Analytical technology transfer testing methods

The transfer of analytical methods may be a component of the overall process of technology transfer involving transfer of several methods simultaneously, or it may be limited to transfer of an existing method to qualify an additional testing site (see Chapter 14). In simplest terms, the analytical method transfer is conducted to ensure the following ... 

The process for the transfer of analytical methodology is, on the surface, a relatively simple operation. In its most common form, analytical method transfer is the verification that a method or test procedure works in an equivalent fashion at two or more different sites or laboratories and meets all acceptance criteria. This process is driven by compliance and governed by a statistical treatment of the resulting data. This interlaboratory transfer aspect of the overall transfer process has been covered comprehensively by McGonigle, who stressed that successful transfers are linked to the method validation process. Method transfer was defined in this case as the introduction of a validated method into a designated laboratory so that it can be used in the same capacity for which it was originally developed. The second portion of the technology transfer... 

In-process testing requires robust methods that are fairly quick and easy to perform. Samples that arrive at the lab during off-hours may not have an experienced analyst who is usually available during the day shift to perform a complex analysis. The use of new analytical technologies during early process development may be suitable for IPC analysis however, as the process development continues to the technical transfer, alternative methods should be developed that are compatible with QC lab capabilities. In addition, analysts should not try to optimize the method to generate other information that is seldom used in a normal manufacturing operation. 

The importance of master plans in the technology transfer process is described by MacLennon Troll. While the master plan is specifically described for the technology transfer process as a whole, it is also applicable to the transfer of analytical methods and its use is becoming more prevalent within the industry. The technology transfer master plan describes the transfer strategy for all of the testing methods described in the specifications for the test article(s) of interest. The master plan is an auditable document that will help the health authorities during the preapproval inspection (PAI) to understand the overall transfer process and make... 

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