12月4日，世界衛生組織（WHO）於發布《藥品生產技術轉移指南》(WHO guidelines on the transfer of technology in pharmaceutical manufacturing)，提供了藥品技術轉讓期間應考慮的指導原則。
本指南主體部分分為12個章節，內容如下：
背景
1.簡介
2.範圍
3.術語
4.盡職調查和差距評估
5.組織與管理
6.質量管理和質量風險管理
7.文件
8.設施
9.設備和儀器
10.確認和驗證
11.產品生命周期和項目管理原則
12.技術轉移項目階段
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藥物製劑質量標準專家委員會（ECSPP）會議上，專家委員會成員聽取了健康產品和檢查良好實踐年度諮詢的最新信息，由於COVID-19大流行，這些系列會議於2020年7月以遠程會議形式召開。會議期間，一些專家為未來的活動提出了一系列建議，其中之一是確定是否應更新WHO藥品生產技術轉移指南。該文件於2011年發布，被認為應該進行更新，尤其是為了支持對COVID-19治療用品的檢查。
The Expert Committee asked the WHO Secretariat to explore this proposal.
專家委員會請世衛組織秘書處探討這一建議。
1. Introduction 簡介
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，生產和控制程序、驗證以及其它相關活動可以從一個場所轉移到另一場所。在某些情況下，這種轉移是在監管機構批准產品後進行的。這種轉移可以是從藥物發現到產品開發、再到進行臨床試驗；或是全面商業化和商業批生產、清潔和驗證。
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.
技術轉移，尤其是不同公司之間的技術轉移，具有法律和經濟內涵。如果此類問題（包括智慧財產權、特許權使用費、定價、利益衝突和保密協議）可能會影響技術方面的開放溝通，則應在計劃和執行轉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.
技術轉移要求採用計劃性的方法，由具備豐富知識並在質量體系內工作的人員進行規劃，其文檔、數據和信息涵蓋開發、生產和質量控制（QC）各個方面（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.
在轉移方（SU）和接收方（RU）之間進行技術轉移。在某些情況下，可能會有一個單獨的部門來管理項目。
1.5. The technology transfer project should fulfil the following general principles and requirements. There should be:
技術轉移項目應滿足以下一般原則和要求。應該有：
• a documented project plan covering the relevant aspects of the project;
•涵蓋項目相關方面的文件化項目計劃；
• a detailed risk management plan;
•詳細的風險管理計劃；
• a comprehensive technical gap analysis, including due diligence performed covering technical and regulatory aspects;
•全面的技術差距分析，包括涵蓋技術和法規方面的盡職調查；
• 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，包括但不限於設施和設備；
• an adequate number of adequately trained personnel with suitable qualifications and experience; and
•有足夠的經過適當培訓的人員，具有適當資質和經驗；
• effective process and product knowledge management.
•有效的工藝和產品知識管理。
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.
技術轉移應包括來自SU的相關文檔、數據、信息和知識，以使RU能夠有效執行指定的工藝或程序，例如在生產和質量控制中。成功的技術轉移應證明：按照SU和RU之間預先商定的標準，RU可以常規化重現所轉讓的產品、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.
應當結合參考文獻（2-14）引用的其它WHO指南以及其它法規指南，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，反映了技術轉移中的當前良好實踐（GxP），並替代了先前發布的版本。
2. Scope 範圍
2.1 This document provides guiding principles on technology transfer.
本文檔提供了有關技術轉移的指導原則。
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.
本指南應用於以下相關的工藝和方法技術轉移：活性藥物成分（API）、中間體、製劑成品（FPP）、工藝驗證、清潔程序開發和驗證，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.
該指南適用於所有藥物劑型，並可通過使用風險管理原則，根據具體情況進行調整。應特別注意某些複雜的製劑，例如無菌產品和定量噴霧劑。
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.
儘管本文檔的重點是藥品，但是這些原則也可以應用於其它產品的生產、相關工藝和控制轉移，這些產品如生物製品、疫苗、醫療器械和載體控制產品。
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.
由於每個轉移項目都是唯一的，因此針對產品或工藝提供的全面指導超出了本文檔的範圍。
2.6. This document does not provide guidance on any legal, ?nancial or commercial considerations associated with technology transfer projects.
就與技術轉移項目相關的任何法律、財務或商業考慮，本文檔不提供指導。
2.7. This document addresses the following principal areas:
本文檔涉及以下主要領域：
• organization and management of the transfer;
•轉讓的組織和管理；
• transfer of development information in production, including but not limited to processing and packaging;
•生產開發信息的轉移，包括但不限於工藝和包裝；
• transfer of development information and analytical procedures;
•開發信息和分析程序的轉移；
• documentation, premises, equipment;
•文件、設施、設備；
• personnel qualification and training;
•人員資質和培訓；
• quality management and risk management;
•質量管理和風險管理；
•life cycle approach;
•生命周期方法；
• control strategy; and
•控制策略；
• qualification and validation.
•確認和驗證。
3. Glossary 術語
The de?nitions given below apply to the terms used in these guidelines. They have been aligned as far as possible with the terminology in related WHO guidelines and Good Practices and included in the WHO Quality Assurance of Medicines Terminology Database - List of Terms and related guideline https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/mqa-terminology-sept-2020.pdf?sfvrsn=48461cfc_5 ), but may have different meanings in other contexts.
以下定義適用於本指南中使用的術語。它們已儘可能與WHO相關指南和良好實踐中的術語保持一致，並已包含在WHO藥品質量保證術語資料庫中，但在其它語境下可能具有不同的含義。
acceptance criteria.
Measurable terms under which a test result will be considered acceptable.
可接受標準
可衡量的項目，在此之內測試結果被認為是可接受的。
active pharmaceutical ingredient (API).
Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body.
活性藥品成分（API）
準備用於生產製劑的物質或其混合物，使用時將成為該製劑的活性成分。此類物質旨在提供藥理活性或其它直接作用，用於疾病的診斷、治癒、緩解、治療或預防，或影響身體的結構和功能。
ALCOA+.
A commonly used acronym for 「attributable, legible, contemporaneous, original and accurate that puts additional emphasis on the attributes of being complete, consistent, enduring and available – implicit basic ALCOA principles.
「可歸屬、清晰、同步、原始和準確」的常用縮寫，+號強調完整、一致、持久和可及的屬性—基本ALCOA原則的暗含意思。
bracketing.
An experimental design to test the extremes of, for example, dosage strength. The design assumes that the extremes will be representative of all the samples between the extremes.
分組
一種用於測試極端情況（例如劑量）的實驗設計。設計假定極端情況將代表極端之間的所有樣本。
change control.
A formal system by which quali?ed representatives of appropriate disciplines review proposed or actual changes that might affect a validated status. The intent is to determine the need for action that would ensure that the system is maintained in a validated state.
變更控制
一個正式的系統：在該系統下，對於可能影響已驗證狀態的提議或實際變更，具備資格的學科代表對此進行審查。目的是確定需要採取的措施，以確保將系統維護在已驗證的狀態。
control strategy.
A planned set of controls, derived from current product and process understanding that assures process performance and product quality. The controls can include parameters and attributes related to API and finished pharmaceutical product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications and the associated methods and frequency of monitoring and control.
控制策略
從當前產品和工藝了解中得出的一套計劃內的控制措施，可確保工藝性能和產品質量。控制措施可以包括：與API和成品製劑的材料和組分有關的參數和屬性、設施和設備的運行條件、過程控制、成品質量標準以及相關監控方法和頻率。
corrective action.
A## ny action to be taken when the results of monitoring at a critical control point indicate a loss of control.
糾正措施
當關鍵控制點的監測結果表明失去控制時，應採取的任何措施。
critical.
Having the potential to impact on product quality or performance in a signi?cant way.
關鍵的
有可能以顯著方式影響產品質量或性能。
critical control point.
A step at which control can be applied and is essential to prevent or eliminate a pharmaceutical quality hazard or to reduce it to an acceptable level.
關鍵控制點
可以應用控制的步驟，對於防止或消除藥品質量危害、或將其降低到可接受水平來說，是必要的。
design quali?cation.
Documented evidence that, for example, the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of good manufacturing practices (GMP).
設計確認
書面證據，例如，設施、支持系統、公用系統、設備和工藝是根據良好生產規範（GMP）的要求設計的。
design space.
The multidimensional combination and interaction of input variables (e.g. material attributes) and process parameters that have been demonstrated to provide assurance of quality.
設計空間
輸入變量（例如材料屬性）和工藝參數的多維組合和交互作用，已證明可提供質量保證。
drug master ?le.
Detailed information concerning a speci?c facility, process or product submitted to the medicines regulatory authority, intended for incorporation into the application for marketing authorization.
藥物主文件
提交給藥監機構的有關特定設施、工藝或產品的詳細信息，意在將其結合至上市許可申請中。
?nished pharmaceutical product (FPP).
A product that has undergone all stages of production, including packaging in its ?nal container and labelling. An FPP may contain one or more active pharmaceutical ingredients (APIs).
成品製劑（FPP）
產品經過了所有生產階段，包括包裝在最終容器中並貼有標籤。FPP可能包含一種或多種活性藥品成分（API）。
gap analysis.
The identi?cation of the critical elements of a process which are available at the sending unit (SU) but are missing from the receiving unit (RU).
差距分析
識別流程中的關鍵元素，這些元素在轉移方（SU）存在，但在接收方（RU）中不存在。
good manufacturing practices (GMP).
That part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.
良好生產規範（GMP）
質量保證的一部分，可確保始終如一地生產和控制藥品，達到適合其預期用途的質量標準，並符合上市許可要求。
in-process control (IPC).
Checks performed during production in order to monitor and, if necessary, to adjust the process to ensure that the product conforms to its speci?cations. The control of the environment or equipment may also be regarded as a part of in-process control.
過程控制（IPC）
在生產中進行的檢查，以監測並在必要時調整工藝，以確保產品符合其質量標準。環境或設備的控制也可以視為過程控制的一部分。
installation quali?cation (IQ).
Documented verification that the installations (such as machines equipment and instruments, computer system components, measuring devices, utilities and manufacturing) used in a processor system are appropriately selected and correctly installed, in accordance with established specifications.
安裝確認（IQ）
書面證明：表明根據已建立的標準，工藝或系統所用裝置（例如，機器設備和儀器、計算機系統組件、測量儀器、公用系統和生產設施）已經恰當選擇並正確安裝。
intercompany transfer.
A transfer of technology between the sites of different companies.
公司間轉移
在不同公司場所之間進行技術轉移。
intracompany transfer.
A transfer of technology between sites of the same group of companies.
公司內部轉移。
同一集團公司場所之間的技術轉移。
operational quali?cation (OQ).
Documented veri?cation that the system or subsystem performs as intended over all anticipated operating ranges.
運行確認（OQ）
書面證明：系統或子系統在所有預期的工作範圍內均按預期運行
performance quali?cation (PQ).
Documented verification that the equipment or system performs consistently and reproducibly within defined specifications and parameters in its normal operating environment (i.e. in the production environment).
性能確認（PQ）
書面證明：在其正常操作環境（即生產環境）中，設備或系統在定義的質量標準和參數範圍內可以一致且可重現地運行。
process validation.
The collection and evaluation of data, from the process design stage through to commercial production, which establishes scientific evidence that a process is capable of continuously delivering the finished pharmaceutical product meeting its predetermined specifications and quality attributes.
工藝驗證
從工藝設計階段到商業生產的數據集合和評估，表明已建立了科學證據，證明工藝能夠持續生產出滿足其預定標準和質量屬性的成品製劑。
quali?cation.
Documented evidence that premises, systems or equipment are able to achieve the predetermined specifications when properly installed, and/or work correctly and lead to the expected results.
確認
書面化的證據，證明設施、系統或設備在正確安裝後能夠達到預定的質量標準，並且/或者正常運行，可達到預期的結果。
quali?cation batches.
Those batches produced by the receiving unit (RU) to demonstrate its ability to reproduce the product .
確認批次
接收方（RU）生產的批次，用於證明其重現產品的能力。
quality assurance (QA).
「Quality assurance」 is a wide-ranging concept covering all matters that individually or collectively in?uence the quality of a product. It is the totality of the arrangements made with the objective of ensuring that pharmaceutical products are of the quality required for their intended use.
質量保證（QA）
「質量保證」是一個廣泛的概念，涵蓋了所有單獨或共同影響產品質量的方面。這是所有工作的綜合，目的是確保藥品具備其既定用途所需的質量。
quality control (QC).
All measures taken, including the setting of speci?cations, sampling, testing and analytical clearance, to ensure that starting materials, intermediates, packaging materials and ?nished pharmaceutical products (FPP) conform with established speci?cations for identity, strength, purity and other characteristics.
質量控制（QC）
針對起始原料、中間體、包裝材料和成品製劑（FPP）所採取的所有措施，包括質量標準設定、取樣、測試和分析清場，以確保符合其既定的鑑別、強度、純度和其它屬性標準。
quality planning.
Part of quality management, focused on setting quality objectives and specifying necessary operational processes and related resources to ful?l the quality objectives.
質量計劃
質量管理的一部分，側重於設定質量目標，並指定必要的操作流程和相關資源，以實現質量目標。
quality policy.
A brief statement that describes the organization’s purpose, overall intentions and strategic direction; provides a framework for quality objectives; and includes a commitment to meet applicable requirements.
質量方針
一個簡要的聲明，描述組織的目的、總體目標和戰略方向；提供質量目標框架；並包括滿足適用要求的承諾
quality risk management (QRM).
A systematic process for the assessment, control, communication and review of risks to the quality of the pharmaceutical product throughout the product’s life cycle.
質量風險管理（QRM）
一個系統流程，在整個產品生命周期中評估、控制、溝通和回顧藥品質量風險。
receiving unit (RU).
The involved disciplines at an organization where a designated product, process or method is expected to be transferred.
接收方（RU）
一個組織中的相關機構，準備接收指定產品、工藝或方法。
sending unit (SU).
The involved disciplines at an organization from where a designated product, process or method is expected to be transferred.
轉移方（SU）
一個組織中的相關機構，準備轉移指定產品、工藝或方法。
standard operating procedure (SOP).
An authorized written procedure giving instructions for performing operations, not necessarily speci?c to a given product or material , but of a more general nature (for example, operation of equipment, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection). Certain standard operating procedures may be used to supplement product-speci?c master and batch production documentation.
標準操作程序（SOP）
經過批准的書面程序，提供執行操作的說明，不一定特定於某個具體的產品或材料，可能具有更一般的性質（例如，設備的操作、維護和清潔、驗證、設施的清潔和環境控制、取樣和檢查）。可以使用某些標準操作程序，來補充特定於產品的主文件和批生產文件。
transfer of technology.
A logical procedure that controls the transfer of any process, together with its documentation and professional expertise between development and manufacture or between manufacture sites. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and/or commercialization to an appropriate, responsible and authorized party.
技術轉移
在開發方和生產方之間，或在生產場所之間，對工藝及其文檔和專業知識轉移進行控制的邏輯化程序。這是一個供遵循的系統化程序，將開發和/或商業化期間獲得的書面知識和經驗轉移給適當的、負責的許可方。
technology transfer report.
A documented summary of a speci?c technology transfer project listing procedures, acceptance criteria, results achieved and conclusions.
技術轉移報告
特定技術轉移項目的一份書面總結文件，列出程序、可接受標準、取得的成果和結論。
validation.
Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.
驗證
證明和記錄工藝、程序或方法可以實際、並持續得到預期結果的活動。
validation master plan (VMP).
A high-level document that summarizes the manufacturer’s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer’s qualification and validation work programme and defines details of and timelines for the work to be performed, including a statement of the responsibilities of those implementing the plan.
驗證主計劃（VMP）
概述生產商總體理念和方法的高層次文件，用於建立性能的充分性。它提供了有關生產商確認和驗證工作計劃的信息，並定義了要執行工作的詳細信息和時間表，包括對實施計劃人員職責的說明。
validation protocol (VP).
A document describing the activities to be performed during validation, including the acceptance criteria.
驗證草案（VP）
描述驗證期間要執行的活動的文件，包括可接受標準。
validation report (VR).
A document in which the records, results and evaluation of validation are documented and summarized. It should also contain a conclusion of the outcome of the validation.
驗證報告（VR）
記錄和總結驗證記錄、結果和評估的文件。它還應包含驗證結果的結論。
4. 盡職調查和差距評估
Due diligence and gap assessments
4.1. A process of due diligence, gap assessment or audits of the SU and RU should be one of the first steps when considering a technology transfer project.
在考慮技術轉移項目時，第一步應該是對SU和RU進行盡職調查/差距評估或審計。
4.2. The suitability and degree of preparedness of the RU should be assessed prior to the start of the transfer. The procedure to be followed should be documented.
轉移開始之前，應評估RU的適用性和準備程度。應記錄要遵循的程序。
4.3. The assessment should be done by a team of appropriately qualified persons with knowledge and experience in the field of GxP and the activity to be transferred.
評估應由具有適當資質的人員組成的團隊進行，這些人員具有GxP和待轉移活動領域知識和經驗。
4.4. The assessment should further cover resources including personnel, premises, equipment and instruments, utilities, QC, documentation, computerized systems, qualification and validation and waste management.
評估應進一步涵蓋資源方面，包括人員、設施、設備和儀器、公用系統、質量控制、文檔、計算機系統、確認和驗證以及廢物管理。
4.5. The assessment to determine feasibility and readiness for technology transfer may include technical, business, regulatory and legal aspects.
確定技術轉移的可行性和準備程度的評估可包括技術、業務、法規和法律方面。
5. 組織與管理
Organization and management
5.1. All technology transfer activities should be organized and planned.
所有技術轉移活動均應進行組織和計劃。
5.2. There should be a formal agreement between the parties which speci?es the responsibilities of each party before, during and after transfer. The agreement should cover, for example, data management, data integrity, documentation and validation.
雙方之間應該有一個正式協議，規定雙方在轉移之前、期間和之後的責任。該協議應涵蓋例如數據管理、數據完整性、文檔和驗證。
5.3. All the necessary activities to be executed during the technology transfer project should be identi?ed, organized and documented at the start of the project. Responsibilities should be defined.
在項目開始時，應確定、組織和記錄技術轉移項目期間要執行的所有必要活動。應確定相關職責。
5.4. The SU should provide the necessary documentation relating to the process, product or procedure to be transferred.
SU應提供與待轉移的工藝、產品或程序相關的必要文件。
5.5. The SU should provide criteria and information on inherent risks, hazards and critical steps associated with the process, product or procedure to be transferred. This may serve as a basis for the risk assessment exercise.
就待轉移工藝、產品或程序相關的固有風險、危害和關鍵步驟，SU應提供有關的標準和信息。這可以作為風險評估活動的基礎。
5.6. The technology transfer should be managed by responsible persons from the SU and RU. A technology transfer team may be appointed with identified and documented responsibilities.
技術轉移應由SU和RU的負責人進行管理。可以任命技術轉移團隊，該團隊具有確定和文件化的職責。
5.7. The team members should have the necessary quali?cations and experience to manage the particular aspects of the transfer.
團隊成員應具有必要的資質和經驗，以管理轉移的特定方面。
5.8. The SU should make all the necessary information and knowledge with regard to the product, process or procedure available in relevant documents in order to ensure a successful transfer.
SU應在相關文檔中提供有關產品、工藝或程序的所有必要信息和知識，以確保成功轉移。
5.9. A training programme should be implemented speci?c to the process, product or procedure to be transferred.
針對要轉移的工藝、產品或程序，應實施培訓計劃。
5.10. Any changes and adaptations made during the course of the project should be fully documented and agreed to by both parties.
在項目進行工藝中進行的任何變更和調整均應完整記錄下來，並徵得雙方的同意。
5.11. The execution of the technology transfer project should be documented in a report which is supported by the relevant data.
技術轉移項目的執行應記錄在一份報告中，並有相關數據支持。
5.12 Data should meet ALCOA+ principles.
數據應符合ALCOA +原則。
6. 質量管理和質量風險管理
Quality management and quality risk management
6.1 The SU and RU should each have an appropriately designed, clearly defined and documented quality system.
SU和RU應分別具有適當設計、明確定義和文件化的質量體系。
6.2 The quality system should be adequately resourced, implemented and maintained.
質量體系應有足夠的資源，並得到實施和維護。
6.3 The quality system should incorporate GxP which should be applied to the life cycle stages of the products and processes, including the technology transfer.
質量體系應包含GxP，將其應用於產品和工藝的生命周期階段中，包括技術轉移。
6.4 The quality system should ensure that:
• responsibilities are clearly specified in writing;
• operations are clearly defined in writing;
• there is a system for quality risk management; and
• arrangements are made for the documented technology transfer.
質量體系應確保：
•以書面形式明確規定職責；
•以書面形式明確定義操作要求；
•有質量風險管理系統；
•技術轉移有文件記錄安排。
6.5 Quality risk management should be implemented as a systematic process for the assessment, control, communication and review of risks.
質量風險管理應作為系統性流程來執行，以便評估、控制、溝通和回顧風險。
6.6 The system for quality risk management should be described in writing and cover appropriate areas such as, but not limited to, premises, equipment, materials, products, production, processes, QC, qualification, validation and the process of technology transfer.
質量風險管理系統應以書面形式描述，並涵蓋適當的領域，例如但不限於設施、設備、物料、產品、生產、工藝、QC、確認、驗證和技術轉移流程。
6.7 The evaluation of the risk should be based on scientific knowledge and experience including that of the process and product.
風險評估應基於科學知識和經驗，包括工藝和產品方面的知識和經驗。
6.8 The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.
質量風險管理過程的工作水平、正式程度和文件記錄應與風險水平相稱。
6.9 The procedures and records for quality risk management should retained.
質量風險管理的程序和記錄應予以保存。
7. 文檔
Documentation
Note: A list with examples of documents commonly required in technology transfer is presented in Appendix 1.
註：附錄1中列出了技術轉移中通常需要的文檔示例清單。
7.1. An authorized technology transfer document should list the intended sequential phases and activities of the transfer. The document should include, for example, the following:
經過批准的技術轉移文件應列出轉移的預期順序階段和活動。該文件應包括例如以下內容：
• title;
標題；
• objective;
目標；
• scope;
範圍;
• name and addresses of the SU and RU;
SU和RU的名稱和地址；
• names of key personnel and their responsibilities;
關鍵人員的姓名及其職責；
• phases of the project and actions;
項目和行動的階段；
• a parallel comparison of premises, equipment, instruments, materials, procedures, and methods;
對設施、設備、儀器、物料、程序和方法進行平行比較；
• experimental design, quality attributes, process parameters and acceptance criteria;
實驗設計、質量屬性、工藝參數和可接受標準；
• information on trial production batches, quali?cation batches and process validation;
有關試生產批次、確認批次和工藝驗證的信息；
• change and deviation management;
變更和偏差管理；
• arrangements for keeping retention samples of active ingredients, intermediates and ?nished products, and information on reference substances where applicable; and
活性成分、中間體和成品的留樣安排，對照品信息（如有）；
• review of the transfer, outcome, signature(s) and date of conclusion of the transfer.
轉移審核、結果、轉移結束時的籤名和日期。
7.2. Standard operating procedures (SOPs) should be followed, describing actions to be taken during the technology transfer process.
應遵循標準操作程序（SOP），該程序描述在技術轉移過程中要採取的措施。
7.3. Records should be maintained for the activities performed during the technology transfer process (e.g. a technology transfer report). The report content should reflect the protocol and SOPs that were followed. The report should summarize the scope of the transfer, the critical parameters as obtained in the SU and RU, and the ?nal conclusions of the transfer. The discrepancies and appropriate actions taken to resolve them should be recorded. Supportive documents with data, results and other relevant information should be referenced in the report and be readily available.
應保存技術轉移過程中進行活動的記錄（例如技術轉移報告）。報告內容應反映所遵循的協議和SOP。該報告應總結轉移的範圍，在SU和RU中獲得的關鍵參數，以及轉移的最終結論。對於差異和為解決這些差異而採取的適當措施，應進行記錄。報告中應參考具有數據、結果和其它相關信息的支持性文件，並應確保隨時可以獲取。
8. 設施
Premises
8.1 The RU should have appropriate premises with the layout, construction and ?nishing to suit the intended operations. Utilities such as heating, ventilation and air conditioning, as well as gas and water systems, should be appropriate for the intended process, product or procedure tobe transferred.
RU應具有適當的設施，其布局、構造和裝修應適合預期的操作。公用設施，如加熱、通風和空調以及氣、水系統，應適合於要轉移的預期工藝、產品或程序。
8.2 The SU should provide the RU with information on relevant health, safety and environmental issues, including:
SU應向RU提供有關健康、安全和環境問題的信息，包括：
• inherent risks of the manufacturing processes (e.g. reactive chemical hazards, exposure limits, ?re and explosion risks);
生產工藝中的固有風險（例如，反應性化學危害、暴露限，火災和爆炸風險）；
• health and safety requirements to minimize operator exposure (e.g. atmospheric containment of pharmaceutical dust);
對健康和安全的要求，以最大程度地減少操作員的暴露（例如，在大氣中藥用粉塵的限制）；
• emergency planning considerations (e.g. in case of gas or dust release, spillage, ?re and ?rewater run-off); and
應急計劃考慮因素（例如，在氣體或粉塵逸出、濺出、失火和消防用水用盡的情況下）；
• identi?cation of waste streams and provisions for re-use, recycling and/or disposal.
識別廢物流，以及重複使用、回收和/或處置的規定。
9. 設備和儀器
Equipment and instruments
9.1 The SU should provide a list of equipment and instruments involved in the production, ?lling, packing and QC testing. The list should include the makes and models of the relevant equipment and instruments.
SU應提供涉及生產、灌裝、包裝和QC測試的設備和儀器清單。該清單應包括相關設備和儀器的品牌和型號。
9.2 Other relevant documentation may include, on a case-by-case basis as required, drawings; manuals; maintenance procedures and records; calibration procedures and records; as well as procedures such as equipment set-up, operation and cleaning.
其它相關文件可根據需要視情況提供，可包括圖紙、手冊、維護程序和記錄、校驗程序和記錄；以及諸如設備設置、操作和清潔之類的程序。
9.3 A review and a side-by-side comparison of equipment and instruments of the SU and RU should be carried out in terms of their working principle, make and models.
對於SU和RU的設備與儀器的工作原理、品牌和型號，應進行審查和一對一比較。
9.4 Where the review and comparison identify any gaps or differences, appropriate action should be taken. This may include the adaptation of existing equipment or acquisition of new equipment. Such action should be taken by following a change management procedure which should be documented.
如果審查和比較發現任何差距或差異，則應採取適當的措施。這可能包括改造現有設備或購買新設備。應遵循變更管理程序，來採取此類措施，並有書面記錄。
9.5 Production volumes and batch sizes at the SU and RU should be compared. Where batch sizes are different, the impact should be assessed and the appropriate action planned and taken. Other factors relating to equipment to be reviewed may include:
應該比較SU和RU的產量和批量。如果批量不同，則應評估影響，並計劃和採取適當的措施。與需審核的設備有關的其它因素可能包括：
• minimum and maximum capacity;
最小和最大產能；
• material of construction of contact surfaces;
接觸面的構造材料；
• critical operating parameters;
關鍵操作參數；
• components (e.g. ?lters, screens, and temperature/pressure sensors); and
部件（例如過濾器、濾網和溫度/壓力傳感器）；
• range of intended use.
既定用途範圍。
9.6 The impact of the potential product to be transferred, on existing products manufactured on site, should be assessed.
應評估潛在轉移產品對工廠生產的現有產品的影響。
10. 確認和驗證
Quali?cation and validation
10.1 The extent of quali?cation and validation to be performed should be determined on the basis of risk management principles.
應根據風險管理原則，確定要執行的確認與驗證的程度。
10.2 The qualification of premises, utilities and equipment should be done in accordance with a qualification master plan and protocols.
設施、公用系統和設備的確認應根據確認主計劃和草案執行。
10.3 Validation, such as process validation, should be done in accordance with a validation master plan and protocols.
驗證（例如工藝驗證）應按照驗證主計劃和草案執行。
10.4 Where technology is transferred to commercial sites, the qualification of equipment and instruments should be completed prior to the actual technology transfer.
如果將技術轉移至商業場所，則在實際技術轉移之前，應完成設備和儀器的確認。
10.5 Process validation usually starts in research and development facilities either as prospective validation (traditional approach) or as stage I process validation (see references regarding the new approaches in process validation; and the life cycle approach). Note: Process validation should be done according to current guidelines as published in current WHO Technical Report Series (3).
工藝驗證通常在研究和開發機構中開始，既可以作為前瞻性驗證（傳統方法），也可以作為第一階段工藝驗證（參見有關工藝驗證新方法和生命周期方法的參考文獻）。註：應根據現行WHO技術報告系列中發布的當前指南進行工藝驗證。
10.6. Procedures including processing and analytical procedures, should be appropriately validated at the SU and transferred to the RU following documented procedures. Verification and validation, as appropriate, should be continued at the RU as identified and documented in the technology transfer protocol.
包括工藝和分析程序在內的程序應在SU處得到適當驗證，再按照書面程序轉移至RU處。必要時，RU應繼續進行確認與驗證，並記錄在技術轉移方案中。
10.7. For cleaning procedures, development and validation should be done in accordance with the guidelines as published in current WHO Technical Report Series (6). Points to consider when using HBEL in cleaning validation (14) should be taken into account in establishing cleaning procedures, cleanability studies and setting acceptance limits.
對於清潔程序，應根據現行WHO技術報告系列中發布的指南進行開發和驗證。在建立清潔程序、清潔性研究和設定可接受限度時，應考慮清潔驗證使用HBEL時的考量要點。
10.8. Analytical procedures should be validated according to the guidelines as published in current WHO Technical Report Series (7).
對於分析程序，應根據現行WHO技術報告系列中發布的指南進行驗證。
10.9. Quali?cation and validation procedures, protocols, data and results should be appropriately recorded. The documents should be retained as defined in procedures.
確認和驗證程序、草案、數據和結果應適當記錄。應按照程序中的規定保存文件。
11. 產品生命周期和項目管理原則
Product life cycle and project management principles
11.1. The relevant stage of the life cycle of the facility, equipment, instrument, utility, product, process or procedure to be transferred should be taken into consideration when the transfer is planned and executed.
在計劃和執行轉移時，應考慮到要轉移的設施、設備、儀器、公用系統、產品、工藝或程序的生命周期的相關階段。
12. 技術轉移項目階段
Phases of a technology transfer project
12.1. The technology transfer project plan may be divided into different phases. These may include, for example:
技術轉移項目計劃可以分為不同的階段。這些可能包括，例如：
• Phase I: Project initiation;
第一階段：項目啟動；
• Phase II: Project proposal;
第二階段：項目方案；
• establishing a team;
建立團隊；
• risk assessment;
風險評估；
• project plan;
項目計劃；
• control strategy;
控制策略；
• Phase III: Project transfer; and
第三階段：項目轉移；
• Phase IV: Project review.
第四階段：項目回顧
第一階段：項目啟動
Phase I: Project initiation
12.2. During the initiation phase of the project, a unit should normally identify the need for the technology transfer. This may be because of lack of capacity, transfer from development to commercial site or transfer from one company to another.
在項目的啟動階段，通常應由一方確定技術轉移的需求。這可能是由於產能不足，從研發轉移到商業場所，或從一家公司轉移到另一家公司。
12.3. The units should establish initial discussion and identify whether or not there is any interest for such a project. (See also section on due diligence above).
雙方應進行初步討論，並確定是否對該項目感興趣。（另請參見上面有關盡職調查的部分）。
12.4. The RU should be able to accommodate the intended activity.
RU應該有能力接收意向活動。
12.5. The RU should have the necessary technical expertise, technology and capability.
RU應該具有必要的技術專家、技術和能力。
12.6. A sufficient level and depth of detail to support the activity, and any further development and optimization at the RU, should be transferred.
對於轉移，應該有足夠的詳細水平和深度，來支持RU的相關該活動、以及任何進一步開發和優化。
第二階段：項目方案
Phase II: Project proposal
12.7. The SU and RU should jointly establish a team that will coordinate activities and execute the technology transfer exercise.
SU和RU應該共同建立一個團隊，來協調活動並執行技術轉移工作。
12.8. The team should perform a risk assessment based on the available data, information and knowledge of the premises, materials, products, procedures and other related information.
團隊應進行風險評估，該評估基於設施、物料、產品、程序的現有數據、信息和知識及其它相關信息。
12.9. The team should prepare the technology transfer document.
團隊應準備技術轉移文件。
12.10. The team should develop a control strategy which includes, for example:
團隊應制定控制策略，例如，包括：
• risks;
風險；
• material attributes;
物料屬性；
• processing steps and stages in production;
生產中的工藝步驟和階段；
• testing steps in QC;
QC檢測步驟；
• equipment working principles and their impact on the process;
設備工作原理及其對工藝的影響；
• critical quality attributes (CQAs), critical process parameters (CPPs) and in-process controls;
關鍵質量屬性（CQA）、關鍵工藝參數（CPP）和過程控制；
• QC instruments;
QC儀器；
• acceptance criteria and limits;
接受標準和限度；
• alarms and trends;
警報和趨勢；
• personnel requirements, such as qualification and training; and
人員要求，例如資質和培訓；
• qualification and validation.
確認與驗證。
第三階段：項目轉移
Phase III: Project transfer
12.11. The team should execute the project in accordance with the procedures and agreed plan.
團隊應按照程序和商定的計劃執行項目。
Production生產:
Starting materials 起始物料
12.12. The speci?cations and relevant functional characteristics of the starting materials (APIs and excipients) to be used at the RU should be consistent with those materials used at the SU. Any properties which are likely to in?uence the process or product should be identi?ed and/or characterized.
RU使用的起始原料（API和輔料）的質量標準和相關功能特性，應與SU中的一致。應識別和/或表徵任何可能影響工藝或產品的特性。
Active pharmaceutical ingredients 活性藥品成分
12.13. The SU should provide the RU with the open part of the Drug Master File (API master ?le), or equivalent information, as well as any relevant additional information on the API of importance for the manufacture of the pharmaceutical product. The following are examples of the information which may typically be provided; however the information needed in each speci?c case should be assessed using the principles of QRM:
SU應向RU提供DMF（API主文件）的公開部分或等同信息，以及有關API的相關附加信息，這些信息對製劑生產非常重要。以下是通常可以提供的信息的示例；但是，應使用QRM原則，評估每種特定情況下所需的信息：
• manufacturer and associated supply chain;
生產商和相關的供應鏈；
• step of the API to be transferred;
要轉移的API步驟；
• ?ow chart of synthesis pathway outlining the process, including entry points for raw materials, critical steps, process controls and intermediates;
概述工藝的合成路的流程圖，包括原料加入點、關鍵步驟、工藝控制和中間體；
• where relevant, de?nitive physical form of the API (including photomicrographs and other relevant data) and any polymorphic and solvate forms;
適當時，API確定的物理形式（包括顯微照片和其它相關數據），以及所有晶型與溶劑化形態；
• solubility pro?le;
溶解度特性；
• if relevant, pH in solution;
溶液中的pH（如相關）；
• partition coef?cient, including the method of determination;
分配係數，包括測定方法；
• intrinsic dissolution rate, including the method of determination;
固有溶出速率，包括測定方法；
• particle size and distribution, including the method of determination;
粒度和分布，包括測定方法；
• bulk physical properties, including data on bulk and tap density, surface area and porosity as appropriate;
體積物理性質，包括適當的體積和堆積密度、表面積和孔隙率數據；
• water content and determination of hygroscopicity, including water activity data and special handling requirements;
水分含量和吸溼性的測定，包括水活性數據和特殊處理要求；
• microbiological considerations (including sterility, bacterial endotoxins and bioburden levels where the API supports microbiological growth) in accordance with national, regional or international pharmacopoeia requirements;
基於國家、地區或國際藥典的要求，對微生物學的考量（包括無菌性、細菌內毒素生物負荷水平——如果API支持微生物生長）；
• speci?cations and justi?cation for release and end-of-life limits;
有關放行和貨架期限度的質量標準和理由；
• summary of stability studies conducted in conformity with current guidelines, including conclusions and recommendations on retest date;
根據當前指南進行穩定性研究的摘要，包括結論和復驗期建議；
• list of potential and observed synthetic impurities, with data to support proposed speci?cations and typically observed levels;
潛在和已發現的合成雜質清單，及支持擬議質量標準的數據和典型檢出水平；
• information on degradants, with a list of potential and observed degradation products and data to support proposed speci?cations and typically observed levels;
有關降解物的信息：列出潛在的和已發現的降解產物，及支持擬議質量標準的數據和典型檢出水平；
• potency factor, indicating observed purity and justi?cation for any recommended adjustment to the input quantity of API for product manufacturing, providing example calculations; and
活性因子，指明已知曉的純度，和生產中對API投料量調整建議的理由，並提供計算示例；
• special considerations with implications for storage and or handling, including but not limited to, safety and environmental factors (e.g. as speci?ed in material safety data sheets) and sensitivity to heat, light or moisture.
對存儲和/或處理有特殊考慮的因素，包括但不限於安全和環境因素（例如，物料安全數據表中規定的），以及對熱、光或溼氣的敏感性。
Excipients 輔料
12.14 The speci?cations and relevant functional characteristics of excipients should be made available by the SU for transfer to the RU site. The following are examples of the information which may typically be provided; however, the information needed in each speci?c case should be assessed using the principles of QRM:
SU應提供輔料的質量標準和相關功能特性，以轉移到RU場所。以下是通常可以提供的信息示例；但是，應使用QRM原則評估每種特定情況下所需的信息：
• manufacturer and associated supply chain;
生產商和相關的供應鏈；
• description of functionality, with justi?cation for inclusion of any antioxidant, preservative or any excipient;
功能描述，加入任何抗氧化、防腐劑或輔料的理由；
• de?nitive form (particularly for solid and inhaled dosage forms);
明確的形式（尤其是固體和吸入劑型）；
• solubility pro?le (particularly for inhaled and transdermal dosage forms);
溶解度特性（特別是對於吸入和透皮劑型）；
• partition coef?cient, including the method of determination (for transdermal dosage forms);
分配係數，包括測定方法（對於透皮劑型）；
• intrinsic dissolution rate, including the method of determination (for transdermal dosage forms);
固有溶出速率，包括測定方法（對於透皮劑型）；
• particle size and distribution, including the method of determination (for solid, inhaled and transdermal dosage forms);
粒徑和分布，包括測定方法（對於固體，吸入和透皮劑型）；
• bulk physical properties, including data on bulk and tap density, surface area and porosity as appropriate (for solid and inhaled dosage forms);
體積物理性質，包括體積和堆積密度、表面積和孔隙率數據（適用於固體和吸入劑型）；
• compaction properties (for solid dosage forms);
壓實特性（用於固體劑型）；
• melting point range (for semi-solid or topical dosage forms);
熔點範圍（對於半固體或局部劑型）；
• pH range (for parenteral, semi-solid or topical, liquid and transdermal dosage forms);
pH範圍（對於注射劑、半固體或局部、液體和透皮劑型）；
• ionic strength (for parenteral dosage forms);
離子強度（對於注射劑）；
• speci?c density or gravity (for parenteral, semi-solid or topical, liquid and transdermal dosage forms);
特定的密度或比重（對於注射劑、半固體或局部、液體和透皮劑型）；
• viscosity and or viscoelasticity (for parenteral, semi-solid or topical, liquid and transdermal dosage forms);
粘度和/或粘彈性（對於注射劑、半固體或局部、液體和透皮劑型）；
• osmolarity (for parenteral dosage forms);
滲透壓（對於注射劑）；
• water content and determination of hygroscopicity, including water activity data and special handling requirements (for solid and inhaled dosage forms);
水分含量和吸溼性的測定，包括水活性數據和特殊處理要求（對於固體和吸入劑型）；
• moisture content range (for parenteral, semisolid or topical, liquid and transdermal dosage forms);
水分含量範圍（對於注射劑、半固體或局部、液體和透皮劑型）；
• microbiological considerations (including sterility, bacterial endotoxins and bioburden levels where the excipient supports microbiological growth) in accordance with national, regional or international pharmacopoeia requirements, as applicable (for general and speci?c monographs);
基於適用的國家、區域或國際藥典要求（通則和特定各論），對微生物學的考量（包括無菌性、細菌內毒素和的生物負荷水平——如輔料支持微生物生長的話）；
• speci?cations and justi?cation for release and end-of-life limits;
有關放行和貨架期限度的質量標準和理由；
• information on adhesives supporting compliance with peel, sheer and adhesion design criteria (for transdermal dosage forms);
有關支持符合剝離、透明和粘附設計標準的粘合劑信息（對於透皮劑型）；
• special considerations with implications for storage and or handling, including but not limited to, safety and environmental factors (e.g. as speci?ed in material safety data sheets {MSDS}) and sensitivity to heat, light or moisture; and
對存儲和/或處理有特殊考慮的因素，包括但不限於安全和環境因素（例如，物料安全數據表MSDS中規定的），以及對熱、光或溼氣的敏感性。
• regulatory considerations (e.g. documentation to support compliance with transmissible animal spongiform encephalopathy certi?cation requirements, where applicable).
監管方面的考慮（例如，在適用的情況下，支持符合可傳染動物海綿狀腦病認證要求的文件）。
Information on process and ?nished pharmaceutical product information工藝信息和成品信息
Processing, packaging 工藝、包裝
12.15. Product, process and procedure knowledge should be an essential part of the transfer process from SU to RU.
產品、工藝和程序知識應該是從SU到RU的轉移的重要組成部分。
12.16. The quality target product profile, critical quality attributes, critical process parameters, material attributes, control strategy and any other impacting elements on the quality of the product should be available. (See also ICH guidelines.)
質量目標產品概況、關鍵質量屬性、關鍵工藝參數、物料屬性、控制策略、以及對產品質量有任何其它影響的要素，都應可以提供。（另請參閱ICH指南）
12.17. The SU should provide the total product quality profile with its qualitative and quantitative composition, physical description, method of manufacture, in-process controls, control method and speci?cations, packaging components and con?gurations, and any safety and handling considerations to the RU.
SU應提供整體產品質量概況，包括定性和定量組成、物理描述、生產方法、過程控制、控制方法和質量標準，包裝組件和參數，以及RU的任何安全和處理注意事項。
12.18. The SU should provide any information on the history of process development which may be required to enable the RU to perform any further development and or process optimization after successful transfer.
SU應該提供有關工藝開發歷史的所有信息，以使RU在成功轉移後能夠執行任何進一步的開發和/或工藝優化。
12.19. Such information may include the following:
這些信息可能包括以下內容：
• information on clinical development (e.g. information on the rationale for the synthesis, route and form selection, technology selection, equipment, clinical tests, and product composition);
有關臨床發展的信息（例如有關合成原理、路線和形式選擇、技術選擇、設備、臨床測試和產品組成信息）；
• information on scale-up activities: process optimization, statistical optimization of critical process parameters, critical quality attributes, pilot report and/or information on pilot-scale development activities indicating the number and disposition of batches manufactured;
有關擴批信息：工藝優化、關鍵工藝參數、關鍵質量屬性的統計優化、中試報告和/或有關中試規模開發活動的信息，說明所生產批次的數量和處置情況；
• information or report on full-scale development activities, indicating the number and disposition of batches manufactured, and deviation and change control (sometimes referred to as change management) reports which led to the current manufacturing process;
有關全批量開發活動的信息或報告，說明生產的批次的數量和處置情況，以及引發當前生產工藝的偏差和變更控制（有時稱為變更管理）報告；
• the change history and reasons (e.g. a change control log, indicating any changes to the process or primary packaging or analytical methods as a part of process optimization or improvement); and
變更歷史和原因（例如，變更控制臺帳、說明工藝、內包或分析方法的所有變更——這作為流程優化或改進的一部分）；
• information on investigations of problems and the outcomes of the investigations.
有關問題調查和調查結果的信息。
12.20. The SU should provide to the RU information on any health, safety and environmental issues associated with the manufacturing processes to be transferred, and the implications thereof (e.g. need for gowning or protective clothing).
SU應向RU提供有關與要轉移的生產工藝相關的任何健康、安全和環境問題的信息，及其影響（例如，需要更衣或防護服）。
12.21. The SU should provide to the RU information on current processing and testing, including but not limited to:
SU應向RU提供有關當前工藝和檢驗的信息，包括但不限於：
• a detailed description of facility requirements and equipment;
設施要求和設備的詳細說明；
• information on starting materials, applicable MSDS and storage requirements for raw materials and ?nished products;
起始物料信息，原料和成品的相關MSDS和儲存要求；
• description of manufacturing steps (narrative and process maps or ?ow charts, and/or master batch records), including quali?cation of in-processing hold times and conditions, order and method of raw material addition and bulk transfers between processing steps;
生產步驟的描述（敘述性和工藝圖或流程圖，和/或主批記錄），包括中間體放置時間和條件的確認，投料順序和方法以及工藝步驟之間的物料轉移；
• description of analytical methods;
分析方法的描述；
• identi?cation and justi?cation of control strategy (e.g. identi?cation of critical performance aspects for speci?c dosage forms, identi?cation of process control points, product quality attributes and quali?cation of critical processing parameter ranges, statistical process control {SPC} charts);
控制策略的識別和論證（例如，特定劑型的關鍵性能方面，過程控制點的的識別，產品質量屬性及關鍵工藝參數範圍的確認，統計過程控制SPC圖）；
• design space, in cases where this has been de?ned;
設計空間（如已界定）；
• validation information (e.g. validation plans and reports);
驗證信息（例如驗證計劃和報告）；
• annual product quality reviews;
年度產品質量回顧；
• stability information;
穩定性信息；
• an authorized set of protocols and work instructions for manufacturing; and
針對生產，一套批准的方案和工作指令；
• environmental conditions or any special requirement needed for the facility or equipment depending on the nature of the product to be transferred.
環境條件或設施或設備所需的任何特殊要求，取決於要轉移的產品的性質。
12.22 During the transfer process, the RU should identify any differences in facilities, systems and capabilities and discuss these with the SU. The potential impact should be understood and satisfactorily addressed in order to assure equivalent product quality. Based on the information received from the SU, the RU should consider its own capability to manufacture and pack the product to the required standards and should develop the relevant site operating procedures and documentation before the start of routine production.
在轉移過程中，RU應確定設施、系統和能力上的任何差異，並與SU進行討論。應理解潛在影響並成功地解決，以確保產品質量具有等同性。根據從SU收到的信息，RU應考慮其自身的能力，以按照要求的標準生產和包裝產品，並應在開始常規生產之前，制定相關的現場操作程序和文件。
12.23 Process development at the RU should address the following tasks:
RU的工藝開發應解決以下任務：
• comparison and assessment of suitability and quali?cation of facility and equipment;
比較和評估設施和設備的適用性和資質；
• description of manufacturing process and ?ow of personnel and of materials at the RU (narrative and or process maps or ?ow charts);
描述RU生產工藝以及人物流（敘述性和/或工藝圖或流程圖）；
• determination of critical steps in manufacture, including hold times, endpoints, sampling points and sampling techniques;
確定生產中的關鍵步驟，包括放置時間、終點、取樣點和取樣技術；
• writing and approval of SOPs for all production operations (e.g. dispensing, granulation or blending or solution preparation, tablet compression, tablet coating, encapsulation, liquid ?lling, primary and secondary packaging and in-process QC), packaging, cleaning, testing and storage;
編寫和批准SOP：為所有生產操作（例如稱量、制粒或混合或溶液製備、片劑壓片、片劑包衣、灌裝，液體灌裝、內包和外包以及工藝中的質量控制）、包裝、清洗、檢測和儲存;
• evaluation of stability information, with generation of site-speci?c stability data if required; and
•評估穩定性信息，並在需要時生成特定地點的穩定性數據；
• compliance with regulatory requirements for any changes made (e.g. in terms of batch size).
•遵守法規要求以進行變更（例如，批量）。
Packaging 包裝
12.24. The transfer of packaging operations should follow the same procedural principles as those of the product processing.
包裝操作的轉移應遵循與產品工藝相同的程序原則。
12.25. Information on packaging to be transferred from the SU to the RU should include speci?cations for a suitable container and closure system, as well as any relevant additional information on design, packing, processing or labelling requirements and tamper-evident and anti- counterfeiting measures.
從SU轉移到RU的包裝信息應包括適合的容器和密閉系統的質量標準，以及有關設計、包裝、工藝或標籤要求，以及防篡改和防偽措施等相關信息。
12.26. For QC testing of packaging components, speci?cations should be provided including drawings, artwork and material.
對於包裝組件的QC檢測，應提供包括圖紙、設計稿和材料在內的質量標準。
12.27. Based on the information provided, the RU should perform a suitability study for the initial quali?cation of the packaging components.
根據提供的信息，RU應該對包裝組件的初始確認進行適用性研究。
12.28. Packaging is considered suitable ...