分析方法转移（AMT）是确保已验证的分析方法能够可靠重现的关键步骤。这些转移因场地变更、外包或内部重组而发生，以确保方法在不同的测试地点保持一致且符合规定。

 

While method transfers are a standard part of QC processes, they often present unforeseen challenges. If a method does not perform as expected, it can lead to extensive investigations and delays, disrupting timelines and increasing costs.
虽然方法转移是质量控制（QC）流程的标准组成部分，但它们常常带来意想不到的挑战。如果一种方法未按预期运行，可能会导致大量的调查和延误，打乱时间表并增加成本。

 

Each AMT involves two key stakeholders:
每次分析方法转移都涉及两个关键的利益相关者：

 

The Transferring Laboratory (TL): the originator of the analytical method and
转出实验室（TL）：分析方法的发起者

 

the Receiving Laboratory (RL): the site implementing the method.
接收实验室（RL）：实施该方法的场所

 

The Sponsor: in most cases, this is the Marketing Authorisation Holder (MAH) or owner of the product.
申办方：在大多数情况下，这是上市许可持有人（MAH）或产品的所有者。

 

Ensuring a smooth transfer requires careful planning, effective communication, and robust documentation.
确保顺利转移需要仔细的规划、有效的沟通和健全的文件记录。

 

This article highlights common pitfalls and best practices to mitigate risks during an AMT.
本文重点介绍了分析方法转移期间的常见陷阱以及降低风险的最佳实践。

 

Key GMP pitfalls and how to avoid them
关键的药品生产质量管理规范（GMP）陷阱以及如何避免它们

 

1. Lack of clearly defined acceptance criteria and expectations
缺乏明确界定的接受标准和要求

 

One of the most significant pitfalls in an AMT is the absence of well-defined acceptance criteria. If criteria are ambiguous or subjective, discrepancies between TL and RL results may lead to disputes and delays.
分析方法转移中最重大的陷阱之一是缺乏明确界定的接受标准。如果标准含糊不清或具有主观性，转出实验室（TL）和接收实验室（RL）的结果差异可能会导致争议和延误。

 

Best Practice:
最佳实践：
 

Establish clear, objective acceptance criteria before initiating the transfer.
在启动转移之前，建立清晰、客观的接受标准。

Use a risk-based approach to define critical method performance parameters.
采用基于风险的方法来定义关键的方法性能参数。

Ensure criteria align with regulatory expectations and validation data.
确保标准与法规要求和验证数据一致。

Document all expectations, responsibilities, and timelines in a shared agreement.
在一份双方协议中记录所有要求、职责和时间安排。

Use a shared working environment to exchange working documents and instructions
使用共享的工作环境来交换工作文件和说明
 

2. Inadequate documentation and protocols
文件和方案不充分
 

A lack of standardized documentation can lead to the misinterpretation of method instructions and inconsistencies in execution.
缺乏标准化的文件可能会导致对方法说明的误解以及执行中的不一致性。

 

Best Practice:
最佳实践：
 

Prepare detailed AMT protocols covering method parameters, equipment requirements, sample handling, and acceptance criteria.
准备涵盖方法参数、设备要求、样品处理和接受标准的详细分析方法转移方案。

Ensure that all involved parties (TL, RL, and sponsor) agree on the protocols well in advance.
确保所有相关方（转出实验室（TL）、接收实验室（RL）和申办方）提前就方案达成一致。

Provide comprehensive method validation reports and historical data to support the transfer.
提供全面的方法验证报告和历史数据以支持转移。
 

3. Poor coordination of samples, standards, and materials
样品、标准品和物料的协调不善
 

Delays or inconsistencies in obtaining reference standards, reagents, or test samples can cause transfer failures and impact data comparability.
在获取对照标准品、试剂或测试样品方面的延误或不一致可能会导致转移失败，并影响数据的可比性。

 

Best Practice:
最佳实践：
 

Develop a time sheet for shipment and availability of all materials.
制定所有物料的运输和可获得性时间表。

Clearly lay out the responsibilities of who is to source the columns, reference standards, samples, etc.
明确规定由谁负责采购色谱柱、对照标准品、样品等的职责。

Agree on logistics
就物流问题达成一致

Define the quality aspects for the logistics service provider, e.g. addition of data loggers for temperature monitoring during transport.
为物流服务提供商定义质量方面的要求，例如在运输过程中增加用于温度监测的数据记录器。
 

4. Insufficient training and knowledge transfer
培训和知识转移不足
 

Failure to adequately train analysts at the RL can result in deviations and inconsistent results.
对接收实验室（RL）的分析人员培训不足可能会导致偏差和不一致的结果。

 

Best Practice:
最佳实践：
 

Conduct knowledge-sharing sessions between TL and RL analysts.
在转出实验室（TL）和接收实验室（RL）的分析人员之间开展知识共享会议。

If feasible, arrange for RL personnel to visit the TL for hands-on training.
如有可能，安排接收实验室（RL）的人员访问转出实验室（TL）进行实际操作培训。

Provide detailed troubleshooting guides to address potential analytical challenges.
提供详细的故障排除指南，以应对潜在的分析挑战。
 

5. Ineffective communication between stakeholders
利益相关者之间的沟通失效
 

Miscommunication can lead to misunderstandings regarding method nuances, acceptance criteria, or troubleshooting steps.
沟通不畅可能会导致对方法细节、接受标准或故障排除步骤的误解。

 

Best Practice:
最佳实践：
 

Establish regular meetings between TL and RL teams.
在转出实验室（TL）和接收实验室（RL）团队之间建立定期会议。

Use structured issue-tracking systems to document and resolve concerns promptly.
使用结构化的问题跟踪系统来记录并及时解决问题。

Maintain an open and transparent dialogue to facilitate real-time problem-solving.
保持开放和透明的对话，以促进实时解决问题。

 

Conclusion
结论
 

Analytical method transfers are a fundamental aspect of Quality Control operations, ensuring that validated methods remain robust and reproducible when transitioning between laboratories.
分析方法转移是质量控制操作的一个基本方面，确保已验证的方法在实验室之间转移时保持稳健和可重现性。

 

By proactively addressing common pitfalls—such as unclear acceptance criteria, poor documentation, logistical issues, inadequate training, and ineffective communication—organizations can significantly improve the success rate of AMTs.
通过主动解决常见的陷阱，如不明确的接受标准、文件记录不善、物流问题、培训不足和沟通无效等，组织可以显著提高分析方法转移的成功率。

 

A well-planned and well-executed method transfer not only ensures regulatory compliance but also enhances the efficiency and reliability of analytical testing across laboratories.
精心规划和执行的方法转移不仅确保符合法规要求，还能提高跨实验室分析测试的效率和可靠性。

 

With a structured approach and commitment to best practices, AMTs can be seamlessly integrated into QC processes, avoiding costly delays and ensuring product quality and consistency.
采用结构化的方法并致力于最佳实践，分析方法转移可以无缝集成到质量控制流程中，避免代价高昂的延误，并确保产品质量和一致性。