial contamination, constructed and ud in such a way as to reduce the introduction, generation and retention of contaminants within the area.
对环境中尘粒和微生物污染有规定控制要求的区域，这类区域的建造和使用应能防止污染物的引入、产生和滞留。
Note
The different degrees of environmental control are defined in the Supplementary Guidelines for the Manufacture of sterile medicinal products.
备注：环境控制的级别的定义见在附录1《无菌药物产品的生产》。
CLEAN/CONTAINED AREA洁净/隔离区
An area constructed and operated in such a manner that will achieve the aims of both a clean area and a contained area at the same time.
文具盒里的争吵建造和使用方式同时达到洁净及隔离目的的区域。
CONTAINMENT隔离
The action of confining a biological agent or other entity within a defined space.四只小天鹅芭蕾舞
将生物载体或其他生物体限制在一个确定区域内的措施。
Primary containment: A system of containment which prevents the escape of a biological agent into the immediate working environment. It involves the u of clod containers or safety biological cabinets along with cure operating procedures.
初级隔离：防止生物载体泄漏到直接工作环境中去的系统。它需要使用密闭容器、生物安全柜并执行标准安全操作规程。
Secondary containment: A system of containment which prevents the escape of a biological agent into the external environment or into other working areas. It involves the u of rooms with specially designed air handling, the existence of airlocks and/or sterilirs for the exit of materials and cure operating procedures. In many cas it may add to the effectiveness of primary containment.
二级隔离：防止生物载体泄漏到外部环境或进入其他工作区域的系统。此系统要求房间采用
特殊设计的空气处理系统、设置气锁/或用于物料退出的灭菌器并遵循安全操作规程。在多
数情况下，二级隔离能增加初级隔离的效果。英雄王成
CONTAINED AREA隔离区域
好段50字
An area constructed and operated in such a manner (and equipped with appropriate air handling and filtration) so as to prevent contamination of the external environment by biological agents from within the area.
配备适当的空气处理和过滤系统，其建造和使用方式能防止微生物载体由里对外造成环境污染的区域。
CONTROLLED AREA控制区／受控区域
An area constructed and operated in such a manner that some attempt is made to control the introduction of potential contamination (an air supply approximating to grade D may be appropriate), and the conquences of accidental relea of living organisms. The level of control exercid should reflect the nature of the organism employed in the process. At a minimum, the area should be maintained at a pressure negative to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants.
建造和运行方式意在控制潜在污染物的进入(送风级别约为D级)及活生物体意外释放的区域。所控制的级别应能反映出工艺中所使用的微生物的性质。至少，这个区域对周边区域呈负压，并能有效去处少量的空气污染物。
COMPUTERISED SYSTEM计算机化系统
A system including the input of data, electronic processing and the output of information to be ud either for reporting or automatic control.
报告或自动控制过程中使用的数据输入、电子处理和信息输出的系统。
CROSS CONTAMINATION交叉污染
Contamination of a material or of a product with another material or product.
原辅料或产品与另外一种物料或产品之间的污染。
CRUDE PLANT (VEGETABLE DRUG)天然植物（也作VEGETABLE DRUG）Fresh or dried medicinal plant or parts thereof.
新鲜或干的草药
CRYOGENIC VESSEL低温容器
A container designed to contain liquefied gas at extremely low temperature.
一种在极低的温度下用来储存液态气体的容器。
CYLINDER气体钢瓶
A container designed to contain gas at a high pressure.
是一种用来储存高压气体的容器。
EXOTIC ORGANISM外来生物体
德州扒鸡怎么吃A biological agent where either the corresponding dia does not exist in a given country or geographical area, or where the dia is the subject of prophylactic measures or an eradication programme undertaken in the given country or geographical area.
与一个特定国家或地域的任何疾病无关的生物载体，或与特定国家或地域疾病控制或根除计划所控制的疾病相应的生物载体。
FINISHED PRODUCT成品
A medicinal product which has undergone all stages of production, including packaging in its final container.
已完成生产所有操作步骤并已包装在最终容器中的药物产品。
HERBAL MEDICINAL PRODUCT草本药物产品
Medicinal product containing, as active ingredients, exclusively plant material and/or vegetable drug preparations.
只含有植物和/或植物原料为活性成分的药物产品。
INFECTED感染
下雨天真Contaminated with extraneous biological agents and therefore capable of spreading infection.
被外来的微生物载体所污染并可能因此传染的现象。
IN-PROCESS CONTROL中间控制
Checks performed during production in order to monitor and if necessary to adjust the process to ensure that the product conforms its specification. The control of the environment or equipment may also be regarded as a part of in-process control.
为确保产品符合有关标准，生产中对工艺过程加以监控，以便在必要时进行调节而做的各种检查。可将对环境或设备控制视作中间控制的内容。
INTERMEDIATE PRODUCT中间产品
Partly procesd material which must undergo further manufacturing steps before it becomes a bulk product.
李白的古诗大全指完成部分加工步骤，尚需进行进一步加工方可成为待包装品的产品。
LIQUIFIABLE GASES液化的气体
Tho which, at the normal filling temperature and pressure, remain as a liquid in the cylinder.
在正常的灌装温度和压力下，在气体钢瓶内保持液态状态的气体。
MANIFOLD多支管灌装头
Equipment or apparatus designed to enable one or more gas containers to be filled simultaneously from the same source.
可以同时从一个气源灌装一个或多个气体钢瓶的设备或仪器。
