人妻秘书ol中文字幕星空传媒影视公司|中文字幕人妻中文字幕成人性电影|国产精品美女久久久久久免费亚洲国产精品中文字幕一区久久|中文字幕在线天堂中文字幕一区一区二区三区|91丨九色丨国产熟女a|亚洲国产精品91|91极品国产|色悠悠国产精品|亚洲av一线二线久久性色|9区中文字幕在线,999中文字幕精品,成人久久不卡一区二区三区,国产av专区网站大全

轉(zhuǎn)移方和接收方的生產(chǎn)量和批量大小應(yīng)進(jìn)行比較,。當(dāng)批量大小不同時,，應(yīng)評估其影響,，計劃并采取適當(dāng)?shù)拇胧Ｅc待審查設(shè)備有關(guān)的其他因素可能包括:

• minimum and maximum capacity;

• 最小和最大能力

• material of construction of contactsurfaces;

• 接觸表面的構(gòu)造材料

• critical operating parameters;

• 關(guān)鍵操作參數(shù)

• components (e.g. filters, screens, andtemperature/pressure sensors); and

• 組件(例如過濾器,、篩和溫度/壓力傳感器);和

• range of intended use.

• 預(yù)計使用范圍

9.6. The impact of the potential product to be transferred, on existingproducts manufactured on site, should be assessed.

應(yīng)評估待轉(zhuǎn)移產(chǎn)品對現(xiàn)場生產(chǎn)的現(xiàn)有產(chǎn)品的影響,。

10. Qualification and validation

確認(rèn)與驗證

10.1. The extent of qualification and validation to be performedshould be determined on the basis of risk management principles.

應(yīng)根據(jù)風(fēng)險管理原則確定確認(rèn)和驗證的范圍,。

10.2. The qualification of premises, utilities and equipmentshould be done in accordance with a qualification master plan and protocols.

廠房,、公用設(shè)施和設(shè)備的確認(rèn)應(yīng)按照確認(rèn)主計劃和方案進(jìn)行。

10.3. Validation, such as process validation, should be done inaccordance with a validation master plan and protocols.

驗證,，例如工藝驗證,，應(yīng)該按照驗證主計劃和方案進(jìn)行。

10.4. Where technology is transferred to commercial sites, thequalification of equipment and instruments should be completed prior to theactual technology transfer.