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

參考文獻(xiàn)

Further reading

拓展閱讀

Abbreviations

縮略語(yǔ)

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

附錄1. 技術(shù)轉(zhuǎn)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(cè)試可能的實(shí)驗(yàn)設(shè)計(jì)和接受標(biāo)準(zhǔn)示例

4. Due diligenceand gap assessments

盡職調(diào)查和差距評(píng)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(shù)轉(zhuǎn)移項(xiàng)目時(shí)，首先應(yīng)對(duì)轉(zhuǎn)移方和接收方進(jìn)行盡職調(diào)查,、差距評(píng)估或?qū)徲?jì),。

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(dāng)性和準(zhǔn)備程度應(yīng)在轉(zhuǎn)移開始之前進(jìn)行評(píng)估。應(yīng)將應(yīng)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(píng)估應(yīng)由一個(gè)具有GxP領(lǐng)域知識(shí)和經(jīng)驗(yàn)的適當(dāng)資質(zhì)的人員組成的團(tuán)隊(duì)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.