3.3 Premises mentioned by building references and activities
所提及厂房的建筑特性及其所执行的功能
[注:根据实际厂房情况按此表进行填写,还可包括留样室、QC实验室、称量室、仓库等的具体情况]3.4 Water
Quality Control or Production Personnel who had special education and training will perform the sampling of the water according to the sampling Standard Operation Procedure from predefined sampling points.
水的取样由经过专门教育与培训的质控或生产人员执行,根据取样标准操作规程按预先指定的取样点进行取样。
City Water and Purified Water are used in the process of API A. Purified Water is prepared by a validated water purification system. Purified water is sampled at an interval of 7 days and tested according to Ph.Eur purified water specifications.
在原料药A的生产过程中使用到了城市用水与纯化水。纯化水由一经过验证的水纯化系统制备,每隔7天取样一次,并按欧洲药典纯化水规格进行检测。
City water supplied by local Water Supply Corporation is tested according to the in-house specifications every 15 days.
由当地自来水公司提供的城市用水根据内控规格每15天检测一次。
[注:城市用水的来源必须符合实情,水的检测周期也必须符合公司的SOP要求。此处需以表格的形式列出纯化水及城市用水的质量规格,并明确行动限与警戒限]3.5 Manufacturing Equipment
生产设备
[注:也就是设备清单,以表格的形式列出生产中所使用主要设备的设备名称、生产者、数量、容量、安装年限等,如离心机、压力过滤器、结晶釜、反应釜、粉碎筛]3.6 Control Laboratory Equipment
实验室控制设备
All major pieces of quality control laboratory equipment are serviced and calibrated at regular intervals depending on the specific item. Service and calibration is documented in logbooks.
The following table references the equipment used for IPC and finished product testing during production:
对QC实验室设备的所有主要部件按规定的项目进行定期维护与校正,维护与校正情况在日志本上进行记录。
[注:列一份QC实验室的设备清单,内容包括设备名称、房间号、数量及安装年限等]3.7 Maintenance and Calibration
保养与校正