Analytical methodology transfer

Mirabaud et al., 2007). Analytical methodologies were first developed and adapted on model samples of beeswax, animal fats and dairy products of different origins (cow, sheep and goat) and then transferred to archaeological materials sampled in the sedimentary matrix or on various ceramic vessels. 

JPT). The transfer of processing equipment, manufacturing systems and analytical methodology was initiated. The initial process characterisation and trial batches were executed at receiving site and effectiveness assessed again using the comparability matrix and the demonstration batches were successfully completed, versus pre-defined acceptance criteria, within a predefined 12-month time frame. 

Analytical testing (preformulation, stability, product release) is a core component of pharmaceutical operations from early R D through manufacturing of the commercial product. The original analytical methods are usually developed by the pioneer pharmaceutical firm and transferred to the provider. In some cases, the early methods are only preliminary methods and are not sufficiently robust to test the quality of downstream (clinical, commercial, and line extension) products and facility quality practices (cleaning validation). In those situations, the supplier is often asked to develop new methods, and in some cases those methods are transferred back to the client. In either scenario, the transfer of validated analytical methodology consists of the following four main tasks [52] ... 

The physical and chemical characterization of any pharmaceutical product is only as reliable as the quality of the analytical methodologies utilized to assess it. Without question, the role of analytical services to the overall drug product development process is invaluable. Good analytical testing with proper controls could mean the difference between a marketable product and one that is eliminated from development. Analytical methodologies intended for characterization and/or assessment of marketed pharmaceutical products must be relevant, validatable, and transferable to manufacturing/quality assurance laboratories. 

The transfer of analytical methodology allows for a successful transfer of technology development for a new drug product. As mentioned previously, it is a very important document, even though on the surface it may appear to be a relatively simple operation (Chapter 14). The important elements of analytical technology transfer are 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... 

The transfer of analytical methodology is a major part of technology transfer, especially when robotics are involved. 

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