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12月4日，世界衛(wèi)生組織（WHO）于發(fā)布《藥品生產(chǎn)技術(shù)轉(zhuǎn)移指南》(WHO guidelines on the transfer of technology in pharmaceutical manufacturing)，提供了藥品技術(shù)轉(zhuǎn)讓期間應(yīng)考慮的指導(dǎo)原則。

 

該文件目前正處于收集意見期，截止日期為2021年2月。此后，將于2021年2-3月份提交專家工作組，進(jìn)行討論，完善后進(jìn)行第2輪意見收集。最終修訂稿計(jì)劃于2021年10月份，提交第56藥物制劑專家委員會(huì)（ECSPP）。

 

本指南主體部分分為12個(gè)章節(jié)，內(nèi)容如下：

 

 

背景

 

1.簡(jiǎn)介

 

2.范圍

 

3.術(shù)語

 

4.盡職調(diào)查和差距評(píng)估

 

5.組織與管理

 

6.質(zhì)量管理和質(zhì)量風(fēng)險(xiǎn)管理

 

7.文件

 

8.設(shè)施

 

9.設(shè)備和儀器

 

10.確認(rèn)和驗(yàn)證

 

11.產(chǎn)品生命周期和項(xiàng)目管理原則

 

12.技術(shù)轉(zhuǎn)移項(xiàng)目的階段

 

以下是該指南的概述部分（背景、簡(jiǎn)介和范圍）的內(nèi)容：

 

Background 背景

 

During the Fifty-fifth World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) meeting, Expert Committee members were updated on the annual consultation of Good Practices for Health Products and Inspection which took place in July 2020 in a series of virtual meetings due to the COVID-19 pandemic. During these virtual meetings, a group of experts made a series of proposals for future activities, one of which was how to determine whether or not the WHO guidelines on the transfer of technology in pharmaceutical manufacturing (1) should also be updated. This document was published in 2011 and it was considered that it should require updating, not least to support the inspections for COVID-19 therapeutics.

 

在第55屆WHO藥物制劑質(zhì)量標(biāo)準(zhǔn)專家委員會(huì)（ECSPP）會(huì)議上，專家委員會(huì)成員聽取了健康產(chǎn)品和檢查良好實(shí)踐年度咨詢的最新信息，由于COVID-19大流行，這些系列會(huì)議于2020年7月以遠(yuǎn)程會(huì)議形式召開。會(huì)議期間，一些專家為未來的活動(dòng)提出了一系列建議，其中之一是確定是否應(yīng)更新WHO藥品生產(chǎn)技術(shù)轉(zhuǎn)移指南。該文件于2011年發(fā)布，被認(rèn)為應(yīng)該進(jìn)行更新，尤其是為了支持對(duì)COVID-19治療用品的檢查。

 

The Expert Committee asked the WHO Secretariat to explore this proposal.

 

專家委員會(huì)請(qǐng)世衛(wèi)組織秘書處探討這一建議。

 

1. Introduction 簡(jiǎn)介

 

1.1. Production and control procedures, validation and other related activities may be transferred from one site to another site prior to obtaining a marketing authorization. In some cases, this transfer takes place after the approval of, for example, a product, by a regulatory authority. This transfer can be, for example, from drug discovery to product development; to clinical trials; or to full-scale commercialization and commercial batch manufacturing; cleaning and validation.

 

在獲得上市許可之前，生產(chǎn)和控制程序、驗(yàn)證以及其它相關(guān)活動(dòng)可以從一個(gè)場(chǎng)所轉(zhuǎn)移到另一場(chǎng)所。在某些情況下，這種轉(zhuǎn)移是在監(jiān)管機(jī)構(gòu)批準(zhǔn)產(chǎn)品后進(jìn)行的。這種轉(zhuǎn)移可以是從藥物發(fā)現(xiàn)到產(chǎn)品開發(fā)、再到進(jìn)行臨床試驗(yàn)；或是全面商業(yè)化和商業(yè)批生產(chǎn)、清潔和驗(yàn)證。

 

1.2. A technology transfer, particularly one between different companies, has legal and economic implications. If such issues, which may include intellectual property rights, royalties, pricing, con?icts of interest and con?dentiality agreements, are expected to impact on the open communication of technical matters in any way, they should therefore be addressed before and during the planning and execution of the transfer.

 

技術(shù)轉(zhuǎn)移，尤其是不同公司之間的技術(shù)轉(zhuǎn)移，具有法律和經(jīng)濟(jì)內(nèi)涵。如果此類問題（包括知識(shí)產(chǎn)權(quán)、特許權(quán)使用費(fèi)、定價(jià)、利益沖突和保密協(xié)議）可能會(huì)影響技術(shù)方面的開放溝通，則應(yīng)在計(jì)劃和執(zhí)行轉(zhuǎn)移之前和過程中加以解決。

 

1.3. A technology transfer requires a planned approach by trained, knowledgeable personnel working within a quality system, with documentation, data and information covering all aspects of development, production and quality control (QC), as applicable.

 

技術(shù)轉(zhuǎn)移要求采用計(jì)劃性的方法，由具備豐富知識(shí)并在質(zhì)量體系內(nèi)工作的人員進(jìn)行規(guī)劃，其文檔、數(shù)據(jù)和信息涵蓋開發(fā)、生產(chǎn)和質(zhì)量控制（QC）各個(gè)方面（如適用）。

 

1.4. A technology transfer takes place between a sending unit (SU) and a receiving unit (RU). In some cases, there may be a separate unit managing the project.

 

在轉(zhuǎn)移方（SU）和接收方（RU）之間進(jìn)行技術(shù)轉(zhuǎn)移。在某些情況下，可能會(huì)有一個(gè)單獨(dú)的部門來管理項(xiàng)目。

 

1.5. The technology transfer project should fulfil the following general principles and requirements. There should be:

 

技術(shù)轉(zhuǎn)移項(xiàng)目應(yīng)滿足以下一般原則和要求。應(yīng)該有：

 

• a documented project plan covering the relevant aspects of the project;

 

•涵蓋項(xiàng)目相關(guān)方面的文件化項(xiàng)目計(jì)劃；

 

• a detailed risk management plan;

 

•詳細(xì)的風(fēng)險(xiǎn)管理計(jì)劃；

 

• a comprehensive technical gap analysis, including due diligence performed covering technical and regulatory aspects;

 

•全面的技術(shù)差距分析，包括涵蓋技術(shù)和法規(guī)方面的盡職調(diào)查；

 

• similar capabilities between the SU and RU, including but not limited to, facilities and equipment;

 

•SU和RU之間具有類似的能力，包括但不限于設(shè)施和設(shè)備；

 

• an adequate number of adequately trained personnel with suitable qualifications and experience; and

 

•有足夠的經(jīng)過適當(dāng)培訓(xùn)的人員，具有適當(dāng)資質(zhì)和經(jīng)驗(yàn)；

 

• effective process and product knowledge management.

 

•有效的工藝和產(chǎn)品知識(shí)管理。

 

1.6 A technology transfer should include relevant documentation, data, information and knowledge from the SU in order to enable the RU to effectively perform the specified process or procedure in, for example, production and QC. A successful transfer of technology should result in proof that the RU can routinely reproduce the transferred product, process or procedure against a prede?ned set of speci?cations as agreed between the SU and RU.

 

技術(shù)轉(zhuǎn)移應(yīng)包括來自SU的相關(guān)文檔、數(shù)據(jù)、信息和知識(shí)，以使RU能夠有效執(zhí)行指定的工藝或程序，例如在生產(chǎn)和質(zhì)量控制中。成功的技術(shù)轉(zhuǎn)移應(yīng)證明：按照SU和RU之間預(yù)先商定的標(biāo)準(zhǔn)，RU可以常規(guī)化重現(xiàn)所轉(zhuǎn)讓的產(chǎn)品、工藝或程序。

 

1.7 This document should be read in conjunction with other WHO guidelines as referenced below (2-14), as well as other regulatory guidelines which include The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7, Q8, Q9, Q10 and Q11. This guideline does not intend to replace any of these guidelines.

 

應(yīng)當(dāng)結(jié)合參考文獻(xiàn)（2-14）引用的其它WHO指南以及其它法規(guī)指南，一起閱讀本文檔，其中包括ICH Q7，Q8，Q9， Q10和Q11。本指南無意取代這些指南。

 

1.8 This version of the guideline provides updated requirements and expectations reflecting current good practices (GxP) in the transfer of technology and replaces the previous version published (1).

 

該指南版本提供了更新的要求和期望，反映了技術(shù)轉(zhuǎn)移中的當(dāng)前良好實(shí)踐（GxP），并替代了先前發(fā)布的版本。

 

2. Scope 范圍

 

2.1 This document provides guiding principles on technology transfer.

 

本文檔提供了有關(guān)技術(shù)轉(zhuǎn)移的指導(dǎo)原則。

 

2.2 This guideline should be applied when transferring the technology of processes and procedures relating to active pharmaceutical ingredients (APIs), in-process bulk materials, ?nished pharmaceutical products (FPPs), process validation, cleaning procedure development and validation and analytical procedures.

 

本指南應(yīng)用于以下相關(guān)的工藝和方法技術(shù)轉(zhuǎn)移：活性藥物成分（API）、中間體、制劑成品（FPP）、工藝驗(yàn)證、清潔程序開發(fā)和驗(yàn)證，以及分析程序。

 

2.3 The guideline applies to all pharmaceutical dosage forms and may be adapted on a case-by- case basis by using risk management principles. Particular attention should be given to certain complex formulations such as, for example, sterile products and metered dose aerosols.

 

該指南適用于所有藥物劑型，并可通過使用風(fēng)險(xiǎn)管理原則，根據(jù)具體情況進(jìn)行調(diào)整。應(yīng)特別注意某些復(fù)雜的制劑，例如無菌產(chǎn)品和定量噴霧劑。

 

2.4. Although this document focuses on pharmaceutical products, the principles can also be applied to the transfer of production, related processes and controls for other products such as biopharmaceutical products, vaccines, medical devices and vector control products.

 

盡管本文檔的重點(diǎn)是藥品，但是這些原則也可以應(yīng)用于其它產(chǎn)品的生產(chǎn)、相關(guān)工藝和控制轉(zhuǎn)移，這些產(chǎn)品如生物制品、疫苗、醫(yī)療器械和載體控制產(chǎn)品。

 

2.5. Because each transfer project is unique, the provision of a comprehensive set of guidelines specific to a product or process is beyond the scope of this document.

 

由于每個(gè)轉(zhuǎn)移項(xiàng)目都是唯一的，因此針對(duì)產(chǎn)品或工藝提供的全面指導(dǎo)超出了本文檔的范圍。

 

2.6. This document does not provide guidance on any legal, ?nancial or commercial considerations associated with technology transfer projects.

 

就與技術(shù)轉(zhuǎn)移項(xiàng)目相關(guān)的任何法律、財(cái)務(wù)或商業(yè)考慮，本文檔不提供指導(dǎo)。

 

2.7. This document addresses the following principal areas:

 

本文檔涉及以下主要領(lǐng)域：

 

• organization and management of the transfer;

 

•轉(zhuǎn)讓的組織和管理；

 

• transfer of development information in production, including but not limited to processing and packaging;

 

•生產(chǎn)開發(fā)信息的轉(zhuǎn)移，包括但不限于工藝和包裝；

 

• transfer of development information and analytical procedures;

 

•開發(fā)信息和分析程序的轉(zhuǎn)移；

 

• documentation, premises, equipment;

 

•文件、設(shè)施、設(shè)備；

 

• personnel qualification and training;

 

•人員資質(zhì)和培訓(xùn)；

 

• quality management and risk management;

 

•質(zhì)量管理和風(fēng)險(xiǎn)管理；

 

•life cycle approach;

 

•生命周期方法；

 

• control strategy; and

 

•控制策略；

 

• qualification and validation.

 

•確認(rèn)和驗(yàn)證。