Analytical Method Transfer Checklist

As you prepare for an upcoming Tech Transfer, have you ensured you are fully equipped to carry out an analytical method transfer? With this straightforward analytical method transfer checklist, you can confidently proceed without uncertainty. But first, let's provide some background:

According to the USP, the transfer of an analytical method is the documented process that qualifies a receiving laboratory to use an analytical method originally developed in a different laboratory (the transferring laboratory). This transfer can occur between internal laboratories within the same organization or between an internal laboratory and an external contracted laboratory.

The relationship between these laboratories can vary. For instance, a manufacturing facility (internal) may develop a method that is then transferred to an external contracted laboratory for testing. Alternatively, the method may be transferred within the same organization, such as from a Product/Process Development laboratory to a Quality Control laboratory.

In ProPharma’s 9 Gate Tech Transfer Methodology, analytical method transfer is completed and verified in Gate 5. This step is crucial as the analytical methods are essential for subsequent formulation and process development. By following our comprehensive guide and utilizing the provided checklist, you can ensure a smooth and efficient analytical method transfer, setting the stage for successful formulation and process development.