良好实践指南：技术转移第三版
Transfer of manufacturing processes and analytical procedures between facilities or laboratories is a necessary part of pharmaceutical development and commercialization. Technology transfers take the outputs of process or method development activities and transfer the knowledge to a different location where a process or analytical procedure will be operated.
在工厂或实验室之间转移生产工艺和分析程序是药品开发和商业化的必要部分。技术转移获取工艺或方法开发活动的结果，并将知识转移到工艺或者方法执行的不同位置。
This Guide presents industry good practices for successful and efficient execution of technology transfer projects. It intends to achieve a balance between risk management and cost effectiveness while aligning with applicable regulatory expectations.
本指南介绍了成功和有效地执行技术转移项目的良好做法。它旨在实现风险管理和成本效益之间的平衡，同时符合适用的监管预期。
This Guide is intended to be used as a generic guide to technology transfer between two parties for any applicable transfers in the product lifecycle. This Guide provides information and tools for its practical application, under three main topics:
本指南旨在作为转移双方在产品生命周期中任何适用转移活动的一般指南。本指南提供了下述三个主题的信息和实践应用工具：
Technology transfer of analytical methods
Technology transfer of drug substance (Active Pharmaceutical Ingredients (APIs))
Technology transfer of drug product (dosage forms manufacturing processes)
分析方法转移
原料药（活性药物成分（API））的技术转移
药物制剂的技术转移(剂型制造工艺)
This third edition of the ISPE Good Practice Guide: Technology Transfer, highlights the following:
第三版《ISPE良好实践指南：技术转移重点介绍了以下内容》：
Alignment with science and risk-based (Quality by Design (QbD)) principles described in ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, ICH Q10 Pharmaceutical Quality System, and ICH Q11 Development and Manufacture of Drug Substance, including reference to Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), material attributes, design space (where used) and, in particular, Control Strategy.
Alignment with the process validation concepts and life cycle approach as described in, for example, FDA Process Validation Guidance, Jan 2011.
Recognition that knowledge management is a critical component of effective technology transfer.
Industry developments and potential regulatory impacts.
Recognition that having a robust quality culture, for both the sending and receiving units, is important for ensuring successful technology transfer.
Addition of redacted case studies as examples.
与ICH Q8药物开发、ICH Q9质量风险管理、ICH Q10药物质量体系和ICH Q11药物开发和制造中描述的科学和基于风险的质量源于设计(QbD))原则一致，包括参考质量目标产品概况(QTPP)、关键质量属性(CQAs）、关键工艺参数（CPP）物料属性、设计空间（如果使用）以及控制策略。
与描述的工艺验证概念和生命周期途径保持一致，如FDA工艺验证指南，2011年1月所述。
认识到知识管理是有效技术转移的关键组成部分。
行业发展和潜在的监管影响
认识到转出和接收方具有稳健的质量文化对于确保成功的技术转移是重要的
修订后的案例研究
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