欧盟GMP 术语 页码：1/9 仅供华润九新内部交流，请勿外传 GLOSSARY 术语 Definitions given below apply to the words as used 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 enclosed space with two or more doors, and which is interposed between two or more rooms, e.g. of differing class of cleanliness, for the purpose of controlling the air-flow between those rooms when they need to be entered. An air-lock is designed for and used 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。 BATCH (OR LOT)批 A defined quantity of starting material, packaging material or product processed in one process or series of processes 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 case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterised 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 comprises all the units of a pharmaceutical form wh...
