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接收方應(yīng)該有適當(dāng)?shù)牟季?、建筑和修整,，以適應(yīng)預(yù)期的操作。公用設(shè)施,，如暖通空調(diào),，以及氣體和水系統(tǒng)，應(yīng)該適合待轉(zhuǎn)移的工藝，產(chǎn)品或程序,。

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

轉(zhuǎn)移方應(yīng)向接收方提供有關(guān)健康,、安全和環(huán)境問題的信息，包括:

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

• 制造過程的固有風(fēng)險(xiǎn)(例如反應(yīng)性化學(xué)危害,、接觸限度,、火災(zāi)和爆炸風(fēng)險(xiǎn));

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

• 健康和安全要求以減少操作人員暴露(例如，空氣中藥物粉塵的控制);

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

• 應(yīng)急計(jì)劃考慮(例如,，氣體或灰塵釋放,、泄漏、火災(zāi)和消防水溢出);和

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

• 識(shí)別廢物流及可再用,、回收及/或處置的規(guī)定,。

9. Equipment and instruments

設(shè)備和儀器

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.

轉(zhuǎn)移方應(yīng)提供一份生產(chǎn)、分裝,、包裝和