1 回答
Provided thatthe new equipment isequivalent to the one currently used, and operates in theapproved range ofprocess parameters, the change is covered by company'squality assurance system.
只要新设备与目前使用的设备相当, 并在批准的工艺参数范围内运行, 则变更由公司的质量保证体系覆盖。
If theintroduction of new equipment has anyimpact on the processes and detailsregistered in module 3 (with the exceptionof section 3.2.A.1 forbiological medicinalpoducts), the MAH should submit theappropriate variation(s).
如果引入新设备对模块3中登记的工艺和细节有任何影响 (生物医药产品3.2.A.1 节除外), 则MAH应提交相应的变更。
