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注:附錄1列有技術(shù)轉(zhuǎn)移通常需要的文件示例。

7.1. An authorized technology transfer document should list theintended sequential phases and activities of the transfer. The document shouldinclude, for example, the following:

應(yīng)有經(jīng)批準(zhǔn)的技術(shù)轉(zhuǎn)移文件列出轉(zhuǎn)移的預(yù)定階段和活動,。例如,，該文件應(yīng)包括下列內(nèi)容:

• title;

• 標(biāo)題

• objective;

• 目的

• scope;

• 范圍

• name and addresses of the SU and RU;

• 轉(zhuǎn)移方和接收方的名稱和地址

• names of key personnel and theirresponsibilities;

• 關(guān)鍵人員的名字及其職責(zé)

• phases of the project and actions;

• 項目的階段和活動

• a parallel comparison of premises,equipment, instruments, materials, procedures, and methods;

• 對廠房、設(shè)備,、儀器,、物料,、程序和方法的平行比較

• experimental design, quality attributes,process parameters and acceptance criteria;

• 實驗設(shè)計、質(zhì)量屬性,、工藝參數(shù)和接受標(biāo)準(zhǔn);

• information on trial production batches,qualification batches and process validation;

• 有關(guān)試產(chǎn)批,、確認(rèn)批和工藝驗證的信息;

• change and deviation management;

• 變更和偏差管理

• arrangements for keeping retention samplesof active ingredients, intermediates and finished products, and information onreference substances where applicable; and

• 活性成分、中間體和成品留樣的保存,，以及有關(guān)對照物質(zhì)的信息(如適用);和

• review of the transfer, outcome, signature(s)and date of conclusion of the transfer.

• 轉(zhuǎn)移,、結(jié)果、轉(zhuǎn)移結(jié)論簽字/日期的審核,。