Requirements and Elements of Analytical Technology Transfer

In this section, the various components necessary to complete a successful comparative testing transfer will be presented and discussed. As will be noted, many of the factors necessary for a compliant transfer are interrelated. 

Preapproved Test Plan/Standard Operating Procedure/Protocol 

Before the planning of any transfer, an approved document that describes both the general transfer process as well as the specific acceptance criteria necessary for the method(s) being transferred needs to be in place. In many companies, it is common for both the R D and quality units to have general standard operating procedures (SOPs) that govern the transfer process. These SOPs describe the details of a method transfer protocol that is specific to the product and methods. The contents of such a protocol were described in various chapters earlier in this text however, they are important and bear repeating here. 

As part of the specific transfer, the number of lots, replicates, and injections (in the case of HPLC) should be expressly presented. For dissolution transfers, the number of individual dosage forms that will be tested should be stipulated. It is necessary to spell out such details so that small differences in the everyday analytical philosophies do not perturb the transfer process. In the case of new techniques that may not be common to the receiving laboratory (i.e., capillary electrophoresis or liquid chromatography/mass spectroscopy), specific training may be necessary before the execution of a transfer protocol. 

As in any scientific document, one must provide a rationale for the parameters chosen and their effect on the overall success of the transfer. This includes an explanation for the system suitability parameters that have been established for the method. System suitability can be a powerful tool for troubleshooting method discrepancies in addition to being a test of the conformance of the system to a set of parameters before analysis. 

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