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參考文獻

Further reading

拓展閱讀

Abbreviations

縮略語

Appendix 1. Example of documentation commonly required for the transferof technology

附錄1. 技術轉移通常需要的文件示例

Appendix 2. Example of possible experimental designs and acceptancecriteria for analytical testing

附錄2. 分析測試可能的實驗設計和接受標準示例

4. Due diligenceand gap assessments

盡職調(diào)查和差距評估

4.1.         A process of duediligence, gap assessment or audits of the SU and RU should be one of the firststeps when considering a technology transfer project.

在考慮技術轉移項目時,，首先應對轉移方和接收方進行盡職調(diào)查,、差距評估或審計。

4.2. The suitability and degree of preparedness of the RU should beassessed prior to the start of the transfer. The procedure to be followedshould be documented.

接收方的適當性和準備程度應在轉移開始之前進行評估,。應將應遵循的程序形成文件,。

4.3. The assessment should be done by a team of appropriately qualifiedpersons with knowledge and experience in the field of GxP and the activity tobe transferred.

評估應由一個具有GxP領域知識和經(jīng)驗的適當資質(zhì)的人員組成的團隊來完成。

4.4. The assessment should further cover resources including personnel,premises, equipment and instruments, utilities, QC, documentation, computerizedsystems, qualification and validation and waste management.