中文字幕一级黄色A级片|免费特级毛片。性欧美日本|偷拍亚洲欧美1级片|成人黄色中文小说网|A级片视频在线观看|老司机网址在线观看|免费一级无码激情黄所|欧美三级片区精品网站999|日韩av超碰日本青青草成人|一区二区亚洲AV婷婷

12月6日，ICH更新了關(guān)于ICH Q8/Q9/Q10的問答文件，其中提及設(shè)計空間、工藝驗證、研發(fā)信息、知識管理等方面：

關(guān)于是否需要設(shè)計空間來實現(xiàn)QBD？ICH表示不一定期望建立設(shè)計空間。

關(guān)于在工藝驗證期間，是否應(yīng)該評估設(shè)計空間的外部邊界？ICH表示不需要，在商業(yè)規(guī)模的工藝驗證研究期間，無需在設(shè)計空間的外部邊界進行工藝確認批次。在開發(fā)研究期間，必須盡早充分探索設(shè)計空間。

關(guān)于生產(chǎn)場地應(yīng)提供哪些研發(fā)信息和文件？ICH表示：生產(chǎn)場地應(yīng)提供有助于確保了解生產(chǎn)工藝和控制策略的基礎(chǔ)的藥物開發(fā)信息，包括選擇關(guān)鍵工藝參數(shù)和關(guān)鍵質(zhì)量屬性的基本原理。藥物開發(fā)和生產(chǎn)之間的科學合作和知識共享對于確保成功轉(zhuǎn)移到生產(chǎn)中至關(guān)重要。

關(guān)于監(jiān)管機構(gòu)是否希望在檢查期間看到正式的知識管理方法？ICH表示對正式的知識管理系統(tǒng)沒有監(jiān)管要求。但是。要求來自不同工藝和系統(tǒng)的知識得到適當利用。

關(guān)于是否有必要購買'ICH合規(guī)解決方案'或ICH Q8、9和10實施軟件來實施ICH指南？ICH表示不需要，ICH 尚未認可任何商業(yè)產(chǎn)品，也不打算這樣做。

翻譯如下：

Is it always necessary to have a Design Space (DS) or Real Time Release Testing (RTRT) to implement QbD?

是否總是需要設(shè)計空間（DS）或?qū)崟r放行測試（RTRT）來實現(xiàn)QbD？

Under Quality by Design, establishing a design space or using RTRT is not necessarily expected [ICH Q8(R2), Step 4].

在“質(zhì)量源于設(shè)計”下，不一定期望建立設(shè)計空間或使用RTRT [ICH Q8（R2），第 4 步]。

Should the outer limits of the Design Space be evaluated during process validation studies at the commercial scale?

在商業(yè)規(guī)模的工藝驗證研究期間，是否應(yīng)該評估設(shè)計空間的外部邊界？

No, there is no need to run the process qualification batches at the outer limits of the design space during process validation studies at commercial scale. The design space must be sufficiently explored earlier during development studies (for scale up see also Chapter 2.1 Design Space Question 2; for life cycle approach see Chapter 1.1 for general clarification Question 3).

不需要，在商業(yè)規(guī)模的工藝驗證研究期間，無需在設(shè)計空間的外部邊界進行工藝確認批次。在開發(fā)研究期間，必須盡早充分探索設(shè)計空間（對于工藝放大，另請參見第2.1 章，設(shè)計空間問題 2;有關(guān)生命周期方法，請參見第 1.1 章，一般說明，問題 3）。

What information and documentation of the development studies should be available at a manufacturing site?

生產(chǎn)現(xiàn)場應(yīng)提供哪些研發(fā)信息和文件？

Pharmaceutical development information (e.g., supporting information on design space, chemometric model, outputs of quality risk management activities,…) is available at the development site. Pharmaceutical development information which is useful to ensure the understanding of the basis for the manufacturing process and control strategy, including the rationale for selection of critical process parameters and critical quality attributes should be available at the manufacturing site. Scientific collaboration and knowledge sharing between pharmaceutical development and manufacturing is essential to ensure the successful transfer to production.

藥物開發(fā)信息（例如，有關(guān)設(shè)計空間、化學計量學模型、質(zhì)量風險管理活動產(chǎn)出的支持信息,...）可在研發(fā)現(xiàn)場獲得。生產(chǎn)現(xiàn)場應(yīng)提供有助于確保了解生產(chǎn)工藝和控制策略的基礎(chǔ)的藥物開發(fā)信息，包括選擇關(guān)鍵工藝參數(shù)和關(guān)鍵質(zhì)量屬性的基本原理。藥物開發(fā)和生產(chǎn)之間的科學合作和知識共享對于確保成功轉(zhuǎn)移到生產(chǎn)中至關(guān)重要。

Do regulatory agencies expect to see a formal knowledge management approach during inspections?

監(jiān)管機構(gòu)是否希望在檢查期間看到正式的知識管理方法？

No. There is no regulatory requirement for a formal knowledge management system. However. it is expected that knowledge from different processes and systems is appropriately utilised. Note: ‘formal’ in this context means a structured approach using a recognised methodology or (IT-) tool, executing and documenting something in a transparent and detailed manner.

不。對正式的知識管理系統(tǒng)沒有監(jiān)管要求。但是。要求來自不同工藝和系統(tǒng)的知識得到適當利用。注意：在這種情況下，“正式”是指使用公認的方法或（IT-）工具的結(jié)構(gòu)化方法，以透明和詳細的方式執(zhí)行和記錄某事。

Is it necessary for a pharmaceutical firm to purchase products that are marketed as 'ICH compliant solutions' or ICH Q8, 9 & 10 Implementation software, etc.to achieve a successful implementation of these ICH guidelines within their companies?

制藥公司是否有必要購買作為'ICH合規(guī)解決方案'或ICH Q8、9和10實施軟件等銷售的產(chǎn)品，在其公司內(nèi)成功實施這些ICH指南？

No. ICH has not endorsed any commercial products and does not intend to do so. ICH is not a regulatory agency with reviewing authority and thus does not have a role in determining or defining ‘ICH compliance’ for any commercial products. If considering such products, firms will need to carry out their own evaluation of these products relative to their business needs. Computer system validation studies should be performed by companies to evaluate the reliability of potential software.

不。ICH 尚未認可任何商業(yè)產(chǎn)品，也不打算這樣做。ICH 不是具有審查權(quán)的監(jiān)管機構(gòu)，因此在確定或定義任何商業(yè)產(chǎn)品的“ICH 合規(guī)性”方面沒有作用。如果考慮此類產(chǎn)品，公司將需要根據(jù)其業(yè)務(wù)需求對這些產(chǎn)品進行自己的評估。公司應(yīng)進行計算機系統(tǒng)驗證研究，以評估潛在軟件的可靠性。