Analytical Technology Transfer in the Pharma Industry

In the pharmaceutical industry, analytical technology transfer (ATT) is a crucial process that involves moving validated analytical methods from one laboratory to another. This is typically done between different locations within the same company or between different companies. The transfer ensures that the recipient laboratory can perform the analytical method reliably and consistently, producing results that are comparable to those obtained by the transferring laboratory.

Importance of ATT

The primary aim of analytical technology transfer is to verify that the receiving lab not only understands and can implement the method but also generates accurate and reliable results. This process is vital for maintaining the integrity of drug development and manufacturing and ensuring that quality control is consistent across different sites.

Regulatory Guidelines

Different regulatory agencies have outlined expectations for ATT. For example, USP 1224, ‘transfer of analytical procedures’, includes detailed instructions that address how to carry out the transfer, how to train personnel at the receiving site, and how to verify that the transferred analytical method performs as expected. Several types of transfers are considered: comparative testing, co-validation between two or more laboratories, revalidation, and even transfer waiver.

Despite the existence of these guidelines, there is often room for interpretation, which can lead to variations in how ATT is executed.

Steps in ATT

A typical analytical technology transfer includes:

• Preparing a detailed transfer protocol.
• Sharing scientific documentation related to the method, including detailed analytical procedures.
• Providing reference samples.
• Executing the required study(ies) at the receiving site to validate the transfer.
• Assessing the results to confirm that the method performs adequately in the new setting.

Challenges and Considerations

Despite its routine nature, ATT can be complex and challenging. Differences in equipment, reagents, personnel, and even environmental conditions between sites can affect the outcome of the transfer. Therefore, a risk analysis is often performed as part of the transfer protocol to identify and mitigate potential issues.

Analytical technology transfer is a key activity in the pharmaceutical industry that supports the safe and effective production of medications. While it is governed by regulatory expectations, the specific practices can vary, requiring careful planning and execution to ensure success.