Thursday 12 July 2012

Tips for Successful Method Transfer

Transferring an analytical method from one laboratory to another should be straightforward but unfortunately it is a process which is often problematic. Recognition of this has resulted in a new USP chapter <1224> Transfer of Analytical Procedures, and a proposal for inclusion in an update of the EU GMP regulations.

The most common source of problems is the analytical method itself. Either the method is not robust, or it may be that it has not been well written, leading to potential misinterpretation. Prevention of these issues involves a thorough review of the method by the sending laboratory prior to any transfer attempt. The robustness of the method should be assessed by investigating the critical method factors. If lack of robustness is identified, then either further method development or implementation of control strategies will be required. Running the method at the receiving laboratory is a good way to check that the method can be followed in a consistent fashion and that the staff and facilities at the receiving laboratory are satisfactory. This analysis should NOT be considered as part of the transfer, rather it is a pre-transfer activity. These measures should help to ensure that the prospects for a successful transfer are good.

Mourne Training Services is introducing a new training course to deal with the topic of transferring analytical methods for pharmaceuticals, which will be held at locations throughout Europe in 2012. In this one day course the different approaches to transfer are explored fully and case studies are used extensively to follow the process from review of the method prior to transfer, to creating a suitable protocol with relevant acceptance criteria, and evaluating the results generated to assess whether the transfer has been successful.

Visit the MTS website for information on where and when the course will be offered, the discounts available including our early booking rate, an online booking form and a detailed course description.

This course is ideal for anyone involved in the transfer of analytical methods. For example: Analytical chemists, laboratory managers/supervisors, quality control analysts/managers, quality assurance managers, and regulatory affairs managers.

Please note: Familiarity with the characteristics studied during analytical method validation is necessary for this course since these are used for method transfer. The MTS course, Validation of Analytical Methods for Pharmaceutical Analysis, is recommended.

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