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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(shí),，應(yīng)評(píng)估其影響，計(jì)劃并采取適當(dāng)?shù)拇胧?。與待審查設(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(guò)濾器,、篩和溫度/壓力傳感器);和

• range of intended use.

• 預(yù)計(jì)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(píng)估待轉(zhuǎn)移產(chǎn)品對(duì)現(xiàn)場(chǎng)生產(chǎn)的現(xiàn)有產(chǎn)品的影響。

10. Qualification and validation

確認(rèn)與驗(yàn)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(xiǎn)管理原則確定確認(rèn)和驗(yàn)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(jì)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(yàn)證,，例如工藝驗(yàn)證,，應(yīng)該按照驗(yàn)證主計(jì)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.