接收方应该有适当的布局、建筑和修整，以适应预期的操作。公用设施，如暖通空调，以及气体和水系统，应该适合待转移的工艺，产品或程序。

8.2. The SU should provide the RU with information on relevant health,safety and environmental issues, including:

转移方应向接收方提供有关健康、安全和环境问题的信息，包括:

• inherent risks of the manufacturing processes (e.g. reactive chemicalhazards, exposure limits, fire and explosion risks);

• 制造过程的固有风险(例如反应性化学危害、接触限度、火灾和爆炸风险);

• health and safety requirements to minimize operator exposure (e.g.atmospheric containment of pharmaceutical dust);

• 健康和安全要求以减少操作人员暴露(例如，空气中药物粉尘的控制);

• emergency planning considerations (e.g. in case of gas or dust release,spillage, fire and firewater run-off); and

• 应急计划考虑(例如，气体或灰尘释放、泄漏、火灾和消防水溢出);和

• identification of waste streams and provisions for re-use, recyclingand/or disposal.

• 识别废物流及可再用、回收及/或处置的规定。

9. Equipment and instruments

设备和仪器

9.1. The SU should provide a list of equipment and instrumentsinvolved in the production, filling, packing and QC testing. The list shouldinclude the makes and models of the relevant equipment and instruments.

转移方应提供一份生产、分装、包装和