Analytical Method Transfer under GMP: tips & pitfalls

Analytical Method Transfer under GMP: tips & pitfalls | QbD Group

4:58

Analytical Method Transfers (AMTs) are a critical step in ensuring the reliable reproduction of validated analytical methods. These transfers occur due to site changes, outsourcing, or internal reorganization, ensuring that methods remain consistent and compliant across different testing locations.

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.

Each AMT involves two key stakeholders:

The Transferring Laboratory (TL): the originator of the analytical method and

the Receiving Laboratory (RL): the site implementing the method.

The Sponsor: in most cases, this is the Marketing Authorisation Holder (MAH) or owner of the product.

Ensuring a smooth transfer requires careful planning, effective communication, and robust documentation.

Based on experience at Quercus Lab, this article highlights common pitfalls and best practices to mitigate risks during an AMT.

Key GMP pitfalls and how to avoid them

1. Lack of clearly defined acceptance criteria and expectations

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.

Best Practice:

Establish clear, objective acceptance criteria before initiating the transfer.

Use a risk-based approach to define critical method performance parameters.

Ensure criteria align with regulatory expectations and validation data.

Document all expectations, responsibilities, and timelines in a shared agreement.

Use a shared working environment to exchange working documents and instructions

2. Inadequate documentation and protocols

A lack of standardized documentation can lead to the misinterpretation of method instructions and inconsistencies in execution.

Best Practice:

Prepare detailed AMT protocols covering method parameters, equipment requirements, sample handling, and acceptance criteria.

Ensure that all involved parties (TL, RL, and sponsor) agree on the protocols well in advance.

Provide comprehensive method validation reports and historical data to support the transfer.

3. Poor coordination of samples, standards, and materials

Delays or inconsistencies in obtaining reference standards, reagents, or test samples can cause transfer failures and impact data comparability.

Best Practice:

Develop a time sheet for shipment and availability of all materials.

Clearly lay out the responsibilities of who is to source the columns, reference standards, samples, etc.

Agree on logistics

Define the quality aspects for the logistics service provider, e.g. addition of data loggers for temperature monitoring during transport.

4. Insufficient training and knowledge transfer

Failure to adequately train analysts at the RL can result in deviations and inconsistent results.

Best Practice:

Conduct knowledge-sharing sessions between TL and RL analysts.

If feasible, arrange for RL personnel to visit the TL for hands-on training.

Provide detailed troubleshooting guides to address potential analytical challenges.

5. Ineffective communication between stakeholders

Miscommunication can lead to misunderstandings regarding method nuances, acceptance criteria, or troubleshooting steps.

Best Practice:

Establish regular meetings between TL and RL teams.

Use structured issue-tracking systems to document and resolve concerns promptly.

Maintain an open and transparent dialogue to facilitate real-time problem-solving.

Conclusion

Analytical method transfers are a fundamental aspect of Quality Control operations, ensuring that validated methods remain robust and reproducible when transitioning between laboratories.

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.

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.

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.

Need support with your Analytical Method Transfer?

Quercus Lab, part of QbD Group, specializes in GMP-compliant method transfers with a strong focus on practical execution, documentation, and troubleshooting. Our experienced team helps you avoid common pitfalls and ensures a smooth transfer process from start to finish.

Get in touch to discuss how we can support your next AMT.